Institutional Review Board, Hospital for Special Surgery
January 14, 2010
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.
We propose a randomized controlled study where 80 patients undergoing patella tendon autografts will be randomized to receive either a subsartorial saphenous nerve block (treatment) or a femoral nerve block (control) in order to compare postoperative pain management between groups. These patients will be enrolled and randomized to control vs. treatment on the day of their procedure. The patients will be followed immediately postoperatively. At discharge, the patient will be given a NRS diary. On postoperative days 1 and 2, we call the patient at a pre-determined time to assess their satisfaction with their pain medication, as well as to verify when block resolution occurs. The NRS diaries, indicating pain scores and amount of pain medication needed, will be collected from the patients at their first follow-up appointment two weeks postoperatively, thus marking the end of the follow-up period.