Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Other: Placebo; Drug: Gabapentin

• Registration Number: NCT02359110
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

The purpose of this study is to prospectively determine the influence of immediate pre-operative gabapentin administration on acute postoperative pain. The investigators hypothesize that immediate post-operative pain will be improved with pre-operative administration of gabapentin.

Detailed Description

The purpose of this study is to prospectively determine the influence of immediate pre-operative gabapentin administration on acute postoperative pain. We hypothesize that immediate post-operative pain will be improved with pre-operative administration of gabapentin.

We plan to conduct a prospective randomized trial to assess the effect of a single immediate pre-operative dose of gabapentin 300mg on immediate post-operative pain in patients undergoing laparoscopy for gynecologic indications. This concept has been studied in patients undergoing abdominal hysterectomy. We aim to study the effect on patients undergoing laparoscopy.

Study Timeline

• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-02-06
• Study First Posted: 2015-02-09
• Study Start: 2015-06
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Results First Submitted: 2018-02-06
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-08
• Last Update Submitted: 2018-03-08
• Results First Posted: 2018-03-12
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 112

Inclusion Criteria

1. The patient must be female and planning to have a laparoscopic or robotic assisted procedure for benign gynecologic indications.
2. Patients must be treated in the department of Obstetrics and Gynecology in the division of Minimally Invasive Gynecologic Surgery.
3. The patient must be in the age range of 18-80 years, in general good health and able to comply with study procedures.

Exclusion Criteria

1. Male patients will be excluded from this study.
2. Patients under 18 years old will be excluded from this study.
3. Pregnant patients. All patients will have a routine pre-operative urine HCG to exclude pregnancy.
4. Patients having abdominal, vaginal or hysteroscopic procedures
5. Allergy to gabapentin
6. Chronic use of gabapentin (greater than 6 months)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug 2	Placebo	Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
Drug 1	Gabapentin	Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.

Primary Outcome Measures

Name	Time	Method
NRS (Numerical Rating Scale)	2-8 hours	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.

Secondary Outcome Measures

Name	Time	Method
VAS (Visual Analog Scale)	2 -6 hours	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).
Total Morphine Consumption	12 hours post-operatively

Trial Locations

Locations (1)

Penn State Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States