Tourniquet Application on Total Knee Arthroplasty

Not Applicable

• Conditions: Total Knee Arthroplasty; Tourniquets
• Interventions: Procedure: Reinflation after early deflation; Procedure: Control

• Registration Number: NCT03256058
• Lead Sponsor: The Affiliated Hospital of Xuzhou Medical University

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.

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-08-18
• Study Start: 2017-08-20
• Study First Posted: 2017-08-21
• Last Update Submitted: 2017-10-22
• Last Update Posted: 2017-10-24
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reinflation after early deflation	Reinflation after early deflation	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.
Control	Control	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.

Primary Outcome Measures

Name	Time	Method
Postoperative pain	48 hours post surgery	tested by Visual Analogue Scale

Secondary Outcome Measures

Name	Time	Method
Hemoglobin	one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation	blood gas analysis g/L
The rate of postoperative limb swelling	24 hours post surgery, 48 hours post surgery	test the perimeter of the surgary limb at four fingers under the inguen,then Calculate the rate by formula (postoperative perimeter-preoperative perimeter)/preoperative perimeter
Lac	one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation	blood gas analysis mmol/L
Endothelin-1	one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation	tested by ELISA
Nitric Oxide	one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation	tested by ELISA
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	blood gas analysis mmHg

Trial Locations

Locations (1)

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China