Regional Anesthesia for Totally Awake Upper Limb Surgery in PEDiatric Population (RATAPED)

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Surgery; Pediatric ALL
• Intervention / Treatment: Drug: local anaesthetic injection

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • IDF
    • Quincy-sous-Sénart, IDF, France, 91480
      • Hôpital Privé Claude Galien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ropivacaine 35%; Local Anesthesia with Ropivacaine	Drug: local anaesthetic injection; Realization by the anesthesiologist of the local anesthesia by single dose of ropivacaine 0.35% in perinervous under ultrasound with distraction by a tablette.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LRA success	percentage of children in whom ALR and surgery were performed without additional sedation or general anesthesia.	2 hours

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Investigators: Principal Investigator: Jean Sende, PHD, Ramsay santé

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2020
• Primary Completion (Actual): October 14, 2021
• Study Completion (Actual): April 14, 2022

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric; surgery; Ropivacaine; local anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 2019-004504-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No