LIDOCAINE HYDROCHLORIDE for Lung cancer

Inclusion criteria

• {"criterion_text":"- Patients undergoing lung tumor resection surgery using video-assisted thoracoscopy."}
• {"criterion_text":"- The patient must be 18 years of age or older."}
• {"criterion_text":"- The patient, or his or her representative, has given consent to participate in the study."}
• {"criterion_text":"- The patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial."}

Exclusion criteria

• {"criterion_text":"- Patients who have previously been diagnosed with chronic pain prior to surgery."}
• {"criterion_text":"- Patients unable to clearly understand the objectives and methodology of the study."}
• {"criterion_text":"- Patients with chronic kidney damage with glomerular filtration < 60 ml/min (stage III-V)."}
• {"criterion_text":"- Patients with liver dysfunction with total bilirubin > 3mg/dL."}
• {"criterion_text":"- Expected surgery lasting more than 6 hours or no extubation plan immediately after surgery."}
• {"criterion_text":"- Patients with < 45kg and > 100kg."}
• {"criterion_text":"- Pregnant or breastfeeding women."}
• {"criterion_text":"- History of hypersensitivity to any of the components of lidocaine or magnesium sulfate."}
• {"criterion_text":"- Patients who for some medical reason are contraindicated in the use of lidocaine or magnesium sulfate."}
• {"criterion_text":"- Patients who are taking analgesics (paracetamol or non-steroidal anti-inflammatory drugs or opioids) in the 7 days prior to surgery."}
• {"criterion_text":"- History of alcohol or drug abuse or psychiatric illness."}
• {"criterion_text":"- History of Congestive Heart Failure or NYHA criteria III-IV or atrioventricular heart block."}
• {"criterion_text":"- Disease of the central nervous system."}
• {"criterion_text":"- Porphyria."}

Primary endpoints

• {"endpoint_text":"- Morphine consumption in the first 24 postoperative hours.","definition_or_measurement_approach":"Measured as total morphine consumption during the first 24 postoperative hours (morphine dose administered in the first 24 h)."}

Secondary endpoints

• {"endpoint_text":"- Postoperative morphine consumption","definition_or_measurement_approach":"Measured as morphine consumption at specified postoperative time points (including first 8 and 12 hours as indicated in objectives)."}
• {"endpoint_text":"- Intensity of pain, at rest and with deep breathing","definition_or_measurement_approach":"Measured using VAS (0-100) and 4-point Verbal Rating Scale (VRS) at 3h, 6h and 24h postoperatively as described in objectives."}
• {"endpoint_text":"- Chronic postoperative pain","definition_or_measurement_approach":"Incidence of chronic postoperative pain assessed at 3 and 7 months using the Verbal Rating Scale (VRS)."}
• {"endpoint_text":"- Neuropathic pain","definition_or_measurement_approach":"Incidence of localized neuropathic pain measured at 20 days, 3 months and 7 months using the PainDetect scale."}
• {"endpoint_text":"- ICU stay and hospital stay.","definition_or_measurement_approach":"Length of ICU stay and total hospital length of stay (days)."}
• {"endpoint_text":"- Adverse events","definition_or_measurement_approach":"Prevalence of specified adverse events (bradycardia, hypotension, pruritus, nausea, vomiting, arrhythmias, postoperative somnolence, metallic taste, dizziness, vertigo, agitation, oral hypoesthesia) in both groups."}
• {"endpoint_text":"- Serious and non-serious pulmonary complications","definition_or_measurement_approach":"Incidence of pulmonary complications during first 7 days, 20 days, 3 and 7 months postoperatively."}
• {"endpoint_text":"- Non-pulmonary complications","definition_or_measurement_approach":"Incidence of non-pulmonary complications during first 7 days, 20 days, 3 and 7 months postoperatively."}
• {"endpoint_text":"- Myocardial damage in non-cardiac surgery","definition_or_measurement_approach":"Incidence of myocardial damage in the postoperative period (definition not detailed in record)."}
• {"endpoint_text":"- Major Cardiovascular Events","definition_or_measurement_approach":"Incidence of major cardiovascular events (MACCE) in the postoperative period (specific definitions not provided in record)."}
• {"endpoint_text":"- Atrial Fibrillation","definition_or_measurement_approach":"Incidence of new-onset atrial fibrillation in the postoperative period."}
• {"endpoint_text":"- Postoperative surgical complications","definition_or_measurement_approach":"Incidence of postoperative surgical complications during the first 30 postoperative days."}
• {"endpoint_text":"- Quality of life","definition_or_measurement_approach":"Measured at 20 days, 3 and 7 months using HRQoL SF-8 questionnaire."}
• {"endpoint_text":"- Postoperative cognitive dysfunction","definition_or_measurement_approach":"Incidence of postoperative cognitive dysfunction assessed on day 3 after surgery (assessment method not detailed in record)."}
• {"endpoint_text":"- Acute Kidney Injury","definition_or_measurement_approach":"Incidence of acute kidney injury at 48 hours postoperatively or within first 7 postoperative days (definitions not detailed in record)."}
• {"endpoint_text":"- Recovery quality","definition_or_measurement_approach":"Quality of recovery measured at 24 and 48 hours postoperatively using the QoR-15 questionnaire."}
• {"endpoint_text":"- Severity of postoperative complications","definition_or_measurement_approach":"Severity assessed using the Clavien-Dindo scale."}
• {"endpoint_text":"- Lung capacity","definition_or_measurement_approach":"Measured by respiratory function tests in the first 24 postoperative hours."}
• {"endpoint_text":"- Oxygenation","definition_or_measurement_approach":"Oxygenation measured at 12 hours after ICU admission and 24 hours after surgery (specific metrics not detailed)."}
• {"endpoint_text":"- Hospital readmissions","definition_or_measurement_approach":"Number of hospital readmissions during the 7-month follow-up after discharge."}
• {"endpoint_text":"- Lung cancer recurrences","definition_or_measurement_approach":"Number of lung cancer recurrences assessed at 1 year after surgery."}

Spain

Earliest CTIS Part Ii Submission Date

06-02-2024

Latest Decision Or Authorization Date

29-07-2025

Processing Time Days

539

Number Of Sites

2

Number Of Participants

128

Primary sponsor

Full Name

Clinica Universidad De Navarra

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain