ROPIVACAINE HYDROCHLORIDE for Supratentorial intracranial surgery | Postoperative pain

Inclusion criteria

• {"criterion_text":"- Age > 18 years\n- Patient admitted to the neurosurgical unit for intracranial supratentorial surgery with flap performed\n- Person affiliated with or benefiting from a social security scheme\n- Free, informed and written consent signed by the participant and the investigating physician (no later than the day of inclusion and before any examination required by the research)."}

Exclusion criteria

• {"criterion_text":"- Awake surgical procedure (systematic scalp blocks required)\n- Aphasia of comprehension preoperatively or expected postoperatively, or any other neurological impairment making pain self-assessment impossible\n- Contraindication to the use of local anesthetics: allergy or history of intoxication with local anesthetics\n- Patients with chronic pain or daily pre-operative morphine consumption\n- Contraindication to adrenaline infiltration: severe ventricular rhythm disorders, severe obstructive cardiomyopathy, unstable coronary insufficiency, hypersensitivity to adrenaline.\n- Pregnant or breast-feeding women\n- Patients under legal protection (persons deprived of their liberty or under guardianship)."}

Primary endpoints

• {"endpoint_text":"- Composite criterion of occurrence of events involving : - Either the need for morphine titration at a dosage greater than 0.05 mg.kg-1 in the immediate postoperative period (i.e., up to 6 h after extubation). - or the existence of severe pain defined by a numerical scale episode > 4 in the immediate post-operative period (i.e. up to 6 hours after extubation).","definition_or_measurement_approach":"Composite endpoint defined as either need for morphine titration > 0.05 mg.kg-1 in immediate postoperative period (up to 6 h after extubation) OR severe pain defined by numerical scale episode > 4 in immediate postoperative period (up to 6 h after extubation). Measurement timeframe: up to 6 hours after extubation."}

Secondary endpoints

• {"endpoint_text":"- ANI will be collected after induction, at the time of intubation, at the time of placement of the Mayfield frame and at the time of incision. Doses of hypnotic (propofol) and analgesic (remifentanil) will be recorded at these times.","definition_or_measurement_approach":"Analgesia Nociception Index (ANI) collected at specified peri-induction timepoints; propofol and remifentanil doses recorded at same times."}
• {"endpoint_text":"- The numerical pain assessment scale will also be collected hourly up to 6 hours after extubation and at 24 hours post-operatively by the nurses in the continuous monitoring unit.","definition_or_measurement_approach":"Hourly numerical pain scale assessments up to 6 hours post-extubation and at 24 hours post-op, recorded by nursing staff in continuous monitoring unit."}
• {"endpoint_text":"- The amount of morphine consumed on an hourly basis up to 6 hours after extubation and at 24 hours post-operatively will be collected using the computerized chart in the continuous care unit.","definition_or_measurement_approach":"Hourly morphine consumption up to 6 hours post-extubation and at 24 hours, collected from computerized medication chart in continuous care unit."}
• {"endpoint_text":"- The occurrence of post-operative nausea and vomiting will also be collected and defined by at least one of the following: the presence of nausea / the need for rescue antiemetic treatment / at least one episode of vomiting. This criterion is collected at 6 and 24 hours post-operatively on the basis of the data on the placard, and assessed by the nurses in the continuous monitoring unit in accordance with departmental practice.","definition_or_measurement_approach":"PONV defined as presence of nausea, need for rescue antiemetic, or ≥1 episode of vomiting; assessed at 6 and 24 hours post-op from monitoring unit records."}
• {"endpoint_text":"- The presence of a persistent headache at 3 months post-op, not attributable to another cause, will be collected by telephone interview. The numerical scale of this headache, if any, the DN4 score and the need to take level 2 or 3 analgesics to treat this pain will also be collected in a declarative manner by telephone by an investigator blinded to the treatment group.","definition_or_measurement_approach":"Persistent headache at 3 months post-op collected by telephone interview; includes numerical pain scale, DN4 neuropathic pain score, and patient-reported use of level 2 or 3 analgesics; interviewer blinded to treatment group."}
• {"endpoint_text":"- The occurrence of surgical site infection will be collected at 3 months post-op.","definition_or_measurement_approach":"Surgical site infection occurrence assessed at 3 months post-op (method of ascertainment: follow-up/records as per protocol)."}
• {"endpoint_text":"- The number of nerves that may have been blocked by ultrasound for each patient will be collected at the time the scalp blocks are made by the practitioner performing them. The approach will also be recorded.","definition_or_measurement_approach":"Number of nerves blocked by ultrasound recorded at time of scalp block and approach/technique documented by practitioner."}

France

Earliest CTIS Part Ii Submission Date

02-05-2025

Latest Decision Or Authorization Date

11-06-2025

Processing Time Days

40

Number Of Sites

1

Number Of Participants

230

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Bordeaux

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Bordeaux University Hopital","duties_or_roles":"Source of monetary support","organisation_type":""}