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
Overview
- Phase
- Phase 4
- Intervention
- Liposomal bupivacaine
- Conditions
- Acute Pain
- Sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Enrollment
- 284
- Locations
- 1
- Primary Endpoint
- The incidence of chronic postoperative pain
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
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.
Arms & Interventions
intervention (liposomal bupivacaine）
Participants randomized to the intervention arm received liposomal bupivacaine for paravertebral block before surgery.
Intervention: Liposomal bupivacaine
control (bupivacaine hydrochloride)
Participants randomized to the intervention arm received bupivacaine hydrochloride for paravertebral block before surgery.
Intervention: Bupivacaine Hydrochloride
Outcomes
Primary Outcomes
The incidence of chronic postoperative pain
Time Frame: postoperative day (POD) 90
The incidence of chronic postoperative pain at 90 days
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.
Secondary Outcomes
- 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)
- Proportion of participants who did not use rescue analgesia(from 0-72 hours after the intervention)
- Score of satisfaction with analgesia(At 72 hours after the intervention)
- The cumulative dosage of rescue analgesia(from 0-72 hours after the intervention)
- Length of hospital stay(From date of surgery until the date of first hospital discharge，assessed up to 1 months)
- Chronic pain score(postoperative day (POD) 90)
- Pain score at rest(30 minutes after recovery from anesthesia,6 hours,12hours, 24hours , 48hours and 72 hours after the intervention)
- The time of first use of rescue analgesia(from 0-72 hours after the intervention)
- First time out-of-bed(From date of surgery until the date of first out-of-bed，assessed up to 7 days)