Research

Subsartorial Saphenous Nerve Block in ACL Reconstruction

IRB Number: 29133
(inactive trial)

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.

Principal Investigator

Mary F. Chisholm, MD

Co-Investigators

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

Summary

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/Exclusion Criteria

Inclusion Criteria:

  • All ASA I-III patients undergoing ambulatory surgery for ACL reconstruction with patellar tendon autograft.
  • BMI <35
  • Smokers included 
  • Ages 16-65

Exclusion Criteria:

  • BMI >35
  • Patient refusal
  • Allergy to study medications
  • NRS >3 with frequent opioid use (including tramadol) prior to surgery—daily for greater than 3 weeks
  • Lower extremity neurological dysfunction  
  • Diabetic
  • Over 65 years of age

Contact Information

Dorothy Marcello
fordc@hss.edu
212.774.2443



Request an Appointment