A Study of Bupivacaine Liposome Injection in the Treatment of Pain After Thoracoscopic Surgery (NCT06529432) | Clinical Trial Compass
RecruitingPhase 2
A Study of Bupivacaine Liposome Injection in the Treatment of Pain After Thoracoscopic Surgery
China96 participantsStarted 2026-03-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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;
✓. ASA Physical Status Classification I-II;
✓. Female subjects of childbearing potential must agree to use contraception and refrain from egg donation from the signing of the informed consent form until 30 days after the last dose of the investigational drug. Serum or urine pregnancy tests must be negative before dosing and during the trial, and they must not be lactating. Male subjects with partners of childbearing potential must agree to use contraception and refrain from sperm donation from the signing of the informed consent form until 30 days after the last dose of the investigational drug.
Exclusion criteria
✕. Pre-existing and combined diseases:
✕. Abnormal laboratory results during screening.
✕. Screening period heart rate \< 50 beats/min or heart rate \> 100 beats/min; 12-lead ECG QTc interval prolonged: male ≥450ms, female ≥470ms.
✕. Subjects with refractory hypertension or a history of refractory hypertension before randomization.
✕
What they're measuring
1
Area under the time curve of pain intensity during exercise (or cough) for 72 hours after administration
Timeframe: 0 minute to 72 hours after administration
. Subjects who allergic to or contraindicated with bupivacaine, other amide local anesthetics, and other drugs that may be used during the trial (e.g., propofol, remazolam, opioids, etc.).
✕. Subjects who used any of the following drugs within 5 drug half-lives prior before randomization (drug half-lives are based on actual drug instructions, or at least 48 hours of elution if half-lives are unknown):