drugset / Trial / NCT06173466

Postoperative Analgesia With Liposomal Bupivacaine Versus Standard Bupivacaine Combined With Dexamethasone

NCT06173466 ↗

Phase 4 Completed 96 enrolled Zhejiang Cancer Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

Liposomal bupivacaine is a novel long-acting local anesthetic approved by the FDA for postoperative analgesia because of its ability to significantly prolong the analgesic effect for up to 72 hours. Up to now, no study has demonstrated the effect of postoperative analgesia with liposomal bupivacaine by thoracic paravertebral block (TPVB). The aim of this study was to evaluate the efficacy of liposomal bupivacaine for pain management and recovery after liver resection. Methods: 96 patients were involved in this randomized, prospective, single-blind study. Patients with hepatocellular carcinoma who were undergoing liver resection were divided into two groups: liposome bupivacaine group (liposomal bupivacaine 133mg) and standard bupivacaine combined with dexamethasone group (standard bupivacaine 150mg and dexamethasone 5mg). Both groups were applied ultrasound guided TPVB. The primary outcome was the cumulative opioid consumptionfor 72 hours. Secodary outcomes included QoR-40 at 72 hours, pain visual analog scale (VAS) score area under the curve (AUC) from 6 hours to 3 months, sleep quality at 1 month and 3 months postoperatively. Adverse events and serious adverse events 3 months after TPVB were also recorded.

Timeline

Start
2023-12-15
Primary completion
2024-02-28
Completion
2024-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 133 mg Other
Subject Bupivacaine Other / unclassified 150 mg Other
Comparator Dexamethasone Small molecule 4 mg Other

Indications