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Clinical Trials in Egypt / NCT06871995
Recruiting Not applicable

Efficacy, Safety and Limitations of Spinal Block for All Infants Under 3 Months

NCT06871995 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-03
Last updated
2025-03-12

Condition(s) studied

Anesthesia

Investigational drug(s) / intervention(s)

spinal block

spinal block: All patients will receive spinal anesthesia via midline approach with patients in sitting position established by assistant under complete aseptic conditions. A subcutaneous bleb using Lidocaine 1% through the needle of an insulin syringe followed by minor skin scratch to will help avoiding possible intrathecal dermoid implantation . A lumbar puncture will be performed in L4-L5 or L5- S1 interspace using 25-G 25-mm pencil-point spinal needle . Depth of epidural space is anticipated at 0.1 mm/kg . After getting free flow of cerebrospinal fluid (CSF) hyperbaric bupivacaine (0.5%) in a dose of 0.5 mg/kg (0.1 ml/kg) will be slowly injected in the subarachnoid space . The end of the injection will be taken as time zero for further data recording.

Study summary

Spinal anesthesia (SA) has been shown to be a viable alternative to general anesthesia (GA) for infants and children for a variety of surgical procedures. SA serves to avoid some of the potential risks of GA including the need for airway manipulation, hemodynamic instability, postoperative apnea, and exposure to medications that may cause neurotoxicity .SA allows the prevention and reduction of perioperative complications even if its duration is an important limiting factor. Because of this limitation, short surgery is the most indicated under SA . Premature infants and neurologically impaired children account for the majority of spinal anesthetics used today .

This study evaluates the effectiveness, safety and limitations of spinal anesthesia when used for all infants under 3 months undergoing lower abdominal surgery at Ain Shams University Hospitals.

Eligibility

Sex
ALL
Min age
1 Day
Max age
3 Months
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Faculty of Medicine Ain Shams University Cairo Egypt Recruiting

More Ain Shams University trials in Egypt

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06871995 on ClinicalTrials.gov ↗ ← All trials in Egypt