NCT05308771

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Tivoli · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	VPC syringe	Use of the visual pressure control syringe for epidural space detection

Timeline

• Start date: 2022-03-25
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2022-04-04
• Last updated: 2022-04-04

Locations

1 site across 1 country: Belgium