Monitoring of Injection Pressure During Regional Anesthesia in Pediatric Patient

NCT03672526 | Terminated

• 1 other identifier: RECHMPL17_0399
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locoregional Anesthesia

Outcome Measures

Primary Outcomes (1)

• injection pressure (injection pressure measured by Compuflo)

  injection pressure measured by Compuflo

  up to 24 hours (during the ALR)

Secondary Outcomes (6)

• 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

  up to 24 hours (during the ALR)

• Pressure values in the different infiltrated compartments

  up to 24 hours (during the ALR)

• Pressure values according to the age of the child

  up to 24 hours (during the ALR)

• Number and ratio of involuntary intra-neural injections

  up to 24 hours (during the ALR)

Study Arms (1)

device compuflo

EXPERIMENTAL

Device: measure of injection pressure by compuflo

Interventions

measure of injection pressure by compuflo DEVICE

injection pressure mesured by Compuflo

device compuflo

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34380, France

Location

Related Publications (1)

• Hertz L, Sola C, Pico J, Aros J, Scott C, Pirat P, Choquet O, Bringuier S, Dadure C. Objective real-time epidural pressure measurement using the CompuFlo(R) device, a mono-center observational study. Anaesth Crit Care Pain Med. 2025 Aug;44(4):101530. doi: 10.1016/j.accpm.2025.101530. Epub 2025 May 1.

  PMID: 40318853 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 14, 2018
• Study Start: October 8, 2018
• Primary Completion: January 24, 2020
• Study Completion: January 24, 2020
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

FR (1)