Analgesic Efficacy of Ultrasound Guided Serratus Anterior Plane Block and Pectoral Nerve Block II

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

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)

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Radical Mastectomy
• Intervention / Treatment: Procedure: Anethesia

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

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Elbasuni, MSC; Phone Number: +201125373436; Email: ahmedelbasuni86@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Al-Azhar University hospitals
    • Contact: Mohamed Abdelgawad, Assist.Prof; Phone Number: +201091945931; Email: abosoad.mohamed2017@gmail.com
    • Principal Investigator: Mohamed Abdelgawad Aboelsuod, Assist.Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women aged 35-65 years.
• BMI 18.5 - 25 kg/m2.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thoracic Epidural Block(Group 1); About 33 Patients will receive thoracic epidural block with an injection of a single shot of 15ml of 0.25% bupivacaine between T4 and T5 vertebrae.	Procedure: Anethesia; To assess the effectiveness of thoracic epidural blockage versus ultrasonic guided PECS II block versus ultrasound guided serratus anterior plane block for postoperative pain management in modified radical mastectomy.
Active Comparator: Ultrasound Guided Sserratus Anterior Plane Block (Group 2); About 33 Patients will receive Ultrasound Guided Sserratus Anterior Plane Block( SAPB) with an injection of 30 ml bupivacaine 0.25% .	Procedure: Anethesia; To assess the effectiveness of thoracic epidural blockage versus ultrasonic guided PECS II block versus ultrasound guided serratus anterior plane block for postoperative pain management in modified radical mastectomy.
Active Comparator: Ultrasound Guided Pectoral Nerve Block (Group 3); About 33 Patients will receive Ultrasound Guided Pectoral Nerve Block ( PECS II) with an injection of 20 ml bupivacaine 0.25% of pectoral-minor above the Serratus anterior muscle.	Procedure: Anethesia; To assess the effectiveness of thoracic epidural blockage versus ultrasonic guided PECS II block versus ultrasound guided serratus anterior plane block for postoperative pain management in modified radical mastectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Post-operative Pain	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	First 24-hour analgesic after Mastectomy

Collaborators and Investigators

• Sponsor: Azhar University
• Investigators: Study Chair: Alaa Aldine Mahmoud Said, Professor, Al-Azhar University, Faculty of medicine for boys

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: December 10, 2023
• First Submitted That Met QC Criteria: December 30, 2023
• First Posted (Estimated): January 3, 2024

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 30, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Radical Mastectomy; thoracic epidural blockage; Ultrasound Guided Serratus Anterior Plane Block; Pectoral Nerve Block II
• Other Study ID Numbers: Ahmed Elbasuni Ali

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No