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
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2022
CompletedStudy Start
First participant enrolled
March 25, 2022
CompletedFirst Posted
Study publicly available on registry
April 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedApril 4, 2022
April 1, 2022
5 months
March 24, 2022
April 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Number of participants with vascular puncture
24 hours
Number of participants with dural puncture
24 hours
Number of participants with nerve damage
Month 3
Operator's satisfaction questionnaire
24 hours
Study Arms (1)
Epidural anesthesia using VPC syringe
EXPERIMENTALEpidural anesthesia detection using VPC syringe
Interventions
Use of the visual pressure control syringe for epidural space detection
Eligibility Criteria
You may qualify if:
- children aged from 0 to 16y
- surgical procedure that can benefit from a lumbar or low thoracic epidural anesthesia
You may not qualify if:
- parental refusal
- allergy to local anesthetics
- coagulation disorders
- spine abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Tivoli
La Louvière, Hainaut, 7100, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emmanuel Noel, MD
Centre Hospitalier Universitaire de Tivoli
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy head of anesthesiology department
Study Record Dates
First Submitted
March 24, 2022
First Posted
April 4, 2022
Study Start
March 25, 2022
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
April 4, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share