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

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

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.

Study Overview

• Status: Terminated
• Conditions: Locoregional Anesthesia
• Intervention / Treatment: Device: measure of injection pressure by compuflo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34380
    • University Hospital of Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: device compuflo	Device: measure of injection pressure by compuflo; injection pressure mesured by Compuflo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
injection pressure (injection pressure measured by Compuflo)	injection pressure measured by Compuflo	up to 24 hours (during the ALR)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Pressure values in the different infiltrated compartments	Pressure values in the different infiltrated compartments	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	up to 24 hours (during the ALR)
Number and ratio of involuntary intra-neural injections	Number and ratio of involuntary intra-neural injections	up to 24 hours (during the ALR)
Number and ratio of secondary paresthesias	Number and ratio of secondary paresthesias	up to 24 hours (during the ALR)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Actual): January 24, 2020
• Study Completion (Actual): January 24, 2020

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: RECHMPL17_0399

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No