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

NCT07041762 | Recruiting

• 1 other identifier: NCI-CAIRO-RISS-ESPB-2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Patients

Keywords

erector spinae block

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain Scores

  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)

  First 24 hours postoperatively

• Total Opioid Consumption

  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)

  First 24 hours postoperatively

Study Arms (2)

Rhomboid Intercostal Block with Sub-Serratus Plane Block

EXPERIMENTAL

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.

Procedure: Rhomboid Intercostal Block with Sub-Serratus Plane Block

Erector Spinae Plane Block

ACTIVE COMPARATOR

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.

Procedure: Erector Spinae Plane Block

Interventions

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.

Rhomboid Intercostal Block with Sub-Serratus Plane Block

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.

Erector Spinae Plane Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

National Cancer Institute - Cairo University

Cairo, Egypt

RECRUITING

Related Links

• Rhomboid intercostal block combined with sub-serratus plane block versus rhomboid intercostal block for postoperative analgesia after video-assisted thoracoscopic surgery: a prospective randomized-controlled trial
• Rhomboid Intercostal and Subserratus Plane Block: A Cadaveric and Clinical Evaluation

Study Officials

• Sayed Mahmoud M Abed, MD

  National Cancer Institute - Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sayed Mahmoud M Abed, MD

CONTACT

+20 122 680 6532; sayed.abed@nci.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind design: Participants, anesthesia providers, investigators, and outcome assessors will be blinded to group allocation. Group assignments will be concealed using opaque sealed envelopes, and blocks will be performed by anesthesiologists not involved in intraoperative care or postoperative evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: double blind

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 27, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)