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
The Second Affiliated Hospital of Chongqing Medical University
Phase
Phase 4
Started
2024-08-26
Last updated
2025-06-27
Condition(s) studied
Acute PainChronic PainPostoperative Pain
Investigational drug(s) / intervention(s)
Liposomal bupivacaineBupivacaine Hydrochloride
Liposomal bupivacaine: Participants randomized to the intervention arm received 266 mg of liposomal bupivacaine for paravertebral block before surgery.(The volume was expanded to 30 mL with normal saline).
Bupivacaine Hydrochloride: Participants randomized to the intervention arm received 0.5% 100 mg of bupivacaine hydrochloride for paravertebral block before surgery.(The volume was expanded to 30 mL with normal saline)
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Area under the movement-evoked pain intensity-time curve — from 0-72 hours after the intervention Area under the pain intensity-time curve in the movement (or coughing) state within 72h after the intervention.
The incidence of chronic postoperative pain — postoperative day (POD) 90 The incidence of chronic postoperative pain at 90 days
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital of Chongqing Medical University
Chongqing
Chongqing Municipality
Recruiting
More The Second Affiliated Hospital of Chongqing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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