Institutional Review Board, Hospital for Special Surgery
March 17, 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.
Gregory A. Liguori, MD
Anna Maria Bombardieri, MD
Kethy M. Jules-Elysee, MD
Richard L. Kahn, MD
Andrew C. Lee, MD
Jodie Curren, RN
Barbara Wukovits, RN
Continuous peripheral nerve blockade involves the percutaneus insertion of a catheter directly adjacent to a peripheral nerve. The catheter is then infused with local anesthetic, resulting in potent, site-specific analgesia that lasts well beyond the normal duration of a single-injection nerve block. Ideally Regional Anesthesia provides profound analgesia without complete sensory and motor block. However, a transient insensate limb is a well-recognized effect of perineural local anesthetic infusion and may result in accidental injury.
The aim of the study is to evaluate the effects of varying local anesthetic concentration and volume on inpatients with continuous popliteal sciatic nerve blocks in order to find the optimal local anesthetic concentration and volume that reduces the incidence of insensate limbs and yet maintains effective analgesia.
We propose to compare the incidence of insensate extremity in 2 groups of patients receiving the same LA at the same total dose (16 mg) but at different concentration and infusion rate (0.2% at 8 ml/h vs 0.4% at 4 ml/h). We hypothesize that the incidence of insensate extremity is lower in the group receiving ropivacaine 0.4% at a basal infusion rate of 4 ml/h.
We will enroll 70 patients (35 per group). The enrollment period will be approximately 1 year. The patients will be enrolled din the study for the duration of the surgery and until discharge or the end of the popliteal catheter infusion, whatever occurs first.