Institutional Review Board, Hospital for Special Surgery

May 11, 2007

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

Christopher A DiMeo, MD

Co-Investigators

Victor M. Zayas, MD
George Anastasian, MD

Summary

We plan to enroll 15 patients within a one year period.  All follow-up will be completed on the operative day.

Inclusion/Exclusion Criteria

Inclusion criteria:

• Any patient between the ages of 18 and 80 years old presenting for surgery of the shoulder (non-English speaking patients will be provided with translators).

Exclusion criteria:

• Any patient who has documented evidence of preoperative hemidiaphragmatic paresis (i.e. on CXR), hoarseness, ptosis, or preoperative brachial plexopathy.
• Any patient with a perceived need for a long acting anesthetic.

Contact Information

Christopher A. DiMeo, MD
212.606.1206

Carey Ford
212.606.1206