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

May 3, 2019 updated by: piya pinsornsak, Thammasat University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Klongluang
      • Pathumthani, Klongluang, Thailand, 12120
        • Thammasat University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patient with venous thromboembolism
Time Frame: 14 days after the operation
14 days after the operation
Quality of bloodless visual field
Time Frame: Intraoperative evaluation
(QBF, 0 = the worst quality, 10 = the best quality)
Intraoperative evaluation
Changes from baseline hemoglobin concentrations
Time Frame: 48 hours after operation
48 hours after operation
Postoperative range of motion
Time Frame: 2 weeks, 6 weeks and 12 weeks
Record with long arm goniometer
2 weeks, 6 weeks and 12 weeks
Number of patient with local soft tissue complications
Time Frame: 14 days after the operation
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
6 weeks, 12 weeks and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Collaborators

Boontanapibul, Krit, M.D.

Investigators

  • Principal Investigator: Piya Pinsornsak, Thammasat University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2019

Primary Completion (Anticipated)

April 30, 2020

Study Completion (Anticipated)

July 31, 2020

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

April 25, 2019

First Posted (Actual)

April 30, 2019

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-EC-OT-1-183/60

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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