Locoregional Anesthesia Clinical Trial
— COMPUFLOOfficial title:
Use of Compuflo in Pediatric Anesthesia: Monitoring of Injection Pressure of Local Anesthetics in Children
Verified date | November 2022 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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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