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Completed

NCT Number: NCT00825344

Preoperative Etanercept Before Inguinal Hernia Surgery

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.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

etanercept

Drug

50 mg subcutaenous preoperatively

Saline

Drug

Given subcutaneously preoperatively

Primary outcomes

  1. Numerical Rating Scale Pain Score

    Time frame: 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 outcomes

  1. Analgesic Usage

    Time frame: 24 hours

    Number of oxycodone/ acetaminophen tablets consumed through 24 hours post-surgery

  2. Chronic Post-surgical Pain

    Time frame: Up to 12 months

    Patients with persistent post-surgical pain

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • John P. Murtha Neuroscience and Pain Institute
  • Walter Reed Army Medical Center

Registry information

Official study title

A Randomized Controlled Study Evaluating Pre-operative Etanercept on the Severity of Postoperative Pain After Inguinal Hernia Surgery.

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jan 21, 2009
Registry last updated
Oct 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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