Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Acute Pain
Chronic Pain
Postoperative Pain
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: Chongqing General Hospital
name: LanZhou University
name: Xiangya Hospital of Central South University
name: Sichuan Provincial People&#39;s Hospital
First posted: 2024-08-26
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Area under the movement-evoked pain intensity-time curve
timeFrame: from 0-72 hours after the intervention
measure: The incidence of chronic postoperative pain
timeFrame: postoperative day (POD) 90
Secondary outcomes:
measure: Area under the rest pain intensity-time curve
timeFrame: from 0-72 hours after the intervention
measure: Movement-evoked pain score
timeFrame: 30 minutes after recovery from anesthesia,6 hours, 12hours, 24hours , 48hours and 72 hours after the intervention
measure: Pain score at rest
timeFrame: 30 minutes after recovery from anesthesia,6 hours,12hours, 24hours , 48hours and 72 hours after the intervention
measure: Proportion of participants who did not use rescue analgesia
timeFrame: from 0-72 hours after the intervention
measure: The cumulative dosage of rescue analgesia
timeFrame: from 0-72 hours after the intervention
measure: The time of first use of rescue analgesia
timeFrame: from 0-72 hours after the intervention
measure: First time out-of-bed
timeFrame: From date of surgery until the date of first out-of-bed，assessed up to 7 days
measure: Length of hospital stay
timeFrame: From date of surgery until the date of first hospital discharge，assessed up to 1 months
measure: Chronic pain score
timeFrame: postoperative day (POD) 90
measure: Score of satisfaction with analgesia
timeFrame: At 72 hours after the intervention
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: He Huang, ph.D
role: STUDY_CHAIR
References: