Trial Outcomes & Findings for Intrathecal Hydromorphone for Post-cesarean Delivery Pain - a Dose Finding Study (NCT NCT01943565)
NCT ID: NCT01943565
Last Updated: 2017-06-19
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
29 participants
Primary outcome timeframe
24hrs after administration of intrathecal hydromorphone
Results posted on
2017-06-19
Participant Flow
Participant milestones
| Measure |
Hydromorphone 25mcg
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)
|
Hydromorphone 50mcg
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)
|
Hydromorphone 100mcg
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 Study
STARTED
|
11
|
9
|
9
|
|
Overall Study
COMPLETED
|
11
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intrathecal Hydromorphone for Post-cesarean Delivery Pain - a Dose Finding Study
Baseline characteristics by cohort
| Measure |
Hydromorphone 25mcg
n=11 Participants
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)
|
Hydromorphone 50mcg
n=9 Participants
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)
|
Hydromorphone 100mcg
n=10 Participants
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
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 24hrs after administration of intrathecal hydromorphonePopulation: One 25 mcg patient is missing data on this outcome
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.
Outcome measures
| Measure |
Hydromorphone 25mcg
n=10 Participants
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)
|
Hydromorphone 50mcg
n=9 Participants
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)
|
Hydromorphone 100mcg
n=9 Participants
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)
|
|---|---|---|---|
|
24hr Post-partum IV Opioid Requirement
|
3.44 mg
Standard Deviation 3.51
|
3.11 mg
Standard Deviation 2.15
|
4.40 mg
Standard Deviation 3.51
|
SECONDARY outcome
Timeframe: 24hrs post administration of IT hydromorphonePopulation: One 25 mcg patient is missing data on this outcome
Intravenously, and to a lesser extent, intrathecally administered opioids can lead to respiratory depressions. Therefore the subjects' oxygen saturation is measured (standard clinical practice).
Outcome measures
| Measure |
Hydromorphone 25mcg
n=10 Participants
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)
|
Hydromorphone 50mcg
n=9 Participants
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)
|
Hydromorphone 100mcg
n=9 Participants
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)
|
|---|---|---|---|
|
Oxygen Saturation, Need for Supplemental Oxygen
|
98.3 percentage oxygenated haemoglobin
Standard Deviation 1.49
|
99.0 percentage oxygenated haemoglobin
Standard Deviation 0.87
|
98.4 percentage oxygenated haemoglobin
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: 24hrs post administration of IT hydromorphonePopulation: One 25 mcg patient was missing data on this measure
IV and IT opioids can induce nausea and vomiting. Outcome measure is reported as percentage of patients with nausea and vomiting requiring rescue medication.
Outcome measures
| Measure |
Hydromorphone 25mcg
n=10 Participants
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)
|
Hydromorphone 50mcg
n=9 Participants
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)
|
Hydromorphone 100mcg
n=9 Participants
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)
|
|---|---|---|---|
|
Patients With Nausea and Vomiting Requiring Rescue Medication
|
3 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 24hrs post administration of IT hydromorphonePopulation: One 25 mcg patient was missing data on this measure
intrathecally administered opioids can cause hypothermia (body temperature \<95F/35C)
Outcome measures
| Measure |
Hydromorphone 25mcg
n=10 Participants
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)
|
Hydromorphone 50mcg
n=9 Participants
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)
|
Hydromorphone 100mcg
n=9 Participants
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)
|
|---|---|---|---|
|
Number of Patients With Hypothermia (Body Temperature < 95F/35C)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24hrs post administration of IT hydromorphoneIT/IV opioids can create visual disturbances. The number of patients with visual disturbances are reported.
Outcome measures
| Measure |
Hydromorphone 25mcg
n=11 Participants
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)
|
Hydromorphone 50mcg
n=9 Participants
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)
|
Hydromorphone 100mcg
n=9 Participants
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)
|
|---|---|---|---|
|
Number of Patients With Visual Disturbances
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24hrs post administration of IT hydromorphonePopulation: One 25 mcg patient is missing data on this outcome
IT opioids can cause pruritus. Persistent pruritus requiring treatment will be recorded.
Outcome measures
| Measure |
Hydromorphone 25mcg
n=10 Participants
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)
|
Hydromorphone 50mcg
n=9 Participants
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)
|
Hydromorphone 100mcg
n=9 Participants
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)
|
|---|---|---|---|
|
Number of Patients With Pruritus
|
0 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Intraoperatively (at time of operation)Population: One 25 mcg patient is missing data on this outcome
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.
Outcome measures
| Measure |
Hydromorphone 25mcg
n=10 Participants
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)
|
Hydromorphone 50mcg
n=9 Participants
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)
|
Hydromorphone 100mcg
n=9 Participants
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)
|
|---|---|---|---|
|
Intraoperative Vasopressor Use: Ephedrine Equivalents
|
60.98 mg
Standard Deviation 26.94
|
56.48 mg
Standard Deviation 32.27
|
45.48 mg
Standard Deviation 19.78
|
SECONDARY outcome
Timeframe: Intraoperatively (at time of operation)Population: One 25 mcg patient is missing data on this outcome
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.
Outcome measures
| Measure |
Hydromorphone 25mcg
n=10 Participants
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)
|
Hydromorphone 50mcg
n=9 Participants
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)
|
Hydromorphone 100mcg
n=9 Participants
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)
|
|---|---|---|---|
|
Intraoperative Vasopressor Use: Phenylephrine Equivalents
|
751.04 mcg
Standard Deviation 331.76
|
695.54 mcg
Standard Deviation 397.42
|
560.11 mcg
Standard Deviation 243.56
|
Adverse Events
Hydromorphone 25mcg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Hydromorphone 50mcg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Hydromorphone 100mcg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hydromorphone 25mcg
n=11 participants at risk
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)
|
Hydromorphone 50mcg
n=9 participants at risk
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)
|
Hydromorphone 100mcg
n=9 participants at risk
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)
|
|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
General disorders
Pain
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place