Trial Outcomes & Findings for Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy (NCT NCT02359110)

Results Overview

The NRS is a numerical scale ranging from 0-10 implemented with adults. Having no pain is rated as a 0 and the worst pain the patient could tolerate is rated as a 10.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

112 participants

Primary outcome timeframe

2-8 hours

Results posted on

2018-03-12

Participant Flow

A total of 125 patients consented to the study, but 13 did not undergo surgery or rescheduled.

A total of 112 patients were enrolled, but 3 did not receive study drug.

Participant milestones

Participant milestones
Measure	Gabapentin Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.	Placebo Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
Overall Study STARTED	55	54
Overall Study COMPLETED	55	54
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gabapentin n=55 Participants Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.	Placebo n=54 Participants Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.	Total n=109 Participants Total of all reporting groups
Age, Continuous	40.4 years STANDARD_DEVIATION 9.8 • n=99 Participants	39.5 years STANDARD_DEVIATION 9.4 • n=107 Participants	39.9 years STANDARD_DEVIATION 9.5 • n=206 Participants
Sex: Female, Male Female	55 Participants n=99 Participants	54 Participants n=107 Participants	109 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
BMI	29.5 kg/m2 STANDARD_DEVIATION 7.2 • n=99 Participants	30.0 kg/m2 STANDARD_DEVIATION 7.7 • n=107 Participants	29.8 kg/m2 STANDARD_DEVIATION 7.4 • n=206 Participants

PRIMARY outcome

Timeframe: 2-8 hours

Population: Our analysis uses all available data. Some participants were not in house for the full 8 hours of collection, others did not complete NRS at the respective time point. Therefore the number at each time point differs from the overall number of participants.

The NRS is a numerical scale ranging from 0-10 implemented with adults. Having no pain is rated as a 0 and the worst pain the patient could tolerate is rated as a 10.

Outcome measures

Outcome measures
Measure	Gabapentin n=55 Participants Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.	Placebo n=54 Participants Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
NRS (Numerical Rating Scale) Hour 2	3.5 units on a scale Interval 2.6 to 4.5	3.4 units on a scale Interval 2.5 to 4.4
NRS (Numerical Rating Scale) Hour 4	5.4 units on a scale Interval 4.3 to 6.5	5.5 units on a scale Interval 4.3 to 6.7
NRS (Numerical Rating Scale) Hour 6	5.3 units on a scale Interval 4.2 to 6.5	5.8 units on a scale Interval 4.4 to 7.1
NRS (Numerical Rating Scale) Hour 8	5.7 units on a scale Interval 4.3 to 7.2	5.1 units on a scale Interval 3.4 to 6.8

SECONDARY outcome

Timeframe: 2 -6 hours

Population: Our analysis uses all available data. Some participants were not in house for the full 6 hours of collection, others did not complete VAS at the respective time point. Therefore the number at each time point differs from the overall number of participants.

The VAS is scored using a horizontal line 100mm in length. The scale is anchored by "no pain" (score of 0) and "worst pain" (score of 100).

Outcome measures

Outcome measures
Measure	Gabapentin n=55 Participants Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.	Placebo n=54 Participants Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
VAS (Visual Analog Scale) Hour 2	37.8 units on a scale Interval 28.9 to 46.6	33.9 units on a scale Interval 25.3 to 42.6
VAS (Visual Analog Scale) Hour 6	38.7 units on a scale Interval 28.6 to 48.7	36.9 units on a scale Interval 26.9 to 46.9

SECONDARY outcome

Timeframe: 12 hours post-operatively

Outcome measures

Outcome measures
Measure	Gabapentin n=55 Participants Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.	Placebo n=54 Participants Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
Total Morphine Consumption	14.3 mg Standard Deviation 12.6	14.7 mg Standard Deviation 12.3

Adverse Events

Gabapentin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Timothy Deimling, M.D.

Penn State Milton S. Hershey Medical Center

Phone: 717-531-3503

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place