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Completed
NCT04846855
Regional Anesthesia for Totally Awake Upper Limb Surgery in PEDiatric Population
Conditions: Surgery, Anesthesia, Local, Pediatric ALL
Sex: All
Ages: 6 Years – 12 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 100
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Location: Hôpital Privé Claude Galien Quincy-sous-Sénart IDF
Summary
Peripheral loco-regional anesthesia (LRA) for anesthetic purposes is a technique widely used in adults for upper limb surgery. In pediatrics, LRA is not classically considered on its own. It is usually performed for analgesic purposes during sedation or general anesthesia. It is entirely possible to carry out awakened peripheral blocks in communicating children, of school age, thus avoiding the issues of GA in pediatrics, in particular in an emergency context. The use of Emla anesthetic skin patches for punctures (perfusion and LRA) as well as the viewing of cartoons on touch tablets during treatment can improve the perception of painless care such as LRA and treatment.
In pediatrics, only ropivacaine at a concentration of 0.2% has Marketing Authorization in pediatrics in children under 12 for the production of peripheral blocks. On the basis of the experience of the Claude Galien Private Hospital in this area, it seems interesting to assess the feasibility of upper limb surgery under anesthetic LRA alone with a dose of ropivacaine at the concentration 0.35% in communicating children, of school age.
Eligibility Criteria
Inclusion Criteria:
* Child aged 6 to 12.
* Able to understand and express themselves.
* Intended for orthopedic surgery of the upper limb involving the hand, wrist, forearm or elbow.
* ASA class 1-2.
* Patient who has given free and informed consent.
* Parent present having given their free and informed consent.
* Affiliated patient or beneficiary of a social security scheme
Exclusion Criteria:
* Refusal of the child and / or parent to participate in the study.
* Immediate vital emergency.
* Duration of planned surgery\> 1h30.
* History of allergy to LA.
* Contraindication to carrying out ALR (local infection, pathology contraindicating ALR, preoperative neurological deficit).
* Refusal by the surgeon.
* Child already sedated or premedicated in the emergency room.
* Digital tablet not available.
* Patient participating in another clinical study.
Source: ClinicalTrials.gov (NCT04846855). StuddyBuddy aggregates publicly available trial information.