Preoperative Etanercept Before Inguinal Hernia Surgery
Completed · Not applicable
Conditions studied: Inguinal Hernia, Postoperative Pain
In brief
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.
Key facts
- Study ID
- NCT00825344
- Run by
- Johns Hopkins University
- People needed
- 77
- Starts
- 2009-01-01
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2017-10-05
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Demonstrable hernia evident using ultrasound, computed tomography, or on physical exam.
- Pt scheduled for unilateral inguinal hernia repair.
- Symptoms present for < 6 months.
You may not qualify if…
- 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.
Where it is running
- Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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