临床试验/NCT04833296

NCT04833296Unknown4 期

Ropivacaine Use in Interscalene Block; What is the Minimal Effective Analgesic Concentration (MEAC 90)

Healthpoint Hospital2 个研究点分布在 1 个国家目标入组 45 人开始时间: 2021年5月1日最近更新: 2021年4月6日

适应症

试验速览

阶段: 4 期
发起方
入组人数: 45
试验地点: 2
主要终点: effective analgesic interscalene block

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study aim to calculate the minimal effective ropivacaine concentration required achieve successful analgesic interscalene block in 90% of patients (MEAC90)

详细描述

Before induction of general anesthesia, all patients will receive interscalene block using 15ml of ropivacaine which concentration will be based on the response of the previous patient.
Based on biased-coin design up-down sequential method: if patient has pain free recovery, a successful block, the next patient will be randomized to receive either the same ropivacaine concentration or a concentration 0.01% w/v less. However, if he has an unsuccessful block, the next patient will receive a concentration 0.01% w/v higher.
Patients with pain free recovery will be considered to have positive response.
Patients' responses will be analyzed to calculate the MEAC90.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients, who are scheduled for shoulder arthroscopy

排除标准

•- <18 y,
•ASA physical class greater >III
•BMI >40 has any contraindication for medications or techniques used in the study

结局指标

主要结局

effective analgesic interscalene block

时间窗: in recovery unit (one hour after surgery)

postoperative pain (will be assessed using numerical rating scale. if ≥ 3, ineffective block will be considered and if \<3, an effective block will be considered

次要结局

未报告次要终点

研究者

发起方

Healthpoint Hospital

申办方类型

Other

责任方

Principal Investigator

主要研究者

Ahmad Muhammad Taha

Consultant of anesthesia

Healthpoint Hospital

研究点 (2)

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