Dinalbuphine Sebacate in Postoperative Pain Control After TKA
NCT ID: NCT07140510
Last Updated: 2025-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2025-10-31
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dinalbuphine Sebacate
Naldebain 150mg/2mL IM
Dinalbuphine Sebacate
Dinalbuphine Sebacate 150 mg intramuscular injection after spinal anesthesia and adductor canal block in the same side of TKA
Placebo
Normal saline 2 mL IM
Normal Saline
Normal saline 2 mL intramuscular injection after spinal anesthesia and adddutor canal block
Interventions
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Dinalbuphine Sebacate
Dinalbuphine Sebacate 150 mg intramuscular injection after spinal anesthesia and adductor canal block in the same side of TKA
Normal Saline
Normal saline 2 mL intramuscular injection after spinal anesthesia and adddutor canal block
Eligibility Criteria
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Inclusion Criteria
* Age 50-90 years
* ASA class I-III
* Participants understand and consent to the protocol of the trial
Exclusion Criteria
* 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
50 Years
90 Years
ALL
No
Sponsors
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Thammasat University
OTHER
Responsible Party
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Supakit Kanitnate
Principal investigator
Locations
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Thammasat University
Khlong Luang, Changwat Pathum Thani, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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OrthoTU14
Identifier Type: -
Identifier Source: org_study_id
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