Clinical trial NCT06231355: Liposomal vs. Conventional Bupivacaine for Pain Control
Official title: Efficacy of Liposomal Bupivacaine Versus Conventional Bupivacaine for Pain Control in Patients Undergoing Laparoscopic Radical Nephrectomy: A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Local Anesthetics
Analgesia
Regional Block
Paravertebral Block
Keywords: liposomal bupivacaine
paravertebral block
postoperative pain
nephrectomy
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: A composite index of pain intensity and opioid consumption (PIOC) between 12 and 72 hours after surgery
timeFrame: Between 12 and 72 hours afer surgery
Secondary outcomes:
measure: Time to onset after paravertebral block
timeFrame: From end of nerve block to initiation of surgery.
measure: Time to maximal block after paravertebral block
timeFrame: From end of nerve block to initiation of surgery.
measure: Extent of paravertebral block
timeFrame: From end of nerve block to 72 hours after surgery.
measure: Paravertebral block-related adverse events.
timeFrame: From end of nerve block to initiation of surgery.
measure: A composite index of pain intensity and opioid consumption (PIOC) within 72 hours after surgery.
timeFrame: Up to 72 hours after surgery
measure: Pain intensity within 72 hours after surgery
timeFrame: Up to 72 hours after surgery
measure: Cumulative opioid consumption within 72 hours after surgery.
timeFrame: Up to 72 hours after surgery
Other outcomes:
measure: Patients' satisfaction with pain management.
timeFrame: Up to 3 days after surgery.
measure: Incidence of postoperative complications
timeFrame: Up to 30 days after surgery
measure: Quality of recovery
timeFrame: At 24 hours after surgery and discharge
measure: Duration of postoperative hospital stay
timeFrame: Up to 30 days after surgery.
measure: Overall in-hospital cost
timeFrame: Up to 30 days after surgery.
measure: Anxiety and depression scores after surgery
timeFrame: At 30 days after surgery.
measure: Postoperative sleep quality
timeFrame: At 1 to 3 days after surgery.
measure: Incidence of pain catastrophizing
timeFrame: At 24 hours after surgery and discharge
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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