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

Primary Purpose

Peripheral Nerve Disorder Associated With Repair of Hernia

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Nerve Disorder Associated With Repair of Hernia focused on measuring inguinal hernia repair, chronic pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo

    Gabapentin

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Pain score
    Visual analog scale

    Secondary Outcome Measures

    Quality-of-life (QOL)
    SF-12

    Full Information

    First Posted
    April 14, 2015
    Last Updated
    April 8, 2016
    Sponsor
    United States Naval Medical Center, San Diego
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02419443
    Brief Title
    The Impact of Perioperative Gabapentin on Chronic Groin Pain After Inguinal Hernia Repair
    Official Title
    The Impact of Perioperative Gabapentin on Chronic Groin Pain After Inguinal Hernia Repair
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    September 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    United States Naval Medical Center, San Diego

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Nerve Disorder Associated With Repair of Hernia
    Keywords
    inguinal hernia repair, chronic pain

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Gabapentin
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Gabapentin
    Other Intervention Name(s)
    Neurontin
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Control group
    Primary Outcome Measure Information:
    Title
    Pain score
    Description
    Visual analog scale
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Quality-of-life (QOL)
    Description
    SF-12
    Time Frame
    24 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Matthew Hannon, M.D.
    Organizational Affiliation
    United States Naval Medical Center, San Diego
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Aggregated results will be made available.
    Citations:
    PubMed Identifier
    12514456
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18716856
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17513656
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18006529
    Citation
    Kong VK, Irwin MG. Gabapentin: a multimodal perioperative drug? Br J Anaesth. 2007 Dec;99(6):775-86. doi: 10.1093/bja/aem316.
    Results Reference
    background
    PubMed Identifier
    29087880
    Citation
    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.
    Results Reference
    derived

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

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