About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Bupivacaine Liposome Injection
- Bupivacaine Hydrochloride Injection