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

NCT ID: NCT05308771

Last Updated: 2022-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-25

Study Completion Date

2022-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Abdominal Hernia Abdominal Wall Defect Abdominal Neoplasm Urogenital Disease Urologic Neoplasms Thoracic Diseases Lung Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Epidural anesthesia using VPC syringe

Epidural anesthesia detection using VPC syringe

Group Type EXPERIMENTAL

VPC syringe

Intervention Type DEVICE

Use of the visual pressure control syringe for epidural space detection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VPC syringe

Use of the visual pressure control syringe for epidural space detection

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Tivoli

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Emmanuel Noel

Deputy head of anesthesiology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emmanuel Noel, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Tivoli

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chu Tivoli

La Louvière, Hainaut, Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Emmanuel Noel, MD

Role: CONTACT

+3264277480

Mickael Leclercq, MD

Role: CONTACT

+3264274932

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Emmanuel Noel, MD

Role: primary

+3264277480

Mickael Leclercq, MD

Role: backup

+3264274932

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VPC 1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Antiseptic-coated Intermittent Urinary Catheter
NCT02697162 WITHDRAWN PHASE2/PHASE3