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临床试验/NCT05325671
NCT05325671已完成不适用

Efficacy of Postoperative Pain Control Between Transarticular VS Periartiucular Multimodal Drug Infiltration in Total Hip Arthroplasty: Double-blinded Randomized Control Trial

Rajavithi Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Visual analogue scale at rest on postoperative day1st and 2nd

研究概览

简要总结

This research aim to improve postoperative outcome in total hip arthroplasty(THA) by using local mixture infiltration as bupivacaine + NSAID + epinephrine + tranxemic acid. In the present time these mixture components has shown to improve THA outcome by aspect of postoperative pain control, postoperative opioid consumption, postoperative bleeding, LOS and postoperative rehabilitation without increasing complication but the accuracy of infiltration technique which gives the best outcome has not been yet discovered.Recently study by Hashimoto et al has risen that these technique can be administrated by both periarticular and intra-articular approach.By considering the complexity of human anatomy around the hip tissue we assume that the intra-articular(transarticular) may given equivalence (may be better) outcome with lowering procedural related complication comparing to periarticular infiltration approach.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patient who would go on cemented and cementless THA
  • age 45-60 years of age
  • voluntary decision exclusion criteria
  • bilateral THA
  • revision surgery
  • history of pelvic and hip surgery previously
  • allergy to medication in protocol
  • CKD stage 4-5, chronic liver disease with Child Pugh B or C
  • pregnancy
  • history of hip injection
  • hypercoagulable state
  • abnormal laboratory coagulation study as INR > 1.4 or aPTT > 1.4
  • abnormal platelet function
  • thrombocytopenia
  • PE , DVT, ischemic stroke, CAD/ischemic heart disease
  • use of anticoagulant or hormonal usage
  • anesthesia by general anesthesia or additional nerve block
  • can not understand PCA usage
  • use postopertive wound drainage

排除标准

  • 未提供

结局指标

主要结局

Visual analogue scale at rest on postoperative day1st and 2nd

时间窗: 1 week

次要结局

  • total morphine consumption in whole postoperative period(1 week)
  • total morphine consumption in first 24 hours postoperative period via PCA pump(1 week)
  • length of stay(1 week)
  • postoperative complication(1 week)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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