An interventional study of measure of injection pressure by compuflo in Locoregional Anesthesia, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged Up to 16 Years. Per ClinicalTrials.gov, last updated 2022-11-10.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other
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.
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.
University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: measure of injection pressure by compuflo
injection pressure mesured by Compuflo
injection pressure (injection pressure measured by Compuflo)
injection pressure measured by Compuflo
Time frame: up to 24 hours (during the ALR)
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
Time frame: 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
Time frame: up to 24 hours (during the ALR)
Pressure values in the different infiltrated compartments
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
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
Number and ratio of involuntary intra-neural injections
Time frame: up to 24 hours (during the ALR)
Number and ratio of secondary paresthesias
Number and ratio of secondary paresthesias
Time frame: up to 24 hours (during the ALR)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier