Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty

Study Overview
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Brief Summary
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Tourniquet use during total knee replacement (TKR) improves visibility, significantly decreases intra-operative blood loss and reduce operative time. However, tourniquet use also has a negative effect on postoperative pain, postoperative range of motion(ROM), wound complication, deep vein thrombosis (DVT), pulmonary embolism (PE), thigh muscle strength, and functional recovery after TKR. Therefore, the investigators conducted a three-arm prospective, randomized, controlled trial study to compare the efficacy of different tourniquet pressure used between systolic blood pressure + 75 mmHg, systolic blood pressure + 100 mmHg, and systolic blood pressure + 150 mmHg.

Detailed Description
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Patients scheduled for unilateral primary TKA; 150 patients were randomly assigned to receive tourniquet pressure used of systolic blood pressure + 75 mmHg, systolic blood pressure + 100 mmHg, and systolic blood pressure + 150 mmHg. All patients had spinal anesthesia, the same operative procedure, and postoperative pain protocol. A visual analogue scale (VAS) for pain were recorded 24, 48 hours, and 2 weeks postoperatively. Quality of bloodless visual field and calculated blood loss were evaluated perioperatively. Postoperative ROM, wound complication, deep vein thrombosis (DVT), pulmonary embolism (PE) were recorded at 2, 6, and 12 weeks. Furthermore, Knee Society Score (KSS) also recorded at 6 weeks, 3 and 6 months. The reviewers were blinded to the treatment group.

Official Title
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Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty: A Prospective, Randomized Controlled Trials

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Tourniquet: Systolic blood pressure + 75 mmHg
* Device: Tourniquet: Systolic blood pressure + 100 mmHg
* Device: Tourniquet: Systolic blood pressure + 150 mmHg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with osteoarthritis in need of a TKR Exclusion Criteria: Inflammatory arthritis Post-traumatic arthritis Body mass index > 30 Kg/m2 A history of or current venous thromboembolic disease Any underlying disease of hemostasis, cirrhosis, chronic renal failure, patients on anticoagulants or strong antiplatelet drugs (e.g. warfarin, clopidogrel) Preoperative hemoglobin <10 g/dL or a platelet count < 140,000 /uL3 Allergy to transamine

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tourniquet: Systolic blood pressure + 75 mmHg<br>Before skin incision | Device: Tourniquet: Systolic blood pressure + 75 mmHg<br>* Spinal block without morphine. Medial parapatellar approach. Same posterior stabilized design and operated by a single surgeon. Drug: Peri-articular Transmine(15 mg/kg) combined with multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg) mixed NSS up to 75 mL. Procedure/Surgery: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to capsular closure and tourniquet deflation<br>|
| Experimental: Tourniquet: Systolic blood pressure + 100 mmHg<br>Before skin incision | Device: Tourniquet: Systolic blood pressure + 100 mmHg<br>* Spinal block without morphine. Medial parapatellar approach. Same posterior stabilized design and operated by a single surgeon. Drug: Peri-articular Transmine(15 mg/kg) combined with multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg) mixed NSS up to 75 mL. Procedure/Surgery: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to capsular closure and tourniquet deflation<br>|
| Experimental: Tourniquet: Systolic blood pressure + 150 mmHg<br>Before skin incision | Device: Tourniquet: Systolic blood pressure + 150 mmHg<br>* Spinal block without morphine. Medial parapatellar approach. Same posterior stabilized design and operated by a single surgeon. Drug: Peri-articular Transmine(15 mg/kg) combined with multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg) mixed NSS up to 75 mL. Procedure/Surgery: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to capsular closure and tourniquet deflation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative visual analogue scale for pain | (VAS, 0 = no pain, 10 = the worst imaginable pain) | 48 hours after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of bloodless visual field | (QBF, 0 = the worst quality, 10 = the best quality) | Intraoperative evaluation | 
| Changes from baseline hemoglobin concentrations |  | 48 hours after operation | 
| Postoperative range of motion | Record with long arm goniometer | 2 weeks, 6 weeks and 12 weeks | 
| Number of patient with local soft tissue complications |  | 14 days after the operation | 
| Number of patient with venous thromboembolism |  | 14 days after the operation | 
| Knee society score | Score from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions | 6 weeks, 12 weeks and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tourniquet, Total knee arthroplasty, Postoperative pain, Range of motion, Wound complication