Breast Cancer Patients
Conditions
Keywords
erector spinae block
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.
Interventions
PROCEDURERhomboid Intercostal Block with Sub-Serratus Plane Block
Ultrasound-guided regional anesthesia combining two injections: Rhomboid Intercostal Block (15 mL of 0.25% bupivacaine injected between rhomboid major and intercostal space) Sub-Serratus Plane Block (15 mL of 0.25% bupivacaine injected between serratus anterior and ribs). Both performed 30-45 minutes before Modified Radical Mastectomy under general anesthesia.
PROCEDUREErector 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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Regional blocks were performed by an experienced anesthesiologist who was not involved in postoperative care. Patients, nurses, and anesthesiologists responsible for postoperative data collection were strictly blinded to group allocations.
Intervention model description
observer-blinded
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORSayed Mahmoud M Abed, MD
National Cancer Institute - Cairo University
Outcome results
None listed