ROPIVACAINE HYDROCHLORIDE for Knee Osteoarthritis

Inclusion criteria

• {"criterion_text":"- All patients undergoing primary total knee arthroplasty who provide consent to participate in the study and whose attending surgeon also agrees to the study."}
• {"criterion_text":"- ASA physical status classification I-III."}
• {"criterion_text":"- BMI 18-40 kg/m2."}

Exclusion criteria

• {"criterion_text":"- Patients who refuse to undergo the block procedure, who refuse to give their consent, or who are unable to cooperate with protocol compliance."}
• {"criterion_text":"- Patients in whom the total dose of local anesthetic exceeds the calculated toxic dose based on their ideal body weight."}
• {"criterion_text":"- Patients requiring general anesthesia."}
• {"criterion_text":"- Age younger than 18 years or older than 90 years."}
• {"criterion_text":"- Patients undergoing bilateral arthroplasty, revision arthroplasties, or prosthetic replacements."}
• {"criterion_text":"- Contraindication for peripheral nerve block (local infection, neurological deficit, complex regional pain syndrome, previous trauma, or surgery on the ipsilateral knee)."}
• {"criterion_text":"- Systemic infection."}
• {"criterion_text":"- Consumption of opioids during the last 4 weeks at doses greater than 30 mg of oral morphine or equivalent."}
• {"criterion_text":"- Patients with a hemorrhagic diathesis or coagulopathy (diagnosed by medical history or laboratory tests)."}
• {"criterion_text":"- Patients with allergies to any medication that is part of the protocol (e.g., allergy to local anesthetics)."}

Primary endpoints

• {"endpoint_text":"- The Numerical Rating Scale (NRS) for pain.","definition_or_measurement_approach":"Evaluated during the first physiotherapy session at 24 hours postoperatively using the Numerical Rating Scale (NRS) for pain assessment."}

Secondary endpoints

• {"endpoint_text":"- Opioid consumption measured in morphine equivalents in milligrams.","definition_or_measurement_approach":"Measured as cumulative consumption of rescue opioids at 24 and 48 hours, expressed in morphine milligram equivalents."}
• {"endpoint_text":"- Range mobility measured by active and passive Range of Motion (ROM) Assessment.","definition_or_measurement_approach":"Assessed by active and passive ROM evaluation during the initial physiotherapy assessment."}
• {"endpoint_text":"- Quality of recovery 15 (QoR 15 questionnare).","definition_or_measurement_approach":"Measured using the QoR-15 questionnaire to assess postoperative recovery quality."}
• {"endpoint_text":"- Evaluate NRS at 0, 12 and 48h postoperatively.","definition_or_measurement_approach":"NRS pain scores recorded at spinal block reversal (0 h) and at 12 and 48 hours postoperatively."}

Spain

Earliest CTIS Part Ii Submission Date

12-01-2026

Latest Decision Or Authorization Date

06-02-2026

Processing Time Days

25

Number Of Sites

1

Number Of Participants

64

Primary sponsor

Full Name

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain