Trial Outcomes & Findings for Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain (NCT NCT01846221)
NCT ID: NCT01846221
Last Updated: 2018-05-03
Results Overview
Pain Visual Analogue Scale (VAS) was evaluated every 5 min for 15 min. 'Success' is defined as at least a 4-point reduction in VAS at 15 min. (0=no pain, 10= worst pain)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
101 participants
Primary outcome timeframe
Baseline, 15 Minutes post epidural administration
Results posted on
2018-05-03
Participant Flow
Participant milestones
| Measure |
Clonidine
Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor
Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.
|
Fentanyl
Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor
Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
|
Overall Study
COMPLETED
|
47
|
51
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Clonidine
Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor
Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.
|
Fentanyl
Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor
Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.
|
|---|---|---|
|
Overall Study
Catheter Failure
|
2
|
0
|
|
Overall Study
Age Exclusion
|
1
|
0
|
Baseline Characteristics
Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain
Baseline characteristics by cohort
| Measure |
Clonidine
n=47 Participants
Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor
Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.
|
Fentanyl
n=51 Participants
Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor
Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
51 participants
n=7 Participants
|
98 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 15 Minutes post epidural administrationPopulation: 3 subjects in the Clonidine group were not included in the analysis due to the following reasons: 2 catheter failures, 1 age exclusion.
Pain Visual Analogue Scale (VAS) was evaluated every 5 min for 15 min. 'Success' is defined as at least a 4-point reduction in VAS at 15 min. (0=no pain, 10= worst pain)
Outcome measures
| Measure |
Clonidine
n=47 Participants
Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor
Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.
|
Fentanyl
n=51 Participants
Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor
Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.
|
|---|---|---|
|
Number of Subjects With Success Rate at 15 Minutes Post-epidural Bolus Injection
|
31 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Baseline, 30 Minutes post epidural administrationPopulation: 46 out of 47 participants were included from the Clonidine group due to 1 participant did not have blood pressure taken at 30 minutes. 48 out of 51 participants were included from the Fentanyl group due to 3 participants did not have blood pressure taken at 30 minutes.
Blood pressure will be measured at different timepoints.
Outcome measures
| Measure |
Clonidine
n=46 Participants
Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor
Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.
|
Fentanyl
n=48 Participants
Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor
Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.
|
|---|---|---|
|
Maternal Systolic Blood Pressure
Baseline
|
123 mm Hg
Interval 91.0 to 172.0
|
121 mm Hg
Interval 83.0 to 146.0
|
|
Maternal Systolic Blood Pressure
30 Minutes
|
116 mm Hg
Interval 87.0 to 150.0
|
118 mm Hg
Interval 87.0 to 141.0
|
SECONDARY outcome
Timeframe: Baseline, 30 Minutes post epidural administrationPopulation: 48 out of 51 participants were included from the Fentanyl group due to 4 participants did not have heart rate taken at 30 minutes.
Heart rate will be measured at different timepoints.
Outcome measures
| Measure |
Clonidine
n=47 Participants
Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor
Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.
|
Fentanyl
n=48 Participants
Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor
Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.
|
|---|---|---|
|
Maternal Heart Rate
Baseline
|
87 beats per minute (BPM)
Interval 57.0 to 155.0
|
84 beats per minute (BPM)
Interval 65.0 to 113.0
|
|
Maternal Heart Rate
30 Minutes
|
84 beats per minute (BPM)
Interval 54.0 to 131.0
|
85 beats per minute (BPM)
Interval 62.0 to 112.0
|
SECONDARY outcome
Timeframe: 1 minute and 5 minutes post deliveryThe Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.
Outcome measures
| Measure |
Clonidine
n=47 Participants
Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor
Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.
|
Fentanyl
n=51 Participants
Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor
Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.
|
|---|---|---|
|
Neonatal Apgar Score
5 Minutes
|
8.94 Apgar score
Interval 8.0 to 9.0
|
8.88 Apgar score
Interval 6.0 to 9.0
|
|
Neonatal Apgar Score
1 Minute
|
8.53 Apgar score
Interval 6.0 to 9.0
|
8.24 Apgar score
Interval 1.0 to 9.0
|
SECONDARY outcome
Timeframe: Upon delivery (approximately up to 8 hours from baseline)Mode of delivery: spontaneous vaginal or instrumental vaginal versus cesarean.
Outcome measures
| Measure |
Clonidine
n=47 Participants
Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor
Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.
|
Fentanyl
n=51 Participants
Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor
Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.
|
|---|---|---|
|
Number of Spontaneous Vaginal Deliveries
|
38 spontaneous vaginal deliveries
|
40 spontaneous vaginal deliveries
|
Adverse Events
Clonidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fentanyl
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
Allison Lee, MD - Assistant Professor of Anesthesiology
Columbia University
Phone: 212-342-2028
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place