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

• Sponsor: Centre Hospitalier Universitaire de Tivoli (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05308771
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 5.3
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Hernia; Abdominal Wall Defect; Abdominal Neoplasm; Urogenital Disease; Urologic Neoplasms; Thoracic Diseases; Lung Diseases	Device: VPC syringe	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Use of Visual Pressure Control (VPC) Syringes for Epidural Space Identification in Pediatric Anesthesia: a Pilot Study
• Actual Study Start Date: Mar 25, 2022
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. successful detection of the epidural space [24 hours]

   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.

Secondary Outcome Measures

1. Number of participants with vascular puncture [24 hours]

   puncture of a vessel with the epidural needle or catheter

2. Number of participants with dural puncture [24 hours]

   dura mater breach with needle

3. Number of participants with nerve damage [Month 3]

   transient of permanent nerve damage

4. Operator's satisfaction questionnaire [24 hours]

   study of the operator's satisfaction by a seven-point rating scale where 1 is extremely dissatisfied and 7 is extremely satisfied

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Tivoli	La Louvière	Hainaut	Belgium	7100

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Tivoli

Investigators

• Principal Investigator: Emmanuel Noel, MD, CHU TIVOLI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emmanuel Noel, Deputy head of anesthesiology department, Centre Hospitalier Universitaire de Tivoli
• ClinicalTrials.gov Identifier: NCT05308771
• Other Study ID Numbers: VPC 1
• First Posted: Apr 4, 2022
• Last Update Posted: Apr 4, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Neoplasms; Urologic Neoplasms; Abdominal Neoplasms; Lung Diseases; Thoracic Diseases; Hernia, Abdominal; Internal Hernia

Study Results

No Results Posted as of Apr 4, 2022