Trial Outcomes & Findings for Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section (NCT NCT01362998)
NCT ID: NCT01362998
Last Updated: 2022-11-14
Results Overview
Participants will be asked to rate their pain on a 10 point Numerical Rating Pain Scale, where zero is no pain and ten is the most intense pain possible.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
At 8, 24 36 and 48 hours after the Cesarean section
Results posted on
2022-11-14
Participant Flow
2 people were recruited for this study, but data was collected for only one of them.
Participant milestones
| Measure |
Preservative Free Morphine
This group will receive 3mg of preservative free morphine epidurally during the procedure.
Preservative free morphine: 3mg given epidurally during the Cesarean section.
|
Fentanyl Infusion
This group will receive an epidural infusion of fentanyl (60 micrograms per hour), which will be started during the Cesarean section and which will continue for the next two days.
Fentanyl: An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
2
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section
Baseline characteristics by cohort
| Measure |
Preservative Free Morphine
This group will receive 3mg of preservative free morphine epidurally during the procedure.
Preservative free morphine: 3mg given epidurally during the Cesarean section.
|
Fentanyl Infusion
n=1 Participants
This group will receive an epidural infusion of fentanyl (60 micrograms per hour), which will be started during the Cesarean section and which will continue for the next two days.
Fentanyl: An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
—
|
27 Years
n=7 Participants
|
27 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Weight, continuous
|
—
|
179 pounds
n=7 Participants
|
179 pounds
n=5 Participants
|
|
Pregnancies, integer
|
—
|
4 Number of pregnancies
n=7 Participants
|
4 Number of pregnancies
n=5 Participants
|
|
Gestational age, continuous
|
—
|
39 Weeks
n=7 Participants
|
39 Weeks
n=5 Participants
|
PRIMARY outcome
Timeframe: At 8, 24 36 and 48 hours after the Cesarean sectionPopulation: No participants in morphine arm.
Participants will be asked to rate their pain on a 10 point Numerical Rating Pain Scale, where zero is no pain and ten is the most intense pain possible.
Outcome measures
| Measure |
Preservative Free Morphine
This group will receive 3mg of preservative free morphine epidurally during the procedure.
Preservative free morphine: 3mg given epidurally during the Cesarean section.
|
Fentanyl Infusion
n=1 Participants
This group will receive an epidural infusion of fentanyl (60 micrograms per hour), which will be started during the Cesarean section and which will continue for the next two days.
Fentanyl: An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.
|
|---|---|---|
|
Postsurgical Pain
8 hours post Cesarean section
|
—
|
3 Units on a 10 point scale
|
|
Postsurgical Pain
24 hours post Cesarean
|
—
|
0 Units on a 10 point scale
|
|
Postsurgical Pain
36 hours post Cesarean
|
—
|
3 Units on a 10 point scale
|
|
Postsurgical Pain
48 hours post Cesarean
|
—
|
7 Units on a 10 point scale
|
SECONDARY outcome
Timeframe: At 8, 24, 36 and 48 hours after the Cesarean sectionPopulation: No patients were in the morphine group
The patient will be asked whether she has nausea or vomiting (yes=1, no=0).
Outcome measures
| Measure |
Preservative Free Morphine
This group will receive 3mg of preservative free morphine epidurally during the procedure.
Preservative free morphine: 3mg given epidurally during the Cesarean section.
|
Fentanyl Infusion
n=1 Participants
This group will receive an epidural infusion of fentanyl (60 micrograms per hour), which will be started during the Cesarean section and which will continue for the next two days.
Fentanyl: An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.
|
|---|---|---|
|
Number of Participants Who Responded Yes to Having Nausea or Vomiting
8 hours after the surgery
|
—
|
0 Participants
|
|
Number of Participants Who Responded Yes to Having Nausea or Vomiting
24 hours after the surgery
|
—
|
0 Participants
|
|
Number of Participants Who Responded Yes to Having Nausea or Vomiting
36 hours after the surgery
|
—
|
0 Participants
|
|
Number of Participants Who Responded Yes to Having Nausea or Vomiting
48 hours after the surgery
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: At 8, 24, 48 and 36 hours after Cesarean sectionPopulation: There were no participants in the morphine arm.
Participants will be asked to rate their satisfaction on a 10 point Numerical Rating Scale (0=worst, 10=best).
Outcome measures
| Measure |
Preservative Free Morphine
This group will receive 3mg of preservative free morphine epidurally during the procedure.
Preservative free morphine: 3mg given epidurally during the Cesarean section.
|
Fentanyl Infusion
n=1 Participants
This group will receive an epidural infusion of fentanyl (60 micrograms per hour), which will be started during the Cesarean section and which will continue for the next two days.
Fentanyl: An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.
|
|---|---|---|
|
Patient Satisfaction
8 hours after the surgery
|
—
|
10 score on a scale
|
|
Patient Satisfaction
24 hours after the surgery
|
—
|
10 score on a scale
|
|
Patient Satisfaction
36 hours after the surgery
|
—
|
10 score on a scale
|
|
Patient Satisfaction
48 hours after the surgery
|
—
|
10 score on a scale
|
SECONDARY outcome
Timeframe: At 8, 24, 36 and 48 hours after the Cesarean sectionPopulation: No participants in the morphine arm.
Participants will be asked whether they have back pain (Yes=1, No=0)
Outcome measures
| Measure |
Preservative Free Morphine
This group will receive 3mg of preservative free morphine epidurally during the procedure.
Preservative free morphine: 3mg given epidurally during the Cesarean section.
|
Fentanyl Infusion
n=1 Participants
This group will receive an epidural infusion of fentanyl (60 micrograms per hour), which will be started during the Cesarean section and which will continue for the next two days.
Fentanyl: An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.
|
|---|---|---|
|
Number of Participants Who Responded Yes to Having Back Pain
8 hours after the surgery
|
—
|
0 Participants
|
|
Number of Participants Who Responded Yes to Having Back Pain
24 hours after the surgery
|
—
|
0 Participants
|
|
Number of Participants Who Responded Yes to Having Back Pain
36 hours after the surgery
|
—
|
0 Participants
|
|
Number of Participants Who Responded Yes to Having Back Pain
48 hours after the surgery
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: At 8, 24, 36 and 48 hours after Cesarean sectionPopulation: No participants in the morphine arm.
Participants will be asked whether they have pruritis (Yes=1, No=0)
Outcome measures
| Measure |
Preservative Free Morphine
This group will receive 3mg of preservative free morphine epidurally during the procedure.
Preservative free morphine: 3mg given epidurally during the Cesarean section.
|
Fentanyl Infusion
n=1 Participants
This group will receive an epidural infusion of fentanyl (60 micrograms per hour), which will be started during the Cesarean section and which will continue for the next two days.
Fentanyl: An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.
|
|---|---|---|
|
Number of Participants Who Responded Yes to Having Pruritis
8 hours after the surgery
|
—
|
1 Participants
|
|
Number of Participants Who Responded Yes to Having Pruritis
24 hours after the surgery
|
—
|
1 Participants
|
|
Number of Participants Who Responded Yes to Having Pruritis
36 hours after the surgery
|
—
|
1 Participants
|
|
Number of Participants Who Responded Yes to Having Pruritis
48 hours after the surgery
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: At 8, 24, 36 and 48 hours after Cesarean sectionPopulation: No participants in morphine arm
Participant's nurse will be asked whether \>400ml was obtained by straight cath (Y=1, No=0)
Outcome measures
| Measure |
Preservative Free Morphine
This group will receive 3mg of preservative free morphine epidurally during the procedure.
Preservative free morphine: 3mg given epidurally during the Cesarean section.
|
Fentanyl Infusion
n=1 Participants
This group will receive an epidural infusion of fentanyl (60 micrograms per hour), which will be started during the Cesarean section and which will continue for the next two days.
Fentanyl: An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.
|
|---|---|---|
|
Number of Participants Who Were Observed by Their Nurse to Have Urinary Retention
8 hours after the surgery
|
—
|
0 Participants
|
|
Number of Participants Who Were Observed by Their Nurse to Have Urinary Retention
24 hours after the surgery
|
—
|
0 Participants
|
|
Number of Participants Who Were Observed by Their Nurse to Have Urinary Retention
36 hours after the surgery
|
—
|
0 Participants
|
|
Number of Participants Who Were Observed by Their Nurse to Have Urinary Retention
48 hours after the surgery
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: At 8, 24, 36 and 48 hours after the Cesarean sectionPopulation: No participants in morphine arm.
Participant's chart will be examined to determine whether the respiratory rate was \<8 per minute (Yes=1, No=0)
Outcome measures
| Measure |
Preservative Free Morphine
This group will receive 3mg of preservative free morphine epidurally during the procedure.
Preservative free morphine: 3mg given epidurally during the Cesarean section.
|
Fentanyl Infusion
n=1 Participants
This group will receive an epidural infusion of fentanyl (60 micrograms per hour), which will be started during the Cesarean section and which will continue for the next two days.
Fentanyl: An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.
|
|---|---|---|
|
Number of Participants Who Were Observed by Their Nurse to Have Respiratory Depression
8 hours after the surgery
|
—
|
0 Participants
|
|
Number of Participants Who Were Observed by Their Nurse to Have Respiratory Depression
24 hours after the surgery
|
—
|
0 Participants
|
|
Number of Participants Who Were Observed by Their Nurse to Have Respiratory Depression
36 hours after the surgery
|
—
|
0 Participants
|
|
Number of Participants Who Were Observed by Their Nurse to Have Respiratory Depression
48 hours after the surgery
|
—
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At 8, 24, 36 and 48 hours after the Cesarean sectionPopulation: No participants in morphine arm.
Participant's nurse will be asked whether the patient required additional pain medications (Yes=1, No=0)
Outcome measures
| Measure |
Preservative Free Morphine
This group will receive 3mg of preservative free morphine epidurally during the procedure.
Preservative free morphine: 3mg given epidurally during the Cesarean section.
|
Fentanyl Infusion
n=1 Participants
This group will receive an epidural infusion of fentanyl (60 micrograms per hour), which will be started during the Cesarean section and which will continue for the next two days.
Fentanyl: An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.
|
|---|---|---|
|
Number of Participants Who Required Additional Pain Medications
8 hours after the surgery
|
—
|
0 Participants
|
|
Number of Participants Who Required Additional Pain Medications
24 hours after the surgery
|
—
|
0 Participants
|
|
Number of Participants Who Required Additional Pain Medications
36 hours after the surgery
|
—
|
0 Participants
|
|
Number of Participants Who Required Additional Pain Medications
48 hours after the surgery
|
—
|
1 Participants
|
Adverse Events
Preservative Free Morphine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fentanyl Infusion
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
Evan Goodman, principal investigator
University Hospitals of Cleveland
Phone: 2168445300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place