Regional Anesthesia for Totally Awake Upper Limb Surgery in PEDiatric Population

NCT04846855 | Completed Phase 4

• 1 other identifier: 2019-004504-35
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery; Anesthesia, Local; Pediatric ALL

Keywords

surgery; local anesthesia; Pediatric; Ropivacaine

Outcome Measures

Primary Outcomes (1)

• LRA success

  percentage of children in whom ALR and surgery were performed without additional sedation or general anesthesia.

  2 hours

Study Arms (1)

Ropivacaine 35%

EXPERIMENTAL

Local Anesthesia with Ropivacaine

Drug: local anaesthetic injection

Interventions

local anaesthetic injection DRUG

Realization by the anesthesiologist of the local anesthesia by single dose of ropivacaine 0.35% in perinervous under ultrasound with distraction by a tablette.

Ropivacaine 35%

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead

Study Sites (1)

Hôpital Privé Claude Galien

Quincy-sous-Sénart, IDF, 91480, France

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Jean Sende, PHD

  Ramsay santé

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: monocentric, interventional, longitudinal, prospective, non-comparative.

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 15, 2021
• Study Start: October 14, 2020
• Primary Completion: October 14, 2021
• Study Completion: April 14, 2022
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

FR (1)