To Investigate the Use of a New Syringe "Visual Pressure Control (VPC)" for Epidural Anesthesia in Children Surgery
Primary Purpose
Abdominal Hernia, Abdominal Wall Defect, Abdominal Neoplasm
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
VPC syringe
Sponsored by
About this trial
This is an interventional supportive care trial for Abdominal Hernia
Eligibility Criteria
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
Sites / Locations
- Chu TivoliRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epidural anesthesia using VPC syringe
Arm Description
Epidural anesthesia detection using VPC syringe
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of participants with vascular puncture
puncture of a vessel with the epidural needle or catheter
Number of participants with dural puncture
dura mater breach with needle
Number of participants with nerve damage
transient of permanent nerve damage
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
Full Information
NCT ID
NCT05308771
First Posted
March 24, 2022
Last Updated
April 1, 2022
Sponsor
Centre Hospitalier Universitaire de Tivoli
1. Study Identification
Unique Protocol Identification Number
NCT05308771
Brief Title
To Investigate the Use of a New Syringe "Visual Pressure Control (VPC)" for Epidural Anesthesia in Children Surgery
Official Title
Use of Visual Pressure Control (VPC) Syringes for Epidural Space Identification in Pediatric Anesthesia: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2022 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire de Tivoli
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Hernia, Abdominal Wall Defect, Abdominal Neoplasm, Urogenital Disease, Urologic Neoplasms, Thoracic Diseases, Lung Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epidural anesthesia using VPC syringe
Arm Type
Experimental
Arm Description
Epidural anesthesia detection using VPC syringe
Intervention Type
Device
Intervention Name(s)
VPC syringe
Intervention Description
Use of the visual pressure control syringe for epidural space detection
Primary Outcome Measure Information:
Title
successful detection of the epidural space
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Number of participants with vascular puncture
Description
puncture of a vessel with the epidural needle or catheter
Time Frame
24 hours
Title
Number of participants with dural puncture
Description
dura mater breach with needle
Time Frame
24 hours
Title
Number of participants with nerve damage
Description
transient of permanent nerve damage
Time Frame
Month 3
Title
Operator's satisfaction questionnaire
Description
study of the operator's satisfaction by a seven-point rating scale where 1 is extremely dissatisfied and 7 is extremely satisfied
Time Frame
24 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel Noel, MD
Phone
+3264277480
Email
enoel@chu-tivoli.be
First Name & Middle Initial & Last Name or Official Title & Degree
Mickael Leclercq, MD
Phone
+3264274932
Email
mleclerc@chu-tivoli.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Noel, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Tivoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Tivoli
City
La Louvière
State/Province
Hainaut
ZIP/Postal Code
7100
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel Noel, MD
Phone
+3264277480
Email
enoel@chu-tivoli.ve
First Name & Middle Initial & Last Name & Degree
Mickael Leclercq, MD
Phone
+3264274932
Email
mleclerc@chu-tivoli.be
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Investigate the Use of a New Syringe "Visual Pressure Control (VPC)" for Epidural Anesthesia in Children Surgery
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