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

NCT06871995 | Recruiting

• 1 other identifier: FMASU MD234/2024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• the success rate of spinal block in abdominal surgeries in infants under 3 months of age.

  Success rate = (no of total patients - no of all converted general anesthesia patients) divided by no of total cases%.

  during the surgery

Secondary Outcomes (5)

• Duration of spinal block in minutes

  during the surgery

• Number of attempts

  during the surgery

• Depth of insertion of the spinal needle

  during the surgery

• Blood glucose level

  every 30 minutes till end of surgery

• Determine the incidence of complications

  after spinal block to end of surgery

Study Arms (1)

one arm All Infants Under 3 Months of Age receiving Spinal Block

EXPERIMENTAL

All Infants Under 3 Months of Age Scheduled for Lower Abdominal Surgery

Procedure: spinal block

Interventions

spinal block PROCEDURE

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.

one arm All Infants Under 3 Months of Age receiving Spinal Block

Eligibility Criteria

• Age: 1 Day - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age under 3 months.
• Physical status: American Society of Anesthesiologists I - II.
• Elective lower abdominal surgeries such as: hernia, hydrocele, undescended testis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• hany mo Elzahaby, prof

  Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

ahmed ma Elewa mohamed, M.S.C

CONTACT

+201028143995; AhmedElfax@med.asu.edu.eg

tarek Sa Shabana, MD

CONTACT

01001594109; Tarek.shabana@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: spinal block in infants less than 3 months of age undergoing lower abdominal surgery

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 12, 2025
• Study Start: March 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-01

Locations

EG (1)