Institutional Review Board, Hospital for Special Surgery
August 22, 2011
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.
Patients ages from 18-90 years old having surgery under epidural anesthesia who have not had prior lumbar spine surgery.
Patientís age is less than 18 or greater than 90.
Patients who have had prior lumbar spine surgery.
Patients in whom an epidural catheter placement is contraindicated:
Bleeding disorders, e.g., hemophilia
History of prior epidural infection