Efficacy and Safety of Liposomal Bupivacaine in Thoracic Paravertebral Nerve Block

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

I. Research purpose

1.1 Main Objective: To investigate the efficacy and safety of bupivacaine liposome thoracic paravertebral nerve block combined with drainage tube analgesia for postoperative analgesia after thoracoscopic lobectomy

1.2 Secondary objective: To investigate the efficacy and safety of drainage tube analgesia after thoracoscopic lobectomy

1.3 Exploratory Objective: To investigate the noninferiority of bupivacaine liposomes in thoracic paravertebral nerve block with standard bupivacaine

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yongtao Sun
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• 1) Age ≥18 years old;

2) Patients undergoing unilateral initial thoracoscopic lobectomy under general anesthesia (TV or robot-assisted);

3) American Society of Anesthesiologists (ASA) Grade I - III;

4) Voluntarily participate in the study and sign the informed consent.

Exclusion Criteria:

• 1) Pregnant or lactating women;

2) Pulmonary wedge-shaped resection;

3) ≥2 thoracic drainage tubes;

4) Abnormal liver function: ALT and/or AST>2×ULN, or

TBIL≥1.5×ULN;

5) Renal function impairment (serum creatinine >176μmol/L), or received dialysis treatment within 28 days before surgery;

6) Participate in another research trial involving an investigational drug within 6 months;

7) A history of drug or alcohol abuse;

8) Long-term use of opioids (more than 3 months or more than 5 mg daily morphine equivalent per day for 1 month);

9) History of allergy to local anesthetics or one of the investigational drugs;

10) Uncontrolled mental or neurological symptoms.