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Completed

NCT Number: NCT02359110

Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gabapentin

Drug

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

Other names: Neurontin, 78309289

Placebo

Other

Patient will receive placebo tab less than 1 hour before surgery

Primary outcomes

  1. NRS (Numerical Rating Scale)

    Time frame: 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 outcomes

  1. VAS (Visual Analog Scale)

    Time frame: 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).

  2. Total Morphine Consumption

    Time frame: 12 hours post-operatively

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

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

Acronym: Gabapentin

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 9, 2015
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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