Avoid With locoregional Analgesia Persistant Postoperative Pain After Surgery In Childre

Phase 1

Recruiting

• Conditions: Post-operative pain after surgery; MedDRA version: 20.1Level: LLTClassification code: 10054711Term: Postoperative pain Class: 10022117; MedDRA version: 21.0Level: LLTClassification code: 10002325Term: Anesthesia local Class: 10042613; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]; Therapeutic area: Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

• Registration Number: CTIS2023-503499-25-00
• Lead Sponsor: Centre Hospitalier Universitaire De Nantes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-21
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

Age = 5 years and < 15 years and 3 month, Indication for surgical treatment of a fracture by osteosynthesis, Patient affiliated to the social security system, Informed and signed consent of patient and one of the two holders of parental authority, Conscious patient (Glasgow score =15), Patient can give a verbal assessment of their pain

Exclusion Criteria

Refusal to participate by one of the two holders of parental authority or by the child, atrioventricular conduction disorders, Sensory neurological deficit of the operated limb on preoperative examination, Ischemia of the operated limb on preoperative examination, Polytrauma patient, Known allergy to Mepivacaine, Patient included in a category 1 interventional clinical trial of analgesic therapy, Patient on anticoagulant drugs, Epilepsy not controlled by a treatment, Porphyria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To show the positive impact of locoregional Analgesia in the prevention of persistant postoperative Pain after orthopedic trauma surgery in children;Secondary Objective: Compare neuropathic pain in the two randomization arms, Compare immediate post-operative pain in the ICU, Compare the persistence over time of this chronic post-surgical pain, if it exists., Compare the incidence of postoperative nausea and vomiting in the ICU, Compare monitoring times in the ICU, Compare opioid consumption during hospitalization., Compare intravenous morphine consumption in the ICU;Primary end point(s): Measurement of pain by a Numerical Rating Scale (NRS) 3 months after pediatric orthopedic trauma surgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Response score to DN4 neuropathic pain screening questionnaire =4/10 at 3, 6 and 12 months.;Secondary end point(s):1st EN score for immediate post-operative care in the Post-Interventional Monitoring Room;Secondary end point(s):Presence of pain assessed by numerical scale >3/10 at 6 and 12 months post-surgery;Secondary end point(s):The number of patients experiencing at least one episode of nausea and one episode of vomiting in the Post-Interventional Monitoring Room.;Secondary end point(s):Duration in minutes of monitoring in the Post-Interventional Monitoring Room;Secondary end point(s):The dose of intravenous opiates received intraoperatively, the dose of intravenous opiates titrated in the Post-Interventional Monitoring Room and the dose of opiates received in the hospital ward during the first 24 hours postoperatively.;Secondary end point(s):The dose of IV morphine received in the ICU.