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Recruiting Phase 3 NCT06271174

Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children

Trial Parameters

Condition Persistent Postoperative Pain
Sponsor Nantes University Hospital
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 208
Sex ALL
Min Age 5 Years
Max Age 183 Months
Start Date 2024-06-06
Completion 2026-06
Interventions
CarbocaineProfofol and/or Suxaméthonium and/or Sévoflurane

Brief Summary

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".

Eligibility Criteria

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

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