Liposomal vs. Conventional Bupivacaine for Pain Control
- Conditions
- Regional BlockParavertebral BlockLocal AnestheticsAnalgesia
- Interventions
- Drug: Performing paravertebral nerve block with bupivacaineDrug: Performing paravertebral nerve block with lipo-bupivacaine
- Registration Number
- NCT06231355
- Lead Sponsor
- Peking University First Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bupivacaine Performing paravertebral nerve block with bupivacaine Paravertebral block is performed with bupivacaine. Lipo-bupivacaine Performing paravertebral nerve block with lipo-bupivacaine Paravertebral block is performed with liposomal bupivacaine.
- Primary Outcome Measures
Name Time Method A composite index of pain intensity and opioid consumption (PIOC) between 12 and 72 hours after surgery 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 Outcome Measures
Name Time Method Time to onset after paravertebral block From end of nerve block to initiation of surgery. Defined as time interval from end of nerve block to appearance of sensory block.
Time to maximal block after paravertebral block From end of nerve block to initiation of surgery. Defined as time interval from end of nerve block to maximal block).
Paravertebral block-related adverse events. From end of nerve block to initiation of surgery. Defined as any unpredictable, unfavourable medical event that is associated with paravertebral block.
Extent of paravertebral block From end of nerve block to 72 hours after surgery. Defined as maximal extent of block.
Pain intensity within 72 hours after surgery 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.
A composite index of pain intensity and opioid consumption (PIOC) within 72 hours after surgery. 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.
Cumulative opioid consumption within 72 hours after surgery. Up to 72 hours after surgery Cumulative opioid consumption within 72 hours after surgery.
Trial Locations
- Locations (1)
Peking University First Hospital
🇨🇳Beijing, Beijing, China