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

Chongqing Medical University

Status and phase: Enrolling; Phase 4

Conditions: Postoperative Pain; Chronic Pain; Acute Pain

Treatments: Drug: Liposomal bupivacaine; Drug: Bupivacaine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06569953

LBPB

Details and patient eligibility

About

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.

Full 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 will:1.Received liposomal bupivacaine or bupivacaine paravertebral block before surgery. 2.Keep a diary of their pain scores within 30min after recovery from anesthesia and 6h, 12h, 24h, 48h, 72h and 90d after the beginning of injection of experimental drugs.

Enrollment: 284 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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284 participants in 2 patient groups

intervention (liposomal bupivacaine）

Experimental group

Description:

Participants randomized to the intervention arm received liposomal bupivacaine for paravertebral block before surgery.

Treatment:

Drug: Liposomal bupivacaine

control (bupivacaine hydrochloride)

Active Comparator group

Description:

Participants randomized to the intervention arm received bupivacaine hydrochloride for paravertebral block before surgery.

Treatment:

Drug: Bupivacaine Hydrochloride