Skip to content

Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children

Unknown statusPhase 3NCT06271174
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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".

Study details

Official title
Impact Evaluation of Perioperative Locoregional Analgesia on Persistent Postoperative Pain in Children After Orthopedic Surgery for Traumatology : a Prospective, Single Center, Randomised Controlled Study.
Conditions
  • Persistent Postoperative Pain
Interventions
  • Drug: Carbocaine
  • Drug: Profofol and/or Suxaméthonium and/or Sévoflurane
Sponsor
Nantes University Hospital
Collaborators
Fondation Apicil
Start date
2024-06-06
Primary completion
2026-06
Sex
All
Age range
from 5 Years to 183 Months
Results posted
No results posted in this snapshot
Countries
France
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age between 5 years old and 15 years and 3 months * Traumatologic orthopedic surgery in CHU Nantes * Conscious patient (Glasgow score =15) * Patients able to give a verbal assessment of their pain * No contraindication to Locoregional Analgesia * Patient member of the social security system * Oral consent of the patient * Signed consent of one of the two holders of parental authority Exclusion Criteria: * Refusal to participate of the patient or one of the two holders of parental authority * Neurologic deficit of the operated limb before intervention * Ischemia of the operated limb before intervention * Polytraumatized patient * Allergia to Carbocaïne * Atrioventricular conduction disorders * Patient included in an other study about analgesia * Anticoagulant treatment * Uncontrolled epilepsy despite treatment * Porphyria

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06271174