Clinical trial · Interventional
Regional Anesthesia for Totally Awake Upper Limb Surgery in PEDiatric Population
Regional Anesthesia for Totally Awake Upper Limb Surgery in PEDiatric Population- RAPATED
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anesthesia, Local | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| local anaesthetic injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ropivacaine 35%
- description
- Local Anesthesia with Ropivacaine
- interventionNames
- Drug: local anaesthetic injection
Primary outcomes (1)
- measure
- LRA success
- timeFrame
- 2 hours
- description
- percentage of children in whom ALR and surgery were performed without additional sedation or general anesthesia.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 12 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available