Hospital for Special Surgery
New York, 10021, United States
NCT Number: NCT01333969
The application of a tourniquet for 5 minutes and subsequent reperfusion before actual inflation of the tourniquet for total knee arthroplasty (ischemic preconditioning) decreases the level of local inflammation and therefore postoperative pain in response to reperfusion of the ischemic extremity.
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Notify Me18 year–99 year
All sexes
Interventional
Not applicable
New York, 10021, United States
During knee surgery your surgeon routinely uses a device called a tourniquet that allows us to temporarily cut of blood supply to the site of surgery. This helps to reduce blood loss and improves operating conditions. When allowing blood back into your leg at the end of the procedure, debris (bone, fat, tissue breakdown products and cement from the surgery) gets washed out and gains access to the rest of your body. In the vast majority of cases this event bares no major clinical consequences, but can rarely result in signs of inflammation of various body systems. Patients with evidence of impaired organ system function such as pre-existing lung and heart disease may be more vulnerable. Previous studies suggest that cutting off the blood supply for a short period of time just before a prolonged episode, could lead to a decrease in the extent of tissue breakdown products in this extremity and may thus be associated with a decrease in the inflammation of other organ systems. We propose to study this theory in knee surgery patients by looking at levels of markers of inflammation present in the blood before and after surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
Time frame: 48hrs after surgery
Visual Analogue Scale (VAS) are used to measure the intensity of pain. The total scale ranged from 0 (no pain) to 10 (excruciating pain). The average value at POD 48hours was reported for each arm/group.
Time frame: At 48hrs after surgery
Postoperative pain management included an epidural infusion of 10mcg/ml bupivacaine 0.06%/hydromorphone with a basal rate of 4 mL, a demand dose of 4 mL, and a lockout of 10 minutes. Basal rates were reduced to 2 mL and 0 mL in the morning of postoperative Days 1 and 2, respectively and epidural catheters removed on postoperative Day 2. Overall epidural volume was the total volume given over 48 hours.
Time frame: At 48 hrs after surgery
muscle tissue oxygenation was measured using a novel noninvasive near infrared spectroscopy device at baseline and at 48 hours postoperatively
Time frame: At 24 hours postoperatively
Time frame: measured at 6 hours, 24 hours, and 48 hours
Periarticular circumference of the knee as compared to contralateral side as crude marker of swelling at 6h, 24, and 48h postoperatively. The data from the specified time points (6h, 24h, and 48h) were combined and the average value was reported for each arm/group.
Time frame: Up to discharge date
Time frame: Up to discharge date
Amount of time until patients reached their physical therapy milestone (40 ft ambulation) during admission
Time frame: 24 hours postoperatively
Time frame: 24 hours postoperatively
Hospital for Special Surgery, New York
Other
The Effect of Ischemic Preconditioning on Postoperative Pain After Total Knee Arthroplasty, a Randomized, Controlled Trial
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