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临床试验/NCT03877835
NCT03877835已完成不适用

Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty: an Exploratory Feasibility Study

University Hospital of North Norway2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
The incidence ipsilateral hemidiaphragmatic paralysis after 30 minutes

研究概览

简要总结

The combination of a modified lateral sagittal infraclavicular block and a suprascapular nerve block has not been studied in a cohort of total arthroplasty patients. Such diaphragm-sparing nerve blocks for shoulder arthroplasty may provide a very good anesthetic alternative in lung diseased patients who are in need for total arthroplasty of the shoulder.

详细描述

The investigators hypothesized that a combination of suprascapular nerve block and lateral sagittal infraclavicular block of the posterior and lateral cords would provide good postoperative analgesia for patients undergoing shoulder arthroplasty.

The primary aims of this study were to document numeric rating scale (NRS, 0-10) and use of morphine equivalents during the first 24 hours after surgery. Secondary aims were to determine the incidence of diaphragm paresis 30 minutes after the block and to quantify postoperative hand grip force at 1 hr.

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

盲法说明

Outcome measures will be performed by an independent assessor

入排标准

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

入选标准

  • 18-78 years old,
  • BMI 20-35 kg.m-2
  • ASA physical status 1-3

排除标准

  • unable to consent,
  • pregnancy,
  • pre-existing severe respiratory disease,
  • use of anticoagulation drugs other than acetylsalicylic acid or dipyridamol,
  • allergy to local anaesthetics,
  • patients on regular opioids,
  • atrioventricular block,
  • peripheral neuropathy.

结局指标

主要结局

The incidence ipsilateral hemidiaphragmatic paralysis after 30 minutes

时间窗: 30 minutes after the blocks

Hemidiaphragmatic paralysis was defined as the absence of diaphragmatic motion during normal respiration, coupled with absent or (paradoxical) cranial diaphragmatic movement when the patient forcefully sniffed.

NRS

时间窗: Postoperatively at 1 hour

Pain on a 0-10 scale where 0=no pain and 10=unbearable pain

次要结局

未报告次要终点

研究者

发起方
University Hospital of North Norway
申办方类型
Other
责任方
Sponsor

研究点 (2)

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