跳至主要内容
临床试验/NCT05691101
NCT05691101招募中不适用

Comparison of Quality of Recovery in Patients Using Continuous Brachial Plexus Block With or Without Intravenous Patient-Controlled Analgesia After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Study

Seoul National University Bundang Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年1月31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
Korean version of the Quality of Recovery-15 questionnaire (QoR-15K) score (0-150, 0: poor recovery, 150: good recovery)

研究概览

简要总结

The goal of this study is to compare the continuous brachial plexus block with or without intravenous patient controlled analgesia(PCA) in patients undergoing arthroscopic rotator cuff repair, in terms of quality of recovery, postoperative pain score, and adverse event.

详细描述

The Bellomic® M silicone balloon infuser, dual continuous petite type (cebika, Uiwang-si, Gyeonggi-do, Republic of Korea) has 2-channel infusion elastomeric pump with two balloon chambers.

This structure allows the simultaneous use of continuous nerve block and intravenous PCA. In addition, intravenous PCA can be continued even when continuous nerve block is discontinued due to discomfort such as numbness, tingling sense or motor block.

This is expected to contribute to the patient satisfaction and quality of recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having arthroscopic rotator cuff repair
  • American Society of Anesthesiologists physical status I-III

排除标准

  • Contraindication to interscalene brachial plexus block
  • Contraindication to fentanyl

结局指标

主要结局

Korean version of the Quality of Recovery-15 questionnaire (QoR-15K) score (0-150, 0: poor recovery, 150: good recovery)

时间窗: Postoperative 24 hour

Patient recovery measured by QoR-15K score

次要结局

  • Pain score(Postoperative 6, 24, 48 hour)
  • Cumulative consumption of PCA and rescue analgesics(Postoperative 24, 48 hour)
  • Occurrence of adverse effects(Postoperative 24, 48 hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ji In Park

Principal Investigator

Seoul National University Bundang Hospital

研究点 (2)

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