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

This study has been completed.
Sponsor:
Collaborator:
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01333969
First received: April 11, 2011
Last updated: January 31, 2013
Last verified: January 2013

April 11, 2011
January 31, 2013
April 2011
April 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01333969 on ClinicalTrials.gov Archive Site
  • Overall epidural volume and oioid consumption over 48h [ Time Frame: Up to 48hrs after surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Levels of leukocytes and tumor necrosis factor-alpha (TNF) and Interleukin 6 (IL6) in drainage fluid at 24hr postoperatively [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
  • Periarticular circumference of the knee at 6h, 24h, and 48h [ Time Frame: Up to 48h ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to discharge date ] [ Designated as safety issue: No ]
  • Physical theraphy milestone [ Time Frame: Up to discharge date ] [ Designated as safety issue: No ]
    Ambulation of 40ft, independent transfer, and range of motion of operative leg
Not Provided
Not Provided
Not Provided
 
The Effect of Ischemic Preconditioning on Postoperative Pain After Total Knee Arthroplasty, a Randomized, Controlled Trial
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
  • Total Knee Arthroplasty
  • Ischemic Preconditioning
  • Postoperative Pain
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.
  • 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).
    Intervention: Procedure: Ischemic Preconditioning
  • No Intervention: Control
    In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01333969
HSS10131
Yes
Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
University of Massachusetts, Worcester
Principal Investigator: Stavros G. Memtsoudis, MD, PhD Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP