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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: VPC syringe


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidural anesthesia using VPC syringe<br>Epidural anesthesia detection using VPC syringe | Device: VPC syringe<br>* Use of the visual pressure control syringe for epidural space detection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with vascular puncture | puncture of a vessel with the epidural needle or catheter | 24 hours | 
| Number of participants with dural puncture | dura mater breach with needle | 24 hours | 
| Number of participants with nerve damage | transient of permanent nerve damage | Month 3 | 
| 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 |