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临床试验/NCT05669898
NCT05669898招募中不适用

Multimodal Analgesia for Unilateral Total Knee Arthroplasty: Impact of Continuous Adductor Canal Infusion Combined With NSAID vs. Intravenous Morphine Patient-controlled Analgesia Combined With Single-injection Adductor Canal Block

Taipei Veterans General Hospital, Taiwan2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
Change in Pain scores at rest and motion

研究概览

简要总结

Multimodal analgesia (MMA) has been endorsed to improve postoperative analgesia and functional activity after surgery, and integrating regional analgesia to reduce the consumption of opioid has also been used in postoperative pain management. The investigator try to find a better combination of MMA for postoperative analgesia and functional recovery for patients receiving TKA in Taiwan, therefore the effect of single-injection and continuous infusion of peripheral nerve block is compared in patient undergoing unilateral TKA. The investigators hypothesize that continuous adductor canal infusion is as effective as single-injection adductor canal block for postoperative pain relief under intravenous PCA after TKA surgery. Based on that, the investigators conduct this prospective, randomized controlled trial to examine our hypothesis.

详细描述

The study compares the effect of two multimodal analgesia protocols, the one integrating IVPCA morphine with single-injection adductor canal block and the other integrating continuous adductor canal infusion with timely administered intravenous tenoxicam, on postoperative analgesia and functional activity after TKA. To assess the outcome of both modalities, The investigators can have more comparative result of pain score and other functional parameters like range of motion of knee joint and muscle strength. Based on that, the investigators try to find a better multimodal analgesic approach for postoperative analgesia and functional recovery for patients receiving TKA in Taiwan. The investigators hypothesize that multimodal analgesia using continuous adductor canal infusion and intravenous tenoxicam are as effective as another modality using IVPCA and single-injection adductor canal block for postoperative pain relief after TKA surgery. However, continuous adductor canal infusion integrated with intravenous tenoxicam might reduce the occurrence of opioid-related side effect and enhance the functional recovery. Based on that, the investigators conduct this prospective, randomized controlled trial to examine our hypothesis.

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
None

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • American Society of Anesthesiologists physical status class IV-V
  • Elevated liver enzymes or liver failure
  • Renal dysfunction (serum creatinine level ≥ 1.5 mg/dL)
  • Cardiac failure
  • Organ transplantation recipient
  • Major neurological deficit with lower extremity muscle weakness
  • Sensory and motor disorders in lower limb
  • Coagulopathy or thrombocytopenia
  • Previous drug dependency
  • Patients who used illicit drugs within six months
  • Chronic use of opioids
  • Allergy to local anesthetics and drug used in experiment
  • Inability to walk independently
  • Inability to comprehend pain assessment
  • Refusal for implanting a continuous peripheral nerve catheter
  • Refusal for enrolling in study

结局指标

主要结局

Change in Pain scores at rest and motion

时间窗: Month 3 after surgery

Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.

次要结局

  • Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index(Month 3 after surgery)
  • Rehabilitation physiotherapy: Knee flexion angle(Month 3 after surgery)
  • Rehabilitation physiotherapy: knee muscle strength(Month 3 after surgery)
  • Functional questionnaire: Brief pain inventory (BPI) short form(Month 3 after surgery)
  • Adverse events(Month 3 after surgery)
  • Rehabilitation physiotherapy: Six minute walk test(Month 3 after surgery)
  • Rehabilitation physiotherapy: Single leg stance test(Month 3 after surgery)
  • Functional questionnaire: Lower extremity functional scale(Month 3 after surgery)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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