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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03931837

Recruitment Status Enrolling by invitation

First Posted April 30, 2019

Last update posted May 7, 2019

Study Description

Brief summary:

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.

  • Condition or Disease:Osteoarthritis, Knee
  • Intervention/Treatment: Device: Tourniquet: Systolic blood pressure + 75 mmHg
    Device: Tourniquet: Systolic blood pressure + 100 mmHg
    Device: Tourniquet: Systolic blood pressure + 150 mmHg
  • Phase: N/A
Detailed Description

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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 150 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty: A Prospective, Randomized Controlled Trials
  • Estimated Study Start Date: May 2019
  • Estimated Primary Completion Date: April 2020
  • Estimated Study Completion Date: July 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Tourniquet: Systolic blood pressure + 75 mmHg
Before skin incision
Device: Tourniquet: Systolic blood pressure + 75 mmHg
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
Experimental: Tourniquet: Systolic blood pressure + 100 mmHg
Before skin incision
Device: Tourniquet: Systolic blood pressure + 100 mmHg
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
Experimental: Tourniquet: Systolic blood pressure + 150 mmHg
Before skin incision
Device: Tourniquet: Systolic blood pressure + 150 mmHg
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
Outcome Measures
  • Primary Outcome Measures: 1. Postoperative visual analogue scale for pain [ Time Frame: 48 hours after operation ]
    (VAS, 0 = no pain, 10 = the worst imaginable pain)
  • Secondary Outcome Measures: 1. Quality of bloodless visual field [ Time Frame: Intraoperative evaluation ]
    (QBF, 0 = the worst quality, 10 = the best quality)
  • 2. Changes from baseline hemoglobin concentrations [ Time Frame: 48 hours after operation ]
  • 3. Postoperative range of motion [ Time Frame: 2 weeks, 6 weeks and 12 weeks ]
    Record with long arm goniometer
  • 4. Number of patient with local soft tissue complications [ Time Frame: 14 days after the operation ]
  • 5. Number of patient with venous thromboembolism [ Time Frame: 14 days after the operation ]
  • 6. Knee society score [ Time Frame: 6 weeks, 12 weeks and 6 months ]
    Score from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
Eligibility Criteria
  • Ages Eligible for Study: 50 to 90 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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

Contacts and Locations
Contacts
Locations

Thailand, Klongluang
Thammasat university hospital
Pathumthani

Sponsors and Collaborators

Thammasat University

Krit Boontanapibul

Investigators

Principal Investigator: Piya Pinsornsak Thammasat university hospital

More Information