Preoperative Etanercept Before Inguinal Hernia Surgery

Not Applicable

Completed

• Conditions: Inguinal Hernia; Postoperative Pain
• Interventions: Drug: Etanercept; Drug: Saline

• Registration Number: NCT00825344
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-20
• Study First Submitted QC: 2009-01-20
• Study First Posted: 2009-01-21
• Primary Completion: 2011-11
• Study Completion: 2012-08
• Results First Submitted: 2013-04-12
• Results First Submitted QC: 2013-10-24
• Results First Posted: 2013-12-13
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-06
• Last Update Posted: 2017-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

1. Demonstrable hernia evident using ultrasound, computed tomography, or on physical exam.
2. Pt scheduled for unilateral inguinal hernia repair.
3. Symptoms present for < 6 months.

Exclusion Criteria

1. Non-elective surgery.
2. Previous hernia repair at the same site, or surgery near the site of the hernia.
3. Demyelinating neurological disease.
4. Current or recent (< 6 years) history of substance abuse.
5. Pregnancy, which will be ruled out by a urine pregnancy test in women of childbearing age.
6. Pre-existing untreated psychiatric condition that could preclude an optimal treatment response (e.g. untreated posttraumatic stress disorder).
7. Unstable medical condition (e.g. unstable angina or congestive heart failure or severe).
8. Rheumatoid arthritis, or other systemic conditions that might respond to TNF inhibitors.
9. Pt is immunosuppressed or is taking other drugs (e.g. corticosteroids) that might suppress the immune system.
10. Systemic infection.
11. Any opioid analgesics within 48 hours of skin incision.
12. Any use of tricyclic antidepressants, serotoninin-norepinephrine reuptake inhibitors, or anticonvulsants within 72 hours of skin incision.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Etanercept	Etanercept 50 mg preoperatively
2	Saline	Subcutaneous saline preoperatively

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale Pain Score	24 hours	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Walter Reed Army Medical Center; 🇺🇸 Washington, D.C., District of Columbia, United States