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NCT Number: NCT07247448

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University

Asyut, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 The needle will be withdrawn until its tip is placed between the pectoralis major and minor muscles, and an additional 10 mL of bupivacaine 0.25% will be injected.

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.

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.

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.

    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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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