Osteo Arthritis of the KneePhase 4NaldebainNCT07140510
Dinalbuphine Sebacate in Postoperative Pain Control After TKA
A Phase 4 study testing Dinalbuphine Sebacate and Normal Saline in people with Osteo Arthritis of the Knee and Total Knee Anthroplasty, run by Thammasat University at 1 site in Thailand.
Trial summary
To evaluate the effectiveness of Dinalbuphine Sebacate for controlling subacute pain after total knee arthroplasty Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Osteo Arthritis of the Knee, Total Knee Anthroplasty
- What is being tested?
- Dinalbuphine Sebacate and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2025to Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritic knee patients underwent unilateral primary TKA
- Age 50-90 years
- ASA class I-III
- Participants understand and consent to the protocol of the trial
Who cannot join
- Morbid obesity (BMI>40)
- Knee osteoarthritis from inflammatory knee arthritis, trauma, infection
- Previous knee surgery
- Cognitive disorder
- Liver disease
- Allergy to NSAIDs, opioids, sesame oil, and benzyl benzoate
- CYP3A4 inhibitor and inducer drugs used
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Thammasat University
Khlong Luang, Changwat Pathum Thani, 12120
Supakit Kanitnate, M.D., +66 899853635, naypenf@hotmail.com
Nattapol Tammachote, M.D.
About this study
Official title: Effectiveness of Dinalbuphine Sebacate in Postoperative Pain Control Following Total Knee Arthroplasty: A Randomized Double Blinded Placebo-controlled Trial
To evaluate the effectiveness of Dinalbuphine Sebacate for controlling subacute pain after total knee arthroplasty
Read the detailed description
A single dose of intramuscular Dinalbuphine Sebacate can mitigate pain for up to 1 week after TKA
- Being tested
- Dinalbuphine Sebacate, Normal Saline
- Keywords
- Dinalbuphine Sebacate, Naldebain, Subacute pain, postoperative pain, total knee arthroplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dinalbuphine SebacateDrug
Dinalbuphine Sebacate 150 mg intramuscular injection after spinal anesthesia and adductor canal block in the same side of TKA
Normal SalineDrug
Normal saline 2 mL intramuscular injection after spinal anesthesia and adddutor canal block
| Study group | Role | What they receive |
|---|---|---|
| Dinalbuphine Sebacate | Experimental | Naldebain 150mg/2mL IM Receives: Drug: Dinalbuphine Sebacate |
| Placebo | Placebo comparator | Normal saline 2 mL IM Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale for pain (VAS 0-100)
Visual analog scale for pain at rest and on motion (knee flexion 90 degrees) using 0-100 mm, where a score of 0 represented no pain and 100 indicated the most severe pain
Measured: Record every 12 hours after surgery until 2 weeks postoperatively, then once weekly until 12 weeks postopertively
Secondary outcomes (7)
The amount of analgesic drug used
The amount of IV morphine and oral tramadol (milligram)
Measured: During hospitalization and at home until 12 weeks after surgery
Adverse effects
Incidence of adverse effects including pyrexia, nausea, vomiting, dizziness, injection site pain, and somnolence
Measured: The first week after surgery
Length of stay
Length of stay (day)
Measured: During hospitalization (from admission to discharge)
Modified WOMAC score
Modified Western Ontario and McMaster Universities Osteoarthritis Index score, including total \& subscore. Each item was scored with a Likert scale (0-4). The overall MOWAC was 0-96 (high score = worse symptoms)
Measured: At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively
Forgotten Joint Score
Forgotten Joint Score (Thai version) with 12 questions. Each item was scored on a Likert scale (0-4). The raw score was converted to a 0-100 scale (0 = worst, 100 = best)
Measured: At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively
Time up and go (TUG) test
Time up and go (TUG) test records the time in seconds when the patient starts standing up from the chair, then walks 3 meters at a normal pace, and turns around to sit on the chair.
Measured: At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively
Knee range of motion
Angle of knee flexion and extension in degrees using a long goniometer
Measured: At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study startOct 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis of the KneeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Supakit Kanitnate, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140510
- Sponsor's protocol ID
- OrthoTU14
- Acronym
- Naldebain
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yeh CY, Jao SW, Chen JS, Fan CW, Chen HH, Hsieh PS, Wu CC, Lee CC, Kuo YH, Hsieh MC, Huang WS, Chung YC, Liou TY, Chiu HH, Tseng WK, Lee KC, Wang JY. Sebacoyl Dinalbuphine Ester Extended-release Injection for Long-acting Analgesia: A Multicenter, Randomized, Double-Blind, And Placebo-controlled Study in Hemorrhoidectomy Patients. Clin J Pain. 2017 May;33(5):429-434. doi: 10.1097/AJP.0000000000000417.
PubMed 27518486
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dinalbuphine Sebacate in Postoperative Pain Control Following Total Knee Arthroplasty: A Randomized Double Blinded Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07140510
- Acronym / sponsor ID
- Naldebain / OrthoTU14
- Keywords
- Dinalbuphine Sebacate, Naldebain, Subacute pain, postoperative pain, total knee arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 24 Aug 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.
To evaluate the effectiveness of Dinalbuphine Sebacate for controlling subacute pain after total knee arthroplasty
Detailed description
A single dose of intramuscular Dinalbuphine Sebacate can mitigate pain for up to 1 week after TKA
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 |
|---|---|---|
| Dinalbuphine Sebacate | Experimental | Drug: Dinalbuphine SebacateNaldebain 150mg/2mL IM |
| Placebo | Placebo comparator | Drug: Normal SalineNormal saline 2 mL IM |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Osteoarthritic knee patients underwent unilateral primary TKA
- Age 50-90 years
- ASA class I-III
- Participants understand and consent to the protocol of the trial
Key exclusion criteria (7 listed)
- Morbid obesity (BMI>40)
- Knee osteoarthritis from inflammatory knee arthritis, trauma, infection
- Previous knee surgery
- Cognitive disorder
- Liver disease
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 |
|---|---|---|
| Dinalbuphine SebacateDinalbuphine Sebacate 150 mg intramuscular injection after spinal anesthesia and adductor canal block in the same side of TKA | Drug | Dinalbuphine Sebacate |
| Normal SalineNormal saline 2 mL intramuscular injection after spinal anesthesia and adddutor canal block | Drug | Placebo |
Primary outcome
Visual analog scale for pain (VAS 0-100)
Time frame: Record every 12 hours after surgery until 2 weeks postoperatively, then once weekly until 12 weeks postopertively
Visual analog scale for pain at rest and on motion (knee flexion 90 degrees) using 0-100 mm, where a score of 0 represented no pain and 100 indicated the most severe pain
7 secondary outcomes
The amount of analgesic drug used
Time frame: During hospitalization and at home until 12 weeks after surgery
Adverse effects
Time frame: The first week after surgery
Length of stay
Time frame: During hospitalization (from admission to discharge)
Modified WOMAC score
Time frame: At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively
Forgotten Joint Score
Time frame: At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively
Time up and go (TUG) test
Time frame: At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively
Knee range of motion
Time frame: At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Results publication: PubMed 27518486Yeh CY, Jao SW, Chen JS, Fan CW, Chen HH, Hsieh PS, Wu CC, Lee CC, Kuo YH, Hsieh MC, Huang WS, Chung YC, Liou TY, Chiu HH, Tseng WK, Lee KC, Wang JY. Sebacoyl Dinalbuphine Ester Extended-release Injection for Long-acting Analgesia: A Multicenter, Randomized, Double-Blind, And Placebo-controlled Study in Hemorrhoidectomy Patients. Clin J Pain. 2017 May;33(5):429-434. doi: 10.1097/AJP.0000000000000417.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dinalbuphine Sebacate and Normal Saline in people with Osteo Arthritis of the Knee and Total Knee Anthroplasty, run by Thammasat University 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 24 Aug 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Supakit Kanitnate, M.D. (+66 899853635, naypeng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale for pain (VAS 0-100) (time frame: Record every 12 hours after surgery until 2 weeks postoperatively, then once weekly until 12 weeks postopertively). 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 NCT07140510, which also lists 1 linked publication.
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 24 Aug 2025.