NCT06529432 A Study of Bupivacaine Liposome Injection in the Treatment of Pain After Thoracoscopic Surgery
| NCT ID | NCT06529432 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Condition | Local Analgesia Via Nerve Block |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2026-03-03 |
| Primary Completion | 2026-11 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Subjects who are willing to strictly follow the clinical trial protocol to complete this study and voluntarily sign informed consent; 2. Elective surgical subjects undergoing lobectomy by single-aperture thoracoscope under general anesthesia; 3. age ≥18 years old , Male or female; 4. 18 kg/m2≤BMI≤30 kg/m2; 5. ASA Physical Status Classification I-II; 6. 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: Participants with any of the following criteri