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Clinical Trials/NCT06187909
NCT06187909
Completed
Not Applicable

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 site in 1 country88 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Ain Shams University
Enrollment
88
Locations
1
Primary Endpoint
Post-operative Pain Severity Assessed by VAS at Zero Time (on Admission to the PACU)
Status
Completed
Last Updated
3 months ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
August 1, 2024
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed abdelghany Khalifa ragab

lecturer of Anesthesia, intensive care and pain management

Ain Shams University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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