Trial Outcomes & Findings for Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management (NCT NCT02944656)
NCT ID: NCT02944656
Last Updated: 2019-08-08
Results Overview
The primary outcome measure is a pain score using a 100-mm visual analog scale (VAS) measured intraoperatively at time of evacuation. "No pain" is scored as 0 and "worst pain imaginable" is scored as 100.
COMPLETED
PHASE4
114 participants
During the procedure on Study Day 1
2019-08-08
Participant Flow
Participants were recruited from the Atlanta Women's Center in Atlanta, Georgia. Enrollment began on December 8, 2016 and all study procedures concluded on June 26, 2018.
A total of 122 individuals were eligible and consented to participate in the study. Six withdrew prior to randomization and an additional 2 withdrew prior to beginning the study, resulting in 114 receiving the intervention.
Participant milestones
| Measure |
Gabapentin Group
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
|
Placebo Group
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
57
|
|
Overall Study
Completed Procedure Day
|
54
|
57
|
|
Overall Study
Completed Day 1 Follow up
|
47
|
47
|
|
Overall Study
COMPLETED
|
47
|
47
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
| Measure |
Gabapentin Group
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
|
Placebo Group
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
|
|---|---|---|
|
Overall Study
No longer eligible
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
7
|
10
|
Baseline Characteristics
Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management
Baseline characteristics by cohort
| Measure |
Gabapentin Group
n=54 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
|
Placebo Group
n=57 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.2 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
26.8 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
26.01 years
STANDARD_DEVIATION 5.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
111 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
106 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
American Indian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
35 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed or multi-racial
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Don't know/Refused/Not Specified
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
57 participants
n=7 Participants
|
111 participants
n=5 Participants
|
|
Gestational age
|
60.1 days
STANDARD_DEVIATION 15.1 • n=5 Participants
|
62.5 days
STANDARD_DEVIATION 13.2 • n=7 Participants
|
61.3 days
STANDARD_DEVIATION 14.10 • n=5 Participants
|
PRIMARY outcome
Timeframe: During the procedure on Study Day 1Population: Participants completing all assessments on the day of the procedure are included in this analysis.
The primary outcome measure is a pain score using a 100-mm visual analog scale (VAS) measured intraoperatively at time of evacuation. "No pain" is scored as 0 and "worst pain imaginable" is scored as 100.
Outcome measures
| Measure |
Gabapentin Group
n=54 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
|
Placebo Group
n=57 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
|
|---|---|---|
|
Pain at Time of Uterine Evacuation
Aspiration
|
67.77 score on a scale
Standard Error 3.63
|
71.06 score on a scale
Standard Error 3.49
|
|
Pain at Time of Uterine Evacuation
Paracervical block
|
63.79 score on a scale
Standard Error 3.77
|
62.21 score on a scale
Standard Error 3.52
|
|
Pain at Time of Uterine Evacuation
Dilation
|
64.58 score on a scale
Standard Error 3.74
|
66.12 score on a scale
Standard Error 3.54
|
SECONDARY outcome
Timeframe: Pre-procedure through post-procedure on Study Day 1Population: Participants completing all assessments on the day of the procedure are included in this analysis.
Pain level at a variety of time points will be measured using a 100-mm visual analog scale (VAS) to log the change in pain levels between the study arms. "No pain" is scored as 0 and "worst pain imaginable" is scored as 100. Pain will be assessed immediately prior to the procedure, at completion of the procedure (removal of the speculum), 10 minutes following the procedure, and 30 minutes following the procedure (at discharge).
Outcome measures
| Measure |
Gabapentin Group
n=54 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
|
Placebo Group
n=57 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
|
|---|---|---|
|
Perioperative Pain Level
10 minutes post-procedure
|
30.64 score on a scale
Standard Error 3.65
|
43.68 score on a scale
Standard Error 3.47
|
|
Perioperative Pain Level
Prior to procedure
|
20.76 score on a scale
Standard Error 3.60
|
22.48 score on a scale
Standard Error 3.49
|
|
Perioperative Pain Level
Speculum removal
|
44.10 score on a scale
Standard Error 3.60
|
47.61 score on a scale
Standard Error 3.52
|
|
Perioperative Pain Level
30 minutes post-procedure
|
20.89 score on a scale
Standard Error 3.68
|
31.65 score on a scale
Standard Error 3.54
|
SECONDARY outcome
Timeframe: Postoperative Day 1Population: Participants completing the follow up assessment one day after the procedure are included in this analysis.
The number of participants reporting filling and using the prescription for ibuprofen postoperatively. During the follow-up phone call on the day after the procedure, participants were asked whether or not they filled the pain medication prescription and if they took any of the medication.
Outcome measures
| Measure |
Gabapentin Group
n=47 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
|
Placebo Group
n=47 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
|
|---|---|---|
|
Number of Participants Using Pain Medication
|
24 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Pre-procedure through post-procedure on Study Day 1Population: Participants completing all assessments on the day of the procedure are included in this analysis.
Nausea level was measured using a 100-mm visual analog scale (VAS) to log the change in nausea levels between the study arms. No nausea is reported as 0 while "worst nausea I have ever felt" is reported at 100. Nausea was reported immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure.
Outcome measures
| Measure |
Gabapentin Group
n=54 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
|
Placebo Group
n=57 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
|
|---|---|---|
|
Perioperative Nausea
Prior to procedure
|
26 score on a scale
Interval 3.0 to 57.0
|
26 score on a scale
Interval 9.0 to 59.0
|
|
Perioperative Nausea
10 minutes post-procedure
|
1 score on a scale
Interval 0.0 to 22.0
|
12 score on a scale
Interval 0.0 to 52.0
|
|
Perioperative Nausea
30 minutes post-procedure
|
0 score on a scale
Interval 0.0 to 16.0
|
5 score on a scale
Interval 0.0 to 26.0
|
SECONDARY outcome
Timeframe: Pre-procedure through post-procedure on Study Day 1Population: Participants completing all assessments on the day of the procedure are included in this analysis.
Participants reported if they vomited during the perioperative period to assess changes in vomiting incidences between the study arms. Vomiting is reported for the time periods of immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure.
Outcome measures
| Measure |
Gabapentin Group
n=54 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
|
Placebo Group
n=57 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
|
|---|---|---|
|
Perioperative Vomiting
Prior to procedure
|
4 Participants
|
7 Participants
|
|
Perioperative Vomiting
10 minutes post-procedure
|
5 Participants
|
2 Participants
|
|
Perioperative Vomiting
30 minutes post-procedure
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Pre-procedure through post-procedure on Study Day 1Population: Participants completing all assessments on the day of the procedure are included in this analysis.
Participants reported how much anxiety they were currently experiencing on a 100-point scale where "No Anxiety" is scored as 0 and "Extremely Anxious" is scored as 100. Anxiety is reported for the time periods of immediately prior to the procedure, 10 minutes after the procedure, and 30 minutes after the procedure.
Outcome measures
| Measure |
Gabapentin Group
n=54 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
|
Placebo Group
n=57 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
|
|---|---|---|
|
Anxiety Levels
Prior to procedure
|
66 score on a scale
Interval 21.0 to 83.0
|
72 score on a scale
Interval 52.0 to 96.5
|
|
Anxiety Levels
10 minutes post-procedure
|
14 score on a scale
Interval 0.0 to 36.0
|
17 score on a scale
Interval 0.0 to 49.0
|
|
Anxiety Levels
30 minutes post-procedure
|
4 score on a scale
Interval 0.0 to 29.0
|
2 score on a scale
Interval 0.0 to 27.0
|
SECONDARY outcome
Timeframe: 10 and 30 minutes post procedure on Study Day 1Population: This analysis includes participants responding to the side effects questions. Two did not answer any questions. Two participants in the gabapentin group did not complete the side effect assessment at 30 minutes post-procedure. One participant in the placebo group did not respond to the assessment of weakness at 30 minutes post-procedure.
Participants were asked if they experienced dizziness, lack of muscle control, sleepiness or drowsiness, weakness or lack of energy, headache, or visual changes.
Outcome measures
| Measure |
Gabapentin Group
n=53 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
|
Placebo Group
n=56 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
|
|---|---|---|
|
Side Effects
Dizziness 10 minutes post-procedure
|
27 Participants
|
23 Participants
|
|
Side Effects
Dizziness 30 minutes post-procedure
|
19 Participants
|
15 Participants
|
|
Side Effects
Lack of muscle control 10 minutes post-procedure
|
9 Participants
|
9 Participants
|
|
Side Effects
Lack of muscle control 30 minutes post-procedure
|
5 Participants
|
10 Participants
|
|
Side Effects
Sleepiness/drowsiness 10 minutes post-procedure
|
38 Participants
|
34 Participants
|
|
Side Effects
Sleepiness/drowsiness 30 minutes post-procedure
|
30 Participants
|
29 Participants
|
|
Side Effects
Weakness 10 minutes post-procedure
|
33 Participants
|
34 Participants
|
|
Side Effects
Weakness 30 minutes post-procedure
|
20 Participants
|
28 Participants
|
|
Side Effects
Headache 10 minutes post-procedure
|
5 Participants
|
4 Participants
|
|
Side Effects
Headache 30 minutes post-procedure
|
4 Participants
|
4 Participants
|
|
Side Effects
Vision changes 10 minutes post-procedure
|
9 Participants
|
11 Participants
|
|
Side Effects
Vision changes 30 minutes post-procedure
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Postoperative Day 1Population: Participants completing the follow up assessment one day after the procedure are included in this analysis.
During the Postoperative Day 1 phone call, participants self reported how much they experienced moderate pain in the last 24 hours where 10 = none of the time and 0 = all of the time. "Moderate pain" was defined according to the perception of each participant.
Outcome measures
| Measure |
Gabapentin Group
n=47 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
|
Placebo Group
n=47 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
|
|---|---|---|
|
Moderate Pain at Postoperation Follow-up Assessment
|
5.2 units on a scale
Standard Deviation 3.5
|
5.2 units on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Postoperative Day 1Population: Participants completing the follow up assessment one day after the procedure are included in this analysis.
During the Postoperative Day 1 phone call, participants self reported how much they experienced severe pain in the last 24 hours where 10 = none of the time and 0 = all of the time. "Severe pain" was defined according to the perception of each participant.
Outcome measures
| Measure |
Gabapentin Group
n=47 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
|
Placebo Group
n=47 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
|
|---|---|---|
|
Severe Pain at Postoperation Follow-up Assessment
|
3.5 units on a scale
Standard Deviation 4.1
|
3.2 units on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Postoperative Day 1Population: Participants completing the follow up assessment one day after the procedure are included in this analysis.
During the Postoperative Day 1 phone call, participants self reported how much they experienced nausea or vomiting in the last 24 hours where 10 = none of the time and 0 = all of the time. Nausea and vomiting were self-reported together as a single outcome.
Outcome measures
| Measure |
Gabapentin Group
n=47 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
|
Placebo Group
n=47 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
|
|---|---|---|
|
Nausea or Vomiting at Postoperation Follow-up Assessment
|
2.3 units on a scale
Standard Deviation 3.9
|
3.2 units on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Postoperative Day 1Population: Participants completing the follow up assessment one day after the procedure are included in this analysis.
During the Postoperative Day 1 phone call, participants self reported whether or not they had vomited since leaving the clinic.
Outcome measures
| Measure |
Gabapentin Group
n=47 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
|
Placebo Group
n=47 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
|
|---|---|---|
|
Vomiting Since Leaving Clinic
Vomiting at least once
|
1 Participants
|
2 Participants
|
|
Vomiting Since Leaving Clinic
No vomiting
|
46 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Postoperative Day 1Population: Participants completing the follow up assessment one day after the procedure are included in this analysis.
Overall satisfaction with the procedure was assessed on a 10-point scale on the day after the procedure, where 1 = very dissatisfied and 10 = very satisfied.
Outcome measures
| Measure |
Gabapentin Group
n=47 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
|
Placebo Group
n=47 Participants
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
|
|---|---|---|
|
Overall Satisfaction With the Procedure
1 (very dissatisfied)
|
0 Participants
|
1 Participants
|
|
Overall Satisfaction With the Procedure
2
|
0 Participants
|
0 Participants
|
|
Overall Satisfaction With the Procedure
3
|
0 Participants
|
2 Participants
|
|
Overall Satisfaction With the Procedure
4
|
0 Participants
|
2 Participants
|
|
Overall Satisfaction With the Procedure
5
|
5 Participants
|
4 Participants
|
|
Overall Satisfaction With the Procedure
6
|
0 Participants
|
1 Participants
|
|
Overall Satisfaction With the Procedure
7
|
4 Participants
|
2 Participants
|
|
Overall Satisfaction With the Procedure
8
|
15 Participants
|
7 Participants
|
|
Overall Satisfaction With the Procedure
9
|
5 Participants
|
11 Participants
|
|
Overall Satisfaction With the Procedure
10 (very satisfied)
|
18 Participants
|
17 Participants
|
Adverse Events
Gabapentin Group
Placebo Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gabapentin Group
n=54 participants at risk
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
|
Placebo Group
n=57 participants at risk
Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.
|
|---|---|---|
|
General disorders
Low Blood Pressure
|
1.9%
1/54 • Data on adverse events were collected from the time of investigational medication administration through the follow up phone call on the day after the procedure.
In addition to specific side effects collected as an outcome measure, adverse effects were tracked and monitored during the study. An adverse event is defined as any health-related reaction, effect, toxicity or abnormal laboratory result experienced during the course of the study, irrespective of relationship to the study intervention.
|
0.00%
0/57 • Data on adverse events were collected from the time of investigational medication administration through the follow up phone call on the day after the procedure.
In addition to specific side effects collected as an outcome measure, adverse effects were tracked and monitored during the study. An adverse event is defined as any health-related reaction, effect, toxicity or abnormal laboratory result experienced during the course of the study, irrespective of relationship to the study intervention.
|
|
Gastrointestinal disorders
Increased nausea and vomiting
|
0.00%
0/54 • Data on adverse events were collected from the time of investigational medication administration through the follow up phone call on the day after the procedure.
In addition to specific side effects collected as an outcome measure, adverse effects were tracked and monitored during the study. An adverse event is defined as any health-related reaction, effect, toxicity or abnormal laboratory result experienced during the course of the study, irrespective of relationship to the study intervention.
|
1.8%
1/57 • Data on adverse events were collected from the time of investigational medication administration through the follow up phone call on the day after the procedure.
In addition to specific side effects collected as an outcome measure, adverse effects were tracked and monitored during the study. An adverse event is defined as any health-related reaction, effect, toxicity or abnormal laboratory result experienced during the course of the study, irrespective of relationship to the study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place