Comparing Post-operative Analgesia After (PECS II) Block and (ESPB) in Modified Radical Mastectomy

NCT06714682 | Completed Results

• 1 other identifier: FMASU MS458/2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the analgesic efficacies of the modified pectoral plane block (PECS II) and the erector spinae plane block (ESPB) after modified radical mastectomy surgery through assessment of post-operative pain severity by Visual Analogue Score at PACU as a primary outcome and at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively also by comparing time of first rescue analgesia and cumulative post-operative meperidine consumption in the first 24 hours as secondary outcomes.

Conditions

Anaesthesia

Outcome Measures

Primary Outcomes (1)

• Post-operative Pain Severity Assessed by Visual Analogue Scale Immediately Postoperative on Admission to the Post Anesthesia Care Unit.

  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

  will be evaluated postoperatively on arrival to PACU (zero time)

Secondary Outcomes (1)

• Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively.

  24 hours post-operative

Study Arms (2)

Ultrasound-Guided Modified Pectoral Plane Block group

ACTIVE COMPARATOR

first group 10 patients

Procedure: Modified Pectoral Plane block group

Erector Spinae Plane Block group

ACTIVE COMPARATOR

second group 10 patients

Procedure: Erector spinae plane block group.

Interventions

Modified Pectoral Plane block group PROCEDURE

The patient will lay supine with the ipsilateral arm abducted and externally rotated and the elbow flexed at 90 degrees. The probe will be placed transversely between the clavicle medially and above and the shoulder joint laterally. After identifying the pectoralis major and minor muscles and the plane between them, the probe will be pushed 1-2 cm caudally and medially. In a caudal tilt, within a biconvex space, the artery will be recognised. After that, the block needle will be inserted in an in-plane approach to the artery's location and 10 mL of 0.25% bupivacaine will be administered Then probe will be moved laterally and caudally towards the anterior axillary fold until the serratus muscle appears beneath the pectoralis minor muscle attaching to the underlying ribs. The needle will target the plane between pectoralis minor and serratus muscles at the level of the third rib, followed by negative aspiration into the fascial plane then injection of 10 mL of 0.25 bupivacaine.

Also known as: PECS II

Ultrasound-Guided Modified Pectoral Plane Block group

Erector spinae plane block group. PROCEDURE

The block will be performed with the patient in a sitting position , The high-frequency linear probe will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinae muscle and the transverse processes identified, the block needle will be inserted in a caudad-to-cephalad direction until the tip lay in the interfacial plane deep to the erector spinae muscle, 20 mL of 0.25% bupivacaine will be administered for block performance.

Also known as: ESPB

Erector Spinae Plane Block group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients scheduled for MRM.
• Age eligible ≥ 40 \& ≤ 65 yrs.
• Patients with American Society of Anesthesiologists (ASA) physical status I, II who will be scheduled for Modified Radical Mastectomy surgery.

You may not qualify if:

• Age \< 40 \& \> 65 years old.
• Declining to give written informed consent.
• History of allergy to the medications used in the study.
• Contraindication to regional anesthesia \[including coagulopathy (platelet count ≤ 80,000, INR ≥ 1.5) and local infection\].
• Severe hepatic impairment (INR ≥ 1.5, Bilirubin ≥ 2, Albumin ≤ 2).
• Renal dysfunction \[GFR \< 50 ml/min calculated by MDRD (Modification of diet in renal disease) equation for GFR estimation (Livio et al., 2008)\].
• Psychiatric disorder.
• Pregnancy.
• Patient with history of thoracic spine surgery.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Results Point of Contact

• Title: Dr. Mohamed Ibrahim , Lecturer of anesthesia
• Organization: Ain Shams university

T.majestic@hotmail.com

01115560811

Study Officials

• Mohamed Ibrahim, MD

  Faculty Of Medicine , Ain Shams University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia, intensive care and pain management

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 4, 2024
• Study Start: June 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 20, 2024
• Last Updated: May 28, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)