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RECRUITING
NCT06271174
PHASE3

Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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".

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.

Key Details

Gender

All

Age Range

5 Years - 183 Months

Study Type

INTERVENTIONAL

Enrollment

208

Start Date

2024-06-06

Completion Date

2026-06

Last Updated

2024-06-12

Healthy Volunteers

No

Interventions

DRUG

Carbocaine

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.

DRUG

Profofol 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