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

Last updated: September 24, 2024
Sponsor: The Second Affiliated Hospital of Chongqing Medical University
Overall Status: Active - Recruiting

Phase

4

Condition

Chronic Pain

Pain

Post-surgical Pain

Treatment

Liposomal bupivacaine

Bupivacaine Hydrochloride

Clinical Study ID

NCT06569953
LBPB
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants who scheduled for elective video-assisted thoracoscopic lobectomy undergeneral 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 indetail.Understand the procedures and methods of this study.Willing to complete thetrial in strict compliance with the clinical trial protocol.Sign the informedconsent form voluntarily.

Exclusion

Exclusion Criteria:

  • with severe cardiovascular and cerebrovascular diseases such as myocardialinfarction,unstable angina pectoris,severe cardiac rhythm disorders (second- andthird-degree heart block,etc.), New York Heart Association (NYHA) functional classIII/IV,Ischemic stroke.

  • with psychiatric disorders (such as schizophrenia,depression,etc.) and cognitiveimpairment.

  • 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 livermetabolism,corticosteroids,benzodiazepines,non-steroidal anti-inflammatorydrugs(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.

Study Design

Total Participants: 284
Treatment Group(s): 2
Primary Treatment: Liposomal bupivacaine
Phase: 4
Study Start date:
August 26, 2024
Estimated Completion Date:
August 31, 2025

Study 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.

Connect with a study center

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 4000000
    China

    Active - Recruiting

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