Actively Recruiting
A Study of Bupivacaine Liposome Injection in the Treatment of Pain After Thoracoscopic Surgery
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-03-12
96
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Bupivacaine Liposome Injection in the Treatment of Pain After Thoracoscopic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to strictly follow the clinical trial protocol and voluntarily sign informed consent
- Undergoing elective lobectomy by single-aperture thoracoscope under general anesthesia
- Age 18 years or older, male or female
- Body mass index (BMI) between 18 kg/m2 and 30 kg/m2
- ASA Physical Status Classification I-II
- Female subjects of childbearing potential must agree to use contraception and have negative pregnancy tests before and during the trial; must not be lactating
- Male subjects with partners of childbearing potential must agree to use contraception
You will not qualify if you...
- History of myocardial infarction, unstable angina, severe arrhythmias (second degree or above), or NYHA grade II or higher within 6 months before randomization
- History of ischemic stroke or transient ischemic attack (TIA)
- Psychiatric disorders such as schizophrenia or depression, or cognitive dysfunction
- Sensory disorders like hyperalgesia
- Other physical pain that may affect postoperative pain evaluation
- Airway or spinal anatomical factors causing ventilation obstruction, bronchiectasis, or severe thoracic adhesion
- Abnormal lab results during screening, including high fasting blood glucose (≥10.0 mmol/L), abnormal liver function (AST, ALT, or bilirubin ≥1.5× ULN), abnormal renal function (creatinine ≥1.5× ULN or dialysis), abnormal coagulation, low platelets (<80×10^9/L), or low hemoglobin (<70 g/L)
- Heart rate below 50 or above 100 beats per minute during screening; prolonged QTc interval (≥450 ms in males, ≥470 ms in females)
- Refractory hypertension or history thereof before randomization
- Allergy or contraindication to bupivacaine, amide local anesthetics, or drugs used in the trial
- Use of certain drugs within 5 half-lives before randomization, including class III antiarrhythmics, strong CYP1A2 and CYP3A4 inhibitors or inducers, corticosteroids, sedatives, pain relief drugs such as NSAIDs (except steady aspirin use ≤100 mg/day), opioids, anticonvulsants, and antidepressants
- History of substance, drug, or alcohol abuse within 1 year prior to randomization
- Excessive consumption of tea, coffee, grapefruit or caffeinated beverages in the 14 days prior to randomization
- Participation in other clinical trials or receipt of investigational drugs/devices within 3 months prior to randomization
- Any other factors deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
T
Thea Yu
CONTACT
J
Jian Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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