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临床试验/NCT04933266
NCT04933266招募中不适用

Ultrasound-guided Subpectoral Plexus Block With Multi-level Thoracic Paravertebral Block for Surgical Anaesthesia During Primary Breast Cancer Surgery: A Prospective Randomized Double-blind Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Proportion of patients requiring intraoperative ketamine

研究概览

简要总结

The objective of this study is to compare two different doses of local anesthetics (10ml vs 20ml of 0.25% levobupivacaine) for subpectoral plexus block (SPPB) in addition to ultrasound guided multi-level of thoracic paravertebral block (m-TPVB) for surgical anaesthesia for major primary breast cancer surgery.

详细描述

Primary breast cancer surgery is one of the most commonly performed surgeries worldwide. It is associated with significant acute postoperative pain and a high incidence of chronic postsurgical pain. Regional anaesthetic techniques are shown to improve outcomes such as postoperative analgesia, nausea, vomiting, delirium and promote early recovery. Currently majority of the breast cancer surgery is performed under general anaesthesia with a multimodal analgesic regimen with or without regional blocks. In fact, it is proved that breast cancer surgery can be done solely under regional anesthesia using multilevel thoracic paravertebral block (TPVB) with deep sedation, but rescue analgesia are often required intraoperatively, especially when surgeons handles the pectoralis muscle. Current evidence suggest that pectoral nerves, which are often described as a pure motor nerves that control movements only, also able to send noxious stimulation such as pain from the pectoral muscles and its deep fascia (via afferent nociceptive fibers) to the brain. Principal investigator proposes that adding a subpectoral plexus block (SPPB) will stop a wider spectrum of afferent nociceptive fibers from sending any pain signals than having thoracic paravertebral block alone. However, there is no report on the amount of local anaesthetic (LA) required to achieve surgical anaesthesia for breast surgery. The aim of this study is to evaluate the effectiveness of two different doses (10ml vs 20ml of 0.25% levobupivacaine) of local anaesthetic (LA) for subpectoral plexus in addition to 3 levels of TPVB injections at T2, T4, and T6 under ultrasound guidance for surgical anaesthesia for major breast cancer surgery.

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
Double (Participant, Outcomes Assessor)

盲法说明

Patients in both study groups will not be able to know the dosage they will receive during the block and therefore will be blinded to group allocation. The "outcome assessor" (research nurse) will not be presented in the procedure room during block placement and thus will also be blinded to group allocation. The anesthesiologist (principal investigator) performing the allocated block will take no further part in the study after block placement.

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

  • scheduled for mastectomy, modified radical mastectomy or breast conservative surgery with lymph node biopsy and with or without axillary dissection

排除标准

  • local skin site infection
  • coagulopathy
  • history of allergy to local anesthetics

结局指标

主要结局

Proportion of patients requiring intraoperative ketamine

时间窗: during surgery

The total number of patients (in percentage) requiring intraoperative ketamine bolus during the surgery

次要结局

  • Total amount of rescue ketamine used(during surgery)
  • Pain score on admission at Post Anaesthetic Care Unit (PACU)(Assessed once on admission at Post Anaesthetic Care Unit immediately after surgery)
  • Pain score at Discharge of Post Anaesthetic Care Unit (PACU)(immediately before discharge from PACU)
  • Specific surgical region requiring rescue ketamine(during surgery)

研究者

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

Prof Manoj K Karmakar

Professor

Chinese University of Hong Kong

研究点 (1)

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