Trial Outcomes & Findings for Spinal Morphine vs. Hydromorphone for Pain Control After Cesarean Delivery (NCT NCT02789410)
NCT ID: NCT02789410
Last Updated: 2019-04-25
Results Overview
Each patient will be interviewed by a member of the study team 24 hours after receiving their spinal anesthetic. Patients will be asked to rate their current level of pain on a Numeric Rating Scale (NRS) of 0 (no pain) to 10 (worst pain imaginable).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
134 participants
Primary outcome timeframe
24 hours after administration of spinal anesthesia
Results posted on
2019-04-25
Participant Flow
Participant milestones
| Measure |
Intrathecal Hydromorphone
Patients will be randomized to receive a one time dose of 75 mcg intrathecal hydromorphone as part of their spinal anesthesia.
Hydromorphone: Hydromorphone is administered as part of spinal anesthesia for post-operative pain relief.
|
Intrathecal Morphine
Patients will be randomized to receive a one time dose of 150 mcg intrathecal morphine as part of their spinal anesthesia.
Morphine: Morphine is administered as part of spinal anesthesia for post-operative pain relief.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
68
|
|
Overall Study
COMPLETED
|
66
|
68
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intrathecal Hydromorphone
n=66 Participants
Patients will be randomized to receive a one time dose of 75 mcg intrathecal hydromorphone as part of their spinal anesthesia.
Hydromorphone: Hydromorphone is administered as part of spinal anesthesia for post-operative pain relief.
|
Intrathecal Morphine
n=68 Participants
Patients will be randomized to receive a one time dose of 150 mcg intrathecal morphine as part of their spinal anesthesia.
Morphine: Morphine is administered as part of spinal anesthesia for post-operative pain relief.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.2 years
STANDARD_DEVIATION 4.4 • n=66 Participants
|
31.9 years
STANDARD_DEVIATION 4.3 • n=68 Participants
|
31.5 years
STANDARD_DEVIATION 4.3 • n=134 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=66 Participants
|
68 Participants
n=68 Participants
|
134 Participants
n=134 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=66 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=134 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
66 participants
n=66 Participants
|
68 participants
n=68 Participants
|
134 participants
n=134 Participants
|
PRIMARY outcome
Timeframe: 24 hours after administration of spinal anesthesiaEach patient will be interviewed by a member of the study team 24 hours after receiving their spinal anesthetic. Patients will be asked to rate their current level of pain on a Numeric Rating Scale (NRS) of 0 (no pain) to 10 (worst pain imaginable).
Outcome measures
| Measure |
Intrathecal Hydromorphone
n=66 Participants
Patients will be randomized to receive a one time dose of 75 mcg intrathecal hydromorphone as part of their spinal anesthesia.
Hydromorphone: Hydromorphone is administered as part of spinal anesthesia for post-operative pain relief.
|
Intrathecal Morphine
n=68 Participants
Patients will be randomized to receive a one time dose of 150 mcg intrathecal morphine as part of their spinal anesthesia.
Morphine: Morphine is administered as part of spinal anesthesia for post-operative pain relief.
|
|---|---|---|
|
NRS Score for Pain (0-10) With Movement 24 Hours After Spinal Administration
|
4 score on a scale
Interval 2.5 to 5.0
|
3 score on a scale
Interval 2.0 to 4.5
|
SECONDARY outcome
Timeframe: 24 hours after administration of spinal anesthesiaThe number of subjects who experienced and self-reported nausea within the first 24 hours after administration of spinal anesthesia.
Outcome measures
| Measure |
Intrathecal Hydromorphone
n=66 Participants
Patients will be randomized to receive a one time dose of 75 mcg intrathecal hydromorphone as part of their spinal anesthesia.
Hydromorphone: Hydromorphone is administered as part of spinal anesthesia for post-operative pain relief.
|
Intrathecal Morphine
n=68 Participants
Patients will be randomized to receive a one time dose of 150 mcg intrathecal morphine as part of their spinal anesthesia.
Morphine: Morphine is administered as part of spinal anesthesia for post-operative pain relief.
|
|---|---|---|
|
Nausea
|
28 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 24 hours after administration of spinal anesthesiaThe number of subjects who experienced and self-reported pruritus within the first 24 hours after administration of spinal anesthesia.
Outcome measures
| Measure |
Intrathecal Hydromorphone
n=66 Participants
Patients will be randomized to receive a one time dose of 75 mcg intrathecal hydromorphone as part of their spinal anesthesia.
Hydromorphone: Hydromorphone is administered as part of spinal anesthesia for post-operative pain relief.
|
Intrathecal Morphine
n=68 Participants
Patients will be randomized to receive a one time dose of 150 mcg intrathecal morphine as part of their spinal anesthesia.
Morphine: Morphine is administered as part of spinal anesthesia for post-operative pain relief.
|
|---|---|---|
|
Pruritus
|
27 Participants
|
28 Participants
|
Adverse Events
Intrathecal Hydromorphone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intrathecal Morphine
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