A Study of Bupivacaine Liposome Injection in the Treatment of Pain After Thoracoscopic Surgery

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu HengRui Medicine Co., Ltd.

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

Treatment groups

96 Participants
are divided into 2 treatment groups