Preoperative Etanercept Before Inguinal Hernia Surgery

NCT00825344 | Completed Results DMC

• 1 other identifier: WU08-6987
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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% 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.

Conditions

Inguinal Hernia; Postoperative Pain

Keywords

postoperative pain; inguinal hernia; chronic postsurgical pain; cytokine; preemptive analgesia; patients with inguinal hernia scheduled for surgery

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale Pain Score

  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.

  24 hours

Secondary Outcomes (2)

• Analgesic Usage

  24 hours

• Chronic Post-surgical Pain

  Up to 12 months

Study Arms (2)

1

EXPERIMENTAL

Etanercept 50 mg preoperatively

Drug: Etanercept

2

PLACEBO COMPARATOR

Subcutaneous saline preoperatively

Drug: Saline

Interventions

Etanercept DRUG

50 mg subcutaenous preoperatively

1

Saline DRUG

Given subcutaneously preoperatively

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Walter Reed Army Medical Center: collaborator
• John P. Murtha Neuroscience and Pain Institute: collaborator

Study Sites (1)

Walter Reed Army Medical Center

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

Location

Related Publications (4)

• Cheek CM, Black NA, Devlin HB, Kingsnorth AN, Taylor RS, Watkin DF. Groin hernia surgery: a systematic review. Ann R Coll Surg Engl. 1998;80 Suppl 1:S1-80.

  PMID: 11432408 BACKGROUND

• Franneby U, Sandblom G, Nordin P, Nyren O, Gunnarsson U. Risk factors for long-term pain after hernia surgery. Ann Surg. 2006 Aug;244(2):212-9. doi: 10.1097/01.sla.0000218081.53940.01.

  PMID: 16858183 BACKGROUND

• Ferzli GS, Edwards E, Al-Khoury G, Hardin R. Postherniorrhaphy groin pain and how to avoid it. Surg Clin North Am. 2008 Feb;88(1):203-16, x-xi. doi: 10.1016/j.suc.2007.10.006.

  PMID: 18267170 BACKGROUND

• Sommer C, Kress M. Recent findings on how proinflammatory cytokines cause pain: peripheral mechanisms in inflammatory and neuropathic hyperalgesia. Neurosci Lett. 2004 May 6;361(1-3):184-7. doi: 10.1016/j.neulet.2003.12.007.

  PMID: 15135924 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative

Interventions

Etanercept; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Only one type of surgery studied; more males than females enrolled (function of military treatment facility and type of population)

Results Point of Contact

• Title: Dr. Steven P. Cohen
• Organization: Johns Hopkins

scohen40@jhmi.edu

410-955-1818

Study Officials

• Scott Rehrig, MD

  Walter Reed Army Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 21, 2009
• Study Start: January 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: August 1, 2012
• Last Updated: October 5, 2017
• Results First Posted: December 13, 2013

Record last verified: 2017-09

Locations

US (1)