Status:
NOT_YET_RECRUITING
Dinalbuphine Sebacate in Postoperative Pain Control After TKA
Lead Sponsor:
Thammasat University
Conditions:
Osteo Arthritis of the Knee
Total Knee Anthroplasty
Eligibility:
All Genders
50-90 years
Phase:
PHASE4
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07140510
Start Date
October 1 2025
End Date
September 1 2026
Last Update
August 24 2025
Active Locations (1)
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1
Thammasat University
Khlong Luang, Changwat Pathum Thani, Thailand, 12120