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Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy (Gabapentin)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring laparoscopy, postoperative pain, gynecology, gabapentin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts 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)

Sites / Locations

  • Penn State Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug 1

Drug 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Total Morphine Consumption

Full Information

First Posted
February 4, 2015
Last Updated
March 8, 2018
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02359110
Brief Title
Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy
Acronym
Gabapentin
Official Title
Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy: A Prospective Double-blinded, Placebo Controlled Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
laparoscopy, postoperative pain, gynecology, gabapentin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug 1
Arm Type
Experimental
Arm Description
Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.
Arm Title
Drug 2
Arm Type
Placebo Comparator
Arm Description
Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurontin, 78309289
Intervention Description
Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Patient will receive placebo tab less than 1 hour before surgery
Primary Outcome Measure Information:
Title
NRS (Numerical Rating Scale)
Description
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.
Time Frame
2-8 hours
Secondary Outcome Measure Information:
Title
VAS (Visual Analog Scale)
Description
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).
Time Frame
2 -6 hours
Title
Total Morphine Consumption
Time Frame
12 hours post-operatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19805679
Citation
Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Spiegel G, Barakat R, Pearl ML, Sharma SK. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009 Nov 10;27(32):5331-6. doi: 10.1200/JCO.2009.22.3248. Epub 2009 Oct 5.
Results Reference
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PubMed Identifier
18312984
Citation
Manwaring JM, Readman E, Maher PJ. The effect of heated humidified carbon dioxide on postoperative pain, core temperature, and recovery times in patients having laparoscopic surgery: a randomized controlled trial. J Minim Invasive Gynecol. 2008 Mar-Apr;15(2):161-5. doi: 10.1016/j.jmig.2007.09.007.
Results Reference
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PubMed Identifier
10036122
Citation
Ott DE, Reich H, Love B, McCorvey R, Toledo A, Liu CY, Syed R, Kumar K. Reduction of laparoscopic-induced hypothermia, postoperative pain and recovery room length of stay by pre-conditioning gas with the Insuflow device: a prospective randomized controlled multi-center study. JSLS. 1998 Oct-Dec;2(4):321-9.
Results Reference
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PubMed Identifier
16376147
Citation
Sills GJ. The mechanisms of action of gabapentin and pregabalin. Curr Opin Pharmacol. 2006 Feb;6(1):108-13. doi: 10.1016/j.coph.2005.11.003. Epub 2005 Dec 22.
Results Reference
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PubMed Identifier
17166126
Citation
Hartrick CT, Kovan JP, Shapiro S. The numeric rating scale for clinical pain measurement: a ratio measure? Pain Pract. 2003 Dec;3(4):310-6. doi: 10.1111/j.1530-7085.2003.03034.x.
Results Reference
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PubMed Identifier
22415535
Citation
Clarke H, Bonin RP, Orser BA, Englesakis M, Wijeysundera DN, Katz J. The prevention of chronic postsurgical pain using gabapentin and pregabalin: a combined systematic review and meta-analysis. Anesth Analg. 2012 Aug;115(2):428-42. doi: 10.1213/ANE.0b013e318249d36e. Epub 2012 Mar 13.
Results Reference
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PubMed Identifier
24807337
Citation
Alayed N, Alghanaim N, Tan X, Tulandi T. Preemptive use of gabapentin in abdominal hysterectomy: a systematic review and meta-analysis. Obstet Gynecol. 2014 Jun;123(6):1221-1229. doi: 10.1097/AOG.0000000000000289.
Results Reference
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PubMed Identifier
17180268
Citation
Alkhamesi NA, Peck DH, Lomax D, Darzi AW. Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial. Surg Endosc. 2007 Apr;21(4):602-6. doi: 10.1007/s00464-006-9087-6. Epub 2006 Dec 16.
Results Reference
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PubMed Identifier
24473153
Citation
Nutthachote P, Sirayapiwat P, Wisawasukmongchol W, Charuluxananan S. A randomized, double-blind, placebo-controlled trial of oral pregabalin for relief of shoulder pain after laparoscopic gynecologic surgery. J Minim Invasive Gynecol. 2014 Jul-Aug;21(4):669-73. doi: 10.1016/j.jmig.2014.01.018. Epub 2014 Jan 25.
Results Reference
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Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy

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