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
284 participants
Aug 26, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- Participants who scheduled for elective video-assisted thoracoscopic lobectomy under general anesthesia.
- Participants were 18 years or older.
- 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 Criteria9
- 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.
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Interventions
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).
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)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06569953