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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sayed Mahmoud M Abed, MD | Contact | +20 122 680 6532 | sayed.abed@nci.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Sayed Mahmoud M Abed, MD | National Cancer Institute - Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute - Cairo University | Recruiting | Cairo | Egypt |
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| Label | URL |
|---|---|
| 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 | View source |
| Rhomboid Intercostal and Subserratus Plane Block: A Cadaveric and Clinical Evaluation | View source |
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Individual Participant Data (IPD) will not be shared due to institutional policies regarding data confidentiality and privacy. Additionally, there is no established infrastructure for secure data sharing or monitoring of secondary data use at this time.
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double blind
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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.
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| 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. |
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