跳至主要内容
临床试验/2024-510942-15-00
2024-510942-15-00招募中3 期

BCS-ORL - Evaluation of the superficial cervical plexus block in oncological throat and neck surgery

Assistance Publique Hopitaux De Paris6 个研究点 分布在 1 个国家目标入组 346 人开始时间: 2025年5月28日最近更新:

试验速览

阶段
3 期
状态
招募中
入组人数
346
试验地点
6
主要终点
Quantity of morphine consumed postoperatively (quantity of morphine titrated in postoperative room + administered by the PCA in mg and mg/kg/d).

研究概览

简要总结

The objective of this study is the reduction in the quantity of IV morphine (titration + PCA morphine) during the first 24 postoperative hours via a locoregional anesthesia technique in patients undergoing throat and neck cancer surgery.

入排标准

年龄范围
18 years 至 65+ years(18-64 Years, 65+ Years)
接受健康志愿者

入选标准

  • Adult patient undergoing ENT cancer surgery with cervicotomy
  • Patient having received oral information from a doctor and signed written consent
  • Affiliation to a social security scheme, Universal Medical Coverage (CMU)

排除标准

  • Patient refusal
  • Patient under AME
  • Altered mental faculties or patient unable to give consent
  • Allergy to local anesthetics
  • Severe respiratory pathology (altered respiratory function tests with 50% < FEV1 < 80%, FEV1/FVC < 70%, COPD stage 2 or more)
  • Preoperative SpO2 less than 92% in ambient air
  • Left heart failure NYHA 3 or more, impaired LVEF < 30% or less
  • Lower respiratory infection in the month preceding surgery
  • History of ENT cancer surgery with cervical lymph node dissection
  • Pregnant or breastfeeding woman

结局指标

主要结局

Quantity of morphine consumed postoperatively (quantity of morphine titrated in postoperative room + administered by the PCA in mg and mg/kg/d).

Quantity of morphine consumed postoperatively (quantity of morphine titrated in postoperative room + administered by the PCA in mg and mg/kg/d).

次要结局

未报告次要终点

研究者

申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Laetitia DESPLANQUE

Scientific

Assistance Publique Hopitaux De Paris

研究点 (6)

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