Clinical Trials Directory

Trials / Completed

CompletedNCT01333969

Ischemic Preconditioning in Total Knee Arthroplasty

The Effect of Ischemic Preconditioning on Postoperative Pain After Total Knee Arthroplasty, a Randomized, Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Hospital for Special Surgery, New York · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREIschemic PreconditioningIn 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.

Timeline

Start date
2011-04-01
Primary completion
2012-04-01
Completion
2012-04-01
First posted
2011-04-12
Last updated
2024-12-27
Results posted
2024-09-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01333969. Inclusion in this directory is not an endorsement.