Levobupivacaine for Hip fracture

Inclusion criteria

• {"criterion_text":"- Patients aged 65 years or older\n- Underwent hip fracture surgery\n- Eligible for intradural anesthesia with levobupivacaine and fentanyl or bupivacaine and fentanyl, as determined in the pre-anesthetic visit.\n- Physical status classified between I and IV according to the American Society of Anesthesiologists (ASA).\n- Weight > 40 kg and Height > 140 cm. Body mass index (BMI) < 50 kg/m²\n- Presence of cardiovascular, respiratory, renal, or endocrine-metabolic condition\n- Provided informed consent to participate in the study."}

Exclusion criteria

• {"criterion_text":"- Uncontrolled arterial hypertension (non-invasive systolic blood pressure >180 mmHg and/or non-invasive diastolic blood pressure >110 mmHg).\n- Heart rate (HR) >120 bpm\n- Oxygen saturation (SpO2) <90% upon arrival at the operating room\n- Contraindications to neuraxial anesthesia, including: Patient refusal, Infection at or near the puncture site, Degenerative neuromuscular disease, Hypovolemia, Coagulopathy or anticoagulant treatment, Extreme morbid obesity or Increased intracranial pressure."}

Primary endpoints

• {"endpoint_text":"- Invasive systolic arterial pressure (PASI), invasive diastolic arterial pressure (PADI), invasive mean arterial pressure (PAMI), arterial oxygen saturation (SatO2) measured in %, heart rate (HR) measured in beats per minute (bpm), and partial oxygen saturation (SpO2%) measured in %.","definition_or_measurement_approach":"Hemodynamic effects measured using invasive arterial pressure measurements (PASI, PADI, PAMI), arterial oxygen saturation (SatO2) in %, heart rate in bpm, and SpO2%."}

Secondary endpoints

• {"endpoint_text":"- Cardiac index (CI), peripheral vascular resistance (PVR), partial arterial oxygen pressure (PaO2), and partial arterial carbon dioxide pressure (PaCO2) measured in mmHg, pH, arterial lactate (Lc) measured in mmol/L, and arterial hemoglobin (Hb) measured in g/dL.\n- Adverse events during surgery and up to 48 hours after the surgical procedure will include: cardiovascular and respiratory adverse events, associated with the surgical technique and with the anesthetic technique.","definition_or_measurement_approach":"Physiologic measures (CI, PVR, PaO2, PaCO2 in mmHg, pH, lactate in mmol/L, Hb in g/dL). Adverse events captured during surgery and up to 48 hours post-surgery, including cardiovascular and respiratory events related to surgical or anesthetic technique."}

Spain

Earliest CTIS Part Ii Submission Date

31-01-2025

Latest Decision Or Authorization Date

04-02-2025

Processing Time Days

4

Number Of Sites

1

Number Of Participants

150

Primary sponsor

Full Name

Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain