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Postoperative Analgesia With Liposomal Bupivacaine Versus Standard Bupivacaine Combined With Dexamethasone

NCT06173466 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-06-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Liposomal bupivacaine

Liposomal bupivacaine 133mg was injected to paravertebral intervals of right T7/8, T8/9, T9//10, T10/11 via ultrasound-guided TPVB

DRUG

Bupivacaine Hydrochloride combined with dexamethasone

Standard bupivacaine combined with dexamethasone 4mg was injected to paravertebral intervals of right T7/8, T8/9, T9//10, T10/11 via ultrasound-guided TPVB

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Principal Investigators

  • Jiangling Wang, Ph. D · Zhejiang Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06173466 on ClinicalTrials.gov