跳至主要内容
临床试验/NCT05439343
NCT05439343进行中(未招募)不适用

Comparison of Analgesic Efficacy and Functional Improvement of Adductor Canal Block and Multimodal Local Infiltration Analgesia for Patients After Bilateral Total Knee Arthroplasty

Taipei Veterans General Hospital, Taiwan2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
64
试验地点
2
主要终点
Pain score

研究概览

简要总结

Total knee arthroplasty (TKA) is associated with moderate to severe pain after operation. There are twenty thousand patients undertaking TKA annually in Taiwan, and the average length of hospital stay is about seven to ten days. In contrast, the length of hospital stay is only three to six days in some literatures. Adequate pain relief after surgery allows patients to mobilize earlier and easier and rehabilitate to reduce the length of hospital stay. By reducing hospital stay, we can reduce medical expenditure of national health insurance. In addition, effective analgesia can reduce the occurrence of chronic post-surgical pain which would compromise life quality and produce socioeconomic problems. This study tries to find a better solution for postoperative analgesia of TKA for patients in Taiwan. The present clinical study compares the effect of adductor canal block and local infiltration on postoperative analgesia and functional activity after TKA. To assess the outcome of both methods in the same patient, we can have more comparative result of pain score and functional parameters like range of motion of knee joint, time and ability to ambulate. Based on that, we try to find a better option for postoperative analgesia for patients receiving TKA in Taiwan.

详细描述

Total knee arthroplasty (TKA) is associated with moderate to severe pain after operation. There are twenty thousand patients undertaking TKA annually in Taiwan, and the average length of hospital stay is about seven to ten days. In contrast, the length of hospital stay is only three to six days in some literature. Some patients choose to receive bilateral TKA simultaneously to avoid repetitive surgery and anesthesia, and are supposed to suffer more than those receiving unilateral TKA. Adequate pain relief after surgery allows patients to mobilize earlier and easier and rehabilitate to reduce the length of hospital stay and postoperative complications. By reducing the length of in-hospital stay and post-operative complication, we can reduce medical expenditure of national health insurance. In addition, effective analgesia can reduce the occurrence of chronic post-surgical pain which would compromise life quality and produce socioeconomic problems. This study tries to find a better solution for postoperative analgesia of TKA for patients in Taiwan. The present clinical study compares the effect of adductor canal block and local infiltration on postoperative analgesia and functional activity after bilateral simultaneous TKA. To assess the outcome of both methods in the same patient, we can have more comparative result of pain score and functional parameters like range of motion of knee joint, muscle power in knee adduction/abduction movement, and time and ability to ambulate. Based on that, we try to find a better option for postoperative analgesia for patients receiving TKA in Taiwan.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants and outcomes assessor will not know which kind of interventions (adductor canal block and local infiltration) is performed on which knee.

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

  • Patients were eligible to enter the study if their age are between 20 to 90 years old and scheduled for bilateral TKA secondary to osteoarthritis.

排除标准

  • American Society of Anesthesiologists (ASA) physical status class IV-V, history of abnormal liver enzymes, hepatic failure, renal insufficiency, cardiac failure, organ transplant, neuropathic pain, history of stroke or major neurological deficit, coagulopathy, thrombocytopenia, sensory and motor disorders in lower limb, previous drug dependency, chronic use of opioids, allergy to local anesthetics and drug used in experiment, inability to walk independently, inability to comprehend pain assessment and patients refusing to have spinal anesthesia or enter this study.

结局指标

主要结局

Pain score

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

  • Knee range of motion(Month 3 after surgery)
  • Six minute walk test(Month 3 after surgery)
  • Single leg stance test(Month 3 after surgery)
  • Functional questionnaires(Month 3 after surgery)
  • Adverse events(Month 3 after surgery)
  • Knee muscle power(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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