SurgeryPhase 4RATAPEDNCT04846855
Regional Anesthesia for Totally Awake Upper Limb Surgery in PEDiatric Population
A Phase 4 study testing local anaesthetic injection in people with Surgery and Anesthesia, Local, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Surgery, Anesthesia, Local, Pediatric ALL
- What is being tested?
- local anaesthetic injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2020to 14 Apr 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
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- Child already sedated or premedicated in the emergency room.
- Digital tablet not available.
- Patient participating in another clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regional Anesthesia for Totally Awake Upper Limb Surgery in PEDiatric Population- RAPATED
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.
Read the detailed description
Peripheral loco-regional anesthesia (LRA) for anesthetic purposes is a technique widely used in adults for upper limb surgery. It allows peripheral surgeries to be performed without putting the patient to sleep and thus avoiding certain disadvantages of general anesthesia (GA).
In pediatrics, LRA is not classically considered on its own. It is usually performed for analgesic purposes during sedation or GA.
Subject to respecting a strict protocol and taking advantage of considerable developments in the field of LRA, it is entirely possible to carry out awakened peripheral blocks in communicating children, of school age, thus avoiding the pitfalls of GA in pediatrics, in particular in an emergency context (inhalation on a full stomach, respiratory risk in children with colds, inhalational anesthesia with an anxiety mask, postoperative vomiting nausea, disorientation and delusions upon waking ...) Indeed, the exclusive use of ultrasound, the use of adapted needles, the improvement of knowledge in sono-anatomy, the reduction in doses and concentrations of local anesthetics are all developments in the field of LRA allowing to improve the conditions of safety, comfort for the patient and success of the technique.
Beyond technical considerations, there are ways to improve the child's experience with care. The use of Emla anesthetic skin patches for punctures (perfusion and ALR) as well as the viewing of cartoons on touch tablets during treatment can improve the perception of painless care such as ALR and treatment. charge in the operating room.
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. Higher concentrations of ropivacaine, used in several pediatric studies, have nevertheless shown their good tolerance and their efficacy Under reserve not to exceed 3mg / kg and to use concentrations up to 0.5% On the basis of these arguments, and with the experience of the Claude Galien Private Hospital in this area, it seems interesting to assess the feasibility of upper limb surgery under anesthetic ALR alone with a dose of ropivacaine at the concentration 0.35% in communicating children, of school age.
- Conditions
- Surgery, Anesthesia, Local, Pediatric ALL
- Being tested
- local anaesthetic injection
- Keywords
- surgery, local anesthesia, Pediatric, Ropivacaine
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local anaesthetic injectionDrug
Realization by the anesthesiologist of the local anesthesia by single dose of ropivacaine 0.35% in perinervous under ultrasound with distraction by a tablette.
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine 35% | Experimental | Local Anesthesia with Ropivacaine Receives: Drug: local anaesthetic injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
LRA success
percentage of children in whom ALR and surgery were performed without additional sedation or general anesthesia.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start14 Oct 2020
- Primary completion14 Oct 2021
- Study completion14 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- monocentric, interventional, longitudinal, prospective, non-comparative.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Sende, PHD, Principal investigator, Ramsay santé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846855
- Sponsor's protocol ID
- 2019-004504-35
- Other IDs
- 2019
- Acronym
- RATAPED
- Status last verified
- Jul 2026
- First submitted
- 12 Apr 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Anesthesia for Totally Awake Upper Limb Surgery in PEDiatric Population- RAPATED
- ClinicalTrials.gov ID
- NCT04846855
- Acronym / sponsor ID
- RATAPED / 2019-004504-35
- Conditions
- Surgery, Anesthesia, Local, Pediatric ALL
- Keywords
- surgery, local anesthesia, Pediatric, Ropivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Peripheral loco-regional anesthesia (LRA) for anesthetic purposes is a technique widely used in adults for upper limb surgery. It allows peripheral surgeries to be performed without putting the patient to sleep and thus avoiding certain disadvantages of general anesthesia (GA).
In pediatrics, LRA is not classically considered on its own. It is usually performed for analgesic purposes during sedation or GA.
Subject to respecting a strict protocol and taking advantage of considerable developments in the field of LRA, it is entirely possible to carry out awakened peripheral blocks in communicating children, of school age, thus avoiding the pitfalls of GA in pediatrics, in particular in an emergency context (inhalation on a full stomach, respiratory risk in children with colds, inhalational anesthesia with an anxiety mask, postoperative vomiting nausea, disorientation and delusions upon waking ...) Indeed, the exclusive use of ultrasound, the use of adapted needles, the improvement of knowledge in sono-anatomy, the reduction in doses and concentrations of local anesthetics are all developments in the field of LRA allowing to improve the conditions of safety, comfort for the patient and success of the technique.
Beyond technical considerations, there are ways to improve the child's experience with care. The use of Emla anesthetic skin patches for punctures (perfusion and ALR) as well as the viewing of cartoons on touch tablets during treatment can improve the perception of painless care such as ALR and treatment. charge in the operating room.
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. Higher concentrations of ropivacaine, used in several pediatric studies, have nevertheless shown their good tolerance and their efficacy Under reserve not to exceed 3mg / kg and to use concentrations up to 0.5% On the basis of these arguments, and with the experience of the Claude Galien Private Hospital in this area, it seems interesting to assess the feasibility of upper limb surgery under anesthetic ALR alone with a dose of ropivacaine at the concentration 0.35% in communicating children, of school age.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- monocentric, interventional, longitudinal, prospective, non-comparative.
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine 35% | Experimental | Drug: local anaesthetic injectionLocal Anesthesia with Ropivacaine |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local anaesthetic injectionRealization by the anesthesiologist of the local anesthesia by single dose of ropivacaine 0.35% in perinervous under ultrasound with distraction by a tablette. | Drug | Ropivacaine 35% |
Primary outcome
LRA success
Time frame: 2 hours
percentage of children in whom ALR and surgery were performed without additional sedation or general anesthesia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Sende, PHD principal investigator
Ramsay santé
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing local anaesthetic injection in people with Surgery and Anesthesia, Local, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LRA success (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.