Ischemic Preconditioning in Total Knee Arthroplasty

Hospital for Special Surgery, New York60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

Conditions

Total Knee Arthroplasty Ischemic Preconditioning Postoperative Pain

Interventions

Ischemic PreconditioningPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All patients undergoing primary total knee arthroplasty Exclusion Criteria: * Patients who chronically use narcotics (\<1 month). * Patients with contraindications (severe peripheral vascular disease, presence of femoral-popliteal bypass grafts, etc.) or no plan for tourniquet use as determined by the clinical care team. * Patients who are on corticosteroids prior to their surgery

Locations (1)

Hospital for Special Surgery

New York, New York, United States

Outcomes

Primary Outcomes

Postoperative Pain at Rest and Exercise as Assessed by Visual Analogue Scale (VAS) Scores at 48h 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: 48hrs after surgery

Secondary Outcomes

Overall Epidural Volume

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 48hrs after surgery

Muscle Oxygenation Over Calf at 48h 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 48 hrs after surgery

Levels of Interleukin 6 (IL6) in Drainage Fluid at 24hr Postoperatively

Time frame: At 24 hours postoperatively

Periarticular Circumference of the Knee at 6h, 24h, and 48h

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: measured at 6 hours, 24 hours, and 48 hours

Hospital Length of Stay

Time frame: Up to discharge date

Data from ClinicalTrials.gov

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