January 14, 2010
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.
Mary F. Chisholm, MD
Gregory Liguori, MD
Daniel B. Maalouf, MD
Jacques T. YaDeau, MD, PhD
Robert G. Marx, MD
Victor M. Zayas, MD
Michael A. Gordon, MD
Dorothy Marcello
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.
Inclusion Criteria:
Exclusion Criteria:
Dorothy Marcello
fordc@hss.edu
212.774.2443