Trial Outcomes & Findings for Single Dose Preoperative Gabapentin Use in Minimally Invasive Hysterectomy for Acute Pain Management (NCT NCT02703259)
NCT ID: NCT02703259
Last Updated: 2020-05-20
Results Overview
Assessment of the amount of narcotic use postoperatively at 24 hours. will use opioid equivalence table to convert all narcotic use to oxycodone equivalents
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
137 participants
Primary outcome timeframe
24 hours
Results posted on
2020-05-20
Participant Flow
Patient were recruited from June 2016 to July 2017 via phone or in the office setting. Potential subjects were informed of the study by investigators and if they desired to participate, they either signed consents forms in the office or on the day of surgery.
There were no events prior to assignment in study arm after participant enrollment.
Participant milestones
| Measure |
Gabapentin
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen, celecoxib, and gabapentin x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:
Gabapentin 600 mg (two capsules of gabapetin 300 mg); Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (two capsules of celecoxib 200 mg) = Total 3 tablets, 4 capsules
Gabapentin
Acetaminophen
Celecoxib
|
Control
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen and celecoxib x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:
Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (four capsules of celecoxib 100 mg) = Total total 3 tablets, 4 capsules
Acetaminophen
Celecoxib
|
|---|---|---|
|
24 Hours Postoperative Assessment
STARTED
|
70
|
67
|
|
24 Hours Postoperative Assessment
COMPLETED
|
68
|
61
|
|
24 Hours Postoperative Assessment
NOT COMPLETED
|
2
|
6
|
|
2 Weeks Postoperative Assessment
STARTED
|
68
|
61
|
|
2 Weeks Postoperative Assessment
COMPLETED
|
58
|
51
|
|
2 Weeks Postoperative Assessment
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
| Measure |
Gabapentin
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen, celecoxib, and gabapentin x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:
Gabapentin 600 mg (two capsules of gabapetin 300 mg); Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (two capsules of celecoxib 200 mg) = Total 3 tablets, 4 capsules
Gabapentin
Acetaminophen
Celecoxib
|
Control
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen and celecoxib x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:
Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (four capsules of celecoxib 100 mg) = Total total 3 tablets, 4 capsules
Acetaminophen
Celecoxib
|
|---|---|---|
|
24 Hours Postoperative Assessment
Lost to Follow-up
|
1
|
4
|
|
24 Hours Postoperative Assessment
excluded from analysis per protocol
|
1
|
2
|
|
2 Weeks Postoperative Assessment
Lost to Follow-up
|
10
|
10
|
Baseline Characteristics
Single Dose Preoperative Gabapentin Use in Minimally Invasive Hysterectomy for Acute Pain Management
Baseline characteristics by cohort
| Measure |
Gabapentin
n=68 Participants
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen, celecoxib, and gabapentin x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:
Gabapentin 600 mg (two capsules of gabapetin 300 mg); Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (two capsules of celecoxib 200 mg) = Total 3 tablets, 4 capsules
Gabapentin
Acetaminophen
Celecoxib
|
Control
n=61 Participants
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen and celecoxib x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:
Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (four capsules of celecoxib 100 mg) = Total total 3 tablets, 4 capsules
Acetaminophen
Celecoxib
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 12.56 • n=99 Participants
|
52.3 years
STANDARD_DEVIATION 11.6 • n=107 Participants
|
51.2 years
STANDARD_DEVIATION 12.17 • n=206 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
43 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American/African
|
25 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=99 Participants
|
61 participants
n=107 Participants
|
129 participants
n=206 Participants
|
|
BMI
< 30 kg/m^2
|
36 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
BMI
>/= 30 kg/m^2
|
32 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Narcotic Use within week prior to surgery
|
11 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
History chronic pain
|
26 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Prior abdominal surgery
|
43 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Preoperative pain score, within past week
|
1.7 units on a scale
STANDARD_DEVIATION 2.9 • n=99 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 3.2 • n=107 Participants
|
1.7 units on a scale
STANDARD_DEVIATION 3.0 • n=206 Participants
|
|
Preoperative pain score, within past 24 hours
|
1.2 units on a scale
STANDARD_DEVIATION 2.5 • n=99 Participants
|
1.1 units on a scale
STANDARD_DEVIATION 2.5 • n=107 Participants
|
1.1 units on a scale
STANDARD_DEVIATION 2.5 • n=206 Participants
|
|
Preoperative pain score, in prep and hold
|
1.0 units on a scale
STANDARD_DEVIATION 2.0 • n=99 Participants
|
0.6 units on a scale
STANDARD_DEVIATION 1.4 • n=107 Participants
|
0.7 units on a scale
STANDARD_DEVIATION 1.7 • n=206 Participants
|
|
Surgery Indication
Abnormal uterine bleeding
|
31 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Surgery Indication
Leiomyomas
|
28 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Surgery Indication
Adenomyosis
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Surgery Indication
Pelvic pain
|
15 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Surgery Indication
Endometriosis
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Surgery Indication
Hyperplasia
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Surgery Indication
Prolapse/Incontinence
|
21 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Hysterectomy Surgical Approach
Vaginal
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Hysterectomy Surgical Approach
Laparoscopic
|
26 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Hysterectomy Surgical Approach
Robotic
|
25 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Procedure other than Hysterectomy
Salpingectomy
|
61 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Procedure other than Hysterectomy
Oophorectomy
|
14 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Procedure other than Hysterectomy
Lysis of Adhesions
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Procedure other than Hysterectomy
Sacral colpopexy
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Procedure other than Hysterectomy
Sacropinous ligament fixation
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Procedure other than Hysterectomy
Sling
|
9 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Procedure other than Hysterectomy
Use of mesh
|
11 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Procedure other than Hysterectomy
Cystoscopy
|
48 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Procedure other than Hysterectomy
Uterosacral ligament fixation
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Procedure other than Hysterectomy
Anterior/posterior repair
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Procedure other than Hysterectomy
Paravaginal repair
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Method of specimen removal
Minilaparotomy
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Method of specimen removal
colpotomy
|
56 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
|
Method of specimen removal
Power morcellation
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
OR time
|
186.3 minutes
STANDARD_DEVIATION 84.3 • n=99 Participants
|
178.9 minutes
STANDARD_DEVIATION 74.6 • n=107 Participants
|
183.8 minutes
STANDARD_DEVIATION 80.4 • n=206 Participants
|
|
Estimated blood loss
|
118.6 mL
STANDARD_DEVIATION 106.6 • n=99 Participants
|
155.9 mL
STANDARD_DEVIATION 271.2 • n=107 Participants
|
137.3 mL
STANDARD_DEVIATION 206.9 • n=206 Participants
|
PRIMARY outcome
Timeframe: 24 hoursAssessment of the amount of narcotic use postoperatively at 24 hours. will use opioid equivalence table to convert all narcotic use to oxycodone equivalents
Outcome measures
| Measure |
Gabapentin
n=68 Participants
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen, celecoxib, and gabapentin x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:
Gabapentin 600 mg (two capsules of gabapetin 300 mg); Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (two capsules of celecoxib 200 mg) = Total 3 tablets, 4 capsules
Gabapentin
Acetaminophen
Celecoxib
|
Control
n=61 Participants
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen and celecoxib x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:
Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (four capsules of celecoxib 100 mg) = Total total 3 tablets, 4 capsules
Acetaminophen
Celecoxib
|
|---|---|---|
|
Narcotic Use at 24 Hours Postop
|
158.8 morphine milligram equivalents
Standard Deviation 109.6
|
175.0 morphine milligram equivalents
Standard Deviation 162.5
|
PRIMARY outcome
Timeframe: 24 hoursPain score assesses patient subjective pain via patient reported numeric analogue scale, range 0-10 with 0 being no pain and 10 being severe pain.
Outcome measures
| Measure |
Gabapentin
n=68 Participants
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen, celecoxib, and gabapentin x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:
Gabapentin 600 mg (two capsules of gabapetin 300 mg); Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (two capsules of celecoxib 200 mg) = Total 3 tablets, 4 capsules
Gabapentin
Acetaminophen
Celecoxib
|
Control
n=61 Participants
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen and celecoxib x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:
Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (four capsules of celecoxib 100 mg) = Total total 3 tablets, 4 capsules
Acetaminophen
Celecoxib
|
|---|---|---|
|
Subjective Pain at 24 Hours Postoperative
|
3.4 score on a scale
Standard Deviation 2.5
|
3.4 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 24 hoursWill assess for known symptoms of gabapentin postoperatively at 24 hours. We will survey subjects regarding their experience of the following symptoms: dizziness/drowsiness, fatigue, loss of balance, blurry vision, tremulousness, swelling, nausea, vomiting, diarrhea, and allergic reaction
Outcome measures
| Measure |
Gabapentin
n=68 Participants
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen, celecoxib, and gabapentin x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:
Gabapentin 600 mg (two capsules of gabapetin 300 mg); Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (two capsules of celecoxib 200 mg) = Total 3 tablets, 4 capsules
Gabapentin
Acetaminophen
Celecoxib
|
Control
n=61 Participants
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen and celecoxib x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:
Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (four capsules of celecoxib 100 mg) = Total total 3 tablets, 4 capsules
Acetaminophen
Celecoxib
|
|---|---|---|
|
Number of Patient With Gabapentin Adverse Effects at 24 Hours Postoperatively
Dizziness
|
17 Participants
|
8 Participants
|
|
Number of Patient With Gabapentin Adverse Effects at 24 Hours Postoperatively
Blurred Vision
|
7 Participants
|
4 Participants
|
|
Number of Patient With Gabapentin Adverse Effects at 24 Hours Postoperatively
Somnolence
|
20 Participants
|
23 Participants
|
|
Number of Patient With Gabapentin Adverse Effects at 24 Hours Postoperatively
Difficulty walking
|
13 Participants
|
11 Participants
|
|
Number of Patient With Gabapentin Adverse Effects at 24 Hours Postoperatively
Tremulousness
|
11 Participants
|
6 Participants
|
|
Number of Patient With Gabapentin Adverse Effects at 24 Hours Postoperatively
Nausea
|
24 Participants
|
25 Participants
|
|
Number of Patient With Gabapentin Adverse Effects at 24 Hours Postoperatively
Vomiting
|
9 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: participants included in analysis differs from participant flow due to subjects loss to follow up at the 2 weeks time frame. study powered to primary outcome at 24 hours postoperative. 10 subjects were lost to follow up at 2 weeks postoperative in both the gabapentin and control arm.
Will assess for known symptoms of gabapentin postoperatively at 2 weeks. We will survey subjects regarding their experience of the following symptoms: dizziness/drowsiness, fatigue, loss of balance, blurry vision, tremulousness, swelling, nausea, vomiting, diarrhea, and allergic reaction
Outcome measures
| Measure |
Gabapentin
n=58 Participants
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen, celecoxib, and gabapentin x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:
Gabapentin 600 mg (two capsules of gabapetin 300 mg); Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (two capsules of celecoxib 200 mg) = Total 3 tablets, 4 capsules
Gabapentin
Acetaminophen
Celecoxib
|
Control
n=51 Participants
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen and celecoxib x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:
Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (four capsules of celecoxib 100 mg) = Total total 3 tablets, 4 capsules
Acetaminophen
Celecoxib
|
|---|---|---|
|
Number of Patient With Gabapentin Adverse Effects at 2 Weeks Postoperatively
Dizziness
|
12 Participants
|
8 Participants
|
|
Number of Patient With Gabapentin Adverse Effects at 2 Weeks Postoperatively
Blurred vision
|
4 Participants
|
3 Participants
|
|
Number of Patient With Gabapentin Adverse Effects at 2 Weeks Postoperatively
Somnolence
|
18 Participants
|
21 Participants
|
|
Number of Patient With Gabapentin Adverse Effects at 2 Weeks Postoperatively
Difficulty walking
|
5 Participants
|
5 Participants
|
|
Number of Patient With Gabapentin Adverse Effects at 2 Weeks Postoperatively
Tremulousness
|
4 Participants
|
2 Participants
|
|
Number of Patient With Gabapentin Adverse Effects at 2 Weeks Postoperatively
Nausea
|
12 Participants
|
7 Participants
|
|
Number of Patient With Gabapentin Adverse Effects at 2 Weeks Postoperatively
Vomiting
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 weeksAssessment of the amount of narcotic use postoperatively at 2 weeks. will use opioid equivalence table to convert all narcotic use to oxycodone equivalents
Outcome measures
| Measure |
Gabapentin
n=58 Participants
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen, celecoxib, and gabapentin x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:
Gabapentin 600 mg (two capsules of gabapetin 300 mg); Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (two capsules of celecoxib 200 mg) = Total 3 tablets, 4 capsules
Gabapentin
Acetaminophen
Celecoxib
|
Control
n=51 Participants
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen and celecoxib x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:
Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (four capsules of celecoxib 100 mg) = Total total 3 tablets, 4 capsules
Acetaminophen
Celecoxib
|
|---|---|---|
|
Narcotic Use at 2 Weeks Postop
|
167.2 morphine milligram equivalents
Standard Deviation 79.3
|
187.3 morphine milligram equivalents
Standard Deviation 185.5
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: participants included in analysis differs from participant flow due to subjects loss to follow up at the 2 weeks time frame. study powered to primary outcome at 24 hours postoperative. 10 subjects were lost to follow up at 2 weeks postoperative in both the gabapentin and control arm.
Assessment of the subject pain score postoperatively at 2 weeks. will use a numeric analog scale from 0-10. The pain scale ranging from 0-10 with 0 representing No Pain and 10 representing the Worst Pain Possible
Outcome measures
| Measure |
Gabapentin
n=58 Participants
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen, celecoxib, and gabapentin x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:
Gabapentin 600 mg (two capsules of gabapetin 300 mg); Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (two capsules of celecoxib 200 mg) = Total 3 tablets, 4 capsules
Gabapentin
Acetaminophen
Celecoxib
|
Control
n=51 Participants
As per the enhanced recovery after surgery protocol at our health institution, subject will receive oral medications prior to surgery including acetaminophen and celecoxib x 1 dose given preoperatively. The number of tablets and capsules will remain identical in both study arms. Medications given include:
Acetaminophen 975 mg (three tablets of acetaminophen 325 mg); Celecoxib 400 mg (four capsules of celecoxib 100 mg) = Total total 3 tablets, 4 capsules
Acetaminophen
Celecoxib
|
|---|---|---|
|
Subjective Pain at 2 Weeks Postop
|
1.3 score on a scale
Standard Deviation 2.0
|
1.4 score on a scale
Standard Deviation 1.8
|
Adverse Events
Gabapentin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place