NCT06231355

Liposomal vs. Conventional Bupivacaine for Pain Control

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 local anesthetic injection. We will evaluate pain severity, opioid consumption, and occurrence of adverse events at the following timepoints, i.e., end of surgery, 30 minutes after surgery, and 2, 6, 12, 24, 36, 48, 60, and 72 hours after surgery. Additionally, occurrence of complications, quality of recovery, and subjective sleep quality will be assessed during hospital stay after surgery.

Conditions

• Local Anesthetics
• Analgesia
• Regional Block
• Paravertebral Block

Interventions

Type	Name	Description
DRUG	Performing paravertebral nerve block with lipo-bupivacaine	Paravertebral block is performed using liposomal bupivacaine.
DRUG	Performing paravertebral nerve block with bupivacaine	Paravertebral block is performed using bupivacaine.

Timeline

• Start date: 2024-02-21
• Primary completion: 2024-09-09
• Completion: 2024-10-14
• First posted: 2024-01-30
• Last updated: 2025-07-30

Locations

1 site across 1 country: China