Institutional Review Board, Hospital for Special Surgery
February 23, 2007
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.
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.