To Investigate the Use of a New Syringe "Visual Pressure Control (VPC)" for Epidural Anesthesia in Children Surgery

Not Applicable

• Conditions: Lung Diseases; Abdominal Wall Defect; Thoracic Diseases; Urogenital Disease; Urologic Neoplasms; Abdominal Hernia; Abdominal Neoplasm
• Interventions: Device: VPC syringe

• Registration Number: NCT05308771
• Lead Sponsor: Centre Hospitalier Universitaire de Tivoli

Brief Summary

Pediatric epidural anesthesia has emerged as a safe and effective regional anesthesia technique for providing intraoperative and postoperative analgesia in thoracic and abdominal surgery. The loss of resistance technique is the gold standard for the placement of the epidural.

The VPC (visual pressure control) syringes developed by PAJUNK enable direct visualization of the introduction of the needle into the epidural space.

Detailed Description

This trial is a non blinded, pilot study. A minimum of 15 children between the ages of 0 and 16 who require surgery that may benefit from epidural anesthesia will be enrolled.

The number of attempts, the complications (dural and vascular punctures, neurological complications) and the degree of satisfaction of the operator measured by a 7-point likert scale will be studied as secondary objectives.

Study Timeline

• Study First Submitted: 2022-03-24
• Study Start: 2022-03-25
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-01
• Last Update Submitted: 2022-04-01
• Study First Posted: 2022-04-04
• Last Update Posted: 2022-04-04
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• children aged from 0 to 16y
• surgical procedure that can benefit from a lumbar or low thoracic epidural anesthesia

Exclusion Criteria

• parental refusal
• allergy to local anesthetics
• coagulation disorders
• spine abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epidural anesthesia using VPC syringe	VPC syringe	Epidural anesthesia detection using VPC syringe

Primary Outcome Measures

Name	Time	Method
successful detection of the epidural space	24 hours	The primary objective will be successful detection of the epidural space by visualization of dural displacement upon injection of local anesthetic with real-time ultrasound and/or absence of pain at the incision established by the absence of more than 10% elevation in heart rate.

Secondary Outcome Measures

Name	Time	Method
Number of participants with vascular puncture	24 hours	puncture of a vessel with the epidural needle or catheter
Number of participants with dural puncture	24 hours	dura mater breach with needle
Number of participants with nerve damage	Month 3	transient of permanent nerve damage
Operator's satisfaction questionnaire	24 hours	study of the operator's satisfaction by a seven-point rating scale where 1 is extremely dissatisfied and 7 is extremely satisfied

Trial Locations

Locations (1)

Chu Tivoli; 🇧🇪 La Louvière, Hainaut, Belgium