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

NCT ID: NCT06815445

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain, Postoperative Total Knee Replacement Tourniquet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study divided into 2 groups. This study was designed to compare the effect of NTU vs BOO in the patients underwent bilateral TKA.

It is a crossover design to compare each knee in each group.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessor will not know whether which group are using tourniquet.

Study Groups

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Non-use of a tourniquet (NTU)

No tourniquet is used throughout the surgery.

Group Type EXPERIMENTAL

None tourniquet

Intervention Type PROCEDURE

No tourniquet is used throughout the surgery.

Partial-use of a tourniquet

Partial use of a tourniquet is throughout the surgery.

Group Type ACTIVE_COMPARATOR

None tourniquet

Intervention Type PROCEDURE

No tourniquet is used throughout the surgery.

Interventions

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None tourniquet

No tourniquet is used throughout the surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Savang Vadhana Memorial Hospital, Thailand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thada Wipatasinlapin, MD

Role: PRINCIPAL_INVESTIGATOR

Queen Savang Vadhana Memorial Hospital, Thailand

Locations

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Thada Wipatasinlapin

Chon Buri, Sriracha, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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043/2566

Identifier Type: -

Identifier Source: org_study_id

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