February 23, 2007
Institutional Review Board, Hospital for Special Surgery
The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the 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 or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.
For further information, see Understanding Clinical Trials/Research Studies.
Jacques T. YaDeau, MD, PhD
Danielle Ludwin, MD
Richard L. Kahn, MD
Devan Bhagat, MD
100 patients will be studied with an estimated enrollment period of 3 months. Follow up will be conducted with a brief interview on the day of surgery and post-operative day 1.
Inclusion criteria are patients age 45-80 undergoing primary total hip arthroplasty for osteoarthritis; patients receiving epidural catheters for anesthesia/analgesia; no contraindications to epidural placement, the ability to understand the numerical rating scale for nausea. Exclusion criteria: patients with prolonged preoperative use of opioid analgesics and/or use of IV PCA. Prolonged preoperative use of opioid is defined as the use of a narcotic-containing tablet greater or equal to 3 times a day for greater or equal to 1 month before surgery.
Barbara Wukovits
212.606.1782