Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04846855 |
| Other study ID # |
2019-004504-35 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
October 14, 2020 |
| Est. completion date |
April 14, 2022 |
Study information
| Verified date |
February 2024 |
| Source |
Ramsay Générale de Santé |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
