Pain, PostoperativeNCT06243575
Comparison of Outcomes Between Intraosseous Femoral and Tibial Injection in Simultaneous Bilateral Total Knee Arthroplasty Patients
A study testing Multimodal Intraosseous Femoral Injection and Multimodal Intraosseous Tibial Injection in people with Pain, Postoperative, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
In patients with osteoarthritis of the knee whose pain cannot be relieved by conservative treatment, total knee arthroplasty (TKA) is the operation that increases the quality of life for the patient. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Multimodal Intraosseous Femoral Injection and Multimodal Intraosseous Tibial Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2024to 31 Dec 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will undergo bilateral Total knee Replacement due to osteoarthritis of both knees
- Used of a cemented, PS design TKA surgery.
- Able to give informed consent
Who cannot join
- Revision TKA
- History of previous knee or hip surgery
- History of allergic reaction or side effects to the drug that will be used in the experiment
- Underlying diseases of chronic kidney disease or chronic liver disease (Child Pugh B or C)
- Pregnancy
- History of coagulopathy or abnormal blood coagulation profile(INR >1.4 or aPTT ratio > 1.4)
Show all 9Show fewer
- History of platelet dysfunction or platelet count < 140,0000/mm3
- History of Thromboembolism
- Use of Anticoagulants.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Rajavithi hospital
Phaya Thai, Bangkok, 10400
About this study
Official title: Comparison of Outcomes Between Multimodal Intraosseous Femoral Injection and Multimodal Intraosseous Tibial Injection, a Randomized Controlled Trial in Simultaneous Bilateral Total Knee Arthroplasty Patients
In patients with osteoarthritis of the knee whose pain cannot be relieved by conservative treatment, total knee arthroplasty (TKA) is the operation that increases the quality of life for the patient. Pain management after total knee arthroplasty TKA is an important consideration to improve patient outcomes and reduce length of stay. Periarticular injections of the knee are one of the techniques used to reduce pain after surgery. Studies have shown that compared to other methods of pain relief, they are effective and safe. At present, no studies to compare between multimodal intraosseous femoral injection \& multimodal intraosseous tibial injection in Simultaneous Bilateral TKA patients.
- Conditions
- Pain, Postoperative
- Being tested
- Multimodal Intraosseous Femoral Injection, Multimodal Intraosseous Tibial Injection
- Keywords
- total knee arthroplasty, intraosseous infiltration
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Intraosseous Femoral InjectionDrug
Intraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in femoral canal
Multimodal Intraosseous Tibial InjectionDrug
Intraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in tibial canal
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Intraosseous Femoral Injection | Experimental | Intraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in femoral canal Receives: Drug: Multimodal Intraosseous Femoral Injection |
| Multimodal Intraosseous Tibial Injection | Experimental | Intraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in tibial canal Receives: Drug: Multimodal Intraosseous Tibial Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score (Visual analog scale)
Visual analog scale (VAS) score from 0-10(0 was no pain, 10 was worst pain ) between multimodal intraosseous femoral injection \& multimodal intraosseous tibial injection
Measured: at 12 hours, 24 hours, 48 hours and 2 weeks after surgery
Secondary outcomes (6)
Amount of painkillers used
Measured: up to 24 hours after surgery
Post operative blood loss
Measured: intraoperative and up to 48 hours postoperatively (include intraoperative and drain)
Knee and Osteoarthritis Outcome Score (KOOS)
minimum and maximum values(0-100), higher scores mean a better outcome.
Measured: post operative 2 weeks
knee range of motion
Measured: post operative 2 weeks
Side effects and complications
Measured: intraoperative to post operative 2weeks
Length of hospital stay
Length of hospital stay record in number of days
Measured: Admit to discharge date (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Feb 2024
- Primary completion30 Mar 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Thakrit Chompoosang, MD, Study director, Department of Medical Services Ministry of Public Health of Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243575
- Sponsor's protocol ID
- 149/66
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brozovich AA, Incavo SJ, Lambert BS, Sullivan TC, Wininger AE, Clyburn TA, Taraballi F, Park KJ. Intraosseous Morphine Decreases Postoperative Pain and Pain Medication Use in Total Knee Arthroplasty: A Double-Blind, Randomized Controlled Trial. J Arthroplasty. 2022 Jun;37(6S):S139-S146. doi: 10.1016/j.arth.2021.10.009. Epub 2022 Mar 7.
PubMed 35272897Fan L, Zhu C, Zan P, Yu X, Liu J, Sun Q, Li G. The Comparison of Local Infiltration Analgesia with Peripheral Nerve Block following Total Knee Arthroplasty (TKA): A Systematic Review with Meta-Analysis. J Arthroplasty. 2015 Sep;30(9):1664-71. doi: 10.1016/j.arth.2015.04.006. Epub 2015 Apr 8.
PubMed 25922311Chompoosang T, Wijit T, Ploynumpon P. Comparison of Outcomes of Multimodal Intraosseous Femoral Injection and Multimodal Intraosseous Tibial Injection: A Randomized Controlled Trial in Simultaneous Bilateral Total Knee Arthroplasty Patients. J Am Acad Orthop Surg Glob Res Rev. 2026 Jul 1;10(7):e25.00375. doi: 10.5435/JAAOSGlobal-D-25-00375. eCollection 2026 Jul 1.
PubMed 42430771
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes Between Multimodal Intraosseous Femoral Injection and Multimodal Intraosseous Tibial Injection, a Randomized Controlled Trial in Simultaneous Bilateral Total Knee Arthroplasty Patients
- ClinicalTrials.gov ID
- NCT06243575
- Acronym / sponsor ID
- 149/66
- Conditions
- Pain, Postoperative
- Keywords
- total knee arthroplasty, intraosseous infiltration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Feb 2024 (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.
In patients with osteoarthritis of the knee whose pain cannot be relieved by conservative treatment, total knee arthroplasty (TKA) is the operation that increases the quality of life for the patient. Pain management after total knee arthroplasty TKA is an important consideration to improve patient outcomes and reduce length of stay. Periarticular injections of the knee are one of the techniques used to reduce pain after surgery. Studies have shown that compared to other methods of pain relief, they are effective and safe. At present, no studies to compare between multimodal intraosseous femoral injection \& multimodal intraosseous tibial injection in Simultaneous Bilateral TKA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Intraosseous Femoral Injection | Experimental | Drug: Multimodal Intraosseous Femoral InjectionIntraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in femoral canal |
| Multimodal Intraosseous Tibial Injection | Experimental | Drug: Multimodal Intraosseous Tibial InjectionIntraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in tibial canal |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who will undergo bilateral Total knee Replacement due to osteoarthritis of both knees
- Used of a cemented, PS design TKA surgery.
- Able to give informed consent
Key exclusion criteria (9 listed)
- Revision TKA
- History of previous knee or hip surgery
- History of allergic reaction or side effects to the drug that will be used in the experiment
- Underlying diseases of chronic kidney disease or chronic liver disease (Child Pugh B or C)
- Pregnancy
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 |
|---|---|---|
| Multimodal Intraosseous Femoral InjectionIntraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in femoral canal | Drug | Multimodal Intraosseous Femoral Injection |
| Multimodal Intraosseous Tibial InjectionIntraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in tibial canal | Drug | Multimodal Intraosseous Tibial Injection |
Primary outcome
Pain score (Visual analog scale)
Time frame: at 12 hours, 24 hours, 48 hours and 2 weeks after surgery
Visual analog scale (VAS) score from 0-10(0 was no pain, 10 was worst pain ) between multimodal intraosseous femoral injection \& multimodal intraosseous tibial injection
6 secondary outcomes
Amount of painkillers used
Time frame: up to 24 hours after surgery
Post operative blood loss
Time frame: intraoperative and up to 48 hours postoperatively (include intraoperative and drain)
Knee and Osteoarthritis Outcome Score (KOOS)
Time frame: post operative 2 weeks
knee range of motion
Time frame: post operative 2 weeks
Side effects and complications
Time frame: intraoperative to post operative 2weeks
Length of hospital stay
Time frame: Admit to discharge date (up to 7 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Background: PubMed 35272897Brozovich AA, Incavo SJ, Lambert BS, Sullivan TC, Wininger AE, Clyburn TA, Taraballi F, Park KJ. Intraosseous Morphine Decreases Postoperative Pain and Pain Medication Use in Total Knee Arthroplasty: A Double-Blind, Randomized Controlled Trial. J Arthroplasty. 2022 Jun;37(6S):S139-S146. doi: 10.1016/j.arth.2021.10.009. Epub 2022 Mar 7.
- Background: PubMed 25922311Fan L, Zhu C, Zan P, Yu X, Liu J, Sun Q, Li G. The Comparison of Local Infiltration Analgesia with Peripheral Nerve Block following Total Knee Arthroplasty (TKA): A Systematic Review with Meta-Analysis. J Arthroplasty. 2015 Sep;30(9):1664-71. doi: 10.1016/j.arth.2015.04.006. Epub 2015 Apr 8.
- Derived from this study: PubMed 42430771Chompoosang T, Wijit T, Ploynumpon P. Comparison of Outcomes of Multimodal Intraosseous Femoral Injection and Multimodal Intraosseous Tibial Injection: A Randomized Controlled Trial in Simultaneous Bilateral Total Knee Arthroplasty Patients. J Am Acad Orthop Surg Glob Res Rev. 2026 Jul 1;10(7):e25.00375. doi: 10.5435/JAAOSGlobal-D-25-00375. eCollection 2026 Jul 1.
- Individual participant dataSharing planned: No
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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.
Thakrit Chompoosang, MD study director
Department of Medical Services Ministry of Public Health of 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 Multimodal Intraosseous Femoral Injection and Multimodal Intraosseous Tibial Injection in people with Pain, Postoperative, run by Department of Medical Services Ministry of Public Health of 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 21 Nov 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thakrit Chompoosang, MD (+66846461916, tk_ortho@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (Visual analog scale) (time frame: at 12 hours, 24 hours, 48 hours and 2 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06243575, which also lists 3 linked publications.
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 21 Nov 2024.