Trial Outcomes & Findings for Gabapentin for Postop Pain After SSLF (NCT NCT03123861)
NCT ID: NCT03123861
Last Updated: 2020-10-26
Results Overview
Post-operative pain at week 1 will be measured by item 2 of the surgical pain scale (SPS). This item asks for the average amount of pain felt during normal activity in the last 24 hours on a scale of 1-10 with 10 representing the most intense/worst pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
45 participants
Primary outcome timeframe
7 days after surgery
Results posted on
2020-10-26
Participant Flow
Participant milestones
| Measure |
Gabapentin
Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg twice a day (BID) for an additional 11 days.
Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.
|
Placebo Oral Capsule
Participants will take placebo for the 2 weeks after surgery.
Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
23
|
|
Overall Study
Received Intervention
|
21
|
22
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Gabapentin
Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg twice a day (BID) for an additional 11 days.
Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.
|
Placebo Oral Capsule
Participants will take placebo for the 2 weeks after surgery.
Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Gabapentin for Postop Pain After SSLF
Baseline characteristics by cohort
| Measure |
Gabapentin
n=22 Participants
Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg BID for an additional 11 days.
Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.
|
Placebo Oral Capsule
n=23 Participants
Participants will take placebo for the 2 weeks after surgery.
Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
61.2 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
62.8 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Body Mass Index
|
29.1 kg / m^2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
28.1 kg / m^2
STANDARD_DEVIATION 4.1 • n=7 Participants
|
28.6 kg / m^2
STANDARD_DEVIATION 4.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days after surgeryPopulation: Participants who underwent sacrospinous ligament fixation surgery with follow-up data 7 days after surgery
Post-operative pain at week 1 will be measured by item 2 of the surgical pain scale (SPS). This item asks for the average amount of pain felt during normal activity in the last 24 hours on a scale of 1-10 with 10 representing the most intense/worst pain.
Outcome measures
| Measure |
Gabapentin
n=19 Participants
Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg BID for an additional 11 days.
Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.
|
Placebo Oral Capsule
n=20 Participants
Participants will take placebo for the 2 weeks after surgery.
Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
|
|---|---|---|
|
Pain During Normal Activities (Surgical Pain Scale Item 2)
|
1.6 units on a scale
Standard Deviation 1.5
|
3.2 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 7 days after surgeryPopulation: Participants who underwent a sacrospinous ligament fixation surgery with follow-up data 7 days after surgery
Gluteal post-op pain will be measured by an item similar to that used for the primary outcome which asks for the average amount of gluteal pain felt during normal activity in the last 24 hours on a scale of 1-10 with 10 representing the most intense/worst pain.
Outcome measures
| Measure |
Gabapentin
n=19 Participants
Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg BID for an additional 11 days.
Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.
|
Placebo Oral Capsule
n=20 Participants
Participants will take placebo for the 2 weeks after surgery.
Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
|
|---|---|---|
|
Gluteal Pain During Normal Activities
|
2.1 units on a scale
Standard Deviation 2.0
|
3.4 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 7 days after surgeryPopulation: Participants who underwent sacrospinous ligament fixation surgery with follow-up data 7 days after surgery
Post-operative pain will be measured by item 4 of the surgical pain scale (SPS). This item asks for how unpleasant or disturbing the worst pain was in the last 24 hours on a scale of 1-10 with 10 representing the most intense/worst pain
Outcome measures
| Measure |
Gabapentin
n=19 Participants
Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg BID for an additional 11 days.
Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.
|
Placebo Oral Capsule
n=20 Participants
Participants will take placebo for the 2 weeks after surgery.
Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
|
|---|---|---|
|
Worst Pain (Surgical Pain Scale Item 4)
|
2.4 units on a scale
Standard Deviation 2.4
|
4.0 units on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: First 14 days after surgeryPopulation: Participants who underwent sacrospinous ligament fixation surgery with follow-up data 7 days after surgery
Median daily post-op narcotic pain medication in morphine milliequivalents per day during the first 14 days after surgery
Outcome measures
| Measure |
Gabapentin
n=19 Participants
Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg BID for an additional 11 days.
Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.
|
Placebo Oral Capsule
n=20 Participants
Participants will take placebo for the 2 weeks after surgery.
Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
|
|---|---|---|
|
Daily Narcotic Use
|
1.6 morphine milliequivalents per day
Interval 0.5 to 4.4
|
1.6 morphine milliequivalents per day
Interval 0.4 to 5.5
|
Adverse Events
Gabapentin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Oral Capsule
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gabapentin
n=21 participants at risk
Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg BID for an additional 11 days.
Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.
|
Placebo Oral Capsule
n=22 participants at risk
Participants will take placebo for the 2 weeks after surgery.
Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 1 • From the day of surgery until the 6-week postoperative visit
|
0.00%
0/22 • From the day of surgery until the 6-week postoperative visit
|
|
Nervous system disorders
Drowsiness
|
4.8%
1/21 • Number of events 1 • From the day of surgery until the 6-week postoperative visit
|
0.00%
0/22 • From the day of surgery until the 6-week postoperative visit
|
Additional Information
Jennifer Wu, MD, MPH, Professor of OBGYN
University of North Carolina at Chapel Hill
Phone: 919-966-0014
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place