Monitoring of Injection Pressure During Regional Anesthesia in Pediatric Patient
- Conditions
- Locoregional Anesthesia
- Interventions
- Device: measure of injection pressure by compuflo
- Registration Number
- NCT03672526
- Lead Sponsor
- University Hospital, Montpellier
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 105
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description device compuflo measure of injection pressure by compuflo -
- Primary Outcome Measures
Name Time Method injection pressure (injection pressure measured by Compuflo) up to 24 hours (during the ALR) injection pressure measured by Compuflo
- Secondary Outcome Measures
Name Time Method Pressure values compared to the threshold value used in adults of 15 Psi up to 24 hours (during the ALR) Pressure values compared to the threshold value used in adults of 15 Psi
Number and ratio of secondary paresthesias up to 24 hours (during the ALR) Number and ratio of secondary paresthesias
Pressure values in the different infiltrated compartments up to 24 hours (during the ALR) Pressure values in the different infiltrated compartments
Pressure values according to the different types of material used up to 24 hours (during the ALR) Pressure values according to the different types of material used
Pressure values according to the age of the child up to 24 hours (during the ALR) Pressure values according to the age of the child
Number and ratio of involuntary intra-neural injections up to 24 hours (during the ALR) Number and ratio of involuntary intra-neural injections
Trial Locations
- Locations (1)
University Hospital of Montpellier
🇫🇷Montpellier, France