The Effect of Different Applications of Tourniquet on Total Knee Arthroplasty
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tourniquets
- Sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Postoperative pain
- Last Updated
- 8 years ago
Overview
Brief Summary
This is a randomized controlled trial designed to research the effects of different tourniquet applications on postoperative pain in patients undergoing total knee arthroplasty, and to guide early postoperative recovery.
Detailed Description
Sixty participants undergoing unilateral TKA would be recruited in this study. On one side, the tourniquet would be inflated immediately before incision and deflated after the use of the cement , and 10 minutes later(after the hardening of the cement) , reinflate the tourniquet and deflate at the end of the operation. On the other side the tourniquet would be inflated immediately before incision and deflated at the end of the operation.The total time of tourniquet inflation is controlled within 90 minutes. The postoperative pain, limb swelling , the score of surgical field, blood pressure during the operation, blood loss, operating time, transfusion rate, deep vein thrombosis (DVT) incidence and clinical outcomes would be monitored for comparison.
Investigators
Eligibility Criteria
Inclusion Criteria
- •American Society of anesthesiologists Grade 1-3 Patients
- •Undergoing unilateral total knee arthroplasty under general anesthesia
- •Should be treated with tourniquet
Exclusion Criteria
- •Tourniquet inflation time is less than 1h, greater than 1.5h
- •Abnormal coagulation function
- •BMI \< 20kg/m2 or \> 35kg/m2
- •History of cerebral infarction
- •History of Peripheral vascular disease
- •Anemia (hemoglobin\<90g/L)
- •Systolic blood pressure (SBP) ≥ 170mmHg
- •Pregnant blood glucose \> 10mmol/L or HbA1c \> 8.5% of diabetic patients
- •History of chronic narcotic use
- •Participate in other clinical trials at the same time
Outcomes
Primary Outcomes
Postoperative pain
Time Frame: 48 hours post surgery
tested by Visual Analogue Scale
Secondary Outcomes
- Hemoglobin(one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation)
- The rate of postoperative limb swelling(24 hours post surgery, 48 hours post surgery)
- Lac(one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation)
- Endothelin-1(one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation)
- Nitric Oxide(one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation)
- partial pressure of oxygen in artery(one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation)