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Clinical Trials/NCT06188156
NCT06188156
Recruiting
Not Applicable

Analgesic Efficacy of Ultrasound Guided Serratus Anterior Plane Block and Pectoral Nerve Block II Compared to Thoracic Epidural Block After Unilateral Modified Radical Mastectomy

Azhar University1 site in 1 country99 target enrollmentFebruary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia
Sponsor
Azhar University
Enrollment
99
Locations
1
Primary Endpoint
Measurement of Post-operative Pain
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Modified Radical Mastectomy accounts for 31% of all breast surgeries and considered the fundamental surgical management for breast cancer. Nearly 40-60% of patients experience severe acute postoperative pain. This pain might persist for 6-12 months and result in post-mastectomy pain syndrome and complex regional pain syndrome (causalgia)

Detailed Description

There are some local or regional nerve blocks in breast surgeries performed as core components of multimodal analgesia and enhanced recovery after surgery (ERAS), including thoracic epidural (TEB), interscalene brachial plexus, paravertebral, ultrasound-guided pectoral nerve block ( PECS II ), ultrasound-guided serratus anterior plane block (SAPB) and erector spinae plane block . Thoracic epidural (TEB) is the gold standard technique following breast surgery, but there is still a problem with the adequacy of thoracic and axillary blockage during lymph node dissection . Modified PECS's block" or PECS block type II aimed to block the axilla that is vital for axillary clearances and the intercostal nerves, necessary for wide excisions which can provide analgesia after breast surgery. In the ultrasound-guided serratus anterior plane block (SAPB), the local anesthetic (LA) is injected in the compartment between the serratus anterior and latissimus dorsi muscles. SAPB anesthetizes the intercostobrachial nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve, and thoracodorsal nerve thus providing analgesia for breast and lateral thoracic wall surgeries

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
February 28, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Azhar University
Responsible Party
Principal Investigator
Principal Investigator

mohamed A Aboelsuod, MD

Assistant Professor of Anesthesia, intensive care and pain management Faculty of Medicine

Azhar University

Eligibility Criteria

Inclusion Criteria

  • Women aged 35-65 years.
  • BMI 18.5 - 25 kg/m
  • American Society of Anesthesiologists (ASA) I-II.

Exclusion Criteria

  • Patient refusal.
  • Coagulopathy.
  • Mental and psychiatric disorders.
  • History of chronic pain.
  • Hypersensitivity or contraindication to any of study drugs
  • Previous chemotherapy.

Outcomes

Primary Outcomes

Measurement of Post-operative Pain

Time Frame: First 24-hour analgesic after Mastectomy

Assessment of the pain post-operatively in patients with pain assessed by VAS score : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain

Study Sites (1)

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