NCT02419443

Brief Summary

A common source of morbidity after IHR is chronic groin pain(CGP), usually defined as pain lasting longer than 3 months. Gabapentin is an anticonvulsant that is also of benefit in the treatment of neuropathic pain. We propose a randomized, double-blind, placebo controlled study of the effect of gabapentin on CGP after IHR. Their pain will be assessed with a visual analogue scale. For those reporting pain, the need for pain medication, or other treatment, and the effect of pain on their quality of life will be recorded.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_4

Status
unknown

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

Study Start

First participant enrolled

August 1, 2011

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 11, 2016

Status Verified

April 1, 2016

Enrollment Period

4.1 years

First QC Date

April 14, 2015

Last Update Submit

April 8, 2016

Conditions

Peripheral Nerve Disorder Associated With Repair of Hernia

Keywords

inguinal hernia repair, chronic pain

Outcome Measures

Primary Outcomes (1)

  • Pain score

    Visual analog scale

    24 months

Secondary Outcomes (1)

  • Quality-of-life (QOL)

    24 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients randomized to the placebo-group were administered placebo-pills orally one hour prior to surgery, then three times a day for a maximum of 6 total doses.

Drug: Placebo

Gabapentin

ACTIVE COMPARATOR

Patients randomized to the gabapentin-group were administered 300 mg orally one hour prior to surgery, then three times a day for a maximum of 6 total dose.

Drug: Gabapentin

Interventions

GabapentinDRUG

Gabapentin is a structural analogue of GABA that decreases activation of voltage-activated calcium channels which may decrease release of excitatory neurotransmitters such as glutamate. Its analgesic mechanisms have been utilized effectively for the treatment of chronic pain in several disorders such as cancer, fibromyalgia and diabetic peripheral neuropathy.

Also known as: Neurontin
Gabapentin
PlaceboDRUG

Control group

Placebo

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients 18 years of age or older undergoing initial inguinal (bilateral or unilateral) hernia repair by any method (i.e. laparoscopic or open surgery)

You may not qualify if:

  • Age less than 18 years of age, recurrent hernias, emergency operations, already taking gabapentin, allergy to gabapentin, pre-existing chronic pain or psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Poobalan AS, Bruce J, Smith WC, King PM, Krukowski ZH, Chambers WA. A review of chronic pain after inguinal herniorrhaphy. Clin J Pain. 2003 Jan-Feb;19(1):48-54. doi: 10.1097/00002508-200301000-00006.

    PMID: 12514456BACKGROUND

  • van Hanswijck de Jonge P, Lloyd A, Horsfall L, Tan R, O'Dwyer PJ. The measurement of chronic pain and health-related quality of life following inguinal hernia repair: a review of the literature. Hernia. 2008 Dec;12(6):561-9. doi: 10.1007/s10029-008-0412-y. Epub 2008 Aug 21.

    PMID: 18716856BACKGROUND

  • Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. doi: 10.1213/01.ane.0000261517.27532.80.

    PMID: 17513656BACKGROUND

  • Kong VK, Irwin MG. Gabapentin: a multimodal perioperative drug? Br J Anaesth. 2007 Dec;99(6):775-86. doi: 10.1093/bja/aem316.

    PMID: 18006529BACKGROUND

  • Quail J, Spence D, Hannon M. Perioperative Gabapentin Improves Patient-Centered Outcomes After Inguinal Hernia Repair. Mil Med. 2017 Nov;182(11):e2052-e2055. doi: 10.7205/MILMED-D-17-00107.

    PMID: 29087880DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Matthew Hannon, M.D.

    United States Naval Medical Center, San Diego

    PRINCIPAL INVESTIGATOR

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
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CDR

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 17, 2015

Study Start

August 1, 2011

Primary Completion

September 1, 2015

Study Completion

September 1, 2016

Last Updated

April 11, 2016

Record last verified: 2016-04