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

Primary Purpose

Total Knee Arthroplasty, Ischemic Preconditioning, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ischemic Preconditioning
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Total Knee Arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Ishcemic Preconditioning

Control

Arm Description

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.

Outcomes

Primary Outcome Measures

Postoperative pain at rest and exercise as assessed by VAS scores on 6h, 24h, and 48h after surgery

Secondary Outcome Measures

Overall epidural volume and oioid consumption over 48h
Muscle oxygenation over calf as measured by non-invasive infrared spectroscopy pre-surgery, 6h, 24h, and 48h after surgery
Levels of leukocytes and tumor necrosis factor-alpha (TNF) and Interleukin 6 (IL6) in drainage fluid at 24hr 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
Hospital length of stay
Physical theraphy milestone
Ambulation of 40ft, independent transfer, and range of motion of operative leg

Full Information

First Posted
April 11, 2011
Last Updated
January 31, 2013
Sponsor
Hospital for Special Surgery, New York
Collaborators
University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT01333969
Brief Title
The Effect of Ischemic Preconditioning on Postoperative Pain After Total Knee Arthroplasty, a Randomized, Controlled Trial
Official Title
The Effect of Ischemic Preconditioning on Postoperative Pain After Total Knee Arthroplasty, a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
Collaborators
University of Massachusetts, Worcester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty, Ischemic Preconditioning, Postoperative Pain

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ishcemic Preconditioning
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
Intervention Type
Procedure
Intervention Name(s)
Ischemic Preconditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative pain at rest and exercise as assessed by VAS scores on 6h, 24h, and 48h after surgery
Time Frame
Up to 48hrs after surgery
Secondary Outcome Measure Information:
Title
Overall epidural volume and oioid consumption over 48h
Time Frame
Up to 48hrs after surgery
Title
Muscle oxygenation over calf as measured by non-invasive infrared spectroscopy pre-surgery, 6h, 24h, and 48h after surgery
Time Frame
Up to 48 hrs after surgery
Title
Levels of leukocytes and tumor necrosis factor-alpha (TNF) and Interleukin 6 (IL6) in drainage fluid at 24hr postoperatively
Time Frame
24 hours postoperatively
Title
Periarticular circumference of the knee at 6h, 24h, and 48h
Description
Periarticular circumference of the knee as compared to contralateral side as curde marker of swelling at 6h, 24, and 48h postoperatively
Time Frame
Up to 48h
Title
Hospital length of stay
Time Frame
Up to discharge date
Title
Physical theraphy milestone
Description
Ambulation of 40ft, independent transfer, and range of motion of operative leg
Time Frame
Up to discharge date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stavros G. Memtsoudis, MD, PhD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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