Status:
RECRUITING
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
Lead Sponsor:
The Second Affiliated Hospital of Chongqing Medical University
Collaborating Sponsors:
People's Hospital of Chongqing
LanZhou University
Conditions:
Acute Pain
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 tho...
Detailed 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 wil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT06569953
Start Date
August 26 2024
End Date
August 31 2025
Last Update
June 27 2025
Active Locations (1)
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1
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 4000000