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

November 28, 2025 updated by: Mohammed Mahmoud Shaker Ahmed, Assiut University
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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Asyut, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PIFB-PECS II
Procedure: PECS II block
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.
Procedure: PIFB
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.
Active Comparator: SAPB
Procedure: SAPB block
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative Pain Scores
Time Frame: 30 minutes, 1hours, 2hours, 4hours, 6hours, 8hours, 12hours and 24 hours
postoperatively, the numeric rating scale (NRS) for pain assessment during rest and ipsilateral arm movement
30 minutes, 1hours, 2hours, 4hours, 6hours, 8hours, 12hours and 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mohammad Mahmoud Shaker, Bachelor's, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 21, 2025

First Posted (Estimated)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PECB II & PIFB VS SAPB in MRM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) underlying the results of this study will be made available to researchers upon reasonable request from the corresponding author after the publication of results, for a period of one year. The shared data will include anonymized variables relevant to the primary and secondary outcomes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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