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RECRUITING
NCT06871995
NA

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

Sponsor: Ain Shams University

View on ClinicalTrials.gov

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.

Official title: Efficacy, Safety and Limitations of Spinal Block When Used for All Infants Under 3 Months of Age Scheduled for Lower Abdominal Surgery

Key Details

Gender

All

Age Range

1 Day - 3 Months

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-03

Completion Date

2026-03

Last Updated

2025-03-12

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

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.

Locations (1)

Faculty of Medicine Ain Shams University

Cairo, Egypt