Liposomal vs. Conventional Bupivacaine for Pain Control

P

Peking University

Status and phase

Enrolling
Phase 4

Conditions

Local Anesthetics
Regional Block
Analgesia
Paravertebral Block

Treatments

Drug: Performing paravertebral nerve block with bupivacaine
Drug: Performing paravertebral nerve block with lipo-bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT06231355
2023-553

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Lipo-bupivacaine
Experimental group
Description:
Paravertebral block is performed with liposomal bupivacaine.
Treatment:
Drug: Performing paravertebral nerve block with lipo-bupivacaine
Bupivacaine
Active Comparator group
Description:
Paravertebral block is performed with bupivacaine.
Treatment:
Drug: Performing paravertebral nerve block with bupivacaine

Trial contacts and locations

1

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Central trial contact

Xu Zhenzhen, MD

Data sourced from clinicaltrials.gov

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