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NCT Number: NCT07041762

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

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.

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Key information

Conditions

Breast Cancer Patients

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Institute - Cairo University

Cairo, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rhomboid Intercostal Block with Sub-Serratus Plane Block

Procedure

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.

Erector Spinae Plane Block

Procedure

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 outcomes

  1. Postoperative Pain Scores

    Time frame: First 24 hours postoperatively

    Postoperative pain will be assessed using the Visual Analog Scale (VAS) both at rest (static) and during movement (dynamic). Assessments will be conducted at 2, 6, 12, and 24 hours following surgery. The VAS is a 10-centimeter scale, where 0 indicates "no pain" and 10 indicates the "worst imaginable pain." Unit of Measure: VAS score (0-10)

  2. Total Opioid Consumption

    Time frame: First 24 hours postoperatively

    The total amount of opioid analgesics administered within the first 24 postoperative hours will be recorded for each patient. All opioid dosages will be converted to intravenous morphine equivalents for standardization.

    Unit of Measure: Milligrams of intravenous morphine equivalents (mg)

Study contacts

Contact information is provided by the study sponsor or research team.

Sayed Mahmoud M Abed, MD

CONTACT

[email protected]

+20 122 680 6532

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: RISS-ESPB

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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