Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children
NCT ID: NCT06271174
Last Updated: 2024-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
208 participants
INTERVENTIONAL
2024-06-06
2026-06-30
Brief Summary
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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".
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Detailed Description
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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".
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Loco-Regional Analgesia
Patients will receive Loco-Regional Analgesia during General Anesthesia, and systemic analgesia if necessary
* Carbocaine
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.
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.
Systemic Analgesia Only
Patients will just receive General Anesthesia and systemic analgesia.
\_ Profofol and/or Suxaméthonium and/or Sévoflurane
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
5 Years
183 Months
ALL
No
Sponsors
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Fondation Apicil
OTHER
Nantes University Hospital
OTHER
Responsible Party
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Locations
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CHU Nantes
Nantes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC23_0009
Identifier Type: -
Identifier Source: org_study_id
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