An interventional study of VPC syringe in Abdominal Hernia, Abdominal Wall Defect and Abdominal Neoplasm, sponsored by Centre Hospitalier Universitaire de Tivoli. Status unknown at 1 site in Belgium. Open to participants aged Up to 16 Years. Per ClinicalTrials.gov, last updated 2022-04-04.
Sponsored by Centre Hospitalier Universitaire de Tivoli · Not applicable, Interventional, and Supportive care
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.
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.
82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.
This study's planned enrollment of 15 is below the median of 90 across 48 interventional studies indexed under Hernia, Abdominal.
Browse Hernia, Abdominal studies →Centre Hospitalier Universitaire de Tivoli is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Epidural anesthesia detection using VPC syringe
Device: VPC syringe
Use of the visual pressure control syringe for epidural space detection
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.
Time frame: 24 hours
Number of participants with vascular puncture
puncture of a vessel with the epidural needle or catheter
Time frame: 24 hours
Number of participants with dural puncture
dura mater breach with needle
Time frame: 24 hours
Number of participants with nerve damage
transient of permanent nerve damage
Time frame: 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
Time frame: 24 hours
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Tivoli