Evaluating spinal anesthesia for infants under 3 months
Efficacy, Safety and Limitations of Spinal Block When Used for All Infants Under 3 Months of Age Scheduled for Lower Abdominal Surgery
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 1 Day to 3 Months |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06871995 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are infants under 3 months old who are scheduled for elective lower abdominal surgeries and are in good physical health.
Not a fit: Patients with coagulopathy, those on anticoagulant therapy, or those with infections at the injection site may not benefit from this study.
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 performed: Previous studies have indicated that spinal anesthesia can be a viable alternative to general anesthesia in pediatric populations, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Cairo
- 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
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.