The Analgesic Efficacy of Pecto-Intercostal Fascial Block Combined With Pectoral Nerve Block II Versus Serratus Plane Block in Modified Radical Mastectomy

NCT07247448 | Active Not Recruiting DMC

• 1 other identifier: PECB II & PIFB VS SAPB in MRM
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to to evaluate the analgesic efficacy of PECS II-PIFB versus SAPB for 24 hours in women aged from 18 to 65 years and scheduled for MRM. The main question it aims to answer is: which nerve block is better regarding the total analgesic consumption and the lowest postoperative complication

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• The analgesic efficacy of PECS II-PIFB versus SAPB in patients scheduled for MRM by the total analgesic consumption (nalbuphine in mg) during the first 24 hours.

  The analgesic efficacy of PECS II-PIFB versus SAPB in patients scheduled for MRM by the total analgesic consumption (nalbuphine in mg) during the first 24 hours.

  24 hours

Secondary Outcomes (1)

• Post operative Pain Scores

  30 minutes, 1hours, 2hours, 4hours, 6hours, 8hours, 12hours and 24 hours

Study Arms (2)

PIFB-PECS II

ACTIVE COMPARATOR

Procedure: PECS II block; Procedure: PIFB

SAPB

ACTIVE COMPARATOR

Procedure: SAPB block

Interventions

PECS II block PROCEDURE

Ultrasound-Guided PECS II Block With the patient in a supine position, her arm in a neutral position, and under complete aseptic technique, a 6 to 13 MHz ultrasound linear transducer probe (Mindray, Shen zhen, China) will be positioned below the distal one-third of the clavicle to visualize the pectoralis major and minor muscles, SAM, pectoral branch of the thoracoacromial artery, the second and third ribs, and the external intercostal muscles between the ribs. The needle will be inserted in-plane in a medial-to-lateral direction until its tip is placed between the SAM and the external intercostal muscles. The first injection will be done below the SAM using 20 mL bupivacaine 0.25% at the level of the second rib to block the intercostobrachial nerves and the lateral branches of the third to the sixth intercostal nerves. The needle will be withdrawn until its tip is placed between the pectoralis major and minor muscles, and an additional 10 mL of bupivacaine 0.25% will be injected.

PIFB-PECS II

SAPB block PROCEDURE

Ultrasound-Guided Serratus Anterior Plane Block (SAPB) The probe will be placed on the mid-axillary line at the level of the fourth rib to visualize the serratus anterior and latissimus dorsi muscles. After establishing the correct level, the needle will be introduced in-plane. After puncturing the serratus muscle and contacting the rib, 40 mL of bupivacaine 0.25% will be deposited between the serratus muscle fascia and the rib periosteum, termed a deep serratus anterior plane block.

SAPB

PIFB PROCEDURE

Ultrasound-Guided PIFB Under complete aseptic technique with the patient in the supine position, a 6 to 13 MHz ultrasound linear transducer probe (Mindray, Shen zhen, China) will be placed 2 or 3 cm parallel to the long axis of the sternal bone to identify the second to fourth costal cartilages and targeting the fourth costal cartilage The needle will be inserted in-plane with the US probe, in a caudal-to-cranial direction. The needle will be advanced until the tip is positioned in the interfascial plane between the pectoralis major muscle and the intercostal muscle. After confirmation of the correct position of the tip of the needle, as shown by separation of the fascial layers on injecting 2 mL normal saline solution, 10 mL of bupivacaine 0.25% will be injected.

PIFB-PECS II

Eligibility Criteria

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

You may qualify if:

• Patients scheduled for elective MRM
• Age 18-65 years
• American Society of Anesthesiologists (ASA) physical state I-II

You may not qualify if:

• Patient refusal.
• Body Mass Index \> 30 kg/m2.
• Skin infection at the site of injection.
• History of renal, liver, cardiac, and neuropsychiatric disorder problems.
• Bleeding or coagulation abnormality.
• Known allergy to any drugs used in this study.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (24)

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MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammad Mahmoud Shaker, Bachelor's

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at Anesthesia, Intensive Care and Pain Management

Model Details: Patients: 70 patients will be enrolled in this study. They will be equally divided into two groups: Group A (PIFB-PECS II): 35 patients will receive 40 mL of 0.25% bupivacaine. * PECS II block divided into 2 injections. 1. 10 ml between the pectoralis major and pectoralis minor 2. 20 ml between the pectoralis minor and stratus anterior muscle * PIFB 10 mL between the pectoralis major and the intercostal muscle. Group B (Serratus plane block): 35 patients will receive 40 mL of 0. 25% bupivacaine.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 25, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)