Dinalbuphine Sebacate in Postoperative Pain Control After TKA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dinalbuphine Sebacate, Normal Saline.
- Who it may be relevant to
- Registry conditions: Osteo Arthritis of the Knee, Total Knee Anthroplasty. Basic parameters: 50 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Dinalbuphine Sebacate in Postoperative Pain Control Following Total Knee Arthroplasty: A Randomized Double Blinded Placebo-controlled Trial
Overview
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
Interventions
- Drug Dinalbuphine Sebacate
Dinalbuphine Sebacate 150 mg intramuscular injection after spinal anesthesia and adductor canal block in the same side of TKA - Drug Normal Saline
Normal saline 2 mL intramuscular injection after spinal anesthesia and adddutor canal block
Primary outcome measures
- 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]
Secondary outcome measures (7)
- 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]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Thailand · 1 center
- Thammasat University — Khlong Luang
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.00000000000004 PMID 27518486
Identifiers
NCT: NCT07140510 · OrthoTU14