MedTrace Logo

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

NCT06871995 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-03-12

No results posted yet for this 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.

Conditions

  • Anesthesia

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • hany mo Elzahaby, prof · Ain Shams University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2025-06-30
Completion
2026-03-31

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06871995 on ClinicalTrials.gov