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Monitoring of Injection Pressure During Regional Anesthesia in Pediatric Patient

Use of Compuflo in Pediatric Anesthesia: Monitoring of Injection Pressure of Local Anesthetics in Children

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03672526
Acronym
COMPUFLO
Enrollment
105
Registered
2018-09-14
Start date
2018-10-08
Completion date
2020-01-24
Last updated
2022-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locoregional Anesthesia

Brief 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. 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.

Interventions

DEVICEmeasure of injection pressure by compuflo

injection pressure mesured by Compuflo

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
injection pressure (injection pressure measured by Compuflo)up to 24 hours (during the ALR)injection pressure measured by Compuflo

Secondary

MeasureTime frameDescription
Pressure values according to the different types of material usedup to 24 hours (during the ALR)Pressure values according to the different types of material used
Pressure values in the different infiltrated compartmentsup to 24 hours (during the ALR)Pressure values in the different infiltrated compartments
Pressure values compared to the threshold value used in adults of 15 Psiup to 24 hours (during the ALR)Pressure values compared to the threshold value used in adults of 15 Psi
Number and ratio of involuntary intra-neural injectionsup to 24 hours (during the ALR)Number and ratio of involuntary intra-neural injections
Number and ratio of secondary paresthesiasup to 24 hours (during the ALR)Number and ratio of secondary paresthesias
Pressure values according to the age of the childup to 24 hours (during the ALR)Pressure values according to the age of the child

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026