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

• ClinicalTrials.gov Identifier: NCT02419443
• Recruitment Status: Unknown
• First Posted: April 17, 2015
• Last Update Posted: April 11, 2016
• Sponsor: United States Naval Medical Center, San Diego
• Information provided by (Responsible Party): Matthew Hannon, United States Naval Medical Center, San Diego

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

United States Naval Medical Center, San Diego

Investigators

• Principal Investigator: Matthew Hannon, M.D.; United States Naval Medical Center, San Diego

More Information

Publications:

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. Review.

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. Review.

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. Review.

Kong VK, Irwin MG. Gabapentin: a multimodal perioperative drug? Br J Anaesth. 2007 Dec;99(6):775-86. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• 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:

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