Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children

NCT06271174 | Recruiting Phase 3

• 1 other identifier: RC23_0009
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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".

Conditions

Persistent Postoperative Pain

Keywords

Persistent Postoperative Pain; Post-surgical chronic pain; Children; Loco-regional Analgesia; Orthopedic surgery

Outcome Measures

Primary Outcomes (1)

• Persistent Postoperative Pain

  Numerical Scale of pain superior to 3 (0 to 10). 0 : no pain - better outcome 10 : max of pain - worse outcome

  3 months after surgery

Secondary Outcomes (12)

• Screening of neuropathic pain if persistent postoperative pain - 3 months

  3 months after surgery.

• Screening of neuropathic pain if persistent postoperative pain - 6 months

  6 months after surgery.

• Screening of neuropathic pain if persistent postoperative pain - 12 months

  12 months after surgery.

• 1st EN score in immediate post-operative ICU before morphine titration

  in Post Interventional Care Unit after the surgery

• Persistent postoperative pain at 6 months.

  6 months after surgery.

Study Arms (2)

Loco-Regional Analgesia

EXPERIMENTAL

Patients will receive Loco-Regional Analgesia during General Anesthesia, and systemic analgesia if necessary * Carbocaine

Drug: Carbocaine; Drug: Profofol and/or Suxaméthonium and/or Sévoflurane

Systemic Analgesia Only

ACTIVE COMPARATOR

Patients will just receive General Anesthesia and systemic analgesia. \_ Profofol and/or Suxaméthonium and/or Sévoflurane

Drug: Profofol and/or Suxaméthonium and/or Sévoflurane

Interventions

Carbocaine DRUG

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.

Also known as: Loco regional Analgesia

Loco-Regional Analgesia

Profofol and/or Suxaméthonium and/or Sévoflurane DRUG

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.

Also known as: General anesthetic

Loco-Regional Analgesia; Systemic Analgesia Only

Eligibility Criteria

• Age: 5 Years - 183 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Fondation Apicil: collaborator

Study Sites (1)

CHU Nantes

Nantes, France

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Mepivacaine; Anesthetics, General

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Central Study Contacts

Rémi Bernardon

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: February 21, 2024
• Study Start: June 6, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

FR (1)