Using liposomal bupivacaine for pain relief after lung surgery
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
This study is testing whether a new form of pain relief called liposomal bupivacaine can help people manage pain better after lung surgery compared to the standard treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 284 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Second Affiliated Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT06569953 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of liposomal bupivacaine administered via paravertebral block for managing acute and chronic pain following video-assisted thoracoscopic lobectomy. Participants will receive either liposomal bupivacaine or standard bupivacaine before surgery and will track their pain levels at various intervals post-surgery. The study is designed as a multicenter, randomized, double-blind, controlled trial to ensure robust results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective video-assisted thoracoscopic lobectomy.
Not a fit: Patients with severe cardiovascular or cerebrovascular diseases, psychiatric disorders, or other significant pain conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide more effective pain management for patients undergoing lung surgery.
How similar studies have performed: Other studies have shown promise with liposomal formulations for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chongqing, Chongqing Municipality
- The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Study coordinator: He Huang, ph.D
- Email: huanghe@cqmu.edu.cn
- Phone: 86+13708385559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.