RecruitingPhase 3NCT06271174

Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children

Impact Evaluation of Perioperative Locoregional Analgesia on Persistent Postoperative Pain in Children After Orthopedic Surgery for Traumatology : a Prospective, Single Center, Randomised Controlled Study.


Sponsor

Nantes University Hospital

Enrollment

208 participants

Start Date

Jun 6, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 5 YearsMax Age: 183 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Carbocaine and a drug called Profofol and/or Suxaméthonium and/or Sévoflurane for people with persistent postoperative pain. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCarbocaine

After general anesthesia and before incision, patients will receive loco-regional analgesia. Carbocaïne will be injected around the nerve responsible of the innervation of the operated area by echography guidance.

DRUGProfofol and/or Suxaméthonium and/or Sévoflurane

General anesthesia Anesthetic induction is performed on a full stomach using : * Intravenous hypnotic Propofol 2-5 mg/kg * A rapid-acting intravenous curare Suxamethonium 1 mg/kg On an empty stomach : \- An intravenous hypnotic Propofol 2 to 5 mg/kg or/and an inhalatory hypnotic, Sevoflurane, as anesthetic co-induction by these 2 agents is generally used in pediatrics.


Locations(1)

CHU Nantes

Nantes, France

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NCT06271174