Institutional Review Board, Hospital for Special Surgery
December 09, 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.
Our study will compare the use of saphenous nerve blocks performed at the adductor canal versus femoral nerve blocks for total knee replacements. We hypothesize that the saphenous nerve block performed at the level of the adductor canal provides adequate pain relief without significantly compromising muscle strength, enabling patients to mobilize early and possibly be discharged earlier to the rehabilitation center.
We will enroll a total of 84 patients (42 patients will receive the saphenous nerve block and 42 will receive the femoral nerve block). Before and after surgery, we will assess motor strength of the operative and nonoperative legs by a neurologic exam (based on a 12 point scale) and by using a hand held dynamometer. Until discharge, we will also record patients’ pain scores, physical therapy progress and satisfaction.
If our study proves the saphenous nerve block to be an effective method of postoperative pain control without compromising quadriceps strength, it would be seen as a better alternative to femoral nerve blocks.
All patients ages 18-90 undergoing primary unilateral total knee arthroplasty
· Planned use of neuraxial anesthesia
· Ability to follow study protocol
· American Society of Anesthesiology (ASA) Class 1-3
· Contraindication to a spinal or epidural anesthetic
· Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
· Hypersensitivity and/or allergy to local anesthetics
· Intraoperative use of any volatile anesthetic
· Patients with a pre-existing neuropathy on the operative limb
· Contraindication to a femoral nerve block or saphenous nerve block
· Allergy to any of the study medications
· ASA Class 4-5
· Non-English speaking patients
David Kim, MD