The Effect of Ischemic Preconditioning on Postoperative Pain After Total Knee Arthroplasty, a Randomized, Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Total Knee Arthroplasty
- Sponsor
- Hospital for Special Surgery, New York
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Postoperative Pain at Rest and Exercise as Assessed by Visual Analogue Scale (VAS) Scores at 48h After Surgery
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Postoperative Pain at Rest and Exercise as Assessed by Visual Analogue Scale (VAS) Scores at 48h After Surgery
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.
Secondary Outcomes
- Overall Epidural Volume(At 48hrs after surgery)
- Muscle Oxygenation Over Calf at 48h After Surgery(At 48 hrs after surgery)
- Levels of Interleukin 6 (IL6) in Drainage Fluid at 24hr Postoperatively(At 24 hours postoperatively)
- Periarticular Circumference of the Knee at 6h, 24h, and 48h(measured at 6 hours, 24 hours, and 48 hours)
- Hospital Length of Stay(Up to discharge date)
- Physical Therapy Milestone(Up to discharge date)
- Levels of Leukocytes in Drainage Fluid at 24hr Postoperatively(24 hours postoperatively)
- Levels of TNF-alpha in Drainage Fluid at 24hr Postoperatively(24 hours postoperatively)