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

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ClinicalTrials.gov Identifier: NCT03672526
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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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.

Condition or disease Intervention/treatment Phase
Locoregional Anesthesia Device: measure of injection pressure by compuflo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Use of Compuflo in Pediatric Anesthesia: Monitoring of Injection Pressure of Local Anesthetics in Children
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : October 8, 2020
Estimated Study Completion Date : October 8, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: device compuflo Device: measure of injection pressure by compuflo
injection pressure mesured by Compuflo


Outcome Measures
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Primary Outcome Measures :
  1. injection pressure (injection pressure measured by Compuflo) [ Time Frame: up to 24 hours (during the ALR) ]
    injection pressure measured by Compuflo


Secondary Outcome Measures :
  1. Pressure values compared to the threshold value used in adults of 15 Psi [ Time Frame: up to 24 hours (during the ALR) ]
    Pressure values compared to the threshold value used in adults of 15 Psi

  2. Pressure values according to the different types of material used [ Time Frame: up to 24 hours (during the ALR) ]
    Pressure values according to the different types of material used

  3. Pressure values in the different infiltrated compartments [ Time Frame: up to 24 hours (during the ALR) ]
    Pressure values in the different infiltrated compartments

  4. Pressure values according to the age of the child [ Time Frame: up to 24 hours (during the ALR) ]
    Pressure values according to the age of the child

  5. Number and ratio of involuntary intra-neural injections [ Time Frame: up to 24 hours (during the ALR) ]
    Number and ratio of involuntary intra-neural injections

  6. Number and ratio of secondary paresthesias [ Time Frame: up to 24 hours (during the ALR) ]
    Number and ratio of secondary paresthesias


Eligibility Criteria
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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672526


Contacts
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Contact: Laurent HERTZ, PD +33 788014415 l-hertz@chu-montpellier.fr

Locations
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France
University Hospital of Montpellier Recruiting
Montpellier, France, 34380
Contact: Laurent HERTZ, PD       l-hertz@chu-montpellier.Fr   
Sponsors and Collaborators
University Hospital, Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03672526    
Other Study ID Numbers: RECHMPL17_0399
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No