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Efficacy and Safety of Liposomal Bupivacaine Injection for Paravertebral Nerve Block in the Treatment of Acute and Chronic Pain After Thoracoscopic Pneumonectomy: A Multicenter, Randomized, Double-blind, Controlled Clinical Trial | Clinical Trials | Clareo Health

RECRUITINGPHASE4

Efficacy and Safety of Liposomal Bupivacaine Injection for Paravertebral Nerve Block in the Treatment of Acute and Chronic Pain After Thoracoscopic Pneumonectomy: A Multicenter, Randomized, Double-blind, Controlled Clinical Trial

NCT06569953•The Second Affiliated Hospital of Chongqing Medical University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of liposomal Bupivacaine administered by paravertebral block for the treatment of acute and chronic pain after video-assisted thoracoscopic lobectomy.

Detailed Description

Researchers will compare liposomal bupivacaine to bupivacaine to see if liposomal bupivacaine works better to treat acute and chronic pain after video-assisted thoracoscopic lobectomy.Participants will:1.Received liposomal bupivacaine or bupivacaine paravertebral block before surgery. 2.Keep a diary of their pain scores within 30min after recovery from anesthesia and 6h, 12h, 24h, 48h, 72h and 90d after the beginning of injection of experimental drugs.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants who scheduled for elective video-assisted thoracoscopic lobectomy under general anesthesia.
•Participants were 18 years or older.
•18 kg/m2≤BMI≤30 kg/m2
•Participants with American Society of Anesthesiology (ASA) physical status I-III.
•Understand the significance, possible benefits, potential risks of the trial in detail.Understand the procedures and methods of this study.Willing to complete the trial in strict compliance with the clinical trial protocol.Sign the informed consent form voluntarily.

Exclusion Criteria

•with severe cardiovascular and cerebrovascular diseases such as myocardial infarction,unstable angina pectoris,severe cardiac rhythm disorders (second- and third-degree heart block,etc.), New York Heart Association (NYHA) functional class III/IV,Ischemic stroke.
•with psychiatric disorders (such as schizophrenia,depression,etc.) and cognitive impairment.
•with sensory disorders such as hyperalgesia.
•with other bodily pain.
•allergy to amide-type local anesthetics or any of the trial drugs
•taking drugs that affect liver metabolism,corticosteroids,benzodiazepines,non-steroidal anti-inflammatory drugs(NSAIDs),opioid agonist-antagonist,central-alpha 2-agonists,anticonvulsants,antidepressants within 72h.
•with a history of alcohol or opioid abuse.
•who were pregnant or lactating.
•who were currently included in another clinical study within 3 months.

Locations (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Key Dates

Start Date

August 26, 2024

Primary Completion Date

August 31, 2025

Completion Date

August 31, 2025

Last Updated

June 27, 2025

Enrollment

284

ESTIMATED participants

Conditions

Acute PainChronic PainPostoperative Pain

Interventions

Liposomal bupivacaine

DRUG

Bupivacaine Hydrochloride

DRUG

Contacts

He Huang, ph.D

CONTACT

86+13708385559 huanghe@cqmu.edu.cn

Guangyou Duan, ph.D

CONTACT

86+18323376014 duangy@hospital.cqmu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Liposomal Bupivacaine Injection for Paravertebral Nerve Block in the Treatment of Acute and Chronic Pain After Thoracoscopic Pneumonectomy: A Multicenter, Randomized, Double-blind, Controlled Clinical Trial

Inclusion Criteria

Exclusion Criteria

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