Institutional Review Board, Hospital for Special Surgery
January 05, 2009
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.
Stavros G. Memtsoudis, MD, PhD
The purpose of this research project is to study the effects of regional anesthesia on the arterial tone in patients after Total Hip Replacement. Your participation will involve a total of 6 study visits while you are in the hospital. These visits will occur only during your day of surgery up to the second day after your surgery. We plan to enroll a total of 90 patients in this study.
Surgery such as total hip replacement results in pain after surgery. Pain following surgery is important to treat, not only for compassionate reasons but also because the pain may increase blood pressure, placing a strain on the heart, especially in older patients or those with heart disease. In people over the age of 55, the increase in blood pressure is usually due to an increase in the stiffness in blood vessels. There are a number of ways to treat pain following hip replacement and it is possible that some ways may result in less strain on the heart than others. The two basic ways of treating the pain are firstly, with an epidural pain pump, the second is with an epidural pain pump combined with blocking of the nerves to the hip (lumbar plexus block) performed in the operating room before the start of surgery. Pain with both techniques can also be aided with pain pills.
Increased arterial tone results in higher blood pressure so that the heart has greater pressure to pump against. Recently, a non-invasive device to measure arterial stiffness has recently become available. This provides us with the opportunity to determine which of the two most common ways of treating pain following hip surgery at HSS is better at preventing an increase in arterial tone following surgery.
• Patients aged 60-100 who are undergoing unilateral primary THA (total hip replacement for one hip) under combined spinal/epidural anesthesia. (medication administered in the area outside the spinal cord to cause a loss of sensation/feeling)
• Only patients assigned to the operating room of the study’s primary investigator (Dr. Goytizolo) and co-investigators are eligible to be consented to participate in the study.
• Patients with prior lumbar spine fusion.
• Patients on chronic pain therapy (greater than one month) with narcotics.
• Surgery other than primary total hip replacement.
• Patients younger than 60 and older than 100.