Preoperative Etanercept Before Inguinal Hernia Surgery

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: John P. Murtha Neuroscience and Pain Institute; Walter Reed Army Medical Center
• Treatments: Etanercept

Criteria

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.