Rhomboid Intercostal Block With Sub-Serratus Plane Block Versus Erector Spinae Block (RISS-ESPB)

Cairo University (CU)

Status: Enrolling

Conditions: Breast Cancer Patients

Treatments: Procedure: Erector Spinae Plane Block; Procedure: Rhomboid Intercostal Block with Sub-Serratus Plane Block

Study type: Interventional

Funder types: Other

Identifiers

NCT07041762

NCI-CAIRO-RISS-ESPB-2025

Details and patient eligibility

About

This study compares two nerve block techniques-Rhomboid Intercostal with Sub-Serratus Plane Block versus Erector Spinae Plane Block-for pain relief after breast cancer surgery. It aims to determine which method provides better postoperative pain control, reduces opioid use, and improves recovery in patients undergoing modified radical mastectomy at the National Cancer Institute, Cairo University.

Full description

This randomized controlled trial aims to evaluate the analgesic efficacy of two ultrasound-guided regional anesthesia techniques-Rhomboid Intercostal Block with Sub-Serratus Plane Block (RIB + SSP) and Erector Spinae Plane Block (ESB)-in patients undergoing Modified Radical Mastectomy (MRM) for breast cancer. Eighty female patients aged 18-65 years with ASA physical status II or III will be enrolled and randomly assigned to receive either RIB + SSP or ESB prior to surgery. Both blocks will be performed under ultrasound guidance 30-45 minutes before induction of general anesthesia.

The primary outcomes are postoperative pain scores measured using the Visual Analog Scale (VAS) and total opioid consumption in the first 24 hours after surgery. Secondary outcomes include intraoperative and postoperative hemodynamic parameters, time to first analgesic request, total intraoperative opioid use, recovery time, patient satisfaction, and incidence of adverse effects such as nausea and vomiting.

The study will be conducted at the National Cancer Institute - Cairo University from June 2025 to June 2026. Ethical approval will be obtained, and written informed consent will be collected. This study aims to identify the more effective and safer regional technique to improve postoperative recovery and reduce opioid dependence in breast cancer patients.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female breast cancer patients undergoing Modified Radical Mastectomy (MRM)

ASA physical status II or III

Age between 18 and 65 years

Body Mass Index (BMI) > 20 kg/m² and < 35 kg/m²

Exclusion criteria

• Patient refusal

ASA physical status IV

Age <18 years or >65 years

BMI < 20 kg/m² or > 35 kg/m²

Known allergy or contraindication to local anesthetics or opioids

History of psychological disorders or chronic pain

Contraindications to regional anesthesia (e.g., coagulopathy, local infection, peripheral neuropathy)

Severe respiratory, cardiac, hepatic, or renal disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Rhomboid Intercostal Block with Sub-Serratus Plane Block

Experimental group

Description:

Participants in this group will receive ultrasound-guided Rhomboid Intercostal Block (20 mL of 0.25% bupivacaine between rhomboid major and intercostal space) followed by Sub-Serratus Plane Block (20 mL of 0.25% bupivacaine between serratus anterior and ribs) 30-45 minutes before general anesthesia for Modified Radical Mastectomy.

Treatment:

Procedure: Rhomboid Intercostal Block with Sub-Serratus Plane Block

Erector Spinae Plane Block

Active Comparator group

Description:

Participants in this group will receive an ultrasound-guided Erector Spinae Plane Block with 30 mL of 0.25% bupivacaine injected into the paraspinal plane at the T4-T5 level, 30-45 minutes prior to general anesthesia for Modified Radical Mastectomy.

Treatment:

Procedure: Erector Spinae Plane Block