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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Total Knee Arthroplasty; Ischemic Preconditioning
• Intervention / Treatment: Procedure: Ischemic Preconditioning

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative pain at rest and exercise as assessed by VAS scores on 6h, 24h, and 48h after surgery	Up to 48hrs after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall epidural volume and oioid consumption over 48h		Up to 48hrs after surgery
Muscle oxygenation over calf as measured by non-invasive infrared spectroscopy pre-surgery, 6h, 24h, and 48h after surgery		Up to 48 hrs after surgery
Levels of leukocytes and tumor necrosis factor-alpha (TNF) and Interleukin 6 (IL6) in drainage fluid at 24hr postoperatively		24 hours postoperatively
Periarticular circumference of the knee at 6h, 24h, and 48h	Periarticular circumference of the knee as compared to contralateral side as curde marker of swelling at 6h, 24, and 48h postoperatively	Up to 48h
Hospital length of stay		Up to discharge date
Physical theraphy milestone	Ambulation of 40ft, independent transfer, and range of motion of operative leg	Up to discharge date

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Collaborators: University of Massachusetts, Worcester

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: April 11, 2011
• First Submitted That Met QC Criteria: April 11, 2011
• First Posted (Estimate): April 12, 2011

Study Record Updates

• Last Update Posted (Estimate): February 1, 2013
• Last Update Submitted That Met QC Criteria: January 31, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Ischemia
• Other Study ID Numbers: HSS10131