Preoperative Etanercept Before Inguinal Hernia Surgery - Full Text View

Sponsors and Collaborators:	Johns Hopkins University Walter Reed Army Medical Center John P. Murtha Neuroscience and Pain Institute
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00825344

Purpose

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.

Condition	Intervention
Inguinal Hernia Postoperative Pain	Drug: Etanercept Drug: Saline

MedlinePlus related topics: Hernia Surgery

Drug Information available for: Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Controlled Study Evaluating Pre-Operative Etanercept on the Severity of Postoperative Pain After Inguinal Hernia Surgery.

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

numerical rating pain score [ Time Frame: First 24 hours, then 1,3,6 and 12 months postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Analgesic usage [ Time Frame: First 24 hours, then 1,3,6 and 12 months postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment:	76
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Etanercept 50 mg preoperatively	Drug: Etanercept 50 mg subcutaenous preoperatively
2: Placebo Comparator Subcutaneous saline preoperatively	Drug: Saline Given subcutaneously preoperatively

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-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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825344

Locations

United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307

Sponsors and Collaborators

Johns Hopkins University

Walter Reed Army Medical Center

John P. Murtha Neuroscience and Pain Institute

Investigators

Study Chair:

Scott Rehrig, MD

Walter Reed Army Medical Center

More Information

Publications:

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.

Fränneby U, Sandblom G, Nordin P, Nyrén O, Gunnarsson U. Risk factors for long-term pain after hernia surgery. Ann Surg. 2006 Aug;244(2):212-9.

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. Review.

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. Review.

Responsible Party:	Johns Hopkins Medical Institutions ( Steven P. Cohen )
Study ID Numbers:	WU08-6987
Study First Received:	January 20, 2009
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00825344 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

postoperative pain
inguinal hernia
chronic postsurgical pain

cytokine
preemptive analgesia
patients with inguinal hernia scheduled for surgery

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Anti-Inflammatory Agents
Immunologic Factors
Pain
TNFR-Fc fusion protein
Immunosuppressive Agents
Signs and Symptoms
Postoperative Complications
Analgesics, Non-Narcotic

Hernia
Hernia, Abdominal
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Hernia, Inguinal
Pain, Postoperative

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Pathological Conditions, Anatomical
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents
Pain
TNFR-Fc fusion protein
Immunosuppressive Agents
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Postoperative Complications

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Hernia
Hernia, Abdominal
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Hernia, Inguinal
Central Nervous System Agents
Pain, Postoperative

ClinicalTrials.gov processed this record on May 07, 2009