Expired Study
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Washington, D.C., District of Columbia 20307


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.


Study summary:

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.


Criteria:

Inclusion Criteria: 1. Demonstrable hernia evident using ultrasound, computed tomography, or on physical exam. 2. Pt scheduled for unilateral inguinal hernia repair. 3. Symptoms present for < 6 months. Exclusion Criteria: 1. Non-elective surgery. 2. Previous hernia repair at the same site, or surgery near the site of the hernia. 3. Demyelinating neurological disease. 4. Current or recent (< 6 years) history of substance abuse. 5. Pregnancy, which will be ruled out by a urine pregnancy test in women of childbearing age. 6. Pre-existing untreated psychiatric condition that could preclude an optimal treatment response (e.g. untreated posttraumatic stress disorder). 7. Unstable medical condition (e.g. unstable angina or congestive heart failure or severe). 8. Rheumatoid arthritis, or other systemic conditions that might respond to TNF inhibitors. 9. Pt is immunosuppressed or is taking other drugs (e.g. corticosteroids) that might suppress the immune system. 10. Systemic infection. 11. Any opioid analgesics within 48 hours of skin incision. 12. Any use of tricyclic antidepressants, serotoninin-norepinephrine reuptake inhibitors, or anticonvulsants within 72 hours of skin incision.


Study is Available At:


Original ID:

WU08-6987


NCT ID:

NCT00825344


Secondary ID:


Study Acronym:


Brief Title:

Preoperative Etanercept Before Inguinal Hernia Surgery


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Johns Hopkins University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

77


Enrollment Type:

Actual


Overall Contact Information

Official Name:Scott Rehrig, MD
Study Chair
Walter Reed Army Medical Center

Study Dates

Start Date:January 2009
Completion Date:August 2012
Completion Type:Actual
Primary Completion Date:November 2011
Primary Completion Type:Actual
Verification Date:September 2017
Last Changed Date:September 6, 2017
First Received Date:January 20, 2009
First Results Date:April 12, 2013

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Chronic Post-surgical Pain
Time Frame:Up to 12 months
Safety Issues:False
Description:Patients with persistent post-surgical pain
Outcome Type:Secondary Outcome
Measure:Analgesic Usage
Time Frame:24 hours
Safety Issues:False
Description:Number of oxycodone/ acetaminophen tablets consumed through 24 hours post-surgery
Outcome Type:Primary Outcome
Measure:Numerical Rating Scale Pain Score
Time Frame:24 hours
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Drug
Name:Etanercept
Description:50 mg subcutaenous preoperatively
Arm Name:1
Intervention Type:Drug
Name:Saline
Description:Given subcutaneously preoperatively
Arm Name:2

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:2
Description:Subcutaneous saline preoperatively
Study Arm Type:Experimental
Arm Name:1
Description:Etanercept 50 mg preoperatively

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Johns Hopkins University
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:Walter Reed Army Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:15135924
Reference Type:Reference
Citation: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. Review.
PMID:18267170
Reference Type:Reference
Citation: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.
PMID:16858183
Reference Type:Reference
Citation: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

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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