Levobupivacaine for Supratentorial brain tumour

Inclusion criteria

• {"criterion_text":"- Patients undergoing craniotomy for supratentorial mass\n- ASA 1-2\n- All genders\n- 18-85 years old"}

Exclusion criteria

• {"criterion_text":"- BMI<18 or >35 or weight <50 kg\n- Renal Insufficiency (under 45ml/min of GFR)\n- Liver dysfunction (defined by presence of ascitis or coagulation dysfunction)\n- Uncontrolled hypertension (more than 160mmHg systolic pressure) at home or requiring more than 2 anti-hypertensive treatments\n- A hypersensitivity and/or a contraindication to one or more of the medications and/or its excipients used in the study Chronic pain (chronic medication and/or presence of a neurostimulator), fibromyalgia, psychiatric disorders, alcoholism and/or chronic use of strong opioids (considered chronic if taking a strong opioid on a daily basis for > 1 week) preoperatively\n- A contraindication to a loco-regional anesthesia technique\n- Pregnancy, breastfeeding or unappropriate contraception use for fertile female subjects (b-HCG will be done for fertile female)\n- Refusal of consent by the patient"}

Primary endpoints

• {"endpoint_text":"- hemodynamic change observed at the time of placement of the spiked headrest (Mayfield's headrest).","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Hemodynamic variation during skin incision, flap and dura mater incision","definition_or_measurement_approach":""}
• {"endpoint_text":"- Analysis of intraoperative parameters (heart rate, blood pressure, Response and State Entropy (RE/SE), Surgical Plethysmographic Index (SPI) at the time of block, incision, craniectomy and dura mater incision.","definition_or_measurement_approach":"Measurement of heart rate, blood pressure, Response and State Entropy (RE/SE), and Surgical Plethysmographic Index (SPI) at specified intraoperative timepoints (block, incision, craniectomy, dura mater incision)."}
• {"endpoint_text":"- Absence of complications related to the block (AL toxicity, infection, etc.)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Level of sleepiness in USPA (RASS score)","definition_or_measurement_approach":"Assessment using RASS score in USPA."}
• {"endpoint_text":"- Pain scores at the different time intervals shown in the table from the PCU to hospital discharge","definition_or_measurement_approach":"Pain scores recorded at specified time intervals from the PCU to hospital discharge (table referenced in protocol)."}
• {"endpoint_text":"- Morphine use in the PACU and in the hospital ward","definition_or_measurement_approach":"Quantification of morphine consumption in the PACU and during hospital stay."}
• {"endpoint_text":"- Length of hospital stay","definition_or_measurement_approach":"Duration of hospitalisation measured in days from admission to discharge."}
• {"endpoint_text":"- Evaluation of QoR15 on D-1, D+1, D+3, D+7","definition_or_measurement_approach":"Quality of Recovery-15 (QoR-15) questionnaire administered on Day -1, Day +1, Day +3 and Day +7."}
• {"endpoint_text":"- Evaluation of patient satisfaction via the EVAN-G score","definition_or_measurement_approach":"Patient satisfaction assessed using the EVAN-G score."}
• {"endpoint_text":"- Presence of PONV, constipation, pruritus during hospitalization","definition_or_measurement_approach":"Recording presence of postoperative nausea and vomiting (PONV), constipation, and pruritus during hospital stay."}

Belgium

Earliest CTIS Part Ii Submission Date

14-08-2024

Latest Decision Or Authorization Date

06-09-2024

Processing Time Days

23

Number Of Sites

1

Number Of Participants

88

Primary sponsor

Full Name

Centre hospitalier universitaire de Liege

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium