NCT07140510尚未招募4 期
Effectiveness of Dinalbuphine Sebacate in Postoperative Pain Control Following Total Knee Arthroplasty: A Randomized Double Blinded Placebo-controlled Trial
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual analog scale for pain (VAS 0-100)
研究概览
简要总结
To evaluate the effectiveness of Dinalbuphine Sebacate for controlling subacute pain after total knee arthroplasty
详细描述
A single dose of intramuscular Dinalbuphine Sebacate can mitigate pain for up to 1 week after TKA
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Dinalbuphine Sebacate
Experimental
Naldebain 150mg/2mL IM
干预措施: Dinalbuphine Sebacate (Drug)
Placebo
Placebo Comparator
Normal saline 2 mL IM
干预措施: Normal Saline (Drug)
结局指标
主要结局
Visual analog scale for pain (VAS 0-100)
时间窗: 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
次要结局
- The amount of analgesic drug used(During hospitalization and at home until 12 weeks after surgery)
- Modified WOMAC score(At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively)
- Adverse effects(The first week after surgery)
- Time up and go (TUG) test(At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively)
- Knee range of motion(At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively)
- Length of stay(During hospitalization (from admission to discharge))
- Forgotten Joint Score(At pre-operative, 2 weeks, 6 weeks, and 12 weeks postoperatively)
研究者
Supakit Kanitnate
Principal investigator
Thammasat University
研究点 (1)
Loading locations...
相似试验
尚未招募
4 期
Postoperative Pain Management on Uvulopalatopharyngoplasty PatientsPain, PostoperativeObstructive Sleep Apnea-hypopnea SyndromePain, AcuteNCT05825495Li-Jen Hsin78
尚未招募
4 期
To compare the effects of Nalbuphine and fentanyl as spinal additivesCTRI/2022/10/046720DR THEJASVI B R30
撤回
早期 1 期
Investigating the Effect of Dronabinol on Post-surgical PainKnee ReplacementArthropathy of KneeNCT04099355New York State Psychiatric Institute
进行中（未招募）
3 期
Dronabinol After Arthroscopic SurgeryKnee InjuriesMeniscus TearSynovitis of KneeChondral Injury of Left KneeChondral Injury of Right KneeLoose Body KneeKnee OsteoarthritisKnee Ligament InjuryNCT05335252Northwestern University30
Unknown
不适用
Pain Control After Orthognathic SurgeryPostoperative PainNCT01418183Chang Gung Memorial Hospital40