Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children (AWA3PASIC)

Impact Evaluation of Perioperative Locoregional Analgesia on Persistent Postoperative Pain in Children After Orthopedic Surgery for Traumatology : a Prospective, Single Center, Randomised Controlled Study.

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".

Study Overview

• Status: Recruiting
• Conditions: Persistent Postoperative Pain
• Intervention / Treatment: Drug: Carbocaine; Drug: Profofol and/or Suxaméthonium and/or Sévoflurane

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".

• Study Type: Interventional
• Enrollment (Estimated): 208
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Rémi Bernardon; Phone Number: +33(0)2 43 48 22 15; Email: remi.bernardon@chu-nantes.fr

Study Locations

• France
  • Nantes, France
    • Recruiting
    • CHU Nantes
    • Contact: Rémi Bernardon; Phone Number: 02.53.48.22.15; Email: remi.bernardon@chu-nantes.fr
    • Principal Investigator: Rémi Bernardon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Loco-Regional Analgesia; Patients will receive Loco-Regional Analgesia during General Anesthesia, and systemic analgesia if necessary; Carbocaine	Drug: Carbocaine; 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.; Other Names: Loco regional Analgesia; Drug: Profofol and/or Suxaméthonium and/or Sévoflurane; 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.; Other Names: General anesthetic
Active Comparator: Systemic Analgesia Only; Patients will just receive General Anesthesia and systemic analgesia. _ Profofol and/or Suxaméthonium and/or Sévoflurane	Drug: Profofol and/or Suxaméthonium and/or Sévoflurane; 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.; Other Names: General anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Persistent postoperative pain at 6 months.	Numerical Scale of pain (0 to 10) 0 : no pain - better outcome 10 : max of pain - worse outcome	6 months after surgery.
Persistent postoperative pain at 12 months.	Numerical Scale of pain (0 to 10) 0 : no pain - better outcome 10 : max of pain - worse outcome	12 months after surgery.
Screening of neuropathic pain if persistent postoperative pain - 3 months	DN4 score (0 to 10) - Self-assessment scale for estimating the probability of neuropathic pain Patient score is equal to or greater than 4/10, the test is positive 0 : minimum value / better outcome 10 : maximul value / worse outcome	3 months after surgery.
Screening of neuropathic pain if persistent postoperative pain - 6 months	DN4 score (0 to 10) - Self-assessment scale for estimating the probability of neuropathic pain Patient score is equal to or greater than 4/10, the test is positive 0 : minimum value / better outcome 10 : maximul value / worse outcome	6 months after surgery.
Screening of neuropathic pain if persistent postoperative pain - 12 months	DN4 score (0 to ten) - Self-assessment scale for estimating the probability of neuropathic pain Patient score is equal to or greater than 4/10, the test is positive 0 : minimum value / better outcome 10 : maximul value / worse outcome	12 months after surgery.
Postoperative nausea and vomiting	presence or absence	In Post Interventional Care Unit - after the surgery-
Time in Post Interventional Care Unit	Evaluation in minutes.	In Post Interventional Care Unit - after the surgery -
Opioïd dose received - Per-operative	Evaluation in milligrammes	Per-operative
Opioïd dose received - in Post Interventional Care Unit	Evaluation in milligrammes	in Post Interventional Care Unit after the surgery-
Opioïd dose received	Evaluation in milligrammes	during the first post-operative 24 hours in the surgery department
Intravenous Morphine dose received in Post Interventional Care Unit	Evaluation in milligrammes	in Post Interventional Care Unit after the surgery-
1st EN score in immediate post-operative ICU before morphine titration	Numerical Scale of pain (0 to 10) 0 : no pain - better outcome 10 : max of pain - worse outcome	in Post Interventional Care Unit after the surgery

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Fondation Apicil

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Children; Orthopedic surgery; Persistent Postoperative Pain; Post-surgical chronic pain; Loco-regional Analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Platelet Aggregation Inhibitors; Anesthetics, Local; Anesthetics, Inhalation; Neuromuscular Agents; Neuromuscular Blocking Agents; Neuromuscular Depolarizing Agents; Anesthetics; Sevoflurane; Anesthetics, General; Succinylcholine; Mepivacaine
• Other Study ID Numbers: RC23_0009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No