Liposomal versus standard bupivacaine for thoracic paravertebral block after thoracoscopic lobectomy
Official title: The Effect of Bupivacaine Liposome Combined With Bupivacaine Hydrochloride on Thoracic Paravertebral Nerve Block for Postoperative Pain After Thoracoscopic Lung Surgery
Run by Qianfoshan Hospital · NCT06165991 · Data updated 2026-11-12
This test checks whether adding long-acting liposomal bupivacaine to standard bupivacaine for thoracic paravertebral nerve blocks reduces pain after thoracoscopic lobectomy in adults.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 496 (estimated) |
| Sponsor | Qianfoshan Hospital Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | January 30, 2026 |
| Study ends | January 31, 2026 |
| Registry record updated | January 9, 2026 |
| Trial ID | NCT06165991 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) scheduled for a first-time unilateral thoracoscopic lobectomy with ASA physical status I–III who can give informed consent and meet liver, kidney, and medication criteria are ideal candidates.
✕Probably not a fit
Patients who are pregnant or lactating, have significant liver or renal dysfunction, long-term opioid use, allergy to local anesthetics, multiple chest drains, or who had wedge resections are unlikely to be eligible or to receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults undergoing unilateral thoracoscopic lobectomy receive ultrasound-guided thoracic paravertebral blocks at T4-5, T6-7, and T8-9 with set volumes of local anesthetic. One group receives a mixture of 10 mL 1.33% liposomal bupivacaine (133 mg) plus 10 mL 0.5% bupivacaine hydrochloride, while the control group receives 20 mL 0.5% bupivacaine hydrochloride (100 mg). All patients have standardized total intravenous anesthesia and intraoperative monitoring, and postoperative pain control and safety are tracked to compare analgesic effect and adverse events. The protocol is designed to determine whether the liposomal formulation provides noninferior or improved postoperative analgesia compared with standard bupivacaine.
Why it matters
Potential benefit: If successful, this approach could provide longer-lasting pain relief and reduce opioid use after thoracoscopic lobectomy.
How similar studies have gone: Previous studies of liposomal bupivacaine in regional nerve blocks have produced mixed results, with some showing longer analgesia and opioid sparing and others showing no clear advantage over standard bupivacaine.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Jinan, Shandong, China Recruiting
Study contacts
- Study coordinator: yong t Sun, PH.D
- Email: sunyongtao1979@163.com
- Phone: 18660795201
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.