Institutional Review Board, Hospital for Special Surgery
April 27, 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.
Enrique A. Goytizolo, M.D.
David H. Kim, M.D.
Anna Westrick, M.D.
Bryan T. Kelly, M.D.
Struan H. Coleman, M.D., Ph.D.
Anil S. Ranawat, M.D.
Matthew C. Rade
This study will examine the addition of a lumbar plexus block to the postoperative analgesic regimen for ambulatory hip arthroscopy as a new way to attack the problem of postoperative pain and the burdensome side effects of systemic narcotics to treat the pain after this procedure. This will be a 2-center study, in collaboration with investigators at Weill Cornell Medical College. We are looking to enroll up to 90 patients over the course of the next 12 months. The follow-up consists of five visits in the Post-Anesthesia Care Unit, one call on the first day following surgery, and one call six months following your surgery.
? American Society of Anesthesiologists (ASA) Class 1-3
? Patients aged 18 to 65 years
? Patients scheduled for primary, unilateral arthroscopic hip surgery by Dr. Kelly, Dr. Coleman, or Dr. Anil Ranawat
? Planned use of neuraxial anesthesia
? Body Mass Index less than 35
? Ability to follow study protocol
? Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
? Contraindication to combined spinal-epidural anesthesia including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
? Contraindication to lumbar plexus block including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
? Infection at the injection site(s)
? Allergy to any of the study medications
? Contraindication to a short course of NSAIDs (renal failure, intolerance)
? ASA Class 4-5
? Patient refusal
? Patients younger than 18 years old and older than 65
? BMI greater than or equal to 35
? Patients with any known indwelling hardware of the lumbar spine.
? Patients with a peripheral neuropathy of the surgical extremity
? Non-English speaking patients
Dr. Jacques T. YaDeau, MD, PhD