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.
Nantes University Hospital
208 participants
Jun 6, 2024
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
Inclusion Criteria8
- 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 Criteria10
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06271174