Monitoring of Injection Pressure During Regional Anesthesia in Pediatric Patient

Locoregional Anesthesia Clinical Trial

— COMPUFLO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03672526
• Other study ID #: RECHMPL17_0399
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Locoregional Anesthesia

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)