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
NCT ID: NCT06569953
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
284 participants
INTERVENTIONAL
2024-08-26
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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intervention (liposomal bupivacaine)
Participants randomized to the intervention arm received liposomal bupivacaine for paravertebral block before surgery.
Liposomal bupivacaine
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).
control (bupivacaine hydrochloride)
Participants randomized to the intervention arm received bupivacaine hydrochloride for paravertebral block before surgery.
Bupivacaine Hydrochloride
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)
Interventions
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Liposomal bupivacaine
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).
Bupivacaine Hydrochloride
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)
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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People's Hospital of Chongqing
OTHER
LanZhou University
OTHER
Xiangya Hospital of Central South University
OTHER
Shapingba District People's Hospital of Chongqing
UNKNOWN
The Second Affiliated Hospital of Chongqing Medical University
OTHER
Responsible Party
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Principal Investigators
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He Huang, ph.D
Role: STUDY_CHAIR
The Second Affiliated Hospital of Chongqing Medical University
Locations
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The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LBPB
Identifier Type: -
Identifier Source: org_study_id
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