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NCT Number: NCT06569953

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 4000000, China

Location status: Recruiting

Location contact

He Huang, ph.D

CONTACT

[email protected]

0086-13708385559

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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)

Primary outcomes

  1. Area under the movement-evoked pain intensity-time curve

    Time frame: from 0-72 hours after the intervention

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

  2. The incidence of chronic postoperative pain

    Time frame: postoperative day (POD) 90

    The incidence of chronic postoperative pain at 90 days

Secondary outcomes

  1. Area under the rest pain intensity-time curve

    Time frame: from 0-72 hours after the intervention

    Area under the pain intensity-time curve at rest within 72h after the intervention.

  2. Movement-evoked pain score

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

    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)

  3. Pain score at rest

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

    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)

  4. Proportion of participants who did not use rescue analgesia

    Time frame: from 0-72 hours after the intervention

    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.

  5. The cumulative dosage of rescue analgesia

    Time frame: from 0-72 hours after the intervention

    The cumulative dosage of rescue analgesia during 0-12 hours, 12-24 hours, 24-48 hours, 48-72hours and 0-72hours after the intervention.

  6. The time of first use of rescue analgesia

    Time frame: from 0-72 hours after the intervention

    The time of first use of rescue analgesia

  7. First time out-of-bed

    Time frame: From date of surgery until the date of first out-of-bed，assessed up to 7 days

    Time of participant's first out-of-bed activity after surgery

  8. Length of hospital stay

    Time frame: From date of surgery until the date of first hospital discharge，assessed up to 1 months

    Duration of participants from hospital admission to hospital discharge

  9. Chronic pain score

    Time frame: postoperative day (POD) 90

    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)

  10. Score of satisfaction with analgesia

    Time frame: At 72 hours after the intervention

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Guangyou Duan, ph.D

CONTACT

[email protected]

86+18323376014

He Huang, ph.D

CONTACT

[email protected]

86+13708385559

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Collaborators

  • LanZhou University
  • People's Hospital of Chongqing
  • Shapingba District People's Hospital of Chongqing
  • Xiangya Hospital of Central South University

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2024
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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