Preoperative Etanercept Before Inguinal Hernia Surgery

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825344
• Other study ID #: WU08-6987
• Status: Completed
• Phase: N/A
• First received: January 20, 2009
• Last updated: September 6, 2017
• Start date: January 2009
• Est. completion date: August 2012

Study information

• Verified date: September 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: August 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Etanercept
50 mg subcutaenous preoperatively
• Saline
Given subcutaneously preoperatively

Locations

Country	Name	City	State
United States	Walter Reed Army Medical Center	Washington, D.C.	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	John P. Murtha Neuroscience and Pain Institute, Walter Reed Army Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Analgesic Usage	Number of oxycodone/ acetaminophen tablets consumed through 24 hours post-surgery	24 hours
Secondary	Chronic Post-surgical Pain	Patients with persistent post-surgical pain	Up to 12 months