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Completed

NCT Number: NCT06231355

Liposomal vs. Conventional Bupivacaine for Pain Control

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Performing paravertebral nerve block with lipo-bupivacaine

Drug

Paravertebral block is performed using liposomal bupivacaine.

Other names: 艾恒平 (Ai Heng Ping), Bupivacaine liposome injection

Performing paravertebral nerve block with bupivacaine

Drug

Paravertebral block is performed using bupivacaine.

Other names: Bupivacaine injection

Primary outcomes

  1. A composite index of pain intensity and opioid consumption (PIOC) between 12 and 72 hours after surgery

    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.

Secondary outcomes

  1. Time to onset after paravertebral block

    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.

  2. Time to maximal block after paravertebral block

    Time frame: From end of nerve block to initiation of surgery.

    Defined as time interval from end of nerve block to maximal block).

  3. Extent of paravertebral block

    Time frame: From end of nerve block to 72 hours after surgery.

    Defined as maximal extent of block.

  4. Paravertebral block-related adverse events.

    Time frame: From end of nerve block to initiation of surgery.

    Defined as any unpredictable, unfavourable medical event that is associated with paravertebral block.

  5. A composite index of pain intensity and opioid consumption (PIOC) within 72 hours after surgery.

    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.

  6. Pain intensity within 72 hours after surgery

    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.

  7. Cumulative opioid consumption within 72 hours after surgery.

    Time frame: Up to 72 hours after surgery

    Cumulative opioid consumption within 72 hours after surgery.

Other outcomes

  1. Patients' satisfaction with pain management.

    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.

  2. Incidence of postoperative complications

    Time frame: Up to 30 days after surgery

    Complications are defined as new-onset medical events that are deemed harmful and required therapeutic intervention.

  3. Quality of recovery

    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.

  4. Duration of postoperative hospital stay

    Time frame: Up to 30 days after surgery.

    Duration of postoperative hospital stay

  5. Overall in-hospital cost

    Time frame: Up to 30 days after surgery.

    Overall in-hospital cost

  6. Anxiety and depression scores after surgery

    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).

  7. Postoperative sleep quality

    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.

  8. Incidence of pain catastrophizing

    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.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2024
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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