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The Impact of Perioperative Gabapentin on Chronic Groin Pain After Inguinal Hernia Repair

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ClinicalTrials.gov Identifier: NCT02419443
Recruitment Status : Unknown
Verified April 2016 by Matthew Hannon, United States Naval Medical Center, San Diego.
Recruitment status was:  Active, not recruiting
First Posted : April 17, 2015
Last Update Posted : April 11, 2016
Sponsor:
Information provided by (Responsible Party):
Matthew Hannon, United States Naval Medical Center, San Diego

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.

Condition or disease Intervention/treatment Phase
Peripheral Nerve Disorder Associated With Repair of Hernia Drug: Gabapentin Drug: Placebo Phase 4

Detailed Description:
Over 500,000 inguinal hernia repairs(IHR) are performed in the United States annually. This is also one of the most common operations performed on the primarily young, male Active Duty population. A common source of morbidity after IHR is chronic groin pain(CGP), usually defined as pain lasting longer than 3 months. The incidence of CGP varies widely in published reports, but in the majority it is 25 to 30%. A major etiology of CGP is thought to be injury to inguinal nerves during surgery. Gabapentin is an anticonvulsant that is also of benefit in the treatment of neuropathic pain. Numerous studies have shown that gabapentin can decrease perioperative pain in patients undergoing surgeries such as hysterectomy, cholecystectomy and spine surgery. Doses and medication regimens varied in these studies, One study in patients undergoing IHR who received a single dose of gabapentin preoperatively, showed a decrease in postoperative pain and in reported pain scores in the first 6 months. We propose a randomized, double-blind, placebo controlled study of the effect of gabapentin on CGP after IHR. Patients will be given placebo or gabapentin. Those given gabapentin, will be given 300 mg orally three times daily for a total of six doses with the first dose given on the morning of surgery. Patients will be evaluated preoperatively and at 1, 6, 12 and 24 months after surgery. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Impact of Perioperative Gabapentin on Chronic Groin Pain After Inguinal Hernia Repair
Study Start Date : August 2011
Actual Primary Completion Date : September 2015
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Placebo Comparator: Placebo
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
Control group

Active Comparator: Gabapentin
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
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.
Other Name: Neurontin




Primary Outcome Measures :
  1. Pain score [ Time Frame: 24 months ]
    Visual analog scale


Secondary Outcome Measures :
  1. Quality-of-life (QOL) [ Time Frame: 24 months ]
    SF-12



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02419443


Sponsors and Collaborators
United States Naval Medical Center, San Diego
Investigators
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Principal Investigator: Matthew Hannon, M.D. United States Naval Medical Center, San Diego
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matthew Hannon, CDR, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT02419443    
Other Study ID Numbers: NMCSD.2010.0123
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: April 11, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Aggregated results will be made available.
Keywords provided by Matthew Hannon, United States Naval Medical Center, San Diego:
inguinal hernia repair, chronic pain
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Neuromuscular Diseases
Nervous System Diseases
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents