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Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia (Apcisaal)

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ClinicalTrials.gov Identifier: NCT02264821
Recruitment Status : Completed
First Posted : October 15, 2014
Results First Posted : June 9, 2015
Last Update Posted : June 9, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Madeleine Wilwerth, Brugmann University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Post Caesarean Analgesia
Interventions Drug: ropivacaine infiltration
Drug: intrathecal morphine
Drug: placebo
Enrollment 192
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ropivacaine Infiltration Rachi Morphine Placebo
Hide Arm/Group Description

ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline

ropivacaine infiltration: wound infiltration

100 µg intrathecal morphine and saline infiltration

intrathecal morphine: 100 µg added to the spinal anaesthesia

intrathecal saline and saline infiltration

placebo: placebo in spinal anaesthesia and in wound infiltration

Period Title: Overall Study
Started 64 [1] 64 [1] 64 [1]
Completed 63 61 58
Not Completed 1 3 6
Reason Not Completed
Protocol Violation             1             3             6
[1]
Double Blind
Arm/Group Title Ropivacaine Infiltration Rachi Morphine Placebo Total
Hide Arm/Group Description

ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline

ropivacaine infiltration: wound infiltration

100 µg intrathecal morphine and saline infiltration

intrathecal morphine: 100 µg added to the spinal anaesthesia

intrathecal saline and saline infiltration

placebo: placebo in spinal anaesthesia and in wound infiltration

Total of all reporting groups
Overall Number of Baseline Participants 63 61 58 182
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 63 participants 61 participants 58 participants 182 participants
30
(27 to 34)
32
(28 to 34)
32
(28 to 37)
32
(27 to 37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 61 participants 58 participants 182 participants
Female
63
 100.0%
61
 100.0%
58
 100.0%
182
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Belgium Number Analyzed 63 participants 61 participants 58 participants 182 participants
63 61 58 182
1.Primary Outcome
Title Duration of Effective Analgesia
Hide Description T0 until first request of morphine PCAIV
Time Frame 30 hours after spinal injection T0
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ropivacaine Infiltration Rachi Morphine Placebo
Hide Arm/Group Description:

ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline

ropivacaine infiltration: wound infiltration

100 µg intrathecal morphine and saline infiltration

intrathecal morphine: 100 µg added to the spinal anaesthesia

intrathecal saline and saline infiltration

placebo: placebo in spinal anaesthesia and in wound infiltration

Overall Number of Participants Analyzed 63 61 58
Median (Inter-Quartile Range)
Unit of Measure: minutes
351
(227 to 594)
380
(215 to 1527)
247
(182 to 338)
2.Primary Outcome
Title Morphine Consumption
Hide Description Morphine consumption with PCAIV
Time Frame 30 hours after spinal injection T0
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ropivacaine Infiltration Rachi Morphine Placebo
Hide Arm/Group Description:

ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline

ropivacaine infiltration: wound infiltration

100 µg intrathecal morphine and saline infiltration

intrathecal morphine: 100 µg added to the spinal anaesthesia

intrathecal saline and saline infiltration

placebo: placebo in spinal anaesthesia and in wound infiltration

Overall Number of Participants Analyzed 63 61 58
Median (Inter-Quartile Range)
Unit of Measure: milligrammes
8
(4 to 20)
4
(1 to 10)
20.5
(9.5 to 31)
3.Secondary Outcome
Title Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.
Hide Description Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus?
Time Frame 30 hours after spinal injection
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ropivacaine Infiltration Rachi Morphine Placebo
Hide Arm/Group Description

ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline

ropivacaine infiltration: wound infiltration

100 µg intrathecal morphine and saline infiltration

intrathecal morphine: 100 µg added to the spinal anaesthesia

intrathecal saline and saline infiltration

placebo: placebo in spinal anaesthesia and in wound infiltration

All-Cause Mortality
Ropivacaine Infiltration Rachi Morphine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ropivacaine Infiltration Rachi Morphine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)   0/61 (0.00%)   0/58 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ropivacaine Infiltration Rachi Morphine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   61/63 (96.83%)   61/61 (100.00%)   58/58 (100.00%) 
Gastrointestinal disorders       
Nausea and/or vomiting  10/63 (15.87%)  18/61 (29.51%)  9/58 (15.52%) 
Skin and subcutaneous tissue disorders       
Pruritus  31/63 (49.21%)  35/61 (57.38%)  21/58 (36.21%) 
Vascular disorders       
Hypotension  22/63 (34.92%)  23/61 (37.70%)  30/58 (51.72%) 
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
Name/Title: Dr Madeleine Wilwerth
Organization: CHU Brugmann
Phone: 003224773996
Responsible Party: Dr Madeleine Wilwerth, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT02264821     History of Changes
Other Study ID Numbers: Apcisaal 01
First Submitted: August 25, 2014
First Posted: October 15, 2014
Results First Submitted: April 22, 2015
Results First Posted: June 9, 2015
Last Update Posted: June 9, 2015