About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Liposomal bupivacaine
DrugParticipants 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
DrugParticipants 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)
Treatment groups
Trial outcomes
Primary outcomes
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.
The incidence of chronic postoperative pain
The incidence of chronic postoperative pain at 90 days
Secondary outcomes
Area under the rest pain intensity-time curve
Area under the pain intensity-time curve at rest within 72h 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)
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)
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.
Sponsors and contacts
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The Second Affiliated Hospital of Chongqing Medical University
Lead sponsor
People's Hospital of Chongqing
Collaborator
LanZhou University
Collaborator
Xiangya Hospital of Central South University
Collaborator
Shapingba District People's Hospital of Chongqing
Collaborator