Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy

Penn State Health

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Other: Placebo; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT02359110

1183

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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112 participants in 2 patient groups, including a placebo group

Drug 1

Experimental group

Description:

Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.

Treatment:

Drug: Gabapentin

Drug 2

Placebo Comparator group

Description:

Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.

Treatment:

Other: Placebo