Status:
RECRUITING
Liposomal and Standard Bupivacaine in Thoracic Paravertebral Block for Post-Thoracoscopic Pain
Lead Sponsor:
Yongtao Sun
Conditions:
Thoracic Paravertebral Block
Postoperative Analgesia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
I. Research purpose 1.1 Main Objective: To investigate the efficacy and safety of bupivacaine liposome thoracic paravertebral nerve block for postoperative analgesia after thoracoscopic lobectomy 1....
Detailed Description
Standard monitoring, including electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (NIBP), pulse oxygen saturation (SpO2), end-tidal carbon dioxide (ETCo2), and bispectral index (BI...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
496 Patients enrolled
Trial Details
Trial ID
NCT06165991
Start Date
June 1 2024
End Date
January 31 2026
Last Update
January 9 2026
Active Locations (1)
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1
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Jinan, Shandong, China, 250014