February 23, 2007

A Randomized Controlled Trial Evaluating the Efficacy and Complications of Interscalene Block Using the Nerve Stimulator vs. Ultrasound Approach

IRB Number: 27003

Institutional Review Board
Hospital for Special Surgery

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

Spencer S. Liu, MD

Co-Investigators

Michael Gordon, MD
Richard Kahn, MD
Gregory Liguori, MD
Daniel Maalouf, MD
Jaime Ortiz, MD
Leonardo Paroli, M.D. Ph.D.
Teena Shetty, MD
Jacques T. YaDeau, M.D. Ph.D.
Victor M. Zayas, MD
Valeria Buschiazzo

Summary

222 patients undergoing arthroscopic shoulder surgery with Interscalene block will be equally randomized into 2 groups of 111.   One group will have their block performed with a nerve stimulator technique.  The other group will have their block performed under ultrasound guidance.  Both techniques are considered standard of care.  The primary outcome is whether one technique results in less risk of transient postoperative neurologic symptoms at one week after surgery, as this may improve safety of this block.  Enrollment period will consist of Jan 2007 to Jan 2009.  Follow-up will include patient contact at 1 week after surgery.  If a patient has transient neurologic symptoms, they will be offered a complementary neurological evaluation by our Neurologist co-investigator including standard diagnostic testing.  They will also be followed monthly until resolution of symptoms.

Inclusion/Exclusion Criteria

Inclusion criteria:
Any patient between the ages of 18 and 75 undergoing an arthroscopic surgical procedure of the shoulder with interscalene block will be eligible.

Exclusion criteria:
A contraindication to interscalene block, including patient refusal, pregnancy, dementia, severe pulmonary disease, and known pre-existing neurologic dysfunction of the operative limb will be grounds for exclusion.  Any subject who, due to a language (despite availability of interpreters) or educational barrier, cannot understand all aspects of the study and consent will be excluded.

Contact Information

Valeria Buschiazzo
212.606.1206

Spencer S. Liu,MD
212.606.1206