Efficacy of Liposomal Bupivacaine Versus Conventional Bupivacaine for Pain Control in Patients Undergoing Laparoscopic Radical Nephrectomy: A Pilot Randomized Trial

2023-553

The goal of this pilot study is to test the hypothesis that liposomal bupivacaine extends the duration of paravertebral block in patients undergoing radical nephrectomy, achieving improved analgesia compared to conventional bupivacaine. The main questions it aims to answer are: * Area under curve of numeric rating scale of pain from 12 to 72 h after surgery. * Cumulative opioid consumption during the period of 12 to 72 h after surgery.

2024-02-21

2024-06-01

2024-07-01

Recruiting

Early phase I

60

Inclusion Criteria: * Age between 18 and 70 years old. * Scheduled for laparoscopic-assisted unilateral radical nephrectomy. * Agree to undergo regional nerve blockade and receive patient-controlled intravenous analgesia after surgery. Exclusion Criteria: * Renal cancer with venous thrombus of grade II or higher, or cases that may convert to open surgery. * Body mass index ≥30 kg/m² or ≤15 kg/m². * Severe renal dysfunction (serum creatinine \>442 μmol/L or requiring renal replacement therapy), severe liver dysfunction (Child-Pugh class C), or American Society of Anesthesiologists class ≥IV. * Contraindications for deep nerve block, including severe spinal deformity or history of spinal surgery, severe coagulation abnormalities (international normalized ratio \>1.7, activated partial thromboplastin time \>4 seconds above normal, platelet count \<80×10⁹/L), trauma or infection at the planned puncture site, or severe lumbar back pain. * Chronic opioid dependence and long-term use of various analgesics for more than 3 months. * Preoperative inability to communicate due to severe dementia, language barriers, or end-stage diseases. * Preoperative concomitant central nervous system and/or peripheral nervous system diseases. * Planned endotracheal intubation and admission to the intensive care unit after surgery. * Known allergy to local anesthetics. * Other conditions that are deemed unsuitable for trial participation by the attending surgeons or investigators.

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2024-04-03