Pain, PostoperativeTKANCT06815445
Postoperative Pain and Blood Loss of Non-use Compared to Partial-use of a Tourniquet in Bilateral Total Knee Replacement
A study testing None tourniquet in people with Pain, Postoperative and Total Knee Replacement, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pain, Postoperative, Total Knee Replacement, Tourniquet
- What is being tested?
- None tourniquet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2022to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with over 50 years of age and diagnosed with bilateral severe knee osteoarthritis undergoing bilateral TKA
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Postoperative, Total Knee Replacement, Tourniquet
- Being tested
- None tourniquet
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None tourniquetProcedure or surgery
No tourniquet is used throughout the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Non-use of a tourniquet (NTU) | Experimental | No tourniquet is used throughout the surgery. Receives: Procedure: None tourniquet |
| Partial-use of a tourniquet | Active comparator | Partial use of a tourniquet is throughout the surgery. Receives: Procedure: None tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Morphine consumption and Visual analog scale for pain minimum 0, maximum 10
Measured: At postoperative Day1,2,3,4
Secondary outcomes (1)
Blood loss
Pre operative hematocrit and post operative hematocrit change
Measured: At postoperative Day1,2,3,4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Nov 2022
- Primary completion1 Aug 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thada Wipatasinlapin, MD, Principal investigator, Queen Savang Vadhana Memorial Hospital, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815445
- Sponsor's protocol ID
- 043/2566
- Acronym
- TKA
- Status last verified
- Jun 2025
- First submitted
- 3 Feb 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain and Blood Loss of Non-use Compared to Partial-use of a Tourniquet in Bilateral Total Knee Replacement: A Randomized- Control Trial
- ClinicalTrials.gov ID
- NCT06815445
- Acronym / sponsor ID
- TKA / 043/2566
- Conditions
- Pain, Postoperative, Total Knee Replacement, Tourniquet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Non-use of a tourniquet (NTU) | Experimental | Procedure: None tourniquetNo tourniquet is used throughout the surgery. |
| Partial-use of a tourniquet | Active comparator | Procedure: None tourniquetPartial use of a tourniquet is throughout the surgery. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with over 50 years of age and diagnosed with bilateral severe knee osteoarthritis undergoing bilateral TKA
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None tourniquetNo tourniquet is used throughout the surgery. | Procedure or surgery | Non-use of a tourniquet (NTU), Partial-use of a tourniquet |
Primary outcome
Postoperative pain
Time frame: At postoperative Day1,2,3,4
Morphine consumption and Visual analog scale for pain minimum 0, maximum 10
1 secondary outcome
Blood loss
Time frame: At postoperative Day1,2,3,4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thada Wipatasinlapin, MD principal investigator
Queen Savang Vadhana Memorial Hospital, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing None tourniquet in people with Pain, Postoperative and Total Knee Replacement, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: At postoperative Day1,2,3,4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.