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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-07-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Breast Cancer Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double blind

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Rhomboid Intercostal Block with Sub-Serratus Plane Block

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.

Group Type EXPERIMENTAL

Rhomboid Intercostal Block with Sub-Serratus Plane Block

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Erector Spinae Plane Block

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No