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临床试验/NCT03352687
NCT03352687已完成不适用

Diaphragmatic Paralysis After Ultrasound Block of the Suprascapular Nerve for Shoulder Surgery : Incidence and Influence of the Approach

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2018年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
2
主要终点
change in diaphragmatic excursion

研究概览

简要总结

Shoulder surgery is a source of intense postoperative pain that justifies the use of opioids. In this context, analgesia provided by locoregional anesthesia (ALR) improves the rehabilitation of patients by reducing the length of hospital stay and morphine consumption. Thus anesthesia of the brachial plexus interscalene (interscalene block or BIS) is considered as the reference technique for the management of post-operative pain after shoulder surgery. It is however provider of hemi-diaphragmatic paralysis (PhD) in nearly 100% of cases. Thus, this technique is usually avoided in patients with respiratory insufficiency. In arthroscopic shoulder surgery, the development of a suprascapular and axillary nerve (SSAX) conjugate block appears to be an effective analgesic alternative in this context.

详细描述

Two ultrasound-guided approaches of the suprascapular nerve (anterior and posterior approaches) have been described in the literature. From an anatomical point of view, the anterior approach could expose patients to the risk of ipsilateral PhD by phrenic nerve block secondary to diffusion of the local anesthetic into the supraclavicular region.

By measuring the diaphragm excursion during a sniff test, ultrasound allows reliable and reproducible analysis of the diaphragm function.

No study has evaluated the incidence of PhD after ultrasound block of the suprascapular nerve. Knowing the influence of the approach on this complication could be of major interest in this context.

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
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

入选标准

  • to benefit from scheduled arthroscopic surgery of the shoulder under general anesthesia
  • Affiliate or beneficiary of a social security scheme
  • Having signed the informed consent

排除标准

  • the existence of contralateral diaphragmatic paralysis
  • pre-existing respiratory insufficiency
  • impossibility of performing diaphragmatic ultrasound
  • the patient's refusal
  • the existence of major spontaneous or acquired haemostatic disorders
  • an infection at the point of puncture
  • allergy to local anesthetics
  • Pregnant or likely to be pregnant
  • Patients under protection of the adults (guardianship, curators or safeguard of justice)
  • Patients whose cognitive state does not allow assessment by the scales used

结局指标

主要结局

change in diaphragmatic excursion

时间窗: 30 minutes

measured on ultrasound between the 30th minute after SSAX and the basal state (i.e. prior to regional anesthesia). The diaphragmatic excursion is the distance traveled by the diaphragm between the functional residual capacity (CRF) and the forced inspiration during a rapid voluntary sniffing (or "sniff test").

次要结局

  • PhD over time(Baseline, 30 minutes, 4 hours and 8 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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