Postoperative Analgesia With Liposomal Bupivacaine Versus Standard Bupivacaine Combined With Dexamethasone

NCT06173466 | Completed Phase 4 DMC

• 1 other identifier: IRB-2023-941 (IIT)
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Liver Cancer

Keywords

Liver Resection; Thoracic Paravertebral Block; Liposomal Bupivacaine

Outcome Measures

Primary Outcomes (1)

• Cumulative opioid consumption of 72 hours after surgery

  Cumulative opioid consumption of 72 hours after surgery were recorded.

  From discharge from post anesthesia care unit (PACU) to 72 hours postoperatively.

Secondary Outcomes (6)

• Quality of recovery 40 (QoR-40) scores of 72 hours

  From discharge from PACU to 72 hours postoperatively.

• Pain visual analog (VAS) scores from 6 hours to 3 months

  From 6 hours to 3 months after surgery.

• Sleep quality

  3 months after surgery.

• Time to first opioid use

  An average time is 2-3 hours after discharge from PACU.

• Plasma bupivacaine concentration

  From 30 minutes after local anesthetics administration to 72 hour after surgery.

Study Arms (2)

Liposomal bupivacaine

EXPERIMENTAL

Patients in the bupivacaine liposomal group were treated with liposome bupivacaine 133 mg under ultrasound-guided TPVB. And ultrasound-guided TPVB was performed at the right T7-8, T8-9, T9-10, and T10-11 paravertebral interval under left lateral decubitus position, with 7.5 ml of medication injected into each paravertebral interval, for a total of 30 ml.

Drug: Liposomal bupivacaine

Standard bupivacaine combined with dexamethasone

ACTIVE COMPARATOR

Patients in the standard control group were treated with 0.5% bupivacaine hydrochloride 150 mg combined with dexamethasone 4 mg. the volume were expended to 30ml in both groups with normal saline. And ultrasound-guided TPVB was performed at the right T7-8, T8-9, T9-10, and T10-11 paravertebral interval under left lateral decubitus position, with 7.5 ml of medication injected into each paravertebral interval, for a total of 30 ml.

Drug: Bupivacaine Hydrochloride combined with dexamethasone

Interventions

Liposomal bupivacaine DRUG

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

Also known as: LB group (experimental group)

Liposomal bupivacaine

Bupivacaine Hydrochloride combined with dexamethasone DRUG

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

Also known as: SB Group (control group)

Standard bupivacaine combined with dexamethasone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Dexamethasone; Control Groups

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jiangling Wang, Ph. D

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patient were performed TPVB in preoperative room before surgery. And the patient, care provider, anesthesiologist in OR, investigator and outcome assessor were blind to the study group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 15, 2023
• Study Start: December 15, 2023
• Primary Completion: February 28, 2024
• Study Completion: May 30, 2024
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)