Trial Outcomes & Findings for Intrathecal Morphine for Cesarean Delivery (NCT NCT05069012)
NCT ID: NCT05069012
Last Updated: 2025-11-13
Results Overview
Time to patient request for first dose of oral rescue pain medicine
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
72 participants
Primary outcome timeframe
72 hours after delivery
Results posted on
2025-11-13
Participant Flow
Participant milestones
| Measure |
50 Micrograms
Patients in this arm will receive 50 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
150 Micrograms
Patients in this arm will receive 150 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
250 Micrograms
Patients in this arm will receive 250 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
24
|
|
Overall Study
COMPLETED
|
23
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intrathecal Morphine for Cesarean Delivery
Baseline characteristics by cohort
| Measure |
50 Micrograms
n=23 Participants
Patients in this arm will receive 50 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
150 Micrograms
n=23 Participants
Patients in this arm will receive 150 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
250 Micrograms
n=24 Participants
Patients in this arm will receive 250 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.0 Years
STANDARD_DEVIATION 3.8 • n=10 Participants
|
33.9 Years
STANDARD_DEVIATION 4.8 • n=10 Participants
|
36.8 Years
STANDARD_DEVIATION 4.9 • n=20 Participants
|
35.6 Years
STANDARD_DEVIATION 4.6 • n=45 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=10 Participants
|
23 Participants
n=10 Participants
|
24 Participants
n=20 Participants
|
70 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=10 Participants
|
20 Participants
n=10 Participants
|
23 Participants
n=20 Participants
|
64 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
8 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
7 Participants
n=45 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=10 Participants
|
16 Participants
n=10 Participants
|
19 Participants
n=20 Participants
|
47 Participants
n=45 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
7 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: 72 hours after deliveryTime to patient request for first dose of oral rescue pain medicine
Outcome measures
| Measure |
50 Micrograms
n=23 Participants
Patients in this arm will receive 50 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
150 Micrograms
n=23 Participants
Patients in this arm will receive 150 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
250 Micrograms
n=24 Participants
Patients in this arm will receive 250 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
|---|---|---|---|
|
Duration of Pain Relief
|
24.5 hours
Interval 3.5 to 34.4
|
29.4 hours
Interval 24.5 to 72.0
|
32 hours
Interval 30.5 to 72.0
|
SECONDARY outcome
Timeframe: 24 hours after deliveryVisual analogue pain scores reported by the patient. Scale measured on a line from 0 to 100 mm, with 0 representing 'no pain' and 100 representing 'worst possible pain'
Outcome measures
| Measure |
50 Micrograms
n=23 Participants
Patients in this arm will receive 50 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
150 Micrograms
n=23 Participants
Patients in this arm will receive 150 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
250 Micrograms
n=24 Participants
Patients in this arm will receive 250 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
|---|---|---|---|
|
Pain Scores
|
2.2 score on a scale
Interval 1.3 to 5.1
|
1.8 score on a scale
Interval 0.8 to 2.3
|
1.9 score on a scale
Interval 0.2 to 2.9
|
SECONDARY outcome
Timeframe: 24 hours after deliveryQuality of Recovery Score following Cesarean Delivery Questionnaire (ObsQoR-11). This is a multi-dimensional wellness scale ranging from 0 (worst) to 120 (best) along 12 axis items.
Outcome measures
| Measure |
50 Micrograms
n=23 Participants
Patients in this arm will receive 50 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
150 Micrograms
n=23 Participants
Patients in this arm will receive 150 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
250 Micrograms
n=24 Participants
Patients in this arm will receive 250 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
|---|---|---|---|
|
Quality of Recovery
|
72 score on a scale
Interval 38.0 to 87.0
|
93 score on a scale
Interval 83.0 to 109.0
|
95 score on a scale
Interval 85.0 to 102.0
|
SECONDARY outcome
Timeframe: 24 hours after deliveryIncidence of nausea and vomiting requiring treatment with a medication
Outcome measures
| Measure |
50 Micrograms
n=23 Participants
Patients in this arm will receive 50 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
150 Micrograms
n=23 Participants
Patients in this arm will receive 150 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
250 Micrograms
n=24 Participants
Patients in this arm will receive 250 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
|---|---|---|---|
|
Nausea
|
4.3 percentage of participants
|
8.7 percentage of participants
|
12.5 percentage of participants
|
SECONDARY outcome
Timeframe: 24 hours after deliveryIncidence of pruritus requiring treatment with a medication
Outcome measures
| Measure |
50 Micrograms
n=23 Participants
Patients in this arm will receive 50 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
150 Micrograms
n=23 Participants
Patients in this arm will receive 150 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
250 Micrograms
n=24 Participants
Patients in this arm will receive 250 micrograms of morphine administered in the spinal fluid as part of their anesthesia for cesarean delivery
Morphine Sulfate: Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
|
|---|---|---|---|
|
Pruritus
|
8.7 percentage of participants
|
4.3 percentage of participants
|
4.1 percentage of participants
|
Adverse Events
50 Micrograms
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
150 Micrograms
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
250 Micrograms
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place