Bilevel Erector Spinae Plane Block Versus Pectoserratus Block for Analgesia in Modified Radical Mastectomy

NCT07650305 | Recruiting DMC

• 1 other identifier: AP2601-201-221-206
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer remains the most frequently diagnosed cancer and a major cause of cancer-related mortality among women worldwide. Modified radical mastectomy (MRM), a common surgical procedure for breast cancer, is associated with significant postoperative pain, which may delay recovery and contribute to the development of chronic postmastectomy pain syndrome (PMPS). To address this, regional anesthesia techniques have been increasingly incorporated into multimodal analgesia strategies to reduce opioid consumption and enhance patient outcomes. Interfascial plane blocks, in particular, offer safe and effective analgesia under ultrasound guidance. The erector spinae plane block (ESPB), first described in 2016, involves injection of local anesthetic deep to the erector spinae muscle and may spread to the paravertebral space, providing both somatic and visceral analgesia. A bilevel approach may enhance dermatomal coverage. Meanwhile, the pectoserratus plane block (PSPB), which combines PECS II and serratus anterior blocks, targets nerves of the anterior and lateral chest wall and has shown efficacy in breast surgery

Conditions

Breast Cancer

Keywords

erector spinae plane block; pectoserratus block; ultrasound

Outcome Measures

Primary Outcomes (1)

• Total post-operative morphine consumption.

  The total 24-hour morphine consumption will be recorded for every patient post operative.

  24 hours after the surgery

Secondary Outcomes (5)

• Total intra-operative fentanyl consumption

  2-3 hours (Surgery time) surgery

• 1st time opioids requested post-operative.

  24 hours after the surgery

• Changes and stability in Mean Arterial Blood Pressure (MAP)

  every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively

• Changes and stability in Heart Rate (HR)

  every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively

• Pain scores using Visual analogue score

  24 hours after the surgery

Study Arms (3)

Ultrasound guided bilevel Erector spinae plane block (ESPB)

ACTIVE COMPARATOR

Before induction of general anesthesia, patients will be positioned in the sitting position leaning forward. The 3rd and 5th vertebral spinous processes will be first identified then the block area will be adequately sterilized and draped. The block will be done as needed using either a high frequency linear probe (6- 13 MHz) or a curved (2-5 MHz) probe of . The probe used to identify the hyperechoic transverse process shadow at approximately 1.5- 2 cm distance from the spinous process deep to the trapezius, rhomboid major, and erector spinae muscles at 3rd, 5th vertebrae. Then, an 18-gauge epidural needle will be inserted in a cephalad-to-caudad direction to reach the transverse process deep to the erector spinae muscle. Correct positioning of the needle will be confirmed through real time visualization of 2 ml saline hydro dissection at both 3rd and 5th vertebrae.20 ml of bupivacaine 0.25% will be injected at each level.

Procedure: Ultrasound guided bilevel Erector spinae plane block (ESPB)

Ultrasound guided Pectoserratus Block (PSPB)

ACTIVE COMPARATOR

For the PECS block, the patient's arm is abducted 90° and externally rotated. The ultrasound probe is positioned beneath the lateral third of the clavicle to locate the axillary vessels and subclavian artery. The probe is moved distally and laterally to the second and third rib space to identify the pectoralis major. A 20G, 100 mm echogenic needle is inserted between the pectoralis muscles; 15 mL of local anesthetic (LA) is administered in 5 cc increments. The probe is then shifted distally and laterally to the third and fourth rib space. The fascial plane between the pectoralis minor and serratus anterior muscles is identified , and 10 mL of LA is injected in 5 cc increments. For the SAPB, the probe is placed on the midaxillary line at the fifth rib level to visualize the serratus anterior and latissimus dorsi. A 22G spinal needle is inserted in-plane at a 45° angle toward the fifth rib. Saline (0.5-1 mL) is injected to open the plane, and 15 mL of 0.25% LA is administered

Procedure: Ultrasound guided Pectoserratus Block

control group

NO INTERVENTION

the patients of this group received general anesthesia without regional plane block

Interventions

Ultrasound guided bilevel Erector spinae plane block (ESPB) PROCEDURE

Ultrasound guided bilevel Erector spinae plane block

Ultrasound guided bilevel Erector spinae plane block (ESPB)

Ultrasound guided Pectoserratus Block PROCEDURE

ultra sound guided combined Pectoral Nerve (PECS II) Block and Serratus anterior (SAPB) plane block

Ultrasound guided Pectoserratus Block (PSPB)

Eligibility Criteria

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

You may qualify if:

• Breast cancer female patients.
• ASA class II and III.
• Age ≥ 18 and ≤ 65 Years.
• Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2.
• Type of surgery; elective breast cancer surgery modified radical mastectomy combined with axillary dissection.

You may not qualify if:

• Patient refusal.
• Age \<18 years or \>65 years.
• BMI \<20 kg/m2 and \>35 kg/m2.
• Major medical conditions.
• Pregnancy or lactation.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute - Cairo University

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ayman Sharawy Abdelrahman Aboul Nasr, MD

  National Cancer Institute Cairo University

  STUDY DIRECTOR

Central Study Contacts

Ayman Sharawy Abdelrahman Aboul Nasr, MD

CONTACT

01282649008; ayman.sharawy@nci.cu.edu.eg

Yousr Farag Abdelhamid, MSc

CONTACT

01095444856; dr.yousrfarag@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: May 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): August 2, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

EG (1)