N/A
N=77
Preoperative Etanercept Before Inguinal Hernia Surgery
Inguinal Hernia · Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT00825344 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Numerical Rating Scale Pain Score — 3.3; 3.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Etanercept (Drug); Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numerical Rating Scale Pain Score |
3.3; 3.9 | — |
| SECONDARY Analgesic Usage |
4.0; 5.8 | — |
| SECONDARY Chronic Post-surgical Pain |
5; 5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00825344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.