Analgesia, Local Anesthetics, Paravertebral Block, Regional Block
Conditions
Keywords
liposomal bupivacaine, paravertebral block, postoperative pain, nephrectomy
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.
Interventions
DRUGPerforming paravertebral nerve block with lipo-bupivacaine
Paravertebral block is performed using liposomal bupivacaine.
DRUGPerforming paravertebral nerve block with bupivacaine
Paravertebral block is performed using bupivacaine.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Extent of paravertebral block | From end of nerve block to 72 hours after surgery. | Defined as maximal extent of 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. |
| 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. |
| 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. |
| Cumulative opioid consumption within 72 hours after surgery. | Up to 72 hours after surgery | Cumulative opioid consumption within 72 hours after surgery. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patients' satisfaction with pain management. | 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. |
| Incidence of postoperative complications | Up to 30 days after surgery | Complications are defined as new-onset medical events that are deemed harmful and required therapeutic intervention. |
| Quality of recovery | 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. |
| Duration of postoperative hospital stay | Up to 30 days after surgery. | Duration of postoperative hospital stay |
| Overall in-hospital cost | Up to 30 days after surgery. | Overall in-hospital cost |
| Anxiety and depression scores after surgery | 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). |
| Postoperative sleep quality | 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. |
| Incidence of pain catastrophizing | 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. |
Countries
China
Outcome results
None listed