Institutional Review Board, Hospital for Special Surgery
April 19, 2011
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Enrique A. Goytizolo, MD
Richard L. Kahn, MD
Kethy M. Jules-Elysee, MD
Devan D. Bhagat, MD
Yi Lin, MD
David J. Mayman, MD
Geoffrey H. Westrich, MD
Douglas E. Padgett, MD
Michael M. Alexiades, MD
Amar S. Ranawat, MD
Jodie Curren, RN
120 patients will be enrolled. This is a randomized placebo-controlled trial. All patients will receive a standard analgesic regimen: femoral nerve blockade + intravenous pain medicine (patient-controlled hydromorphone) + pills for pain (“Percocet”). Patients will randomly receive 0, 50, 100 or 150 mg of pregabalin twice a day for 12 days and once a day for postoperative day 13 and 14. Pregabalin is approved for chronic pain, and is commonly but not always used at HSS (and elsewhere) for acute postoperative pain. Patients will be followed while in the hospital, and contacted by telephone after discharge. Patients will be asked about their pain levels, and about side effects from the pain medications. Follow-up will last three months.
- Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
- Age 18 to 80 years old
- Planned use of regional anesthesia
- Ability to follow study protocol
- English speaking (primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)
- Patients younger than 18 years old and older than 80
- Patients intending to receive general anesthesia
- Allergy or intolerance to one of the study medications
- Patients with an ASA of IV
- Patients with hepatic (liver) failure
- Patients with chronic renal (kidney) failure
- Patients with difficult to manage diabetes mellitus, including insulin-dependence
- Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- Chronic opioid use (taking opioids for longer than 3 months)
- Chronic Neurontin/Lyrica use
- Patients with major prior open knee surgery on the same side as the arthroplasty.
Jacques T. YaDeau, MD, PhD