Clinical trial NCT03256058: Tourniquet Application on Total Knee Arthroplasty
Official title: The Effect of Different Applications of Tourniquet on Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tourniquets
Total Knee Arthroplasty
Lead sponsor: The Affiliated Hospital of Xuzhou Medical University
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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
* Asked to withdraw from the trial

Primary outcomes:
measure: Postoperative pain
timeFrame: 48 hours post surgery
Secondary outcomes:
measure: The rate of postoperative limb swelling
timeFrame: 24 hours post surgery, 48 hours post surgery
measure: Endothelin-1
timeFrame: one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation
measure: Nitric Oxide
timeFrame: one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation
measure: Lac
timeFrame: one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation
measure: Hemoglobin
timeFrame: one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation
measure: partial pressure of oxygen in artery
timeFrame: one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
affiliation: The Affiliated Hospital of Xuzhou Medical University
name: Guanglei Wang, MD
role: STUDY_DIRECTOR
References:
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