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临床试验/NCT06187909
NCT06187909已完成不适用

Ultrasound-Guided Modified Pectoral Plane (PECS II) Block Versus Midpoint Transverse Process to Pleura (MTP) Block for Postoperative Analgesia of Modified Radical Mastectomy

Ain Shams University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2024年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
1
主要终点
Post-operative Pain Severity Assessed by VAS at Zero Time (on Admission to the PACU)

研究概览

简要总结

This randomized controlled study aims to compare the analgesic efficacy of the ultrasound-guided modified pectoral nerve block (PECS II) and the midpoint transverse process to pleura (MTP) block in female patients undergoing modified radical mastectomy (MRM). Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS) over the first 24 hours, with additional evaluation of opioid consumption and complications.

详细描述

Modified radical mastectomy (MRM) is associated with significant postoperative pain, which may increase opioid use, delay recovery, and contribute to chronic post-mastectomy pain syndrome. This study compares two regional analgesic techniques: the ultrasound-guided modified pectoral nerve block (PECS II) and the midpoint transverse process to pleura (MTP) block.

The PECS II block involves the injection of local anesthetic between the pectoralis minor and serratus anterior muscles, targeting the pectoral nerves and lateral cutaneous branches of intercostal nerves (T2-T6). It is widely used for anterior chest wall analgesia after breast surgery. The MTP block, a more recent paravertebral-domain technique, deposits anesthetic midway between the transverse process and the pleura, allowing spread to dorsal and ventral rami via the superior costotransverse ligament and potentially achieving broader thoracic segment coverage.

This randomized trial evaluates postoperative pain control using the Visual Analog Scale (VAS) over 24 hours, along with opioid consumption and adverse events. The aim is to determine whether the MTP block offers superior analgesia and an opioid-sparing effect compared to the PECS II block.

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
Single (Outcomes Assessor)

盲法说明

Patients were sedated during block placement; however, due to the distinct anatomical sites of the two techniques, full patient blinding could not be ensured. Outcome assessors gathering postoperative data were blinded to group allocation, and the anesthesiologists performing the blocks were not engaged in data collection.

入排标准

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

入选标准

  • Female patients scheduled for modified radical mastectomy (MRM).
  • Age between 40 and 65 years.
  • American Society of Anesthesiologists (ASA) physical status I-II.

排除标准

  • Known allergy to local anesthetics.
  • Coagulopathy.
  • Infection at the site of injection.
  • Patient refusal.
  • Inability to understand or use the pain scale.

结局指标

主要结局

Post-operative Pain Severity Assessed by VAS at Zero Time (on Admission to the PACU)

时间窗: will be evaluated post-operatively at zero time

Visual Analogue Scale is a scale for pain assessment ranging from 0 to 10 where 0 is minimum and means no pain while 10 is maximum and means maximum pain which means worse outcome

次要结局

  • Post-operative Pain Severity Assessed by VAS at Hour-2, Hour-4, Hour-8, Hour-12, Hour-18 and Hour-24.(24 hours postoperatively)
  • Time of First Rescue Analgesia(24 hours postoperatively)
  • Cumulative Post-operative Nalbuphine Consumption in the First 24 Hours(24 hours postoperatively)
  • Incidence of Postoperative Side Effects and Complications(24 hours postoperatively)

研究者

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

Ahmed abdelghany Khalifa ragab

lecturer of Anesthesia, intensive care and pain management

Ain Shams University

研究点 (1)

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PECS II vs. MTP for Analgesia After MRM | 临床试验