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

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05308771
• Other study ID #: VPC 1
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2022
• Est. completion date: September 2022

Study information

• Verified date: April 2022
• Source: Centre Hospitalier Universitaire de Tivoli
• Contact: Emmanuel Noel, MD
• Phone: +3264277480
• Email: enoel[@]chu-tivoli.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• VPC syringe
Use of the visual pressure control syringe for epidural space detection

Locations

Country	Name	City	State
Belgium	Chu Tivoli	La Louvière	Hainaut

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Tivoli

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with vascular puncture	puncture of a vessel with the epidural needle or catheter	24 hours
Secondary	Number of participants with dural puncture	dura mater breach with needle	24 hours
Secondary	Number of participants with nerve damage	transient of permanent nerve damage	Month 3
Secondary	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