Status:
COMPLETED
Preoperative Etanercept Before Inguinal Hernia Surgery
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Walter Reed Army Medical Center
John P. Murtha Neuroscience and Pain Institute
Conditions:
Inguinal Hernia
Postoperative Pain
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
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-b...
Eligibility Criteria
Inclusion
- Demonstrable hernia evident using ultrasound, computed tomography, or on physical exam.
- Pt scheduled for unilateral inguinal hernia repair.
- Symptoms present for \< 6 months.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00825344
Start Date
January 1 2009
End Date
August 1 2012
Last Update
October 5 2017
Active Locations (1)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307