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Could kids have upper limb surgery fully awake? new trial tests the idea

NCT ID NCT04846855

Symptom relief Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This trial tests whether a local anesthetic injection (ropivacaine) can keep children aged 6 to 12 awake and comfortable during upper limb surgery, avoiding general anesthesia. Children watch cartoons on a tablet for distraction while the anesthetic is given. The study aims to see how often surgery can be completed without sedation or general anesthesia.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a local anesthetic injection of ropivacaine 0.35%
What this could lead to
If successful, this approach could offer a needle-free, sedation-free option for upper limb surgery in school-age children, reducing risks and recovery time.
What could go wrong
This is a small, single-site feasibility study. The higher ropivacaine concentration may not be safe or effective in all children, and results may not apply to younger or less cooperative kids.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

100 people

The number who actually took part.

Started

Oct 2020

Finished

Apr 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

childhood acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anesthesia, local Pediatric ALL Surgery

Contacts and locations

Locations

  • Hôpital Privé Claude Galien

    Quincy-sous-Sénart, IDF, 91480, France

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