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

Not Applicable

Recruiting

• Conditions: Breast Cancer Patients

• Registration Number: NCT07041762
• Lead Sponsor: Cairo University

Brief Summary

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.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27
• Primary Completion: 2026-06-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total Opioid Consumption	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)
Postoperative Pain Scores	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)

Trial Locations

Locations (1)

National Cancer Institute - Cairo University; 🇪🇬 Cairo, Egypt