Institutional Review Board, Hospital for Special Surgery
June 30, 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 of Dr Levine or Dr Roberts.
· Scheduled for discharge from HSS after foot or ankle surgery.
· A single-injection popliteal fossa nerve block is judged appropriate.
· Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion).
· Patients aged 18-75 years.
· Surgery that will cause pain at sites outside the distal lower extremity (e.g. iliac crest bone graft).
· Bilateral surgery
· Chronic pain (defined as regular use of opioid analgesics for > 3 months).
· Chronic use of steroids (defined as regular use of steroids for > 3 months).
Contraindication to performance of the popliteal fossa nerve block with 30 cc 0.25% bupivacaine with clonidine (e.g. alleged bupivacaine sensitivity, low body weight, clonidine allergy, etc.).
· Contraindications to dexamethasone or buprenorphine (e.g. allergy, Insulin Dependent Diabetes Mellitus, etc.)
· Inability of the patient to describe postoperative pain (e.g. psychiatric disorder, dementia).
· Non-English speaking patients (the questionnaire is in English, and translations would have to be separately validated)