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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06231355
Study type Interventional
Source Peking University First Hospital
Contact Xu Zhenzhen, MD
Phone +8618811591915
Email zjxvzhenzhen@126.com
Status Recruiting
Phase Phase 4
Start date February 21, 2024
Completion date July 2024

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