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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 15
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Nantes
RECRUITING
Nantes
Contact Information
Primary
Rémi Bernardon
remi.bernardon@chu-nantes.fr
+33(0)2 43 48 22 15
Time Frame
Start Date: 2024-06-06
Estimated Completion Date: 2026-06
Participants
Target number of participants: 208
Treatments
Experimental: Loco-Regional Analgesia
Patients will receive Loco-Regional Analgesia during General Anesthesia, and systemic analgesia if necessary~* Carbocaine
Active_comparator: Systemic Analgesia Only
Patients will just receive General Anesthesia and systemic analgesia.~\_ Profofol and/or Suxaméthonium and/or Sévoflurane
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital
Collaborators: Fondation Apicil

This content was sourced from clinicaltrials.gov

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