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

Nantes University Hospital (NUH)

Status and phase: Enrolling; Phase 3

Conditions: Persistent Postoperative Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06271174

RC23_0009

Details and patient eligibility

About

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".

Full 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".

Enrollment: 208 estimated patients

Sex: All

Ages: 5 years to 183 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

Loco-Regional Analgesia

Experimental group

Description:

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

Treatment:

Drug: Carbocaine

Drug: Profofol and/or Suxaméthonium and/or Sévoflurane

Systemic Analgesia Only

Active Comparator group

Description:

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

Treatment:

Drug: Profofol and/or Suxaméthonium and/or Sévoflurane