Rhomboid intercostal + sub‑serratus plane block versus erector spinae block for pain after modified radical mastectomy
Analgesic Efficacy of Rhomboid Intercostal Block With Sub-Serratus Plane Block Versus Erector Spinae Block in Breast Cancer Surgery
This test will see if a combined rhomboid intercostal and sub‑serratus plane nerve block or an erector spinae block gives better pain relief and reduces opioid use for women having modified radical mastectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07041762 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial enrolling 80 women aged 18–65 with ASA II–III who are undergoing modified radical mastectomy at the National Cancer Institute, Cairo University. Participants are randomly assigned to receive either an ultrasound‑guided rhomboid intercostal block combined with a sub‑serratus plane block (RIB+SSP) or an ultrasound‑guided erector spinae plane block (ESB) 30–45 minutes before induction of general anesthesia. Primary outcomes are postoperative pain scores on the Visual Analog Scale and total opioid consumption in the first 24 hours; secondary outcomes include hemodynamic parameters, time to first analgesic request, recovery time, patient satisfaction, and adverse effects. The aim is to identify which regional technique provides better analgesia, reduces opioid need, and improves early recovery after mastectomy.
Who should consider this trial
Good fit: Ideal candidates are female breast cancer patients aged 18–65 with ASA II–III and BMI between 20 and 35 kg/m² who are scheduled for modified radical mastectomy and have no contraindications to regional anesthesia.
Not a fit: Patients with contraindications to regional anesthesia, chronic pain or psychological disorders, extreme BMI, severe organ disease, or those outside the age range are unlikely to benefit from the trial interventions.
Why it matters
Potential benefit: If successful, the preferred block could improve post‑operative pain control, lower opioid use, and speed early recovery for mastectomy patients.
How similar studies have performed: Erector spinae plane blocks have shown analgesic benefit in prior studies for breast surgery, while the combined RIB+SSP approach is less extensively studied and therefore more novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cairo
- National Cancer Institute - Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Sayed Mahmoud M Abed, MD — National Cancer Institute - Cairo University
- Study coordinator: Sayed Mahmoud M Abed, MD
- Email: sayed.abed@nci.cu.edu.eg
- Phone: +20 122 680 6532
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.