RecruitingPhase 3

Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children

France208 participantsStarted 2024-06-06

Plain-language 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".

Who can participate

Age range

5 Years – 183 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Persistent Postoperative Pain

Timeframe: 3 months after surgery

Trial details

NCT IDNCT06271174

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Rémi Bernardon

+33(0)2 43 48 22 15 remi.bernardon@chu-nantes.fr

View on ClinicalTrials.gov More Persistent Postoperative Pain trials