Rhomboid Intercostal Sub-serratus Plane Blocks and Erector Spinae Plane Block in Mastectomy Surgeries

A Comparative Study Between Ultrasound Guided Combined Rhomboid Intercostal and Sub- Serratus Plane Blocks and Erector Spinae Plane Block as Perioperative Analgesia in Mastectomy Surgeries in Cancer Breast Patients

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.

Erector spinae plane block is a novel para-spinal regional anesthesia technique, , promises to provide effective visceral as well as somatic analgesia after carcinoma of the breast surgeries.

The ultrasound-guided rhomboid intercostal block sub-serratus plane block (RISS) is a novel analgesic technique The RISS block anesthetizes the lateral cutaneous branches of the thoracic intercostal nerves and can be used in multiple clinical settings for chest wall and upper abdominal analgesia

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Erector Spinae Plane Block; Procedure: Ultrasound Guided Combined Rhomboid Intercostal Sub-serratus Plane Blocks

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.

Erector spinae plane block is a novel para-spinal regional anesthesia technique, promises to provide effective visceral as well as somatic analgesia after carcinoma of the breast surgeries.

The ultrasound-guided rhomboid intercostal block (RIB) and rhomboid intercostal block sub-serratus plane block (RISS) are two novel analgesic techniques . Additionally, the RISS block anesthetizes the lateral cutaneous branches of the thoracic intercostal nerves and can be used in multiple clinical settings for chest wall and upper abdominal analgesia

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asmaa Elsayed Khalil Elmoghazy, MD; Phone Number: 0020 01009468049; Email: asmaakhalilmd2017@gmail.com
• Study Contact Backup: Name: Ayman Sharawy Abdelrahman Aboul Nasr, MD; Phone Number: 0020 01282649008; Email: ayman.sharawy@nci.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • Recruiting
    • National Cancer Institute - Cairo University
    • Contact: Ayman Sharawy AbdelRahman Aboul Nasr, MSc; Phone Number: 0020 +201282649008; Email: dr.ayman_sh3rawy@yahoo.com
    • Contact: Asmaa Elsayed Khalil Elmoghazy, MD; Phone Number: 01009468049; Email: asmaakhalilmd2017@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Breast cancer female patients.
2. ASA class II and III.
3. Age ≥ 18 and ≤ 60 Years.
4. Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
5. Type of surgery; elective breast cancer surgery (either modified radical mastectomy or conservative breast surgery) 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: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound guided Rhomboid intercostal block sub-serratus plane block (RISS).; With the patient in the lateral decubitus position, a rhomboid intercostal block will be performed under ultrasound guidance using a linear probe (6-12 MHz). The transducer will be positioned medial to the scapular border to obtain an oblique sagittal view. A 17G Tuohy needle will be advanced in-plane from a superomedial to an inferolateral direction through the trapezius and rhomboid major muscles, and 10 mL of 0.25% bupivacaine will be injected at the T5-T6 level. The probe will then be moved caudally and laterally to identify the plane between the serratus anterior and external intercostal muscles for a sub-serratus block at T6-T9. Using the same skin entry point, the needle will be redirected caudolaterally, and 15 mL of 0.25% bupivacaine will be administered superficial to the intercostal muscles.	Procedure: Ultrasound Guided Combined Rhomboid Intercostal Sub-serratus Plane Blocks; Ultrasound Guided Combined Rhomboid Intercostal Sub-serratus Plane Blocks
Active Comparator: Ultrasound guided Erector spinae plane block (ESPB); The patient will be placed in sitting position. The spine will be palpated from C7 downward to T5 and point will be marked to identify the spinous process. After ensuring skin asepsis, the high frequency (5-13 MHz) linear probe of ultrasound machine (Sonosite, Bothwell, USA) will be placed in a sterile sheath 3 cm lateral to the T5 spinous process. The three muscles from outward will be recognized: trapezius, rhomboidus major, and erector spinae muscle. An 18-gauge Tuohy needle will be inserted using an in-plane superior to inferior approach to place the tip into fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip was confirmed by visible fluid spread below erector spinae muscle off the bony shadow of the transverse process. A total of 20 ml of 0.5% bupivacaine will be injected through the needle.	Procedure: Erector Spinae Plane Block; Erector Spinae 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
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: Principal Investigator: Ayman Sharawy Abdelrahman Aboul Nasr, MD, National Cancer Institute Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: erector spinae plane block; ultra sound; Rhomboid Intercostal and Sub-serratus Plane Blocks
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: AP2512-501-144-205

Drug and device information, study documents

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