The Effect of Ischemic Preconditioning on Postoperative Pain After Total Knee Arthroplasty, a Randomized, Controlled Trial
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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 |
- 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 ]
- 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
| Enrollment: | 60 |
| Study Start Date: | April 2011 |
| Primary Completion Date: | April 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).
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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.
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No Intervention: Control
In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
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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 |
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| United States, New York | |
| Hospital for Special Surgery | |
| New York, New York, United States, 10021 | |
| 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: | January 31, 2013 |
| 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 June 18, 2013