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A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants (GAS)

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ClinicalTrials.gov Identifier: NCT00756600
Recruitment Status : Completed
First Posted : September 22, 2008
Results First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Collaborators:
Royal Children's Hospital
Royal Hospital for Sick Children
Murdoch Childrens Research Institute
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Mary Ellen McCann, Boston Children's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Inguinal Hernia
Interventions Drug: Regional Anesthesia
Drug: General Anesthesia
Enrollment 643
Recruitment Details  
Pre-assignment Details There are no significant events that occur after enrollment and before randomization.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot. General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Period Title: Overall Study
Started 287 356
Completed 287 356
Not Completed 0 0
Arm/Group Title Regional Anesthesia General Anesthesia Total
Hide Arm/Group Description Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot. General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block. Total of all reporting groups
Overall Number of Baseline Participants 287 356 643
Hide Baseline Analysis Population Description
Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group were included in the published analysis.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 287 participants 356 participants 643 participants
<=18 years
287
 100.0%
356
 100.0%
643
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 287 participants 356 participants 643 participants
68.9  (30.8) 71.1  (31.7) 70 [1]   (NA)
[1]
Data required to calculate the total standard deviation could not be found despite all efforts to locate the underlying data
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 287 participants 356 participants 643 participants
Female
55
  19.2%
52
  14.6%
107
  16.6%
Male
232
  80.8%
304
  85.4%
536
  83.4%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
New Zealand Number Analyzed 205 participants 242 participants 447 participants
7 9 16
Canada Number Analyzed 205 participants 242 participants 447 participants
10 20 30
Netherlands Number Analyzed 205 participants 242 participants 447 participants
19 17 36
United States Number Analyzed 205 participants 242 participants 447 participants
34 52 86
Italy Number Analyzed 205 participants 242 participants 447 participants
45 50 95
United Kingdom Number Analyzed 205 participants 242 participants 447 participants
27 22 49
Australia Number Analyzed 205 participants 242 participants 447 participants
63 72 135
[1]
Measure Analysis Population Description:

Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis.

The number of participants from each region were the only ones ultimately analyzed and published.

1.Primary Outcome
Title Full Scale IQ Score
Hide Description

The primary outcome will be the Wechsler Preschool and Primary Scale of Intelligence-Third Edition (WPPSI-III) full scale IQ score. Verbal, visuo-spatial and processing speed skills are incorporated into the Full Scale IQ score, which is indicative of general intellectual ability.

Minimum score: 45 Maximum score:145 Higher scores are associated with higher IQ scores (better outcome).

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 205 242
Mean (Standard Deviation)
Unit of Measure: score on scale
100.5  (14.3) 100.1  (15.3)
2.Secondary Outcome
Title Verbal IQ
Hide Description

Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Verbal IQ

Minimum possible score:45 Maximum possible score:145

A higher score indicates higher verbal IQ (better outcome).

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Time Frame At 5 years corrected age.
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 206 240
Mean (Standard Deviation)
Unit of Measure: score on scale
101.8  (14.7) 100.9  (15.4)
3.Secondary Outcome
Title Performance IQ
Hide Description

Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Performance IQ

Minimum possible score:45 Maximum possible score:145

A higher score indicates a higher performance IQ (better outcome).

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Time Frame At 5 years corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 206 241
Mean (Standard Deviation)
Unit of Measure: score on scale
100.7  (15.2) 101.2  (15.9)
4.Secondary Outcome
Title Processing Speed Quotient
Hide Description

Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Processing speed quotient

Minimum possible score:45 Maximum possible score:145

A higher score indicates a better outcome.

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Time Frame At 5 years corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 196 220
Mean (Standard Deviation)
Unit of Measure: score on scale
95.8  (14.5) 96.3  (15.4)
5.Secondary Outcome
Title Sentence Repetition Scaled Score
Hide Description

Developmental Neuropsychological Assessment second edition (NEPSY-II) sub test: Sentence Repetition scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 175 202
Mean (Standard Deviation)
Unit of Measure: score on scale
9.7  (2.9) 9.7  (2.8)
6.Secondary Outcome
Title Auditory Attention Combined Scaled Score
Hide Description

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Auditory Attention combined scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Time Frame At 5 years corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 167 183
Mean (Standard Deviation)
Unit of Measure: score on scale
9.0  (2.7) 9.3  (3.0)
7.Secondary Outcome
Title Statue Scaled Score
Hide Description

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Statue scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Time Frame At 5 years corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 160 182
Mean (Standard Deviation)
Unit of Measure: score on scale
8.8  (3.5) 8.6  (3.6)
8.Secondary Outcome
Title Inhibition Combined Scaled Score
Hide Description

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Inhibition combined scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Time Frame At 5 years corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 150 160
Mean (Standard Deviation)
Unit of Measure: score on scale
8.3  (3.1) 8.9  (3.0)
9.Secondary Outcome
Title Word Generation Scaled Score
Hide Description

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Word Generation Scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Time Frame At 5 years corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 182 199
Mean (Standard Deviation)
Unit of Measure: score on scale
9.4  (3.4) 9.3  (3.3)
10.Secondary Outcome
Title Affect Recognition Scaled Score
Hide Description

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Affect Recognition scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Time Frame At 5 years corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 174 208
Mean (Standard Deviation)
Unit of Measure: score on scale
10.6  (2.8) 10.4  (3.2)
11.Secondary Outcome
Title Memory for Names and Memory for Names Delay
Hide Description

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Memory for Names and Memory for Names Delay

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Time Frame At 5 years corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 180 208
Mean (Standard Deviation)
Unit of Measure: score on scale
8.1  (3.2) 8.1  (3.2)
12.Secondary Outcome
Title Theory of Mind Scaled Score
Hide Description

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Theory of Mind scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Time Frame At 5 years corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 163 178
Mean (Standard Deviation)
Unit of Measure: score on scale
9.8  (2.9) 9.3  (3.0)
13.Secondary Outcome
Title Speeded Naming Combined Scaled Score
Hide Description

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Speeded Naming combined scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Time Frame At 5 years corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia1 General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 132 142
Mean (Standard Deviation)
Unit of Measure: score on scale
9.7  (3.0) 9.8  (3.2)
14.Secondary Outcome
Title Fingertip Tapping Repetitions Scaled Score
Hide Description

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test:Fingertip tapping repetitions scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score is indicative of a better outcome.

Time Frame At 5 years corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 180 195
Mean (Standard Deviation)
Unit of Measure: score on scale
9.8  (3.4) 9.7  (3.4)
15.Secondary Outcome
Title Fingertip Tapping Sequences Scaled Score
Hide Description

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: fingertip tapping sequences scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Time Frame At 5 years corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 173 183
Mean (Standard Deviation)
Unit of Measure: score on scale
8.1  (3.4) 7.7  (3.6)
16.Secondary Outcome
Title Design Copy Process Total Scaled Score
Hide Description

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Design Copy Process Total Scaled Score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Time Frame At 5 years corrected age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 172 207
Mean (Standard Deviation)
Unit of Measure: score on a scale
9.6  (3.4) 9.9  (3.1)
17.Secondary Outcome
Title Word Reading Standard Score
Hide Description

Weschler Individual Achievement Test (WIAT-II Abbreviated) to assess the academic skills of the child: Word Reading standard score

Minimum possible score: 45 Maximum possible score: 145

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

A higher score indicates a better outcome.

Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 147 167
Mean (Standard Deviation)
Unit of Measure: score on scale
92.3  (18.1) 92.8  (211)
18.Secondary Outcome
Title Numerical Operations Standard Score
Hide Description

Weschler Individual Achievement Test (WIAT-II Abbreviated) to Assess the Academic Skills of the Child: Numerical Operations standard score

Minimum possible score: 45 Maximum possible score: 145

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

A higher score indicates a better outcome.

Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 146 161
Mean (Standard Deviation)
Unit of Measure: score on scale
98.8  (16.2) 96.2  (20.8)
19.Secondary Outcome
Title Spelling Standard Score
Hide Description

Weschler Individual Achievement Test (WIAT-II Abbreviated) to Assess the Academic Skills of the Child: Spelling standard score

Minimum possible score: 45 Maximum possible score: 145

A higher score indicates a better outcome.

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 141 152
Mean (Standard Deviation)
Unit of Measure: score on scale
90.1  (13.2) 90.8  (16.5)
20.Secondary Outcome
Title Numbers Total Scaled Score
Hide Description

Children's Memory Scale (CMS):Numbers Total scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 194 229
Mean (Standard Deviation)
Unit of Measure: score on scale
8.3  (3.2) 8.1  (3.4)
21.Secondary Outcome
Title Word Lists 1 (Learning) Scaled Score
Hide Description

Children's Memory Scale (CMS): Word Lists 1 (learning) scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 186 224
Mean (Standard Deviation)
Unit of Measure: score on scale
8.3  (3.4) 8.6  (3.5)
22.Secondary Outcome
Title Memory and Learning Word Lists II (Delayed) Scaled Score
Hide Description

Children's Memory Scale (CMS): Memory and learning Word Lists II (delayed) scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 178 209
Mean (Standard Deviation)
Unit of Measure: score on scale
9.7  (2.8) 9.6  (2.9)
23.Secondary Outcome
Title The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function
Hide Description

Full title: The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function

Preschool Version Parent Form (BRIEF-P) to measure behavioural executive abilities.

Minimum possible score: 40 Maximum possible score: 110

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

A higher score indicates a worse outcome.

Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 198 232
Mean (Standard Deviation)
Unit of Measure: score on scale
48.4  (12.5) 51.5  (13.4)
24.Secondary Outcome
Title The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System
Hide Description

Full title: The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System

- 2nd edition (ABAS-II) to measure the child's adaptive behavior.

Minimum possible score: 45 Maximum possible score: 145

A higher score indicates a better outcome.

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 168 200
Mean (Standard Deviation)
Unit of Measure: score on scale
95.9  (16.3) 94.1  (16.5)
25.Secondary Outcome
Title Total Problems Score
Hide Description

Child Behaviour Checklist Caregiver Questionnaire (CBCL): Total Problems Score to measure behavioural problems

Minimum possible score: 40 Maximum possible score: 100

A higher score indicates a worse outcome.

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 215 254
Mean (Standard Deviation)
Unit of Measure: score on scale
44.6  (11.7) 46.7  (12.5)
26.Secondary Outcome
Title Internalising Problems T Score
Hide Description

Child Behaviour Checklist Caregiver Questionnaire (CBCL): CBCL internalising problems T score

Minimum possible score: 40 Maximum possible score: 100

A higher score indicates a worse outcome.

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 215 254
Mean (Standard Deviation)
Unit of Measure: score on scale
46.1  (12.5) 48.0  (12.5)
27.Secondary Outcome
Title Externalising Problems T Score
Hide Description

Child Behaviour Checklist Caregiver Questionnaire (CBCL): externalising problems T score

Minimum possible score: 40 Maximum possible score: 100

A higher score indicates a worse outcome.

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 215 254
Mean (Standard Deviation)
Unit of Measure: score on scale
44.0  (10.7) 45.8  (11.9)
28.Secondary Outcome
Title Speech or Language Interventions
Hide Description Speech or language issues/interventions. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 214 257
Measure Type: Number
Unit of Measure: participants
18 17
29.Secondary Outcome
Title Psychomotor Interventions
Hide Description Psychomotor issues/interventions. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 214 257
Measure Type: Number
Unit of Measure: participants
8 6
30.Secondary Outcome
Title Number of Participants With Global Developmental Delay
Hide Description Child has global developmental delay. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 204 238
Measure Type: Number
Unit of Measure: participants
2 0
31.Secondary Outcome
Title Number of Participants With Attention Deficit Hyperactivity Disorder
Hide Description Child has been diagnosed with Attention Deficit Hyperactivity Disorder. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 214 257
Measure Type: Number
Unit of Measure: participants
3 4
32.Secondary Outcome
Title Number of Participants With Autism Spectrum Disorder
Hide Description Child has been diagnosis with Autism Spectrum Disorder. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 211 251
Measure Type: Number
Unit of Measure: participants
5 11
33.Secondary Outcome
Title Number of Participants With a Hearing Abnormality
Hide Description Child has a hearing abnormality. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 213 252
Measure Type: Number
Unit of Measure: participants
8 11
34.Secondary Outcome
Title Number of Participants With a Visual Defect in Either Eye
Hide Description Child has a visual defect in either eye. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 213 254
Measure Type: Number
Unit of Measure: participants
21 31
35.Secondary Outcome
Title Number of Participants With a Hearing Aid
Hide Description Child has a hearing aid. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 211 251
Measure Type: Number
Unit of Measure: participants
0 3
36.Secondary Outcome
Title Number of Participants Who Are Legally Blind
Hide Description Child is legally blind. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 212 254
Measure Type: Number
Unit of Measure: participants
0 0
37.Secondary Outcome
Title Number of Participants Who Have Cerebral Palsy
Hide Description Child has cerebral palsy. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 213 254
Measure Type: Number
Unit of Measure: participants
1 3
38.Secondary Outcome
Title Parents' Awareness of Group Allocation
Hide Description Whether or not a parent is aware of which treatment group their child was allocated to. This variable will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 287 356
Measure Type: Number
Unit of Measure: caregivers
105 118
39.Secondary Outcome
Title Awareness of Group Allocation by Psychologist
Hide Description These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 287 356
Measure Type: Number
Unit of Measure: psychologists
7 7
40.Secondary Outcome
Title Awareness of Group Allocation by Pediatrician
Hide Description [Not Specified]
Time Frame At 5 years chronological age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description:
Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Number of Participants Analyzed 287 356
Measure Type: Number
Unit of Measure: Pediatricians
13 13
Time Frame Adverse Events were not monitored/assessed
Adverse Event Reporting Description Adverse Events were not monitored/assessed
 
Arm/Group Title Regional Anesthesia General Anesthesia
Hide Arm/Group Description Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot. General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
All-Cause Mortality
Regional Anesthesia General Anesthesia
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Regional Anesthesia General Anesthesia
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Regional Anesthesia General Anesthesia
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Mary Ellen McCann
Organization: Boston Children's Hospital Anesthesia Foundation
Phone: 6173557737
EMail: mary.mccann@childrens.harvard.edu
Layout table for additonal information
Responsible Party: Mary Ellen McCann, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT00756600    
Other Study ID Numbers: 06-07-0320
First Submitted: September 18, 2008
First Posted: September 22, 2008
Results First Submitted: March 19, 2020
Results First Posted: April 29, 2020
Last Update Posted: April 29, 2020