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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Postoperative Pain; Acute Pain
• Intervention / Treatment: Drug: Liposomal bupivacaine; Drug: Bupivacaine Hydrochloride

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 284
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: He Huang, ph.D; Phone Number: 86+13708385559; Email: huanghe@cqmu.edu.cn
• Study Contact Backup: Name: Guangyou Duan, ph.D; Phone Number: 86+18323376014; Email: duangy@hospital.cqmu.edu.cn

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 4000000
      • Recruiting
      • The Second Affiliated Hospital of Chongqing Medical University
      • Contact: He Huang, ph.D; Phone Number: 0086-13708385559; Email: huanghe@cqmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention (liposomal bupivacaine）; Participants randomized to the intervention arm received liposomal bupivacaine for paravertebral block before surgery.	Drug: 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).
Active Comparator: control (bupivacaine hydrochloride); Participants randomized to the intervention arm received bupivacaine hydrochloride for paravertebral block before surgery.	Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the rest pain intensity-time curve	Area under the pain intensity-time curve at rest within 72h after the intervention.	from 0-72 hours after the intervention
Movement-evoked pain score	Use pain Numeric Rating Scale(NRS) to evaluate the movement-evoked pain score at 30minutes after recovery from anesthesia and at 6 hours, 12hours, 24hours , 48hours and 72 hours after the intervention.(NRS scale 0-10, where 0 was no pain, and 10 was the worst possible pain)	30 minutes after recovery from anesthesia,6 hours, 12hours, 24hours , 48hours and 72 hours after the intervention
Pain score at rest	Use pain Numeric Rating Scale(NRS) to evaluate the pain score at rest at 30minutes after recovery from anesthesia and at 6 hours, 12hours, 24hours , 48hours and 72 hours after the intervention.(NRS scale 0-10, where 0 was no pain, and 10 was the worst possible pain)	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	Proportion of participants who did not use rescue analgesia during 0-12 hours, 12-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after the intervention.	from 0-72 hours after the intervention
The cumulative dosage of rescue analgesia	The cumulative dosage of rescue analgesia during 0-12 hours, 12-24 hours, 24-48 hours, 48-72hours and 0-72hours after the intervention.	from 0-72 hours after the intervention
The time of first use of rescue analgesia	The time of first use of rescue analgesia	from 0-72 hours after the intervention
First time out-of-bed	Time of participant's first out-of-bed activity after surgery	From date of surgery until the date of first out-of-bed，assessed up to 7 days
Length of hospital stay	Duration of participants from hospital admission to hospital discharge	From date of surgery until the date of first hospital discharge，assessed up to 1 months
Chronic pain score	Use pain Numeric Rating Scale(NRS) to evaluate the movement-evoked pain score and rest pain score at 90 days after surgery.(NRS scale 0-10, where 0 was no pain, and 10 was the worst possible pain)	postoperative day (POD) 90
Score of satisfaction with analgesia	At 72 hours after the intervention,the participants rated the satisfaction with analgesia.Satisfaction rating scale 0-5,where 0 was poor drug effectiveness, and 5 was excellent drug efficacy)	At 72 hours after the intervention

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Collaborators: Xiangya Hospital of Central South University; LanZhou University; People's Hospital of Chongqing; Shapingba District People's Hospital of Chongqing
• Investigators: Study Chair: He Huang, ph.D, The Second Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Acute Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: LBPB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No