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

Use of Visual Pressure Control (VPC) Syringes for Epidural Space Identification in Pediatric Anesthesia: a Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Diseases; Urologic Neoplasms; Abdominal Hernia; Abdominal Wall Defect; Abdominal Neoplasm; Urogenital Disease; Thoracic Diseases
• Intervention / Treatment: Device: VPC syringe

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emmanuel Noel, MD; Phone Number: +3264277480; Email: enoel@chu-tivoli.be
• Study Contact Backup: Name: Mickael Leclercq, MD; Phone Number: +3264274932; Email: mleclerc@chu-tivoli.be

Study Locations

• Belgium
  • Hainaut
    • La Louvière, Hainaut, Belgium, 7100
      • Recruiting
      • Chu Tivoli
      • Contact: Mickael Leclercq, MD; Phone Number: +3264274932; Email: mleclerc@chu-tivoli.be
      • Contact: Emmanuel Noel, MD; Phone Number: +3264277480; Email: enoel@chu-tivoli.ve

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epidural anesthesia using VPC syringe; Epidural anesthesia detection using VPC syringe	Device: VPC syringe; Use of the visual pressure control syringe for epidural space detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
successful detection of the epidural space	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.	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Tivoli

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Urogenital Neoplasms; Neoplasms by Site; Pathological Conditions, Anatomical; Hernia; Neoplasms; Lung Diseases; Urologic Neoplasms; Abdominal Neoplasms; Thoracic Diseases; Hernia, Abdominal; Internal Hernia
• Other Study ID Numbers: VPC 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No