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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333969
• Other study ID #: HSS10131
• Status: Completed
• Phase: N/A
• First received: April 11, 2011
• Last updated: January 31, 2013
• Start date: April 2011

Study information

• Verified date: January 2013
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Ischemia
• Ischemic Preconditioning
• Pain, Postoperative
• Postoperative Pain
• Total Knee Arthroplasty

Intervention

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.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain at rest and exercise as assessed by VAS scores on 6h, 24h, and 48h after surgery		Up to 48hrs after surgery	No
Secondary	Overall epidural volume and oioid consumption over 48h		Up to 48hrs after surgery	No
Secondary	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	No
Secondary	Levels of leukocytes and tumor necrosis factor-alpha (TNF) and Interleukin 6 (IL6) in drainage fluid at 24hr postoperatively		24 hours postoperatively	No
Secondary	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	No
Secondary	Hospital length of stay		Up to discharge date	No
Secondary	Physical theraphy milestone	Ambulation of 40ft, independent transfer, and range of motion of operative leg	Up to discharge date	No