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

NCT06569953 | Recruiting Phase 4

• 1 other identifier: LBPB
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

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 thoracoscopic lobectomy.

Conditions

Acute Pain; Chronic Pain; Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• Area under the movement-evoked pain intensity-time curve

  Area under the pain intensity-time curve in the movement (or coughing) state within 72h after the intervention.

  from 0-72 hours after the intervention

• The incidence of chronic postoperative pain

  The incidence of chronic postoperative pain at 90 days

  postoperative day (POD) 90

Secondary Outcomes (10)

• Area under the rest pain intensity-time curve

  from 0-72 hours after the intervention

• Movement-evoked pain score

  30 minutes after recovery from anesthesia,6 hours, 12hours, 24hours , 48hours and 72 hours after the intervention

• Pain score at rest

  30 minutes after recovery from anesthesia,6 hours,12hours, 24hours , 48hours and 72 hours after the intervention

• Proportion of participants who did not use rescue analgesia

  from 0-72 hours after the intervention

• The cumulative dosage of rescue analgesia

  from 0-72 hours after the intervention

Study Arms (2)

intervention (liposomal bupivacaine）

EXPERIMENTAL

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

Drug: Liposomal bupivacaine

control (bupivacaine hydrochloride)

ACTIVE COMPARATOR

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

Drug: Bupivacaine Hydrochloride

Interventions

Liposomal bupivacaine DRUG

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).

intervention (liposomal bupivacaine）

Bupivacaine Hydrochloride DRUG

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)

control (bupivacaine hydrochloride)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who scheduled for elective video-assisted thoracoscopic lobectomy under general anesthesia.
• Participants were 18 years or older.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead
• People's Hospital of Chongqing: collaborator
• LanZhou University: collaborator
• Xiangya Hospital of Central South University: collaborator
• Shapingba District People's Hospital of Chongqing: collaborator

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 4000000, China

RECRUITING

MeSH Terms

Conditions

Acute Pain; Chronic Pain; Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• He Huang, ph.D

  The Second Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

Central Study Contacts

He Huang, ph.D

CONTACT

86+13708385559; huanghe@cqmu.edu.cn

Guangyou Duan, ph.D

CONTACT

86+18323376014; duangy@hospital.cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization was performed in a 1:1 ratio with the use of block randomization.SAS software (version 9.4 or higher) was used to generate the random number and the treatment group to which the random number was assigned.Assignment of Randomization Numbers Using the Interactive Web Response System (IWRS).

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 26, 2024
• Study Start: August 26, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

CN (1)