Clinical trial NCT02359110: Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy
Official title: Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy: A Prospective Double-blinded, Placebo Controlled Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: laparoscopy
postoperative pain
gynecology
gabapentin
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2015-02-09
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: NRS (Numerical Rating Scale)
timeFrame: 2-8 hours
Secondary outcomes:
measure: VAS (Visual Analog Scale)
timeFrame: 2 -6 hours
measure: Total Morphine Consumption
timeFrame: 12 hours post-operatively
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
References:
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