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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03672526
Other study ID # RECHMPL17_0399
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 8, 2018
Est. completion date January 24, 2020

Study information

Verified date November 2022
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 105
Est. completion date January 24, 2020
Est. primary completion date January 24, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 16 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
measure of injection pressure by compuflo
injection pressure mesured by Compuflo

Locations

Country Name City State
France University Hospital of Montpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary injection pressure (injection pressure measured by Compuflo) injection pressure measured by Compuflo up to 24 hours (during the ALR)
Secondary 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 up to 24 hours (during the ALR)
Secondary Pressure values according to the different types of material used Pressure values according to the different types of material used up to 24 hours (during the ALR)
Secondary Pressure values in the different infiltrated compartments Pressure values in the different infiltrated compartments up to 24 hours (during the ALR)
Secondary Pressure values according to the age of the child Pressure values according to the age of the child up to 24 hours (during the ALR)
Secondary Number and ratio of involuntary intra-neural injections Number and ratio of involuntary intra-neural injections up to 24 hours (during the ALR)
Secondary Number and ratio of secondary paresthesias Number and ratio of secondary paresthesias up to 24 hours (during the ALR)
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