Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
NCT Number: NCT06231355
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 4
Beijing, Beijing Municipality, 100034, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Paravertebral block is performed using liposomal bupivacaine.
Other names: 艾恒平 (Ai Heng Ping), Bupivacaine liposome injection
Paravertebral block is performed using bupivacaine.
Other names: Bupivacaine injection
Time frame: Between 12 and 72 hours afer 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: From end of nerve block to initiation of surgery.
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.
Defined as time interval from end of nerve block to maximal block).
Time frame: From end of nerve block to 72 hours after surgery.
Defined as maximal extent of block.
Time frame: From end of nerve block to initiation of surgery.
Defined as any unpredictable, unfavourable medical event that is associated with paravertebral block.
Time frame: Up to 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
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.
Time frame: Up to 3 days after surgery.
Patients' satisfaction with pain management will be assessed with the numeric rating scale (an 11-point scale where 0 = the most unsatisfied and 10 = the most satisfied.
Time frame: Up to 30 days after surgery
Complications are defined as new-onset medical events that are deemed harmful and required therapeutic intervention.
Time frame: At 24 hours after surgery and discharge
Quality of recovery will be assessed with the QoR-15 questionnaire; scores range from 0 to 150, with higher score indicating better quality of recovery.
Time frame: Up to 30 days after surgery.
Duration of postoperative hospital stay
Time frame: Up to 30 days after surgery.
Overall in-hospital cost
Time frame: At 30 days after surgery.
Anxiety and depression scores will be assessed with the hospital anxiety and depression scale (HADS, scores range from 0 to 21 for either anxiety or depression, with higher score indicating more severe anxiety and depression).
Time frame: At 1 to 3 days after surgery.
Postoperative sleep quality will be assessed with the numeric rating scale, scale range from 0 to 10, with higher score indicating better quality of sleep.
Time frame: At 24 hours after surgery and discharge
Pain catastrophizing will be assessed with the pain catastrophizing scale, scale range from 0 to 52, with higher score(>38) indicating pain catastrophizing.
Peking University First Hospital
Other
Efficacy of Liposomal Bupivacaine Versus Conventional Bupivacaine for Pain Control in Patients Undergoing Laparoscopic Radical Nephrectomy: A Pilot Randomized Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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