SPSIP versus ESPB nerve blocks for pain control after modified radical mastectomy
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block Versus Erector Spinae Plane Block for Postoperative Pain Management After Modified Radical Mastectomy: A Randomized Clinical Trial
This trial tests whether the newer SPSIP nerve block reduces pain and opioid (morphine) use more than the erector spinae plane block after modified radical mastectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT07446868 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial compares two ultrasound-guided regional anesthesia techniques—serratus posterior superior intercostal plane (SPSIP) block and erector spinae plane (ESPB) block—in adults undergoing modified radical mastectomy for breast cancer. Participants will be randomized to receive one of the blocks perioperatively and followed for postoperative pain scores and total morphine consumption, with the primary outcome being total morphine use in the immediate postoperative period. Standard perioperative care and multimodal analgesia protocols will be maintained, and recruitment is limited to ASA II–III patients aged 18–65 with BMI between 20 and 35 kg/m². Secondary measures likely include pain scores over time, opioid-related adverse effects, and recovery metrics such as time to mobilization.
Who should consider this trial
Good fit: Women with breast cancer scheduled for modified radical mastectomy who are 18–65 years old, ASA physical status II–III, have BMI between 20 and 35 kg/m², and can give informed consent are ideal candidates.
Not a fit: Patients with chronic opioid use, contraindications to regional anesthesia, severe cardiorespiratory/hepatic/renal disease, extreme BMI outside the eligibility range, or significant psychiatric disorders are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, SPSIP could provide better postoperative pain relief and reduce opioid requirements after mastectomy, potentially speeding recovery and lowering opioid side effects.
How similar studies have performed: Erector spinae plane block has demonstrated effectiveness for breast surgery analgesia in prior studies, while SPSIP is a newer technique supported mainly by limited preliminary reports.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Female patients diagnosed with breast cancer Scheduled for modified radical mastectomy (MRM) American Society of Anesthesiologists (ASA) physical status II or III Age 18-65 years Body mass index (BMI) \> 20 kg/m² and \< 35 kg/m² Ability to understand the study protocol and provide written informed consent Exclusion Criteria: Patient refusal to participate ASA physical status IV or higher BMI ≤ 20 kg/m² or ≥ 35 kg/m² Known hypersensitivity or contraindication to local anesthetics, opioids, or study medications History of chronic pain or regular opioid use Significant psychiatric disorders affecting pain assessment Contraindications to regional anesthesia (e.g., infection at injection site, coagulopathy, pre-existing peripheral neuropathy) Severe respiratory, cardiac, hepatic, or renal disease
Where this trial is running
Cairo, Cairo Governorate
- National Cancer Institute - Cairo University — Cairo, Cairo Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Sayed M Abed, MD — Associate Professor of Anesthesia and Pain Management, National Cancer Institute -- Cairo University
- Study coordinator: Sayed 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.