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

NCT06815445 | Completed DMC

• 1 other identifier: 043/2566
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative; Total Knee Replacement; Tourniquet

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  Morphine consumption and Visual analog scale for pain minimum 0, maximum 10

  At postoperative Day1,2,3,4

Secondary Outcomes (1)

• Blood loss

  At postoperative Day1,2,3,4

Study Arms (2)

Non-use of a tourniquet (NTU)

EXPERIMENTAL

No tourniquet is used throughout the surgery.

Procedure: None tourniquet

Partial-use of a tourniquet

ACTIVE COMPARATOR

Partial use of a tourniquet is throughout the surgery.

Procedure: None tourniquet

Interventions

None tourniquet PROCEDURE

No tourniquet is used throughout the surgery.

Non-use of a tourniquet (NTU); Partial-use of a tourniquet

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

Study Sites (1)

Thada Wipatasinlapin

Chon Buri, Sriracha, 20110, Thailand

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Thada Wipatasinlapin, MD

  Queen Savang Vadhana Memorial Hospital, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will not know whether which group are using tourniquet.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: November 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: October 30, 2024
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

TH (1)