Clinical trial NCT06271174: Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Persistent Postoperative Pain
Keywords: Persistent Postoperative Pain
Post-surgical chronic pain
Children
Loco-regional Analgesia
Orthopedic surgery
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Fondation Apicil
First posted: 2024-02-21
Enrollment: 208
Sex: ALL
Minimum age (years): 5
Maximum age (years): 183
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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".

Detailed description: Patients between 5 years old and 15 years, 3 months old operated for a traumatologic orthopedic surgery in CHU Nantes will be included in this study.

Patients between 5 years old and 15 years, 3 months old operated for a traumatologic orthopedic surgery in CHU Nantes will be included in this study.

They will be randomized in two groups. General anesthesia will be administered in both groups.

One arm will receive a locoregional analgesia guiding by echography before incision with a local anesthetic (Carbocaïne) and a systemic analgesia if necessary. One arm will only receive a systemic analgesia.

The drugs used for general anesthesia and systemic analgesia will be standardized in the two groups.

The incidence of persistent postoperative pain at 3, 6 and 12 months will be compared in both arms. A screening of a neuropathic pain will be realized if a pain exists.

The consumption of opioids the first 24 postoperative hours, the time spent in the post interventional care unit and the incidence of nausea, vomiting will also be compared.

The goal is to show the decrease of the incidence of the persistent postoperative pain and a better recovery in the post interventional care unit in the group "locoregional analgesia".

Eligibility 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

Primary outcomes:
measure: Persistent Postoperative Pain
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Screening of neuropathic pain if persistent postoperative pain - 3 months
timeFrame: 3 months after surgery.
measure: Screening of neuropathic pain if persistent postoperative pain - 6 months
timeFrame: 6 months after surgery.
measure: Screening of neuropathic pain if persistent postoperative pain - 12 months
timeFrame: 12 months after surgery.
measure: 1st EN score in immediate post-operative ICU before morphine titration
timeFrame: in Post Interventional Care Unit after the surgery
measure: Persistent postoperative pain at 6 months.
timeFrame: 6 months after surgery.
measure: Persistent postoperative pain at 12 months.
timeFrame: 12 months after surgery.
measure: Postoperative nausea and vomiting
timeFrame: In Post Interventional Care Unit - after the surgery-
measure: Time in Post Interventional Care Unit
timeFrame: In Post Interventional Care Unit - after the surgery -
measure: Opioïd dose received - Per-operative
timeFrame: Per-operative
measure: Opioïd dose received - in Post Interventional Care Unit
timeFrame: in Post Interventional Care Unit after the surgery-
measure: Opioïd dose received
timeFrame: during the first post-operative 24 hours in the surgery department
measure: Intravenous Morphine dose received in Post Interventional Care Unit
timeFrame: in Post Interventional Care Unit after the surgery-
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
Study officials:
References: