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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
61
Paravertebral block is performed using liposomal bupivacaine.
Paravertebral block is performed using bupivacaine.
Peking University First Hospital
Beijing, Beijing Municipality, China
A composite index of pain intensity and opioid consumption (PIOC) between 12 and 72 hours after surgery
The composite index of pain intensity and opioid consumption (PIOC) will be calculated using the area under curve (AUC) of pain intensity and cumulative opioid consumption between 12 and 72 hours in the postoperative period.
Time frame: Between 12 and 72 hours afer surgery
Time to onset after paravertebral block
Defined as time interval from end of nerve block to appearance of sensory block.
Time frame: From end of nerve block to initiation of surgery.
Time to maximal block after paravertebral block
Defined as time interval from end of nerve block to maximal block).
Time frame: From end of nerve block to initiation of surgery.
Extent of paravertebral block
Defined as maximal extent of block.
Time frame: From end of nerve block to 72 hours after surgery.
Paravertebral block-related adverse events.
Defined as any unpredictable, unfavourable medical event that is associated with paravertebral block.
Time frame: From end of nerve block to initiation of surgery.
A composite index of pain intensity and opioid consumption (PIOC) within 72 hours after surgery.
The composite index of pain intensity and opioid consumption (PIOC) will be calculated using the area under curve (AUC) of pain intensity and cumulative opioid consumption between 0.5 and 72 hours in the postoperative period.
Time frame: Up to 72 hours after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pain intensity within 72 hours after surgery
The pain intensity will be assessed both at rest and with movement with the numeric rating scale (an 11-point scale where 0 = no pain, and 10 = the most severe pain) at 0.5, 2, 6, 12, 24, 36, 48, 60, and 72 hours after surgery.
Time frame: Up to 72 hours after surgery
Cumulative opioid consumption within 72 hours after surgery.
Cumulative opioid consumption within 72 hours after surgery.
Time frame: Up to 72 hours after surgery