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

NCT07390448 | Recruiting DMC

• 1 other identifier: AP2512-501-144-205
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

erector spinae plane block; Rhomboid Intercostal and Sub-serratus Plane Blocks; ultra sound

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 (4)

• 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

Study Arms (2)

Ultrasound guided Rhomboid intercostal block sub-serratus plane block (RISS).

ACTIVE COMPARATOR

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 Erector spinae plane block (ESPB)

ACTIVE COMPARATOR

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

Interventions

Ultrasound Guided Combined Rhomboid Intercostal Sub-serratus Plane Blocks PROCEDURE

Ultrasound Guided Combined Rhomboid Intercostal Sub-serratus Plane Blocks

Ultrasound guided Rhomboid intercostal block sub-serratus plane block (RISS).

Erector Spinae Plane Block PROCEDURE

Erector Spinae Plane Block

Ultrasound guided Erector spinae plane block (ESPB)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayman Sharawy Abdelrahman Aboul Nasr, MD

CONTACT

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

Asmaa Elsayed Khalil Elmoghazy, MD

CONTACT

01009468049; asmaakhalilmd2017@gmail.com

Study Design

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

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

EG (1)