Postoperative Pain and Blood Loss of Non-use Compared to Partial-use of a Tourniquet in Bilateral Total Knee Replacement (TKA)

June 10, 2025 updated by: Queen Savang Vadhana Memorial Hospital, Thailand

Postoperative Pain and Blood Loss of Non-use Compared to Partial-use of a Tourniquet in Bilateral Total Knee Replacement: A Randomized- Control Trial

Postoperative pain and blood loss of non-use compared to partial-use of a tourniquet in bilateral total knee replacement: A Randomized- Control Trial This study aimed to compare the effects of non-use (NTU) and partial-use (before osteotomy to skin closure; BOO) of a tourniquet in bilateral total knee arthroplasty (TKA) on postoperative pain and complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite numerous meta-analyses, and randomized-control trials (RCTs), there is still no conclusive evidence on the most effective, and efficient method of using a tourniquet.

There is gap of knowledge of method of tourniquet usage. Hence this study will provide the best method to apply tourniquet.

Study Type

Interventional

Enrollment (Actual)

20

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
    • Sriracha
      • Chon Buri, Sriracha, Thailand, 20110
        • Thada Wipatasinlapin

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with over 50 years of age and diagnosed with bilateral severe knee osteoarthritis undergoing bilateral TKA

Exclusion Criteria:

  • patients having undergone previous knee surgery
  • patients being subject to uncontrolled hypertension, coagulopathy, or recent knee sepsis
  • patients with an ASA physical status grade > 2,
  • inability to use patient-controlled analgesia (PCA), such as communication, or cognitive issues, or those patients who were allergic to medications used in the treatment process.

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-use of a tourniquet (NTU)
No tourniquet is used throughout the surgery.
Procedure: None tourniquet
No tourniquet is used throughout the surgery.
Active Comparator: Partial-use of a tourniquet
Partial use of a tourniquet is throughout the surgery.
Procedure: None tourniquet
No tourniquet is used throughout the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: At postoperative Day1,2,3,4
Morphine consumption and Visual analog scale for pain minimum 0, maximum 10
At postoperative Day1,2,3,4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: At postoperative Day1,2,3,4
Pre operative hematocrit and post operative hematocrit change
At postoperative Day1,2,3,4

Collaborators and Investigators

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

Sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Investigators

  • Principal Investigator: Thada Wipatasinlapin, MD, Queen Savang Vadhana Memorial Hospital, Thailand

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 (Actual)

November 1, 2022

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

October 30, 2024

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

February 7, 2025

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 10, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 043/2566

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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