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

Centre Hospitalier Universitaire de Tivoli

Status: Unknown

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

Treatments: Device: VPC syringe

Study type: Interventional

Funder types: Other

Identifiers

NCT05308771

VPC 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Epidural anesthesia using VPC syringe

Experimental group

Description:

Epidural anesthesia detection using VPC syringe

Treatment:

Device: VPC syringe