Search / Trial NCT06231355

Liposomal vs. Conventional Bupivacaine for Pain Control

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Jan 29, 2024

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Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Liposomal Bupivacaine Paravertebral Block Postoperative Pain Nephrectomy

ClinConnect Summary

This clinical trial is studying a type of pain relief called liposomal bupivacaine to see if it works better than conventional bupivacaine for patients undergoing a specific kidney surgery called radical nephrectomy. The main goal is to find out if liposomal bupivacaine can help reduce pain for a longer time after surgery and decrease the amount of opioid medication needed for pain management.

To participate in this study, you need to be between 18 and 70 years old and scheduled for laparoscopic-assisted kidney surgery. You should also be willing to receive a nerve block for pain relief and have a patient-controlled pain medication system after the surgery. If you have certain health issues like severe kidney or liver problems, or if you have had significant spinal surgery, you may not be eligible. If you join the study, you can expect to receive either the new liposomal bupivacaine or the conventional bupivacaine for pain management, and researchers will monitor your pain levels and medication use during your recovery.

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.

Trial Officials

Dong-Xin Wang, MD, PhD

Principal Investigator

Peking University First Hospital

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