Search / Trial NCT06231355

Liposomal vs. Conventional Bupivacaine for Pain Control

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Jan 29, 2024

Trial Information

Current as of October 07, 2024

Recruiting

Keywords

Liposomal Bupivacaine Paravertebral Block Postoperative Pain Nephrectomy

Description

Random numbers will be generated by an independent biostatistician in a 1:1 ratio, sealed in sequentially numbered opaque envelopes, and stored by a study coordinator. Only anesthesiologists who perform paravertebral block know group allocation but are not involved in other parts of the trial. Patients, other health-care team members, and investigators for data collection and outcome assessment are masked from group assignments. Paravertebral block will be performed with either liposomal bupivacaine or plain bupivacaine. The efficacy of nerve block will be assessed every 5 minutes after lo...

Gender

ALL

Eligibility criteria

  • 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.

About Peking University First Hospital

Peking University First Hospital is a leading medical institution in China, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital leverages its extensive expertise in various medical fields to conduct rigorous studies aimed at improving patient outcomes and contributing to global medical knowledge. With a multidisciplinary team of skilled researchers and clinicians, Peking University First Hospital is dedicated to the ethical conduct of clinical research, ensuring the highest standards of safety and efficacy in its trials. The institution plays a vital role in translating scientific discoveries into effective treatments, thereby enhancing the quality of care for patients both locally and worldwide.

Locations

Beijing, Beijing, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0