Preventing persistent postoperative pain in children using locoregional analgesia
Impact Evaluation of Perioperative Locoregional Analgesia on Persistent Postoperative Pain in Children After Orthopedic Surgery for Traumatology : a Prospective, Single Center, Randomised Controlled Study.
This study is testing if a special pain relief method given before surgery can help children aged 5 to 15 avoid long-lasting pain after orthopedic surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 208 (estimated) |
| Ages | 5 Years to 183 Months |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes) |
| Trial ID | NCT06271174 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of locoregional analgesia in preventing persistent postoperative pain in children undergoing traumatologic orthopedic surgery. Participants aged 5 to 15 years will be randomized into two groups: one receiving locoregional analgesia before incision and the other receiving only systemic analgesia. The study aims to compare the incidence of persistent postoperative pain at 3, 6, and 12 months post-surgery, alongside evaluating opioid consumption and recovery metrics in the post-interventional care unit. This is the first randomized controlled trial focusing on this approach in a pediatric population.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 15 years undergoing orthopedic surgery at CHU Nantes.
Not a fit: Patients with contraindications to locoregional analgesia or those with pre-existing neurological deficits may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of chronic pain in children after surgery, improving their overall recovery and quality of life.
How similar studies have performed: Previous studies on locoregional analgesia have shown mixed results, making this approach both novel and potentially impactful in the pediatric population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Nantes
- CHU Nantes — Nantes, France (Recruiting)
Study contacts
- Study coordinator: Rémi Bernardon
- Email: remi.bernardon@chu-nantes.fr
- Phone: +33(0)2 43 48 22 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.