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The Effect of Ischemic Preconditioning on Postoperative Pain After Total Knee Arthroplasty, a Randomized, Controlled Trial
This study is currently recruiting participants.
Verified December 2011 by Hospital for Special Surgery, New York

First Received on April 11, 2011.   Last Updated on December 5, 2011   History of Changes
Sponsor: Hospital for Special Surgery, New York
Collaborator: University of Massachusetts, Worcester
Information provided by (Responsible Party): Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01333969
  Purpose

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.


Condition Intervention
Total Knee Arthroplasty
Ischemic Preconditioning
Postoperative Pain
Procedure: Ischemic Preconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Effect of Ischemic Preconditioning on Postoperative Pain After Total Knee Arthroplasty, a Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ishcemic Preconditioning
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).
Procedure: Ischemic Preconditioning
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.
No Intervention: Control
In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333969

Contacts
Contact: Pamela M Shaw, BS 2127742964 shawp@hss.edu

Locations
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Pamela Shaw, BS     212-774-2964     shawp@hss.edu    
Contact: Daniel Yoo, MB     646-797-8948     yood@hss.edu    
Principal Investigator: Stavros G Memtsoudis, MD,PhD            
Sponsors and Collaborators
Hospital for Special Surgery, New York
University of Massachusetts, Worcester
Investigators
Principal Investigator: Stavros G. Memtsoudis, MD, PhD Hospital for Special Surgery, New York
  More Information

No publications provided

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01333969     History of Changes
Other Study ID Numbers: HSS10131
Study First Received: April 11, 2011
Last Updated: December 5, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ischemia
Pain, Postoperative
Pathologic Processes
Postoperative Complications
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2012