Tourniquet Application on Total Knee Arthroplasty

Xuzhou Medical University

Status: Unknown

Conditions: Tourniquets; Total Knee Arthroplasty

Treatments: Procedure: Reinflation after early deflation; Procedure: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03256058

XYFY-2017-052

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Reinflation after early deflation

Active Comparator group

Description:

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.The total time of tourniquet inflation is controlled within 90 minutes.

Treatment:

Procedure: Reinflation after early deflation

Control

Placebo Comparator group

Description:

The tourniquet would be inflated immediately before incision and deflated at the end of the operation. The inflation of tourniquet should not last more than 90 minutes.

Treatment:

Procedure: Control