Liposomal vs. Conventional Bupivacaine for Pain Control

April 2, 2024 updated by: Dong-Xin Wang, Peking University First Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University first hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lipo-bupivacaine
Paravertebral block is performed with liposomal bupivacaine.
Drug: Performing paravertebral nerve block with lipo-bupivacaine
Paravertebral block is performed using liposomal bupivacaine.
Other Names:
  • 艾恒平 (Ai Heng Ping)
  • Bupivacaine liposome injection
Active Comparator: Bupivacaine
Paravertebral block is performed with bupivacaine.
Drug: Performing paravertebral nerve block with bupivacaine
Paravertebral block is performed using bupivacaine.
Other Names:
  • Bupivacaine injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Between 12 and 72 hours afer surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative opioid consumption within 72 hours after surgery.
Time Frame: Up to 72 hours after surgery
Cumulative opioid consumption within 72 hours after surgery.
Up to 72 hours after surgery
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.
From end of nerve block to initiation of surgery.
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).
From end of nerve block to initiation of surgery.
Extent of paravertebral block
Time Frame: From end of nerve block to 72 hours after surgery.
Defined as maximal extent of block.
From end of nerve block to 72 hours after surgery.
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.
From end of nerve block to initiation of surgery.
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.
Up to 72 hours after surgery
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.
Up to 72 hours after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 30 days after surgery
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.
At 24 hours after surgery and discharge
Duration of postoperative hospital stay
Time Frame: Up to 30 days after surgery.
Duration of postoperative hospital stay
Up to 30 days after surgery.
Overall in-hospital cost
Time Frame: Up to 30 days after surgery.
Overall in-hospital cost
Up to 30 days after surgery.
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).
At 30 days after surgery.
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.
At 24 hours after surgery and discharge
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.
Up to 3 days after surgery.
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.
At 1 to 3 days after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Principal Investigator: Dong-Xin Wang, MD, PhD, Peking University first hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

January 21, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-553

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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