Abdominal HerniaNCT05308771
To Investigate the Use of a New Syringe "Visual Pressure Control (VPC)" for Epidural Anesthesia in Children Surgery
A study testing VPC syringe in people with Abdominal Hernia and Abdominal Wall Defect, run by Centre Hospitalier Universitaire de Tivoli at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Abdominal Hernia, Abdominal Wall Defect, Abdominal Neoplasm
- What is being tested?
- VPC syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Mar 2022to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged from 0 to 16y
- surgical procedure that can benefit from a lumbar or low thoracic epidural anesthesia
Who cannot join
- parental refusal
- allergy to local anesthetics
- coagulation disorders
- spine abnormalities
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Chu Tivoli
La Louvière, Hainaut, 7100
Emmanuel Noel, MD, +3264277480, enoel@chu-tivoli.ve
Mickael Leclercq, MD, +3264274932, mleclerc@chu-tivoli.be
About this study
Official title: Use of Visual Pressure Control (VPC) Syringes for Epidural Space Identification in Pediatric Anesthesia: a Pilot Study
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.
Read the 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.
- Conditions
- Abdominal Hernia, Abdominal Wall Defect, Abdominal Neoplasm, Urogenital Disease, Urologic Neoplasms, Thoracic Diseases
- Being tested
- VPC syringe
- Medical subject headings
- Hernia, Abdominal, Abdominal Neoplasms, Urogenital Diseases, Urologic Neoplasms, Thoracic Diseases, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPC syringeDevice
Use of the visual pressure control syringe for epidural space detection
| Study group | Role | What they receive |
|---|---|---|
| Epidural anesthesia using VPC syringe | Experimental | Epidural anesthesia detection using VPC syringe Receives: Device: VPC syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (4)
Number of participants with vascular puncture
puncture of a vessel with the epidural needle or catheter
Measured: 24 hours
Number of participants with dural puncture
dura mater breach with needle
Measured: 24 hours
Number of participants with nerve damage
transient of permanent nerve damage
Measured: 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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start25 Mar 2022
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Tivoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmanuel Noel, Centre Hospitalier Universitaire de Tivoli
- Investigators
- Emmanuel Noel, MD, Principal investigator, Centre Hospitalier Universitaire de Tivoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308771
- Sponsor's protocol ID
- VPC 1
- Status last verified
- Apr 2022
- First submitted
- 24 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Visual Pressure Control (VPC) Syringes for Epidural Space Identification in Pediatric Anesthesia: a Pilot Study
- ClinicalTrials.gov ID
- NCT05308771
- Acronym / sponsor ID
- VPC 1
- Conditions
- Abdominal Hernia, Abdominal Wall Defect, Abdominal Neoplasm, Urogenital Disease, Urologic Neoplasms, Thoracic Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de TivoliUniversity, hospital or other
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidural anesthesia using VPC syringe | Experimental | Device: VPC syringeEpidural anesthesia detection using VPC syringe |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children aged from 0 to 16y
- surgical procedure that can benefit from a lumbar or low thoracic epidural anesthesia
Key exclusion criteria (4 listed)
- parental refusal
- allergy to local anesthetics
- coagulation disorders
- spine abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VPC syringeUse of the visual pressure control syringe for epidural space detection | Device | Epidural anesthesia using VPC syringe |
Primary outcome
successful detection of the epidural space
Time frame: 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.
4 secondary outcomes
Number of participants with vascular puncture
Time frame: 24 hours
Number of participants with dural puncture
Time frame: 24 hours
Number of participants with nerve damage
Time frame: Month 3
Operator's satisfaction questionnaire
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Noel, MD principal investigator
Centre Hospitalier Universitaire de Tivoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VPC syringe in people with Abdominal Hernia and Abdominal Wall Defect, run by Centre Hospitalier Universitaire de Tivoli at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel Noel, MD (+3264277480, enoel@chu-tivoli.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful detection of the epidural space (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.