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Preoperative Etanercept Before Inguinal Hernia Surgery

Primary Purpose

Inguinal Hernia, Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Etanercept

Saline

About this trial

This is an interventional prevention trial for Inguinal Hernia focused on measuring postoperative pain, inguinal hernia, chronic postsurgical pain, cytokine, preemptive analgesia, patients with inguinal hernia scheduled for surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Walter Reed Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Etanercept 50 mg preoperatively

Subcutaneous saline preoperatively

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Analgesic Usage

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

Chronic Post-surgical Pain

Patients with persistent post-surgical pain

Full Information

NCT ID

NCT00825344

First Posted

January 20, 2009

Last Updated

September 6, 2017

Sponsor

Johns Hopkins University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00825344

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inguinal Hernia, Postoperative Pain

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Etanercept 50 mg preoperatively

Arm Title

Arm Type

Placebo Comparator

Arm Description

Subcutaneous saline preoperatively

Intervention Type

Drug

Intervention Name(s)

Etanercept

Intervention Description

50 mg subcutaenous preoperatively

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

Given subcutaneously preoperatively

Primary Outcome Measure Information:

Title

Numerical Rating Scale Pain Score

Description

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Analgesic Usage

Description

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

Time Frame

24 hours

Title

Chronic Post-surgical Pain

Description

Patients with persistent post-surgical pain

Time Frame

Up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott Rehrig, MD

Organizational Affiliation

Walter Reed Army Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Walter Reed Army Medical Center

City

Washington, D.C.

State/Province

District of Columbia

ZIP/Postal Code

20307

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

11432408

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.

Results Reference

background

PubMed Identifier

16858183

Citation

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.

Results Reference

background

PubMed Identifier

18267170

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.

Results Reference

background

PubMed Identifier

15135924

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. doi: 10.1016/j.neulet.2003.12.007.

Results Reference

background

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Preoperative Etanercept Before Inguinal Hernia Surgery

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