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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03931837
Recruitment Status : Enrolling by invitation
First Posted : April 30, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Krit Boontanapibul
Information provided by (Responsible Party):
piya pinsornsak, Thammasat University

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 Intervention/treatment Phase
Osteoarthritis, Knee Device: Tourniquet: Systolic blood pressure + 75 mmHg Device: Tourniquet: Systolic blood pressure + 100 mmHg Device: Tourniquet: Systolic blood pressure + 150 mmHg Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 1, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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




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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931837


Locations
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Thailand
Thammasat university hospital
Pathumthani, Klongluang, Thailand, 12120
Sponsors and Collaborators
Thammasat University
Krit Boontanapibul
Investigators
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Principal Investigator: Piya Pinsornsak Thammasat university hospital
Publications:

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Responsible Party: piya pinsornsak, Principal Investigator, Thammasat University
ClinicalTrials.gov Identifier: NCT03931837    
Other Study ID Numbers: MTU-EC-OT-1-183/60
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by piya pinsornsak, Thammasat University:
Tourniquet
Total knee arthroplasty
Postoperative pain
Range of motion
Wound complication
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Pain, Postoperative
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms