Preoperative Etanercept Before Inguinal Hernia Surgery
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain, Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/7/2017 |
| Start Date: | January 2009 |
| End Date: | August 2012 |
A Randomized Controlled Study Evaluating Pre-operative Etanercept on the Severity of Postoperative Pain After Inguinal Hernia Surgery.
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.
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.
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.
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
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.
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