Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy: A Prospective Double-blinded, Placebo Controlled Randomized Study

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Gabapentin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must be female and planning to have a laparoscopic or robotic assisted procedure for benign gynecologic indications. Patients must be treated in the department of Obstetrics and Gynecology in the division of Minimally Invasive Gynecologic Surgery. 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: Male patients will be excluded from this study. Patients under 18 years old will be excluded from this study. Pregnant patients. All patients will have a routine pre-operative urine HCG to exclude pregnancy. Patients having abdominal, vaginal or hysteroscopic procedures Allergy to gabapentin Chronic use of gabapentin (greater than 6 months)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug 1<br>Patients will receive Gabapentin 300mg tab less than 1 hour before surgery. | Drug: Gabapentin<br>* Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.<br>* Other names: 78309289;|
| Placebo Comparator: Drug 2<br>Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery. | Other: Placebo<br>* Patient will receive placebo tab less than 1 hour before surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS (Numerical Rating Scale) | 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. | 2-8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS (Visual Analog Scale) | 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). | 2 -6 hours | 
| Total Morphine Consumption |  | 12 hours post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopy, postoperative pain, gynecology, gabapentin