The objective of this study is to evaluate the efficacy, safety, and tolerability of bupivacaine liposomes for paravertebral nerve block in the treatment of thoracoscopic postoperative pain, and to evaluate the relevant human pharmacokinetics.
Subjects who are willing to strictly follow the clinical trial protocol to complete this study and voluntarily sign informed consent;
Elective surgical subjects undergoing lobectomy by single-aperture thoracoscope under general anesthesia;
age ≥18 years old , Male or female;
18 kg/m2≤BMI≤30 kg/m2;
Abnormal laboratory results during screening.
Abnormal renal function: serum creatinine (Cr) ≥1.5×ULN, or dialysis subjects.
Abnormal coagulation function: PT> upper normal value +3s and/or APTT > upper normal value +10s.
Platelet (PLT) <80×109/L.
Parallel
Bupivacaine Liposome Injection
DrugBupivacaine Liposome Injection Low Dose or Moderate Dose or High Dose
Bupivacaine Hydrochloride Injection
DrugBupivacaine Hydrochloride Injection Low Dose or Moderate Dose or High Dose
Area under the time curve of pain intensity during exercise (or cough) for 72 hours after administration
Area under the curve of pain intensity and time in exercise (or cough) state in 0-12h, 12-24h, 12-48h and 12-72h after administration
Area under the curve of pain intensity and time in resting state in 0-12h, 12-24h, 12-48h, 12-72h and 0-72h after administration
Pain intensity scores in resting state and exercise (or cough) state, including within 30 minutes after anesthesia recovery and various time points after administration (6h, 8h, 12h, 18h, 24h, 30h, 36h, 48h, 72h)
The duration of the first pain intensity score ≥4 points during exercise (or cough) after anesthesia recovery
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