Comparing liposomal and conventional bupivacaine for pain control after kidney surgery
Efficacy of Liposomal Bupivacaine Versus Conventional Bupivacaine for Pain Control in Patients Undergoing Laparoscopic Radical Nephrectomy: A Pilot Randomized Trial
This study is testing whether a new form of bupivacaine can provide longer-lasting pain relief after kidney surgery compared to the standard version.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06231355 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate whether liposomal bupivacaine can extend the duration of pain relief provided by paravertebral blocks in patients undergoing radical nephrectomy, compared to conventional bupivacaine. Participants will be randomly assigned to receive either liposomal or plain bupivacaine, with their pain levels and opioid consumption monitored at various intervals post-surgery. The study employs a double-blind design to ensure unbiased results, with assessments of pain severity, opioid use, and recovery quality throughout the hospital stay.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 scheduled for laparoscopic-assisted unilateral radical nephrectomy.
Not a fit: Patients with severe renal or liver dysfunction, significant obesity or underweight, or contraindications for nerve block procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing kidney surgery, potentially reducing opioid consumption.
How similar studies have performed: Previous studies have shown promising results with liposomal bupivacaine in various surgical settings, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing
- Peking University First Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
- Study coordinator: Xu Zhenzhen, MD
- Email: zjxvzhenzhen@126.com
- Phone: +8618811591915
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.