Liposomal versus standard bupivacaine for thoracic paravertebral block after thoracoscopic lobectomy

The Effect of Bupivacaine Liposome Combined With Bupivacaine Hydrochloride on Thoracic Paravertebral Nerve Block for Postoperative Pain After Thoracoscopic Lung Surgery

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
• Enrollment: 496 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qianfoshan Hospital (Academic / other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06165991 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Jinan, Shandong

• Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: yong t Sun, PH.D

Conditions Thoracic Paravertebral Block; Postoperative Analgesia; Thoracoscopic Lobectomy; liposomal bupivacaine; Thoracic paravertebral nerve block; Postoperative analgesia; thoracoscopic lobectomy