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

Launched by THE SECOND AFFILIATED HOSPITAL OF CHONGQING MEDICAL UNIVERSITY · Aug 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called liposomal Bupivacaine, which is given through a specific injection to help manage pain after a type of surgery known as video-assisted thoracoscopic lobectomy. The goal of the trial is to find out how effective and safe this treatment is for people experiencing both acute (short-term) and chronic (long-term) pain after their surgery.

To participate in the trial, individuals must be at least 18 years old and scheduled for the surgery. They also need to have a certain range of body weight and overall health, as determined by a medical assessment. Participants will be closely monitored throughout the study and will have the chance to learn more about the potential benefits and risks of this new treatment. It’s important to note that people with certain health conditions or who are currently taking specific medications may not be eligible to join. This trial aims to improve pain management options for patients undergoing this type of surgery.

Gender

ALL

Eligibility criteria

• 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.