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临床试验/NCT07581886
NCT07581886尚未招募不适用

Comparison of Single-shot vs. Continuous Adductor Canal Block Analgesic Effects With Catheter Positioning Confirmation in Total Knee Arthroplasty: a Double-blinded Prospective Randomized Controlled Trial

Yonsei University0 个研究点目标入组 78 人开始时间: 2026年5月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
78

研究概览

简要总结

This study compares the analgesic efficacy of single-dose adductor canal block (sACB) versus continuous-dose adductor canal block (cACB) for postoperative pain management in total knee replacement patients. To ensure a high level of clinical accuracy, the investigation specifically focuses on a cACB cohort where ultrasound confirmation ensures the catheter remains correctly positioned for a full 48 hours. Participants are assigned to groups using a 1:1 randomization protocol via computer-generated tables to eliminate selection bias. Clinical consistency is maintained by using identical pharmacological agents across both groups: 0.5% Heavy Bupivacaine for spinal anesthesia and 0.5% ropivacaine with 1:200,000 epinephrine for the nerve block itself. Furthermore, both groups adhere to a standardized multimodal analgesic schedule to control for external variables. In the cACB group, intravenous patient-controlled analgesia (IV PCA) serves as a designated rescue therapy should the catheter fail. The primary technical evaluation occurs 48 hours post-surgery, utilizing ultrasound to verify catheter placement and quantify pain levels. Beyond immediate recovery, the study evaluates long-term success through Patient-Reported Outcome Measures (PROMs) at a 12-week follow-up, focusing on functional restoration and the patient's overall quality of life. By isolating the variable of catheter stability, the research aims to provide a definitive comparison of whether the continuous delivery of local anesthetic offers a statistically significant clinical advantage over a single-dose administration in the context of modern orthopedic recovery protocols.

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
Single (Participant)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 40-80 yrs
  • Scheduled for unilateral total knee arthroplatsy
  • ASA I-III
  • BMI 18-35 kg/㎡
  • Able to read and understand consent form

排除标准

  • Allergy to local anesthetics
  • Infection at the block site
  • History of neuropathy or peripheral nerve disease
  • Coagulation disorders or use of anticoagulants (if discontinuation is not possible)
  • Communication disorders or cognitive impairment
  • Chronic opioid use (≥30 MME/day, 3 months or more)
  • Severe chronic pain (NRS ≥7/10, 3 months or more)
  • Renal impairment (eGFR <30 mL/min/1.73m²)
  • Hepatic impairment (Child-Pugh C)
  • Blood coagulation disorders
  • Pregnancy

研究者

申办方类型
Other
责任方
Sponsor

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