Trial Outcomes & Findings for Effect of Gabapentin on Orthopedic Pain (NCT NCT01546857)

Last Updated: 2021-01-19

Results Overview

A questionnaire was administered asking participants about the quality of their sleep on the night of surgery asked on postoperative day 1, and on the first postoperative night ( POD 2) . Scored on a scale of zero to 3. Zero meaning poor postoperative sleep and 3 indicating better postoperative sleep.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

34 participants

Primary outcome timeframe

Night of surgery (POD 1) and Postoperative Day 2.(POD 2)

Results posted on

2021-01-19

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo one dose in the evening of surgery and post op day #1. Placebo: Placebo	Gabapentin Gabapentin 400mg orally at 9pm on the evening of surgery and first day post operatively Gapabentin: 400mg orally at 9pm day of surgery and the first evening post operatively.
Overall Study STARTED	14	20
Overall Study COMPLETED	12	17
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo one dose in the evening of surgery and post op day #1. Placebo: Placebo	Gabapentin Gabapentin 400mg orally at 9pm on the evening of surgery and first day post operatively Gapabentin: 400mg orally at 9pm day of surgery and the first evening post operatively.
Overall Study Withdrawal by Subject	2	3

Baseline Characteristics

We enrolled 34 subjects but 5 withdrew from the study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=14 Participants Placebo one dose in the evening of surgery and post op day #1. Placebo: Placebo	Gabapentin n=20 Participants Gabapentin 400mg orally at 9pm on the evening of surgery and first day post operatively Gapabentin: 400mg orally at 9pm day of surgery and the first evening post operatively.	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=12 Participants • We enrolled 34 subjects but 5 withdrew from the study.	0 Participants n=17 Participants • We enrolled 34 subjects but 5 withdrew from the study.	0 Participants n=29 Participants • We enrolled 34 subjects but 5 withdrew from the study.
Age, Categorical Between 18 and 65 years	12 Participants n=12 Participants • We enrolled 34 subjects but 5 withdrew from the study.	17 Participants n=17 Participants • We enrolled 34 subjects but 5 withdrew from the study.	29 Participants n=29 Participants • We enrolled 34 subjects but 5 withdrew from the study.
Age, Categorical >=65 years	0 Participants n=12 Participants • We enrolled 34 subjects but 5 withdrew from the study.	0 Participants n=17 Participants • We enrolled 34 subjects but 5 withdrew from the study.	0 Participants n=29 Participants • We enrolled 34 subjects but 5 withdrew from the study.
Age, Continuous	53.33 years n=14 Participants	54.6 years n=20 Participants	54.1 years n=34 Participants
Sex: Female, Male Female	6 Participants n=12 Participants • 34 subject were enrolled but 5 withdrew from the study.	7 Participants n=17 Participants • 34 subject were enrolled but 5 withdrew from the study.	13 Participants n=29 Participants • 34 subject were enrolled but 5 withdrew from the study.
Sex: Female, Male Male	6 Participants n=12 Participants • 34 subject were enrolled but 5 withdrew from the study.	10 Participants n=17 Participants • 34 subject were enrolled but 5 withdrew from the study.	16 Participants n=29 Participants • 34 subject were enrolled but 5 withdrew from the study.
Region of Enrollment United States	12 Participants n=14 Participants	17 Participants n=20 Participants	29 Participants n=34 Participants
ASA Class Class 1	0 Participants n=12 Participants • 34 subjects were enrolled but 5 withdrew from the study.	1 Participants n=17 Participants • 34 subjects were enrolled but 5 withdrew from the study.	1 Participants n=29 Participants • 34 subjects were enrolled but 5 withdrew from the study.
ASA Class Class 2	5 Participants n=12 Participants • 34 subjects were enrolled but 5 withdrew from the study.	5 Participants n=17 Participants • 34 subjects were enrolled but 5 withdrew from the study.	10 Participants n=29 Participants • 34 subjects were enrolled but 5 withdrew from the study.
ASA Class Class 3	7 Participants n=12 Participants • 34 subjects were enrolled but 5 withdrew from the study.	11 Participants n=17 Participants • 34 subjects were enrolled but 5 withdrew from the study.	18 Participants n=29 Participants • 34 subjects were enrolled but 5 withdrew from the study.
Pittsburgh Sleep Quality Index	7.333 units on a scale STANDARD_DEVIATION 4.355 • n=12 Participants • while we enrolled 34 subjects, 5 withdrew from the study.	6.765 units on a scale STANDARD_DEVIATION 3.562 • n=17 Participants • while we enrolled 34 subjects, 5 withdrew from the study.	7.0 units on a scale STANDARD_DEVIATION 3.796 • n=29 Participants • while we enrolled 34 subjects, 5 withdrew from the study.

PRIMARY outcome

Timeframe: Night of surgery (POD 1) and Postoperative Day 2.(POD 2)

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo one dose in the evening of surgery and post op day #1. Placebo: Placebo	Gabapentin n=17 Participants Gabapentin 400mg orally at 9pm on the evening of surgery and first day post operatively Gapabentin: 400mg orally at 9pm day of surgery and the first evening post operatively.
Quality of Sleep. POD 1	1.333 units on a scale Standard Deviation 0.651	1.235 units on a scale Standard Deviation 1.091
Quality of Sleep. POD 2	1 units on a scale Standard Deviation 0.853	0.647 units on a scale Standard Deviation 0.862

PRIMARY outcome

Timeframe: 48 hours post operatively

Patient Controlled Analgesia use over 48 hours reported in Morphine equivalent dosage.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo one dose in the evening of surgery and post op day #1. Placebo: Placebo	Gabapentin n=17 Participants Gabapentin 400mg orally at 9pm on the evening of surgery and first day post operatively Gapabentin: 400mg orally at 9pm day of surgery and the first evening post operatively.
Opioid Consumption	11.88 mg Standard Deviation 6.3	11.02 mg Standard Deviation 9.75

SECONDARY outcome

Timeframe: 48 hours post operatively

Severity of pain measure on a scale from zero to ten. Zero no pain to ten severe pain.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Placebo one dose in the evening of surgery and post op day #1. Placebo: Placebo	Gabapentin n=17 Participants Gabapentin 400mg orally at 9pm on the evening of surgery and first day post operatively Gapabentin: 400mg orally at 9pm day of surgery and the first evening post operatively.
Visual Analogue Scale for Pain	5.15 units on a scale Standard Deviation 2.28	4.38 units on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: Duration of hospital stay up to 48 hours

Population: These data were not collected.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Gabapentin

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

Jean Daniel Eloy

Rutgers-New Jersey Medical School

Phone: 9739721470

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place