Abdominal Hernia, Abdominal Neoplasm, Abdominal Wall Defect, Lung Diseases, Thoracic Diseases, Urogenital Disease, Urologic Neoplasms
Conditions
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.
Interventions
DEVICEVPC syringe
Use of the visual pressure control syringe for epidural space detection
Sponsors
Centre Hospitalier Universitaire de Tivoli
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with vascular puncture | 24 hours | puncture of a vessel with the epidural needle or catheter |
| Number of participants with dural puncture | 24 hours | dura mater breach with needle |
| Number of participants with nerve damage | Month 3 | transient of permanent nerve damage |
| 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 |
Countries
Belgium
Contacts
Primary ContactEmmanuel Noel, MD
Backup ContactMickael Leclercq, MD
Outcome results
None listed