Trial Outcomes & Findings for Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration (NCT NCT02725710)
NCT ID: NCT02725710
Last Updated: 2019-07-02
Results Overview
Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
5 minutes
Results posted on
2019-07-02
Participant Flow
Recruited between August 2016 and June 2018.
One subject randomized to gabapentin withdrew from the procedure.
Participant milestones
| Measure |
Group 1: Placebo
Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure
|
Group 2: Gabapentin
Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.
Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
47
|
|
Overall Study
COMPLETED
|
47
|
47
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1: Placebo
Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure
|
Group 2: Gabapentin
Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.
Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration
Baseline characteristics by cohort
| Measure |
Group 1: Placebo
n=48 Participants
Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure
|
Group 2: Gabapentin
n=47 Participants
Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.
Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.8 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
31.7 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
31.7 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
95 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
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
87 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 (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
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 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
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 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
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
47 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Baseline Pain
|
3.3 units on a scale
n=5 Participants
|
3.0 units on a scale
n=7 Participants
|
3.0 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 minutesScore range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.
Outcome measures
| Measure |
Group 1: Placebo
n=48 Participants
Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure
|
Group 2: Gabapentin
n=47 Participants
Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.
Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
|
|---|---|---|
|
Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure
|
35.7 score on a scale
Standard Deviation 27.5
|
37.1 score on a scale
Standard Deviation 30.4
|
SECONDARY outcome
Timeframe: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minuteMeasured at baseline, 10 minutes post-procedure, and 30 minutes post-procedure. Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.
Outcome measures
| Measure |
Group 1: Placebo
n=48 Participants
Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure
|
Group 2: Gabapentin
n=47 Participants
Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.
Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
|
|---|---|---|
|
Pain Score on the 100-mm VAS
Baseline
|
3.3 units on a scale
Interval 0.5 to 22.3
|
3.0 units on a scale
Interval 0.0 to 9.0
|
|
Pain Score on the 100-mm VAS
10 minutes
|
19.8 units on a scale
Interval 7.5 to 42.5
|
20.0 units on a scale
Interval 3.0 to 47.5
|
|
Pain Score on the 100-mm VAS
30 minutes
|
12.6 units on a scale
Interval 3.3 to 30.8
|
9.5 units on a scale
Interval 1.0 to 31.5
|
SECONDARY outcome
Timeframe: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutesScore range of 0 to 100, where 0 means no nausea and 100 means worst nausea in my life.
Outcome measures
| Measure |
Group 1: Placebo
n=48 Participants
Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure
|
Group 2: Gabapentin
n=47 Participants
Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.
Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
|
|---|---|---|
|
Perioperative Nausea as Measured by 100-mm VAS
Baseline
|
3.0 units on a scale
Interval 0.0 to 12.5
|
3.0 units on a scale
Interval 0.0 to 20.0
|
|
Perioperative Nausea as Measured by 100-mm VAS
10 minutes
|
2.5 units on a scale
Interval 0.0 to 14.0
|
1.0 units on a scale
Interval 0.0 to 15.0
|
|
Perioperative Nausea as Measured by 100-mm VAS
30 minutes
|
2.3 units on a scale
Interval 0.0 to 10.8
|
1.0 units on a scale
Interval 0.0 to 18.0
|
SECONDARY outcome
Timeframe: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutesOutcome measures
| Measure |
Group 1: Placebo
n=48 Participants
Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure
|
Group 2: Gabapentin
n=47 Participants
Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.
Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
|
|---|---|---|
|
Number of Subjects Experiencing Perioperative Vomiting
30 minutes
|
1 Participants
|
5 Participants
|
|
Number of Subjects Experiencing Perioperative Vomiting
Baseline
|
1 Participants
|
0 Participants
|
|
Number of Subjects Experiencing Perioperative Vomiting
10 minutes
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 5 minutes, 10 minutes, 30 minutes, dischargePopulation: One subject in the placebo group did not have anxiety at discharge measured.
Score range of 0 to 100, where 0 means no anxiety and 100 means extremely anxious.
Outcome measures
| Measure |
Group 1: Placebo
n=48 Participants
Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure
|
Group 2: Gabapentin
n=47 Participants
Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.
Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
|
|---|---|---|
|
Perioperative Anxiety as Measured by the 100-mm VAS
5 minutes
|
24.5 units on a scale
Interval 10.0 to 50.5
|
23.5 units on a scale
Interval 6.0 to 49.5
|
|
Perioperative Anxiety as Measured by the 100-mm VAS
10 minutes
|
14.5 units on a scale
Interval 3.8 to 43.5
|
11.0 units on a scale
Interval 4.0 to 36.0
|
|
Perioperative Anxiety as Measured by the 100-mm VAS
30 minutes
|
13.3 units on a scale
Interval 2.8 to 25.0
|
7.0 units on a scale
Interval 2.5 to 27.5
|
|
Perioperative Anxiety as Measured by the 100-mm VAS
Discharge
|
10.5 units on a scale
Interval 2.0 to 27.0
|
8.0 units on a scale
Interval 3.0 to 23.0
|
SECONDARY outcome
Timeframe: 24 hours post-operativelyPopulation: The number of subjects analyzed for "ibuprofen and oxycodone" and "oxycodone only" reflects the number of subjects that received a prescription for opiates.
Pain medications included ibuprofen and oxycodone.
Outcome measures
| Measure |
Group 1: Placebo
n=48 Participants
Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure
|
Group 2: Gabapentin
n=47 Participants
Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.
Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
|
|---|---|---|
|
Number of Subjects Using Pain Medications
No pain medication
|
10 Participants
|
17 Participants
|
|
Number of Subjects Using Pain Medications
Ibuprofen only
|
23 Participants
|
23 Participants
|
|
Number of Subjects Using Pain Medications
Ibuprofen and oxycodone
|
9 Participants
|
6 Participants
|
|
Number of Subjects Using Pain Medications
Oxycodone only
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 10 minutes post-procedureSide effects noted are dizziness, ataxia, somnolence, asthenia, headache, and amblyopia.
Outcome measures
| Measure |
Group 1: Placebo
n=48 Participants
Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure
|
Group 2: Gabapentin
n=47 Participants
Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.
Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
|
|---|---|---|
|
Number of Subjects Experiencing Side Effects
Ataxia
|
8 Participants
|
6 Participants
|
|
Number of Subjects Experiencing Side Effects
Somnolence
|
37 Participants
|
41 Participants
|
|
Number of Subjects Experiencing Side Effects
Asthenia
|
31 Participants
|
27 Participants
|
|
Number of Subjects Experiencing Side Effects
Headache
|
5 Participants
|
5 Participants
|
|
Number of Subjects Experiencing Side Effects
Amblyopia
|
3 Participants
|
3 Participants
|
|
Number of Subjects Experiencing Side Effects
Dizziness
|
14 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Post-operative day 1Population: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-operative day 1Population: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-operative day 1Population: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-operative day 1Population: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-operative day 1Population: Data not collected.
Outcome measures
Outcome data not reported
Adverse Events
Group 1: Placebo
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Group 2: Gabapentin
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Placebo
n=48 participants at risk
Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure
|
Group 2: Gabapentin
n=47 participants at risk
Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.
Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
29.2%
14/48 • 10 minutes post-procedure
|
42.6%
20/47 • 10 minutes post-procedure
|
|
Nervous system disorders
Ataxia
|
16.7%
8/48 • 10 minutes post-procedure
|
12.8%
6/47 • 10 minutes post-procedure
|
|
General disorders
Somnolence
|
77.1%
37/48 • 10 minutes post-procedure
|
87.2%
41/47 • 10 minutes post-procedure
|
|
Nervous system disorders
Asthenia
|
64.6%
31/48 • 10 minutes post-procedure
|
57.4%
27/47 • 10 minutes post-procedure
|
|
Nervous system disorders
Headache
|
10.4%
5/48 • 10 minutes post-procedure
|
10.6%
5/47 • 10 minutes post-procedure
|
|
Eye disorders
Amblyopia
|
6.2%
3/48 • 10 minutes post-procedure
|
6.4%
3/47 • 10 minutes post-procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place