Monitoring of Injection Pressure During Regional Anesthesia in Pediatric Patient (COMPUFLO)

University Hospital Center (CHU)

Status: Terminated

Conditions: Locoregional Anesthesia

Treatments: Device: measure of injection pressure by compuflo

Study type: Interventional

Funder types: Other

Identifiers

NCT03672526

RECHMPL17_0399

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

device compuflo

Experimental group

Treatment:

Device: measure of injection pressure by compuflo