Postoperative Analgesia With Liposomal Bupivacaine Versus Standard Bupivacaine Combined With Dexamethasone

• Status: Recruiting
• Trial end date: 2024-05-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Treatments: Bupivacaine; Dexamethasone

Criteria

Inclusion Criteria:

• 18-75 years old;

• American Society of Anesthesiologist physical status I-III;

• Child-Pugh score A-B;

• Non anergic to medication used in this study;

• Optional/scheduled for liver resection;

• Approved participation before study.

Exclusion Criteria:

• Patients with contraindications for local nerve block such as spinal anatomic structure abnormality or local infection of puncture area;

• Anergic to medications used in this study;

• Patient have chronic pain;

• Patient receiving anticoagulants, opioids or have a history of narcotic abuse or alcohol abuse;

• Unable to complete postoperative pain score assessment or questionnaires or have mental disorders;

• Pregnant;

• BMI ≥30 kg/m2;

• Patient involving in other studies.