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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural anesthesia using VPC syringe | Experimental | Epidural anesthesia detection using VPC syringe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VPC syringe | Device | Use of the visual pressure control syringe for epidural space detection |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emmanuel Noel, MD | Contact | +3264277480 | enoel@chu-tivoli.be | |
| Mickael Leclercq, MD | Contact | +3264274932 | mleclerc@chu-tivoli.be |
| Name | Affiliation | Role |
|---|---|---|
| Emmanuel Noel, MD | Centre Hospitalier Universitaire de Tivoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Tivoli | Recruiting | La Louvière | Hainaut | 7100 | Belgium |
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| 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 |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D000008 | Abdominal Neoplasms |
| D000091642 | Urogenital Diseases |
| D014571 | Urologic Neoplasms |
| D013896 | Thoracic Diseases |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D052801 | Male Urogenital Diseases |
| D014570 | Urologic Diseases |
| D012140 | Respiratory Tract Diseases |
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