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Intrathecal Hydromorphone for Post-cesarean Delivery Pain - a Dose Finding Study

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ClinicalTrials.gov Identifier: NCT01943565
Recruitment Status : Terminated (Research question answered by another group of researchers (Sviggum et al))
First Posted : September 17, 2013
Results First Posted : June 19, 2017
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Dirk Varelmann, MD, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Conditions Healthy
Pain
Pregnancy
Interventions Drug: Hydromorphone 25mcg
Drug: Hydromorphone 50mcg
Drug: Hydromorphone 100mcg
Drug: spinal anesthesia
Enrollment 29

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hydromorphone 25mcg Hydromorphone 50mcg Hydromorphone 100mcg
Hide Arm/Group Description

The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

Period Title: Overall Study
Started 11 9 9
Completed 11 9 9
Not Completed 0 0 0
Arm/Group Title Hydromorphone 25mcg Hydromorphone 50mcg Hydromorphone 100mcg Total
Hide Arm/Group Description

The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

Total of all reporting groups
Overall Number of Baseline Participants 11 9 10 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 10 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
9
 100.0%
10
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 10 participants 30 participants
Female
11
 100.0%
9
 100.0%
10
 100.0%
30
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 11 participants 9 participants 10 participants 30 participants
11
 100.0%
9
 100.0%
10
 100.0%
30
 100.0%
1.Primary Outcome
Title 24hr Post-partum IV Opioid Requirement
Hide Description Intrathecal (IT) hydromorphone added to intrathecally administered local anesthetics for spinal anesthesia increases patient comfort by decreasing post-operative pain. This leads to a decrease in the post-operative intravenous hydromorphone requirements.
Time Frame 24hrs after administration of intrathecal hydromorphone
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One 25 mcg patient is missing data on this outcome
Arm/Group Title Hydromorphone 25mcg Hydromorphone 50mcg Hydromorphone 100mcg
Hide Arm/Group Description:

The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

Overall Number of Participants Analyzed 10 9 9
Mean (Standard Deviation)
Unit of Measure: mg
3.44  (3.51) 3.11  (2.15) 4.40  (3.51)
2.Secondary Outcome
Title Oxygen Saturation, Need for Supplemental Oxygen
Hide Description Intravenously, and to a lesser extent, intrathecally administered opioids can lead to respiratory depressions. Therefore the subjects' oxygen saturation is measured (standard clinical practice).
Time Frame 24hrs post administration of IT hydromorphone
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One 25 mcg patient is missing data on this outcome
Arm/Group Title Hydromorphone 25mcg Hydromorphone 50mcg Hydromorphone 100mcg
Hide Arm/Group Description:

The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

Overall Number of Participants Analyzed 10 9 9
Mean (Standard Deviation)
Unit of Measure: percentage oxygenated haemoglobin
98.3  (1.49) 99.0  (0.87) 98.4  (1.33)
3.Secondary Outcome
Title Patients With Nausea and Vomiting Requiring Rescue Medication
Hide Description IV and IT opioids can induce nausea and vomiting. Outcome measure is reported as percentage of patients with nausea and vomiting requiring rescue medication.
Time Frame 24hrs post administration of IT hydromorphone
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One 25 mcg patient was missing data on this measure
Arm/Group Title Hydromorphone 25mcg Hydromorphone 50mcg Hydromorphone 100mcg
Hide Arm/Group Description:

The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

Overall Number of Participants Analyzed 10 9 9
Measure Type: Count of Participants
Unit of Measure: Participants
3
  30.0%
2
  22.2%
2
  22.2%
4.Secondary Outcome
Title Number of Patients With Hypothermia (Body Temperature < 95F/35C)
Hide Description intrathecally administered opioids can cause hypothermia (body temperature <95F/35C)
Time Frame 24hrs post administration of IT hydromorphone
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One 25 mcg patient was missing data on this measure
Arm/Group Title Hydromorphone 25mcg Hydromorphone 50mcg Hydromorphone 100mcg
Hide Arm/Group Description:

The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

Overall Number of Participants Analyzed 10 9 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number of Patients With Visual Disturbances
Hide Description IT/IV opioids can create visual disturbances. The number of patients with visual disturbances are reported.
Time Frame 24hrs post administration of IT hydromorphone
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydromorphone 25mcg Hydromorphone 50mcg Hydromorphone 100mcg
Hide Arm/Group Description:

The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

Overall Number of Participants Analyzed 11 9 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Number of Patients With Pruritus
Hide Description IT opioids can cause pruritus. Persistent pruritus requiring treatment will be recorded.
Time Frame 24hrs post administration of IT hydromorphone
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One 25 mcg patient is missing data on this outcome
Arm/Group Title Hydromorphone 25mcg Hydromorphone 50mcg Hydromorphone 100mcg
Hide Arm/Group Description:

The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

Overall Number of Participants Analyzed 10 9 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4
  44.4%
3
  33.3%
7.Secondary Outcome
Title Intraoperative Vasopressor Use: Ephedrine Equivalents
Hide Description IT (intrathecal) applied local anesthetics and opioids can cause arterial and venous vasodilation leading to a decrease in afterload as well as preload. This is typically treated with volume replacement and vasopressors (acutely). Total intraoperative vasopressor use will be reported for ephedrine equivalents.
Time Frame Intraoperatively (at time of operation)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One 25 mcg patient is missing data on this outcome
Arm/Group Title Hydromorphone 25mcg Hydromorphone 50mcg Hydromorphone 100mcg
Hide Arm/Group Description:

The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

Overall Number of Participants Analyzed 10 9 9
Mean (Standard Deviation)
Unit of Measure: mg
60.98  (26.94) 56.48  (32.27) 45.48  (19.78)
8.Secondary Outcome
Title Intraoperative Vasopressor Use: Phenylephrine Equivalents
Hide Description

IT (intrathecal ) applied local anesthetics and opioids can cause arterial and venous vasodilation leading to a decrease in afterload as well as preload. This is typically treated with volume replacement and vasopressors (acutely).

Total intraoperative vasopressor use will be reported for phenylephrine equivalents.

Time Frame Intraoperatively (at time of operation)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One 25 mcg patient is missing data on this outcome
Arm/Group Title Hydromorphone 25mcg Hydromorphone 50mcg Hydromorphone 100mcg
Hide Arm/Group Description:

The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

Overall Number of Participants Analyzed 10 9 9
Mean (Standard Deviation)
Unit of Measure: mcg
751.04  (331.76) 695.54  (397.42) 560.11  (243.56)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hydromorphone 25mcg Hydromorphone 50mcg Hydromorphone 100mcg
Hide Arm/Group Description

The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia

Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg

spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg)

All-Cause Mortality
Hydromorphone 25mcg Hydromorphone 50mcg Hydromorphone 100mcg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Hydromorphone 25mcg Hydromorphone 50mcg Hydromorphone 100mcg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/9 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hydromorphone 25mcg Hydromorphone 50mcg Hydromorphone 100mcg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/11 (9.09%)      1/9 (11.11%)      1/9 (11.11%)    
Gastrointestinal disorders       
Nausea  0/11 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1
General disorders       
Pain  1/11 (9.09%)  1 0/9 (0.00%)  0 1/9 (11.11%)  1
Nervous system disorders       
Dizziness  0/11 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1
Psychiatric disorders       
Anxiety  1/11 (9.09%)  1 1/9 (11.11%)  1 0/9 (0.00%)  0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dirk J Varelmann, MD
Organization: Brigham and Women's Hospital
Phone: 617-732-8280
Responsible Party: Dirk Varelmann, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01943565     History of Changes
Other Study ID Numbers: 2013P001850
Hydromorphone_IT ( Other Identifier: BrighamHospital )
First Submitted: September 12, 2013
First Posted: September 17, 2013
Results First Submitted: May 22, 2017
Results First Posted: June 19, 2017
Last Update Posted: June 19, 2017