Preoperative Etanercept Before Inguinal Hernia Surgery

Study Overview
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Brief Summary
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Inguinal hernia repair is one of the most frequently performed operations in young men. Persistent pain after inguinal surgery represents a significant cause of disability, occurring in between 15%-35% of cases. In a majority of these patients, their groin pain persisted after a previous hernia repair. The main type of chronic postsurgical pain is neuropathic, caused by injured nerves. One of the principal components in the pathophysiology of postsurgical pain is cytokines, specifically tumor necrosis factor (TNF). In animal studies, injecting TNF inhibitors before nerve injury can reduce pain behaviors and neuropathology. Finding a way to reduce the incidence of postsurgical pain after hernia repair could enhance function, and reduce the need for opioids and other analgesics. The investigators intend to conduct the first randomized, controlled study evaluating whether preemptive administration of a tumor necrosis inhibitor can reduce postoperative pain and opioid consumption after hernia repair. This is important because the degree and intensity of postsurgical pain is a major predictor for the development of chronic postsurgical pain.

Detailed Description
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76 patients with an inguinal hernia scheduled for surgical repair will be randomized in a 1:1 ratio to receive either subcutaneous etanercept or saline before skin incision. The study will be double-blind (i.e. neither the surgeon, anesthesiologist, nor the person administering the injection will know which group they were assigned to). Group I will receive 50 mg of subcutaneous etanercept mixed in 1 ml sterile water 90-120 before skin incision. Group II will receive 1 ml of sterile water 90-120 before skin incision. The anesthesia and surgical procedures will be standardized. For the next 24 hours, patients will keep a q4 hour pain diary recording their average pain on a 0-10 numerical rating scale. They will also record the number of Percocet tablets they took. All patients will be seen 1 month after their surgery, where their average pain score, work status, and analgesic intake (if any) will be recorded. Patients will then be followed with a telephone follow-up 3, 6 and 12-months post-procedure, where the same variables will be recorded.

Official Title
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A Randomized Controlled Study Evaluating Pre-operative Etanercept on the Severity of Postoperative Pain After Inguinal Hernia Surgery.

Conditions
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Inguinal Hernia, Postoperative Pain

Intervention / Treatment
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* Drug: Etanercept
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Demonstrable hernia evident using ultrasound, computed tomography, or on physical exam. Pt scheduled for unilateral inguinal hernia repair. Symptoms present for < 6 months. Exclusion Criteria: Non-elective surgery. Previous hernia repair at the same site, or surgery near the site of the hernia. Demyelinating neurological disease. Current or recent (< 6 years) history of substance abuse. Pregnancy, which will be ruled out by a urine pregnancy test in women of childbearing age. Pre-existing untreated psychiatric condition that could preclude an optimal treatment response (e.g. untreated posttraumatic stress disorder). Unstable medical condition (e.g. unstable angina or congestive heart failure or severe). Rheumatoid arthritis, or other systemic conditions that might respond to TNF inhibitors. Pt is immunosuppressed or is taking other drugs (e.g. corticosteroids) that might suppress the immune system. Systemic infection. Any opioid analgesics within 48 hours of skin incision. Any use of tricyclic antidepressants, serotoninin-norepinephrine reuptake inhibitors, or anticonvulsants within 72 hours of skin incision.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Etanercept 50 mg preoperatively | Drug: Etanercept<br>* 50 mg subcutaenous preoperatively<br>|
| Placebo Comparator: 2<br>Subcutaneous saline preoperatively | Drug: Saline<br>* Given subcutaneously preoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale Pain Score | 0-10 pain score through 24-hours post-surgery. 0 is no pain and 10 is the worse pain imaginable. The primary outcome reported measure is the average of 4 scores, each comprised of 6-hour time intervals during the 24hour period. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic Usage | Number of oxycodone/ acetaminophen tablets consumed through 24 hours post-surgery | 24 hours | 
| Chronic Post-surgical Pain | Patients with persistent post-surgical pain | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, inguinal hernia, chronic postsurgical pain, cytokine, preemptive analgesia, patients with inguinal hernia scheduled for surgery