Evaluating spinal anesthesia for infants under 3 months
Official title: Efficacy, Safety and Limitations of Spinal Block When Used for All Infants Under 3 Months of Age Scheduled for Lower Abdominal Surgery
Run by Ain Shams University · NCT06871995 · Data updated 2026-11-12
This study is testing if spinal anesthesia is a safe and effective option for infants under 3 months who need lower abdominal surgery, to reduce the risks of using general anesthesia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Day to 3 Months |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | March 2025 |
| Main results expected | June 2025 |
| Study ends | March 2026 |
| Registry record updated | March 12, 2025 |
| Trial ID | NCT06871995 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are infants under 3 months old who are scheduled for elective lower abdominal surgeries and are in good physical health.
✕Probably not a fit
Patients with coagulopathy, those on anticoagulant therapy, or those with infections at the injection site may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study assesses the efficacy, safety, and limitations of spinal anesthesia in infants under 3 months undergoing lower abdominal surgeries at Ain Shams University Hospitals. It involves careful preoperative evaluations, including clinical examinations and laboratory tests, to determine eligibility for spinal anesthesia. The study aims to minimize the risks associated with general anesthesia by using spinal block techniques tailored for this vulnerable age group. Monitoring and supportive measures will be implemented throughout the procedure to ensure patient safety.
Why it matters
Potential benefit: If successful, this approach could provide a safer anesthesia option for infants, reducing the risks associated with general anesthesia.
How similar studies have gone: Previous studies have indicated that spinal anesthesia can be a viable alternative to general anesthesia in pediatric populations, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * Age under 3 months. * Physical status: American Society of Anesthesiologists I - II. * Elective lower abdominal surgeries such as: hernia, hydrocele, undescended testis Exclusion Criteria: * Patient's parents or legal guardian refusing to do this specific procedure. * Coagulopathy, use of anti-coagulant or antiplatelet therapy. * Infection at the site of injection.
Where it's running
-
Faculty of Medicine Ain Shams University
Cairo, Egypt Recruiting
Study contacts
- Study coordinator: ahmed ma Elewa mohamed, M.S.C
- Email: AhmedElfax@med.asu.edu.eg
- Phone: +201028143995
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.