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

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Tourniquet: Systolic blood pressure + 75 mmHg
Tourniquet: Systolic blood pressure + 100 mmHg
Tourniquet: Systolic blood pressure + 150 mmHg
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Tourniquet, Total knee arthroplasty, Postoperative pain, Range of motion, Wound complication

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Thammasat university hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Tourniquet: Systolic blood pressure + 75 mmHg

Tourniquet: Systolic blood pressure + 100 mmHg

Tourniquet: Systolic blood pressure + 150 mmHg

Arm Description

Before skin incision

Before skin incision

Before skin incision

Outcomes

Primary Outcome Measures

Postoperative visual analogue scale for pain
(VAS, 0 = no pain, 10 = the worst imaginable pain)

Secondary Outcome Measures

Quality of bloodless visual field
(QBF, 0 = the worst quality, 10 = the best quality)
Changes from baseline hemoglobin concentrations
Postoperative range of motion
Record with long arm goniometer
Number of patient with local soft tissue complications
Number of patient with venous thromboembolism
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

Full Information

First Posted
April 16, 2019
Last Updated
May 3, 2019
Sponsor
Thammasat University
Collaborators
Boontanapibul, Krit, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT03931837
Brief Title
Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty
Official Title
Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty: A Prospective, Randomized Controlled Trials
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Anticipated)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University
Collaborators
Boontanapibul, Krit, M.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Tourniquet, Total knee arthroplasty, Postoperative pain, Range of motion, Wound complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tourniquet: Systolic blood pressure + 75 mmHg
Arm Type
Experimental
Arm Description
Before skin incision
Arm Title
Tourniquet: Systolic blood pressure + 100 mmHg
Arm Type
Experimental
Arm Description
Before skin incision
Arm Title
Tourniquet: Systolic blood pressure + 150 mmHg
Arm Type
Experimental
Arm Description
Before skin incision
Intervention Type
Device
Intervention Name(s)
Tourniquet: Systolic blood pressure + 75 mmHg
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Tourniquet: Systolic blood pressure + 100 mmHg
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Tourniquet: Systolic blood pressure + 150 mmHg
Intervention Description
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 Measure Information:
Title
Postoperative visual analogue scale for pain
Description
(VAS, 0 = no pain, 10 = the worst imaginable pain)
Time Frame
48 hours after operation
Secondary Outcome Measure Information:
Title
Quality of bloodless visual field
Description
(QBF, 0 = the worst quality, 10 = the best quality)
Time Frame
Intraoperative evaluation
Title
Changes from baseline hemoglobin concentrations
Time Frame
48 hours after operation
Title
Postoperative range of motion
Description
Record with long arm goniometer
Time Frame
2 weeks, 6 weeks and 12 weeks
Title
Number of patient with local soft tissue complications
Time Frame
14 days after the operation
Title
Number of patient with venous thromboembolism
Time Frame
14 days after the operation
Title
Knee society score
Description
Score from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
Time Frame
6 weeks, 12 weeks and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piya Pinsornsak
Organizational Affiliation
Thammasat University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thammasat university hospital
City
Pathumthani
State/Province
Klongluang
ZIP/Postal Code
12120
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
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Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty

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