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临床试验/NCT02916342
NCT02916342已完成4 期

Interscalene Brachial Block Versus Combined Supraprascapular: Axillary Nerve Blocks - Respiratory and Acute Pain-related Outcomes

Centre Hospitalier Universitaire Vaudois2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
30
试验地点
2
主要终点
Presence of hemidiaphragmatic paresis (yes/no)

研究概览

简要总结

The interscalene block provides effective analgesia after shoulder surgery. It consists of injecting local anaesthetic within the brachial plexus, in the interscalene groove, between the anterior and middle scalene muscles. Unfortunately, this technique is associated with respiratory complications such as hemidiaphragmatic paresis due to the spread of the local anaesthetic towards the phrenic nerve that lies close to the brachial plexus, with an incidence up to 100%. The diaphragmatic paresis may be a serious side-effect, especially in patients suffering from a reduced respiratory function such as chronic obstructive pulmonary disease; this entity may even represent a contraindication to the performance of the block.

The shoulder is mainly innervated by the suprascapular and axillary nerves, both of them coming from C5 and C6 branches of the brachial plexus block. Recently, several authors have successfully identified and block these two nerves under ultrasound guidance. Only one randomised controlled trial compared interscalene block with a combination of suprascapular and axillary nerve blocks, and showed inconclusive results probably due to the absence of ultrasound guidance; indeed, analgesia was equivalent at the sixth postoperative hour, while patients with an interscalene block had reduced pain scores in the recovery room. Besides, the authors did not investigate the impact on the respiratory function.

In that randomised controlled trial, the investigators would like to compare the analgesic efficacy and the respiratory outcomes between the interscalene block and the combined suprascapular-axillary nerve blocks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

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

  • ASA physical status I-III;
  • 18-85 years of age, inclusive;
  • surgery less than 3 hours.

排除标准

  • indication for catheter insertion;
  • contraindications to brachial plexus block (e.g., allergy to local anaesthetics, malignancy or infection in the area);
  • existing neurological deficit in the area to be blocked;
  • pregnancy;
  • history of neck surgery or radiotherapy;
  • severe respiratory disease;
  • chest deformity;
  • inability to understand the informed consent and demands of the study;
  • patient refusal.

结局指标

主要结局

Presence of hemidiaphragmatic paresis (yes/no)

时间窗: 30 minutes after the injection

次要结局

  • Pain scores in phase 1 recovery (visual analogue scale, 0-10)(2 hours after surgery)
  • Peak expiratory flow (liters/minute)(30 minutes after the injection)
  • Forced expiratory volume in 1 second (liters)(30 minutes after the injection)
  • Forced vital capacity (liters)(30 minutes after the injection)
  • Intravenous morphine consumption in phase 1 recovery (mg)(2 hours postoperatively)
  • Oxycodone consumption at 24 hours postoperatively (mg)(Postoperative day 1)
  • Pain scores at 24 hours postoperatively (visual analogue scale, 0-10)(Postoperative day 1)

研究者

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

Eric Albrecht

PD Dr

Centre Hospitalier Universitaire Vaudois

研究点 (2)

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