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Recruiting 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

Phase IV Interventional Acute Pain Chronic Pain Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Liposomal bupivacaine, Bupivacaine Hydrochloride.
Who it may be relevant to
Registry conditions: Acute Pain, Chronic Pain, Postoperative Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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.

Interventions

  • 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).
  • 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)

Primary outcome measures

  • Area under the movement-evoked pain intensity-time curve [Time frame: from 0-72 hours after the intervention]
  • The incidence of chronic postoperative pain [Time frame: postoperative day (POD) 90]
Secondary outcome measures (10)
  • Area under the rest pain intensity-time curve [Time frame: from 0-72 hours after the intervention]
  • Movement-evoked pain score [Time frame: 30 minutes after recovery from anesthesia,6 hours, 12hours, 24hours , 48hours and 72 hours after the intervention]
  • Pain score at rest [Time frame: 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 [Time frame: from 0-72 hours after the intervention]
  • The cumulative dosage of rescue analgesia [Time frame: from 0-72 hours after the intervention]
  • The time of first use of rescue analgesia [Time frame: from 0-72 hours after the intervention]
  • First time out-of-bed [Time frame: From date of surgery until the date of first out-of-bed，assessed up to 7 days]
  • Length of hospital stay [Time frame: From date of surgery until the date of first hospital discharge，assessed up to 1 months]
  • Chronic pain score [Time frame: postoperative day (POD) 90]
  • Score of satisfaction with analgesia [Time frame: At 72 hours after the intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital of Chongqing Medical University — Chongqing

Identifiers

NCT: NCT06569953 · LBPB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗