跳至主要内容
临床试验/NCT03713255
NCT03713255招募中不适用

Analgesic Benefits of the Novel Mid-point Transverse Process to Pleura (MTP) Block for Ambulatory Breast Cancer Surgery: A Randomized Controlled Trial

Ottawa Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年1月1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
150
试验地点
1
主要终点
Postoperative analgesia during the first 24 hours.

研究概览

简要总结

This study will compare the analgesic effects of midpoint transverse process to pleura (MTP) block to control as well as thoracic paravertebral block.

详细描述

Paravertebral blocks (PVBs) are frequently used for regional anesthesia for breast surgery. Ultrasound-guided paravertebral block is an advanced skill. The needle tip can be difficult to visualize with ultrasound, and the proximity to neurovascular structures as well as the pleura presents a risk of neurovascular injection and pneumothorax respectively. The midpoint transverse-process to pleura (MTP) block incorporates a novel needle endpoint that is technically easier to achieve and more distant from neurovascular structures and the pleura compared to traditional PVB. This study will compare the analgesic effects of MTP block to control and PVB.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Quadruple (participant, care provider, investigator, outcomes assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • English or French Speaking
  • Scheduled for major breast surgery
  • ASA physical status classification I-III
  • BMI <30kg/m2

排除标准

  • Prior ipsilateral breast surgery
  • Pre-existing neurological deficit or peripheral neuropathy involving the ipsilateral chest
  • Contraindications to regional anesthesia
  • Patient refusal of regional technique
  • Chronic pain disorder
  • Chronic opioid use
  • Inability to provide informed consent

结局指标

主要结局

Postoperative analgesia during the first 24 hours.

时间窗: 48 hours

Measured by opioid (equivalents of morphine) consumption and pain scores on a numerical rating scale.

次要结局

  • Post-operative quality of recovery during the first 24 hours.(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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