Actively Recruiting
Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children
Led by Nantes University Hospital · Updated on 2024-06-12
208
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
N
Nantes University Hospital
Lead Sponsor
F
Fondation Apicil
Collaborating Sponsor
AI-Summary
What this Trial Is About
Persistent postoperative pain is a substantial pain (scores 4-10 using a 0-10 numeric scale) that develops 3 months after surgery. Persistent postoperative pain can be a problem even in ambulatory surgery. Loco-regional analgesia could prevent the occurrence of this pathology but contradictory results are found in ancient studies. This study is the first randomized controlled study in children about loco-regional analgesia and persistent postoperative pain in traumatologic orthopedic surgery. One interventional arm will receive a locoregional analgesia after general anesthesia and before incision. The other arm will only receive systemic analgesia during general anesthesia. The incidence of persistent postoperative pain at 3, 6 and 12 months will be compared in these two groups. The goal is to show the decrease of the incidence of the persistent postoperative pain in the group "locoregional analgesia".
CONDITIONS
Official Title
Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 5 years old and 15 years and 3 months
- Traumatologic orthopedic surgery at CHU Nantes
- Conscious patient with Glasgow score of 15
- Able to give a verbal assessment of their pain
- No contraindication to loco-regional analgesia
- Member of the social security system
- Oral consent from the patient
- Signed consent from one parent or legal guardian
You will not qualify if you...
- Refusal to participate by patient or parent/legal guardian
- Neurologic deficit of the operated limb before surgery
- Ischemia of the operated limb before surgery
- Polytraumatized patient
- Allergy to Carbocaine
- Atrioventricular conduction disorders
- Participation in another analgesia study
- Use of anticoagulant treatment
- Uncontrolled epilepsy despite treatment
- Porphyria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU Nantes
Nantes, France
Actively Recruiting
Research Team
R
Rémi Bernardon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here