Efficacy of Lower Tourniquet Pressure During Total Knee Arthroplasty

Not Applicable

• Conditions: Osteoarthritis
• Interventions: Procedure: Conventional tourniquet pressure; Procedure: Low tourniquet pressure

• Registration Number: NCT01993758
• Lead Sponsor: Seoul National University Hospital

Brief Summary

This study aims to determine whether the lower tourniquet pressure, which is set by adding 120mmHg (millimeter of mercury) on the systolic blood pressure just before tourniquet inflation, are efficient and safe during total knee arthroplasty, compared with the conventional tourniquet pressure: 150mmHg above the systolic blood pressure before tourniquet inflation.

Detailed Description

We will compare the two groups of patients undergoing total knee arthroplasty, which the tourniquet pressure will be set differently: systolic blood pressure plus 120mmHg vs. systolic blood pressure plus 150mmHg, the conventional method, in terms of efficacy and safety.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-22
• Primary Completion: 2016-03
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• The patients undergoing total knee arthroplasty

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Exclusion Criteria

• Systolic blood pressure measured at ward > 200mmHg
• Thigh circumference > 78cm
• Anesthesia other than spinal anesthesia
• Simultaneous bilateral total knee arthroplasty
• The patients who disagreed the enrollment of this study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional tourniquet pressure	Conventional tourniquet pressure	The patients in this group will undertake total knee arthroplasty under conventional tourniquet pressure, which will be set as the pressure added by 150mmHg on the last systolic blood pressure just before tourniquet inflation.
Low tourniquet pressure	Low tourniquet pressure	The patients in this group will undertake total knee arthroplasty under low tourniquet pressure, which will be set as the pressure added by 120mmHg on the last systolic blood pressure just before tourniquet inflation.

Primary Outcome Measures

Name	Time	Method
Acquisition of bloodless surgical field just after skin incision	just after skin incision during operation	Dichotomous variable determined during operation by operator (Yes or No)

Secondary Outcome Measures

Name	Time	Method
symptomatic venous-thromboembolism	within 7 days after surgery	It includes deep vein thrombosis and pulmonary embolism which are symptomatic and diagnosed by confirmative test, such as CT angiogram.
Skin problem on the site of tourniquet application	posteoperative 2nd day	It includes ecchymosis, bullae formation and skin necrosis.
Failure of acquiring bloodless surgical field during operation	after skin incision through the point of tourniquet deflation
Increasement of tourniquet pressure to acquire bloodless surgical field	after skin incision though the point of tourniquet deflation	We will increase the tourniquet pressure by 30mmHg from the initial tourniquet pressure, if we will fail to achieve bloodless surgical field during operation. The increasement of tourniquet pressure will be recorded if it will be needed during operation.
Thigh pain on the site of tourniquet application	postoperative 2nd day	measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale
Knee pain	postoperative 2nd day	measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale
Nerve palsy	within 7 days after surgery

Trial Locations

Locations (1)

Joint Reconstruction Center, Seoul National University Bundang Hospital; 🇰🇷 Seongnam-Si, Gyeonggi-do, Korea, Republic of