Trial Outcomes & Findings for Gabapentin for Perioperative Pain Relief in Surgical Abortion (NCT NCT04292171)
NCT ID: NCT04292171
Last Updated: 2020-12-02
Results Overview
100mm Visual analog scale (VAS) for level of pain, 1-100, 1=no pain, 100= extreme pain
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
219 participants
Primary outcome timeframe
5 minutes postoperative
Results posted on
2020-12-02
Participant Flow
Participant milestones
| Measure |
Gabapentin Arm
Gabapentin 600 mg given 1-2 hours prior to surgical abortion
Gabapentin: Preoperative treatment with Gabapentin
|
Placebo Arm
Placebo (vit C) given 1-2 hours prior to surgical abortion
Placebos: Preoperative treatment with Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
109
|
110
|
|
Overall Study
COMPLETED
|
107
|
109
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Gabapentin Arm
Gabapentin 600 mg given 1-2 hours prior to surgical abortion
Gabapentin: Preoperative treatment with Gabapentin
|
Placebo Arm
Placebo (vit C) given 1-2 hours prior to surgical abortion
Placebos: Preoperative treatment with Placebo
|
|---|---|---|
|
Overall Study
Pharmacy error
|
2
|
0
|
|
Overall Study
Delivered prior to procedure
|
0
|
1
|
Baseline Characteristics
Gabapentin for Perioperative Pain Relief in Surgical Abortion
Baseline characteristics by cohort
| Measure |
Gabapentin Arm
n=107 Participants
Gabapentin 600 mg given 1-2 hours prior to surgical abortion
Gabapentin: Preoperative treatment with Gabapentin
|
Placebo Arm
n=109 Participants
Placebo (vit C) given 1-2 hours prior to surgical abortion
Placebos: Preoperative treatment with Placebo
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.7 years
STANDARD_DEVIATION 6.26 • n=5 Participants
|
27.1 years
STANDARD_DEVIATION 6.03 • n=7 Participants
|
27.4 years
STANDARD_DEVIATION 6.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
36 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
53 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/ African American
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hawiian/Pacific Islander
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
other
|
17 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
more than one
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
107 participants
n=5 Participants
|
109 participants
n=7 Participants
|
216 participants
n=5 Participants
|
|
Pregnancy History
Previous Pregnancy "YES"
|
82 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Pregnancy History
History of Vaginal deliveries
|
40 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Pregnancy History
History of cesarean delivery
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Pregnancy History
History of Abortions
|
51 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Pregnancy History
History of Miscarriages
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Pregnancy History
History of Stillbirths
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Pregnancy History
history of ectopic pregnancy
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Pregnancy History
History of Surgical Abortion
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Living Arrangements
Alone
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Living Arrangements
with Partner
|
44 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Living Arrangements
with Children
|
28 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Living Arrangements
with Friends
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Living Arrangements
with Family
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 minutes postoperative100mm Visual analog scale (VAS) for level of pain, 1-100, 1=no pain, 100= extreme pain
Outcome measures
| Measure |
Gabapentin Arm
n=107 Participants
Gabapentin 600 mg given 1-2 hours prior to surgical abortion
Gabapentin: Preoperative treatment with Gabapentin
|
Placebo Arm
n=109 Participants
Placebo (vit C) given 1-2 hours prior to surgical abortion
Placebos: Preoperative treatment with Placebo
|
|---|---|---|
|
Pain Score
|
17 score on a scale
Interval 0.0 to 60.0
|
17 score on a scale
Interval 2.0 to 53.0
|
SECONDARY outcome
Timeframe: 24 hours postopPopulation: We lost to followup 40 in Gaba arm, 48 in the placebo arm at 24 hrs - these patients did not respond to our calls
Pain at 24 hours postoperative on 100mm VAS, 1=no pain, 100=extreme pain
Outcome measures
| Measure |
Gabapentin Arm
n=67 Participants
Gabapentin 600 mg given 1-2 hours prior to surgical abortion
Gabapentin: Preoperative treatment with Gabapentin
|
Placebo Arm
n=61 Participants
Placebo (vit C) given 1-2 hours prior to surgical abortion
Placebos: Preoperative treatment with Placebo
|
|---|---|---|
|
Pain Score 24
|
0 score on a scale
Interval 0.0 to 20.0
|
1 score on a scale
Interval 0.0 to 12.5
|
SECONDARY outcome
Timeframe: 24 hours postoperativeNausea at 24 hours using 100mm VAS, 1=none, 100=extreme
Outcome measures
| Measure |
Gabapentin Arm
n=68 Participants
Gabapentin 600 mg given 1-2 hours prior to surgical abortion
Gabapentin: Preoperative treatment with Gabapentin
|
Placebo Arm
n=61 Participants
Placebo (vit C) given 1-2 hours prior to surgical abortion
Placebos: Preoperative treatment with Placebo
|
|---|---|---|
|
Nausea
|
1.74 VAS 100mm
Standard Deviation 10.923
|
1.74 VAS 100mm
Standard Deviation 8.140
|
SECONDARY outcome
Timeframe: 24 hours postoperativeVomiting at 24 hrs, 100mm VAS, 1=none, 100=extreme
Outcome measures
| Measure |
Gabapentin Arm
n=68 Participants
Gabapentin 600 mg given 1-2 hours prior to surgical abortion
Gabapentin: Preoperative treatment with Gabapentin
|
Placebo Arm
n=61 Participants
Placebo (vit C) given 1-2 hours prior to surgical abortion
Placebos: Preoperative treatment with Placebo
|
|---|---|---|
|
Vomiting
|
0.85 VAS 100mm
Standard Deviation 6.063
|
0.74 VAS 100mm
Standard Deviation 5.125
|
SECONDARY outcome
Timeframe: 30 minutes postoperative100mm Visual analog scale for level of pain, 1-100, 1=no pain, 100= extreme pain
Outcome measures
| Measure |
Gabapentin Arm
n=107 Participants
Gabapentin 600 mg given 1-2 hours prior to surgical abortion
Gabapentin: Preoperative treatment with Gabapentin
|
Placebo Arm
n=109 Participants
Placebo (vit C) given 1-2 hours prior to surgical abortion
Placebos: Preoperative treatment with Placebo
|
|---|---|---|
|
Pain Score at 30 Minutes Postoperative
|
20 score on a scale
Interval 3.0 to 55.0
|
23 score on a scale
Interval 3.0 to 57.0
|
Adverse Events
Gabapentin Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Arm
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
Adam V. Levy MD
University of Nevada Las Vegas School of Medicine
Phone: 702-671-2300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place