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

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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

Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date May 7, 2019
Estimated Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
Postoperative visual analogue scale for pain [ Time Frame: 48 hours after operation ]
(VAS, 0 = no pain, 10 = the worst imaginable pain)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • Quality of bloodless visual field [ Time Frame: Intraoperative evaluation ]
    (QBF, 0 = the worst quality, 10 = the best quality)
  • Changes from baseline hemoglobin concentrations [ Time Frame: 48 hours after operation ]
  • Postoperative range of motion [ Time Frame: 2 weeks, 6 weeks and 12 weeks ]
    Record with long arm goniometer
  • Number of patient with local soft tissue complications [ Time Frame: 14 days after the operation ]
  • Number of patient with venous thromboembolism [ Time Frame: 14 days after the operation ]
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • Quality of bloodless visual field [ Time Frame: Intraoperative evaluation ]
    (QBF, 0 = the worst quality, 10 = the best quality)
  • Changes from baseline hemoglobin concentrations [ Time Frame: 48 hours after operation ]
  • Postoperative range of motion [ Time Frame: 2 weeks, 6 weeks and 12 weeks ]
    Record with long arm goniometer
  • Local soft tissue complications [ Time Frame: 14 days after the operation ]
  • Number of patient with venous thromboembolism [ Time Frame: 14 days after the operation ]
  • Knee society score [ Time Frame: 6 weeks, 12 weeks and 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty
Official Title  ICMJE Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty: A Prospective, Randomized Controlled Trials
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Tourniquet: Systolic blood pressure + 75 mmHg
    Before skin incision
    Intervention: Device: Tourniquet: Systolic blood pressure + 75 mmHg
  • Experimental: Tourniquet: Systolic blood pressure + 100 mmHg
    Before skin incision
    Intervention: Device: Tourniquet: Systolic blood pressure + 100 mmHg
  • Experimental: Tourniquet: Systolic blood pressure + 150 mmHg
    Before skin incision
    Intervention: Device: Tourniquet: Systolic blood pressure + 150 mmHg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: April 25, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03931837
Other Study ID Numbers  ICMJE MTU-EC-OT-1-183/60
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party piya pinsornsak, Thammasat University
Study Sponsor  ICMJE Thammasat University
Collaborators  ICMJE Krit Boontanapibul
Investigators  ICMJE
Principal Investigator: Piya Pinsornsak Thammasat university hospital
PRS Account Thammasat University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP