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

Bilevel Erector Spinae Plane Block Versus Pecto-serratus Block for Analgesia in Modified Radical Mastectomy in Cancer Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Ultrasound guided bilevel Erector spinae plane block (ESPB); Procedure: Ultrasound guided Pectoserratus Block

Detailed Description

Breast cancer is the most common diagnosed malignancy among females and the 5th cause of cancer-related deaths with an estimated number of 2.3 million new cases and 685,000 deaths worldwide in 2020.

Different modalities are used for management of breast cancer including surgery, radiation therapy (RT), chemotherapy (CT), endocrine (hormone) therapy (ET), and targeted therapy. Modified Radical Mastectomy (MRM) is one of the main modalities of breast cancer treatment. It accounts for 31% of all breast surgeries. It has been reported that 40% of the females complain from moderate-to-severe pain in the immediate post-operative period after breast cancer surgery.

Acute post-mastectomy pain can cause adverse impacts on the patients as delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay. It is also an important factor leading to the development of chronic post mastectomy pain syndrome (PMPS) in almost half of the patients.

Various regional anesthetic techniques have been described for postoperative pain relief after mastectomy, for example, thoracic epidural anesthesia, intercostal nerve block, paravertebral block, serratus anterior plane block, and pectoral nerve I and II blocks. All of them offer satisfactory pain relief after mastectomy.

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayman Sharawy Abdelrahman Aboul Nasr, MD; Phone Number: 0020 01282649008; Email: ayman.sharawy@nci.cu.edu.eg
• Study Contact Backup: Name: Yousr Farag Abdelhamid, MSc; Phone Number: 01095444856; Email: dr.yousrfarag@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • Recruiting
    • National Cancer Institute - Cairo University
    • Contact: Yousr Farag Abdelhamid, MSc; Phone Number: 01095444856; Email: dr.yousrfarag@gmail.com
    • Contact: Ayman Sharawy AbdelRahman Aboul Nasr, MD; Phone Number: 0020 +201282649008; Email: ayman.sharawy@nci.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patient refusal.
2. Age <18 years or >65 years.
3. BMI <20 kg/m2 and >35 kg/m2.
4. Major medical conditions.
5. Pregnancy or lactation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound guided bilevel Erector spinae plane block (ESPB); 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 bilevel Erector spinae plane block
Active Comparator: Ultrasound guided Pectoserratus Block (PSPB); 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; ultra sound guided combined Pectoral Nerve (PECS II) Block and Serratus anterior (SAPB) plane block
No Intervention: control group; the patients of this group received general anesthesia without regional plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intra-operative fentanyl consumption	the rescue analgesia will be administered intra-operative by fentanyl IV and the total fentanyl used will be recorded and compared between the groups	2-3 hours (Surgery time) surgery
Pain scores using Visual analogue score	Pain scores using Visual analogue score (VAS) (0 mm = no pain to 10mm = worst pain imaginable) at predetermined time intervals (1, 2, 6, 12 and 24h) postoperative.	24 hours after the surgery
1st time opioids requested post-operative.	In case of postoperative pain recorded, rescue analgesia will be provided as IV morphine (3 mg) then continuous infusion of morphine through Patient Controlled Analgesia ( PCA ) to keep the VAS scores<3. The total 24-hour morphine consumption will be recorded for every patient.	24 hours after the surgery
Changes and stability in Mean Arterial Blood Pressure (MAP)	Change in Mean Arterial Blood Pressure (MAP) in mmHg	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)	Change in heart rate (HR) in beat\min	every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt
• Investigators: Study Director: Ayman Sharawy Abdelrahman Aboul Nasr, MD, National Cancer Institute Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 2, 2026

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: ultrasound; erector spinae plane block; pectoserratus block
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: AP2601-201-221-206

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No