Trial Outcomes & Findings for Comparison of 0.1 and 0.05mg Intrathecal Morphine for Post-cesarean Analgesia. (NCT NCT03427463)
NCT ID: NCT03427463
Last Updated: 2024-12-19
Results Overview
This is defined as the number of hours until the first rescue dose of medication was given to participants within the first 24-hours post-op.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
229 participants
Primary outcome timeframe
24 hours
Results posted on
2024-12-19
Participant Flow
Participant milestones
| Measure |
Receiving 0.1 mg IT Morphine
Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
receiving 0.1 mg IT morphine: Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
|
Recieving 0.05 mg IT Morphine
Patients will receive 0.05 mg of intrathecal morphine
recieving 0.05 mg IT morphine: Patients will receive 0.05 mg of intrathecal morphine
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
114
|
|
Overall Study
COMPLETED
|
101
|
100
|
|
Overall Study
NOT COMPLETED
|
14
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of 0.1 and 0.05mg Intrathecal Morphine for Post-cesarean Analgesia.
Baseline characteristics by cohort
| Measure |
Receiving 0.1 mg IT Morphine
n=101 Participants
Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
receiving 0.1 mg IT morphine: Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
|
Recieving 0.05 mg IT Morphine
n=100 Participants
Patients will receive 0.05 mg of intrathecal morphine
recieving 0.05 mg IT morphine: Patients will receive 0.05 mg of intrathecal morphine
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 5.19 • n=5 Participants
|
31.7 years
STANDARD_DEVIATION 6.07 • n=7 Participants
|
31.6 years
STANDARD_DEVIATION 5.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
97 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
68 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
24 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Prior C-Section, yes
|
65 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursThis is defined as the number of hours until the first rescue dose of medication was given to participants within the first 24-hours post-op.
Outcome measures
| Measure |
Receiving 0.1 mg IT Morphine
n=101 Participants
Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
receiving 0.1 mg IT morphine: Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
|
Recieving 0.05 mg IT Morphine
n=100 Participants
Patients will receive 0.05 mg of intrathecal morphine
recieving 0.05 mg IT morphine: Patients will receive 0.05 mg of intrathecal morphine
|
|---|---|---|
|
Time to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery.
|
NA hours
The median wasn't reached in the 0.1 group, therefore 95% CI is not able to be estimated.
|
23.5 hours
Interval 14.5 to 38.0
|
SECONDARY outcome
Timeframe: up to 48 hoursThis outcome evaluated the amount of time reported in hours after c-section the patient first ambulated.
Outcome measures
| Measure |
Receiving 0.1 mg IT Morphine
n=101 Participants
Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
receiving 0.1 mg IT morphine: Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
|
Recieving 0.05 mg IT Morphine
n=100 Participants
Patients will receive 0.05 mg of intrathecal morphine
recieving 0.05 mg IT morphine: Patients will receive 0.05 mg of intrathecal morphine
|
|---|---|---|
|
Time to First Ambulation After C-section
|
13.6 hours
Interval 0.4 to 72.5
|
13.7 hours
Interval 2.42 to 75.0
|
SECONDARY outcome
Timeframe: From the time of the procedure through discharge, up to 48 hours.This outcome looks at whether or not any opioid medications were given during the participant's hospital stay, reporting the number of subjects who received opioid pain medication during the admission.
Outcome measures
| Measure |
Receiving 0.1 mg IT Morphine
n=101 Participants
Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
receiving 0.1 mg IT morphine: Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
|
Recieving 0.05 mg IT Morphine
n=100 Participants
Patients will receive 0.05 mg of intrathecal morphine
recieving 0.05 mg IT morphine: Patients will receive 0.05 mg of intrathecal morphine
|
|---|---|---|
|
Opioid Medication Given During the Participant's Hospital Stay.
|
74 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: 24-hours post operatively and 48-hours post operativelySubjective pain with ambulation reported by participants using visual analogue scales (VAS) ranging from 0-100 at the 24-hour post-op time point and 48-hour post-op time point. The lower the number, the better the outcome.
Outcome measures
| Measure |
Receiving 0.1 mg IT Morphine
n=101 Participants
Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
receiving 0.1 mg IT morphine: Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
|
Recieving 0.05 mg IT Morphine
n=100 Participants
Patients will receive 0.05 mg of intrathecal morphine
recieving 0.05 mg IT morphine: Patients will receive 0.05 mg of intrathecal morphine
|
|---|---|---|
|
Subjective Pain Rating Using Visual Analogue Scales (VAS) Ranging From 0-100.
48-hours post-op
|
44.2 units on a scale
Interval 39.7 to 48.8
|
45.9 units on a scale
Interval 41.4 to 50.5
|
|
Subjective Pain Rating Using Visual Analogue Scales (VAS) Ranging From 0-100.
24-hours post-op
|
47.9 units on a scale
Interval 43.4 to 52.4
|
49.6 units on a scale
Interval 45.1 to 54.1
|
SECONDARY outcome
Timeframe: 24 hours post operavtivelyThe presence of opiate side effects (nausea, vomiting, and pruritus) was evaluated from 0-24 hours post-op.
Outcome measures
| Measure |
Receiving 0.1 mg IT Morphine
n=101 Participants
Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
receiving 0.1 mg IT morphine: Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
|
Recieving 0.05 mg IT Morphine
n=100 Participants
Patients will receive 0.05 mg of intrathecal morphine
recieving 0.05 mg IT morphine: Patients will receive 0.05 mg of intrathecal morphine
|
|---|---|---|
|
Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus)
Pruritis, yes
|
60 participants
|
58 participants
|
|
Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus)
Any post-op nausea and/or vomiting, or itching, yes
|
68 participants
|
62 participants
|
|
Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus)
Post-Op nausea, yes
|
21 participants
|
27 participants
|
|
Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus)
Post-op vomiting, yes
|
11 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 48 hours post-opPatients were asked to mark their satisfaction with pain control using a Visual Analog Scale (VAS) from 0-100. The higher the number, the more satisfied they were with the post-op pain control
Outcome measures
| Measure |
Receiving 0.1 mg IT Morphine
n=101 Participants
Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
receiving 0.1 mg IT morphine: Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
|
Recieving 0.05 mg IT Morphine
n=100 Participants
Patients will receive 0.05 mg of intrathecal morphine
recieving 0.05 mg IT morphine: Patients will receive 0.05 mg of intrathecal morphine
|
|---|---|---|
|
Overall Patient Satisfaction With Pain Control
|
93.75 units on a scale
Interval 75.0 to 100.0
|
94.5 units on a scale
Interval 75.0 to 100.0
|
Adverse Events
Receiving 0.1 mg IT Morphine
Serious events: 0 serious events
Other events: 68 other events
Deaths: 0 deaths
Recieving 0.05 mg IT Morphine
Serious events: 0 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Receiving 0.1 mg IT Morphine
n=101 participants at risk
Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
receiving 0.1 mg IT morphine: Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
|
Recieving 0.05 mg IT Morphine
n=100 participants at risk
Patients will receive 0.05 mg of intrathecal morphine
recieving 0.05 mg IT morphine: Patients will receive 0.05 mg of intrathecal morphine
|
|---|---|---|
|
Gastrointestinal disorders
Post-Op Nausea
|
20.8%
21/101 • Number of events 21 • Adverse event data was collected from randomization through 48-hours postoperatively.
|
27.0%
27/100 • Number of events 27 • Adverse event data was collected from randomization through 48-hours postoperatively.
|
|
Gastrointestinal disorders
Post-Op Vomiting
|
10.9%
11/101 • Number of events 11 • Adverse event data was collected from randomization through 48-hours postoperatively.
|
12.0%
12/100 • Number of events 12 • Adverse event data was collected from randomization through 48-hours postoperatively.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
59.4%
60/101 • Number of events 60 • Adverse event data was collected from randomization through 48-hours postoperatively.
|
58.0%
58/100 • Number of events 58 • Adverse event data was collected from randomization through 48-hours postoperatively.
|
Additional Information
Katherine Hatter, M.D.
Medical University of South Carolina
Phone: (843) 792-5454
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place