Clinical trial NCT01333969: Ischemic Preconditioning in Total Knee Arthroplasty
Official title: The Effect of Ischemic Preconditioning on Postoperative Pain After Total Knee Arthroplasty, a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Ischemic Preconditioning
Postoperative Pain
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
First posted: 2011-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Postoperative Pain at Rest and Exercise as Assessed by Visual Analogue Scale (VAS) Scores at 48h After Surgery
timeFrame: 48hrs after surgery
Secondary outcomes:
measure: Overall Epidural Volume
timeFrame: At 48hrs after surgery
measure: Muscle Oxygenation Over Calf at 48h After Surgery
timeFrame: At 48 hrs after surgery
measure: Levels of Interleukin 6 (IL6) in Drainage Fluid at 24hr Postoperatively
timeFrame: At 24 hours postoperatively
measure: Periarticular Circumference of the Knee at 6h, 24h, and 48h
timeFrame: measured at 6 hours, 24 hours, and 48 hours
measure: Hospital Length of Stay
timeFrame: Up to discharge date
measure: Physical Therapy Milestone
timeFrame: Up to discharge date
measure: Levels of Leukocytes in Drainage Fluid at 24hr Postoperatively
timeFrame: 24 hours postoperatively
measure: Levels of TNF-alpha in Drainage Fluid at 24hr Postoperatively
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Stavros G. Memtsoudis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Memtsoudis SG, Stundner O, Yoo D, Gonzalez Della Valle A, Boettner F, Bombardieri AM, Jules-Elysee K, Poultsides L, Ma Y, Sculco TP. Does limb preconditioning reduce pain after total knee arthroplasty? A randomized, double-blind study. Clin Orthop Relat Res. 2014 May;472(5):1467-74. doi: 10.1007/s11999-013-3106-4.