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
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
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
NCT ID
NCT02419443
First Posted
April 14, 2015
Last Updated
April 8, 2016
Sponsor
United States Naval Medical Center, San Diego
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
Learn more about this trial
The Impact of Perioperative Gabapentin on Chronic Groin Pain After Inguinal Hernia Repair
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