NCT02359110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for phase_4 postoperative-pain

Timeline
Completed

Started Jun 2015

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 12, 2018

Completed
Last Updated

March 12, 2018

Status Verified

March 1, 2018

Enrollment Period

1.6 years

First QC Date

February 4, 2015

Results QC Date

February 6, 2018

Last Update Submit

March 8, 2018

Conditions

Postoperative Pain

Keywords

laparoscopypostoperative paingynecologygabapentin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • VAS (Visual Analog Scale)

    2 -6 hours

  • Total Morphine Consumption

    12 hours post-operatively

Study Arms (2)

Drug 1

EXPERIMENTAL

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

Drug: Gabapentin

Drug 2

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

GabapentinDRUG

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

Also known as: Neurontin, 78309289
Drug 1
PlaceboOTHER

Patient will receive placebo tab less than 1 hour before surgery

Drug 2

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (9)

  • 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.

    PMID: 19805679BACKGROUND

  • 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.

    PMID: 18312984BACKGROUND

  • 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.

    PMID: 10036122BACKGROUND

  • 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.

    PMID: 16376147BACKGROUND

  • 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.

    PMID: 17166126BACKGROUND

  • 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.

    PMID: 22415535BACKGROUND

  • 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.

    PMID: 24807337BACKGROUND

  • 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.

    PMID: 17180268BACKGROUND

  • 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.

    PMID: 24473153BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Timothy Deimling, M.D.
Organization
Penn State Milton S. Hershey Medical Center
tdeimling@pennstatehealth.psu.edu
717-531-3503

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; Minimally Invasive Gyn Surgery Fellow

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 9, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 12, 2018

Results First Posted

March 12, 2018

Record last verified: 2018-03

Locations

US(1)