January 14, 2008
Supraclavicular vs Interscalene Brachial Plexus Block for Shoulder Surgery
IRB Number: 27122
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
Christopher A DiMeo, MD
Co-Investigators
Victor M Zayas, MD
Andrew JD Cameron, MBChBCarey E Ford, BA
Summary
60 patients undergoing shoulder surgery within a one year period will be randomized to one of two different ultrasound guided nerve block techniques to study the related side effect profile. All follow up will be completed on the operative day.
Inclusion/Exclusion Criteria
Inclusion criteria;
• Age 18 – 80
• Patients at the Hospital for Special Surgery undergoing shoulder surgery.
Exclusion criteria;
• Patients with documented evidence of preoperative hemidiaphragmatic paresis (ie on CXR)
• Patients with preoperative hoarseness.
• Patients with preoperative ptosis
• Patients with preoperative brachial plexopathy
• Patients with a perceived need for a long acting anesthetic, such that the local anesthetic agents described in the study protocol would not be appropriate.
• Contraindication to regional blockade (local cellulitis, coagulopathy, allergy to local anesthetic agents).
• Patients undergoing total shoulder joint replacement surgery.
Contact Information
Christopher A DiMeo, MD
212.606.1206
dimeoc@hss.edu
Carey E Ford, BA
212.606.1206
fordc@hss.edu
Andrew JD Cameron, MBChB
212.606.1206
camerona@hss.edu
Victor Zayas, MD
212.606.1206
zayasv@hss.edu
