Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06815445
Acronym
TKA
Enrollment
20
Registered
2025-02-07
Start date
2022-11-01
Completion date
2024-10-30
Last updated
2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Total Knee Replacement, Tourniquet

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.

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.

Interventions

PROCEDURENone tourniquet

No tourniquet is used throughout the surgery.

Sponsors

Queen Savang Vadhana Memorial Hospital, Thailand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative painAt postoperative Day1,2,3,4Morphine consumption and Visual analog scale for pain minimum 0, maximum 10

Secondary

MeasureTime frameDescription
Blood lossAt postoperative Day1,2,3,4Pre operative hematocrit and post operative hematocrit change

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026