Menu
Recruiting NCT07041762

Rhomboid Intercostal Block With Sub-Serratus Plane Block Versus Erector Spinae Block

No phase Interventional Breast Cancer Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rhomboid Intercostal Block with Sub-Serratus Plane Block, Erector Spinae Plane Block.
Who it may be relevant to
Registry conditions: Breast Cancer Patients. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Analgesic Efficacy of Rhomboid Intercostal Block With Sub-Serratus Plane Block Versus Erector Spinae Block in Breast Cancer Surgery

Overview

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.

Detailed 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.

Interventions

  • Procedure Rhomboid Intercostal Block with Sub-Serratus Plane Block
    Ultrasound-guided regional anesthesia combining two injections: Rhomboid Intercostal Block (20 mL of 0.25% bupivacaine injected between rhomboid major and intercostal space) Sub-Serratus Plane Block (20 mL of 0.25% bupivacaine injected between serratus anterior and ribs). Both performed 30-45 minutes before Modified Radical Mastectomy under general anesthesia.
  • Procedure Erector Spinae Plane Block
    Ultrasound-guided regional block with 30 mL of 0.25% bupivacaine injected into the paraspinal plane at the T4-T5 level, between the erector spinae muscle and the transverse processes. Performed 30-45 minutes prior to general anesthesia for Modified Radical Mastectomy.

Primary outcome measures

  • Postoperative Pain Scores [Time frame: First 24 hours postoperatively]
  • Total Opioid Consumption [Time frame: First 24 hours postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • National Cancer Institute - Cairo University — Cairo

Identifiers

NCT: NCT07041762 · NCI-CAIRO-RISS-ESPB-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗