The Analgesic Efficacy of Pecto-Intercostal Fascial Block Combined With Pectoral Nerve Block II Versus Serratus Plane Block in Modified Radical Mastectomy
NCT07247448 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2025-12-02
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
Interventions
- 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 The needle will be withdrawn until its tip is placed between the pectoralis major and minor muscles, and an additional 10 mL of bupivacaine 0.25% will be injected.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
-
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.
- 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.
Sponsors & Collaborators
-
Assiut University
lead OTHER
Principal Investigators
-
Mohammad Mahmoud Shaker, Bachelor's · Assiut University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-15
- Primary Completion
- 2026-11-30
- Completion
- 2026-11-30
Countries
- Egypt
Study Locations
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