Regional Anesthesia for Totally Awake Upper Limb Surgery in PEDiatric Population (NCT04846855) | Clinical Trial Compass
CompletedPhase 4
Regional Anesthesia for Totally Awake Upper Limb Surgery in PEDiatric Population
France100 participantsStarted 2020-10-14
Plain-language 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.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
LRA success
Timeframe: 2 hours
Trial details
NCT IDNCT04846855
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche