Locoregional AnesthesiaCOMPUFLONCT03672526
Monitoring of Injection Pressure During Regional Anesthesia in Pediatric Patient
A study testing measure of injection pressure by compuflo in people with Locoregional Anesthesia, run by University Hospital, Montpellier at 1 site in France.
Trial summary
A low injection pressure is one of the safety elements to check the correct position of the needle during regional anesthesia. Subjective assessment of pressure during manual injection of local anesthetic is most commonly used. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Locoregional Anesthesia
- What is being tested?
- measure of injection pressure by compuflo
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 8 Oct 2018to 24 Jan 2020
- 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
- Minor patient (0-16 years old) with consent of the major legal representative
- Affiliated to the social security
- Informed written consent, notification on the anesthesia sheet
Who cannot join
- Patient over 16 years old
- Patient under tutorship / curatorship
- Young girl with known or suspected ongoing pregnancy
- Known allergy to local anesthetics
- Hemostatic disorder
- Local infection at the puncture site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Compuflo in Pediatric Anesthesia: Monitoring of Injection Pressure of Local Anesthetics in Children
A low injection pressure is one of the safety elements to check the correct position of the needle during regional anesthesia. Subjective assessment of pressure during manual injection of local anesthetic is most commonly used. In adults, the monitoring of the injection pressure has already been evaluated and makes it possible to objectify the pressure of the injection pressure. This is possible thanks to a device named Compuflo. No study has measured injection pressures during a regional anesthesia in children. The main objective is to control the injection pressures exercised in daily clinical practice during pediatric regional anesthesia with the Compuflo. Regional anesthesia will be proposed and explained during the anesthesia consultation. The procedure will be performed according to the habits of the anesthesiologist in charge of the patient. Only the addition of the Local Anesthetic Injection Pressure monitoring (Compuflo) to the needle changes the usual setup.
Read the detailed description
The purpose of this study is to evaluate the usual practice using Compuflo, allowing the continuous measurement of the injection pressure of the local anesthetic at the needle level. On the day of the surgery, an anesthesiologist "operator" will realize the echo-guided regional anesthesia, qualifying aloud every injection realized (site or compartment of injection, and volume injected). An "observer" anesthesiologist will note the demographic data (age and weight), then the material data (minimum stimulation intensity, type and size of needles and syringes used), and finally he will note the maximum pressure levels reached during the injections performed.
- Conditions
- Locoregional Anesthesia
- Being tested
- measure of injection pressure by compuflo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measure of injection pressure by compufloDevice
injection pressure mesured by Compuflo
| Study group | Role | What they receive |
|---|---|---|
| device compuflo | Experimental | Not described Receives: Device: measure of injection pressure by compuflo |
What is being measured
The primary outcome is the main question the study is designed to answer.
injection pressure (injection pressure measured by Compuflo)
injection pressure measured by Compuflo
Measured: up to 24 hours (during the ALR)
Secondary outcomes (6)
Pressure values compared to the threshold value used in adults of 15 Psi
Pressure values compared to the threshold value used in adults of 15 Psi
Measured: up to 24 hours (during the ALR)
Pressure values according to the different types of material used
Pressure values according to the different types of material used
Measured: up to 24 hours (during the ALR)
Pressure values in the different infiltrated compartments
Pressure values in the different infiltrated compartments
Measured: up to 24 hours (during the ALR)
Pressure values according to the age of the child
Pressure values according to the age of the child
Measured: up to 24 hours (during the ALR)
Number and ratio of involuntary intra-neural injections
Number and ratio of involuntary intra-neural injections
Measured: up to 24 hours (during the ALR)
Number and ratio of secondary paresthesias
Number and ratio of secondary paresthesias
Measured: up to 24 hours (during the ALR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start8 Oct 2018
- Primary completion24 Jan 2020
- Study completion24 Jan 2020
Why it stopped: decision of the principal investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Locoregional AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672526
- Sponsor's protocol ID
- RECHMPL17_0399
- Acronym
- COMPUFLO
- Status last verified
- Nov 2022
- First submitted
- 11 Sep 2018
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hertz L, Sola C, Pico J, Scott C, Choquet O, Pirat P, Saour AC, Bringuier S, Dadure C. Objective Real-Time Peripheral Regional Anesthesia Pressure Measurement in Children Using the CompuFlo Device, a Mono-Center Observational Study. Paediatr Anaesth. 2026 Apr;36(4):412-420. doi: 10.1002/pan.70113. Epub 2026 Jan 14.
PubMed 41532315Hertz L, Sola C, Pico J, Aros J, Scott C, Pirat P, Choquet O, Bringuier S, Dadure C. Objective real-time epidural pressure measurement using the CompuFlo(R) device, a mono-center observational study. Anaesth Crit Care Pain Med. 2025 Aug;44(4):101530. doi: 10.1016/j.accpm.2025.101530. Epub 2025 May 1.
PubMed 40318853
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Compuflo in Pediatric Anesthesia: Monitoring of Injection Pressure of Local Anesthetics in Children
- ClinicalTrials.gov ID
- NCT03672526
- Acronym / sponsor ID
- COMPUFLO / RECHMPL17_0399
- Conditions
- Locoregional Anesthesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: decision of the principal investigator
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 14 Sep 2018 (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.
A low injection pressure is one of the safety elements to check the correct position of the needle during regional anesthesia. Subjective assessment of pressure during manual injection of local anesthetic is most commonly used. In adults, the monitoring of the injection pressure has already been evaluated and makes it possible to objectify the pressure of the injection pressure. This is possible thanks to a device named Compuflo. No study has measured injection pressures during a regional anesthesia in children. The main objective is to control the injection pressures exercised in daily clinical practice during pediatric regional anesthesia with the Compuflo. Regional anesthesia will be proposed and explained during the anesthesia consultation. The procedure will be performed according to the habits of the anesthesiologist in charge of the patient. Only the addition of the Local Anesthetic Injection Pressure monitoring (Compuflo) to the needle changes the usual setup.
Detailed description
The purpose of this study is to evaluate the usual practice using Compuflo, allowing the continuous measurement of the injection pressure of the local anesthetic at the needle level. On the day of the surgery, an anesthesiologist "operator" will realize the echo-guided regional anesthesia, qualifying aloud every injection realized (site or compartment of injection, and volume injected). An "observer" anesthesiologist will note the demographic data (age and weight), then the material data (minimum stimulation intensity, type and size of needles and syringes used), and finally he will note the maximum pressure levels reached during the injections performed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| device compuflo | Experimental | Device: measure of injection pressure by compuflo |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Minor patient (0-16 years old) with consent of the major legal representative
- Affiliated to the social security
- Informed written consent, notification on the anesthesia sheet
Key exclusion criteria (6 listed)
- Patient over 16 years old
- Patient under tutorship / curatorship
- Young girl with known or suspected ongoing pregnancy
- Known allergy to local anesthetics
- Hemostatic disorder
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 |
|---|---|---|
| measure of injection pressure by compufloinjection pressure mesured by Compuflo | Device | device compuflo |
Primary outcome
injection pressure (injection pressure measured by Compuflo)
Time frame: up to 24 hours (during the ALR)
injection pressure measured by Compuflo
6 secondary outcomes
Pressure values compared to the threshold value used in adults of 15 Psi
Time frame: up to 24 hours (during the ALR)
Pressure values according to the different types of material used
Time frame: up to 24 hours (during the ALR)
Pressure values in the different infiltrated compartments
Time frame: up to 24 hours (during the ALR)
Pressure values according to the age of the child
Time frame: up to 24 hours (during the ALR)
Number and ratio of involuntary intra-neural injections
Time frame: up to 24 hours (during the ALR)
Number and ratio of secondary paresthesias
Time frame: up to 24 hours (during the ALR)
Results and safety
The study was stopped early (reason given: decision of the principal investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Derived from this study: PubMed 41532315Hertz L, Sola C, Pico J, Scott C, Choquet O, Pirat P, Saour AC, Bringuier S, Dadure C. Objective Real-Time Peripheral Regional Anesthesia Pressure Measurement in Children Using the CompuFlo Device, a Mono-Center Observational Study. Paediatr Anaesth. 2026 Apr;36(4):412-420. doi: 10.1002/pan.70113. Epub 2026 Jan 14.
- Derived from this study: PubMed 40318853Hertz L, Sola C, Pico J, Aros J, Scott C, Pirat P, Choquet O, Bringuier S, Dadure C. Objective real-time epidural pressure measurement using the CompuFlo(R) device, a mono-center observational study. Anaesth Crit Care Pain Med. 2025 Aug;44(4):101530. doi: 10.1016/j.accpm.2025.101530. Epub 2025 May 1.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measure of injection pressure by compuflo in people with Locoregional Anesthesia, run by University Hospital, Montpellier at 1 site in France.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 Nov 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 France. 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?
The study was stopped early (reason given: decision of the principal investigator). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
injection pressure (injection pressure measured by Compuflo) (time frame: up to 24 hours (during the ALR)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03672526, which also lists 2 linked publications.
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 10 Nov 2022.