Mepivacaine hydrochloride for Postoperative pain

Inclusion criteria

• {"criterion_text":"- Age ≥ 5 years and < 15 years and 3 month"}
• {"criterion_text":"- Indication for surgical treatment of a fracture by osteosynthesis"}
• {"criterion_text":"- Patient affiliated to the social security system"}
• {"criterion_text":"- Informed and signed consent of patient and one of the two holders of parental authority"}
• {"criterion_text":"- Conscious patient (Glasgow score =15)"}
• {"criterion_text":"- Patient can give a verbal assessment of their pain"}

Exclusion criteria

• {"criterion_text":"- Refusal to participate by one of the two holders of parental authority or by the child"}
• {"criterion_text":"- atrioventricular conduction disorders"}
• {"criterion_text":"- Sensory neurological deficit of the operated limb on preoperative examination"}
• {"criterion_text":"- Ischemia of the operated limb on preoperative examination"}
• {"criterion_text":"- Polytrauma patient"}
• {"criterion_text":"- Known allergy to Mepivacaine"}
• {"criterion_text":"- Patient included in a category 1 interventional clinical trial of analgesic therapy"}
• {"criterion_text":"- Patient on anticoagulant drugs"}
• {"criterion_text":"- Epilepsy not controlled by a treatment"}
• {"criterion_text":"- Porphyria"}

Primary endpoints

• {"endpoint_text":"- Measurement of pain by a Numerical Rating Scale (NRS) 3 months after pediatric orthopedic trauma surgery","definition_or_measurement_approach":"Pain measured by Numerical Rating Scale (NRS) at 3 months after pediatric orthopedic trauma surgery."}

Secondary endpoints

• {"endpoint_text":"- Response score to DN4 neuropathic pain screening questionnaire ≥4/10 at 3, 6 and 12 months.","definition_or_measurement_approach":"DN4 neuropathic pain screening questionnaire; response defined as DN4 score ≥4/10 measured at 3, 6 and 12 months."}
• {"endpoint_text":"- 1st EN score for immediate post-operative care in the Post-Interventional Monitoring Room","definition_or_measurement_approach":"Immediate postoperative pain assessed by first Numerical Rating Scale (EN) score in the Post-Interventional Monitoring Room."}
• {"endpoint_text":"- Presence of pain assessed by numerical scale >3/10 at 6 and 12 months post-surgery","definition_or_measurement_approach":"Presence of pain defined as numerical scale score >3/10 measured at 6 and 12 months post-surgery."}
• {"endpoint_text":"- The number of patients experiencing at least one episode of nausea and one episode of vomiting in the Post-Interventional Monitoring Room.","definition_or_measurement_approach":"Count of patients with at least one episode of nausea and at least one episode of vomiting in the Post-Interventional Monitoring Room."}
• {"endpoint_text":"- Duration in minutes of monitoring in the Post-Interventional Monitoring Room","definition_or_measurement_approach":"Monitoring duration measured in minutes in the Post-Interventional Monitoring Room."}
• {"endpoint_text":"- The dose of intravenous opiates received intraoperatively, the dose of intravenous opiates titrated in the Post-Interventional Monitoring Room and the dose of opiates received in the hospital ward during the first 24 hours postoperatively.","definition_or_measurement_approach":"Quantification of opiate doses administered intraoperatively, in the Post-Interventional Monitoring Room (titrated), and in the ward during first 24 hours post-op."}
• {"endpoint_text":"- The dose of IV morphine received in the ICU.","definition_or_measurement_approach":"Dose of intravenous morphine received in the Post-Interventional Monitoring Room / ICU measured (total dose)."}

France

Earliest CTIS Part Ii Submission Date

10-01-2024

Latest Decision Or Authorization Date

12-03-2026

Processing Time Days

792

Number Of Sites

1

Number Of Participants

222

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nantes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Fondation APICIL","duties_or_roles":"","organisation_type":""}
• {"country":"","full_name":"CHU Nantes - Appel d'offre interne","duties_or_roles":"","organisation_type":""}