ROPIVACAINE HYDROCHLORIDE for Lumbar arthrodesis|Spinal arthrodesis

Inclusion criteria

• {"criterion_text":"- Participant must be ≥18 years old at the time of signing the Informed Consent\n- To have a lumbar arthrodesis programmed at the Hospital Universitari Arnau de Vilanova de Lleida\n- ASA grade I-III\n- Participant must be capable of giving Informed Consent"}

Exclusion criteria

• {"criterion_text":"- Specific contraindications for Ropivacaine treatment\n- Other medical conditions or comorbidities which, in the opinion of the Investigator, would interfere with study compliance or data interpretation\n- Mujeres embarazadas o en periodo de lactancia\n- IMC >35\n- Known medical history or evidence of severe liver disease and/or renal impairment (eGFR <30).\n- Previous back surgery\n- Evidence of immunological diseases\n- Evidence of malignancy\n- Systemic active infection that requires treatment\n- Skin disease at the puncture site\n- Active psychiatric disorder, including, but not limited to schizophrenia, bipolar disorder, or severe depression requiring current pharmacological intervention"}

Primary endpoints

• {"endpoint_text":"- Morphine demand during the 48 hours after surgery","definition_or_measurement_approach":"Measured as morphine consumption/demand in mg during the first 48 hours after surgery (reduction in morphine consumption in mg is main objective)."}

Secondary endpoints

• {"endpoint_text":"- Changes in the VAS scale just after surgery, at 8, 16, 24 and 48 hours after surgery","definition_or_measurement_approach":"Measured using VAS (visual analogue scale) at immediate post-surgery and at 8, 16, 24 and 48 hours post-surgery."}
• {"endpoint_text":"- Changes in SFMPQ at 24 and 48 hours after surgery","definition_or_measurement_approach":"Measured using the Short-Form McGill Pain Questionnaire (SFMPQ) at 24 and 48 hours after surgery."}
• {"endpoint_text":"- Changes in QoR-15 scales at 24 and 48 hours after surgery","definition_or_measurement_approach":"Measured using the QoR-15 (Quality of Recovery) questionnaire at 24 and 48 hours after surgery."}
• {"endpoint_text":"- Duration of hospitalization after surgery","definition_or_measurement_approach":"Measured as length of hospital stay following the surgery (days)."}
• {"endpoint_text":"- Number of adverse effects associated with the drug within the first 48 hours after surgery","definition_or_measurement_approach":"Count of adverse effects attributable to the drug occurring within the first 48 hours post-surgery."}

Spain

Earliest CTIS Part Ii Submission Date

28-11-2024

Latest Decision Or Authorization Date

10-12-2024

Processing Time Days

12

Number Of Sites

1

Number Of Participants

111

Primary sponsor

Full Name

Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain