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

18 Years
70 Years
Not Enrolling
Inguinal Hernia, Postoperative Pain

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Trial Information

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

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.

Inclusion Criteria:

1. Demonstrable hernia evident using ultrasound, computed tomography, or on physical

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

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

8. Rheumatoid arthritis, or other systemic conditions that might respond to TNF

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

numerical rating pain score

Outcome Description:

0-10 pain score

Outcome Time Frame:

24 hours

Safety Issue:


Principal Investigator

Scott Rehrig, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Walter Reed Army Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2009

Completion Date:

August 2012

Related Keywords:

  • Inguinal Hernia
  • Postoperative Pain
  • postoperative pain
  • inguinal hernia
  • chronic postsurgical pain
  • cytokine
  • preemptive analgesia
  • patients with inguinal hernia scheduled for surgery
  • Hernia
  • Hernia, Inguinal
  • Pain, Postoperative



Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000