Institutional Review Board, Hospital for Special Surgery
March 17, 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.
Jacques T. YaDeau, MD, PhD
The best way to provide analgesia after total knee arthroplasty is hotly debated. There are two protocols in use at HSS. Both protocols have their proponents, but there are limited data for making an informed choice of protocols. For total knee arthroplasty at HSS, femoral nerve blockade is commonly added to epidural analgesia, as this reduces pain with physical therapy. However, epidural analgesia can be associated with nausea, pruritus, dizziness, and orthostatic hypotension. Femoral nerve blockade reduces pain but also causes quadriceps weakness. These side-effects can slow physical therapy and may prolong the time until the patient is ready for discharge. Some surgeons at HSS have decided to use a different analgesic protocol, based on a peri-articular injection. This protocol avoids epidural analgesia, systemic opioids and nerve blockade. However, patients are given oral opioids as part of a multimodal pain therapy. We propose to compare peri-articular injection to femoral nerve blockade and epidural PCA. We will enroll 90 total patients (45 per study arm). The enrollment period will be approximately one year and the duration of the follow-up with study patients will be six months following their procedure.
- Patients with osteoarthritis scheduled for primary bicompartmental total knee arthroplasty with a participating surgeon
- Age 18 to 80 years old
- Planned use of regional anesthesia
- Ability to follow study protocol
- Patients younger than 18 years old and older than 80
- Patients intending to receive general anesthesia
- Allergy or intolerance to one of the study medications
- Patients with an ASA of IV
- Patients with insulin-dependent diabetes
- Patients with hepatic (liver) failure
- Patients with chronic renal (kidney) failure
- Chronic opioid use (taking opioids for longer than 3 months)
Jacques T. YaDeau, MD, PhD