Liposomal bupivacaine to reduce pain after VATS

The Efficacy and Safety of Liposomal Bupivacaine Plus Bupivacaine Local Incisional Infiltration for Postoperative Pain in Patients Undergoing Video-assisted Thoracoscopic Surgery:A Multi-Center Randomized Controlled Trial

This test will see if a long‑acting liposomal bupivacaine injection at the incision eases postoperative pain for adults having VATS lung surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07432711 on ClinicalTrials.gov

What this trial studies

This interventional trial compares incision-site local injection of standard bupivacaine to liposomal bupivacaine combined with bupivacaine in adults undergoing elective video-assisted thoracoscopic lobectomy or wedge resection. Participants receive the assigned local anesthetic at the surgical incision and are followed after surgery for pain scores, opioid consumption, and postoperative complications. Liposomal bupivacaine is a sustained-release formulation intended to provide analgesia for up to 72 hours, which the trial will test against conventional bupivacaine infiltration. Outcomes will focus on acute postoperative pain control and measures related to recovery and adverse events.

Who should consider this trial

Good fit: Adults 18–64 years old with ASA physical status I–III scheduled for elective VATS lobectomy or wedge resection who can give informed consent and have no chronic pain or other exclusion criteria.

Not a fit: Patients with chronic pain syndromes, certain cardiac conduction problems, unstable coronary disease, uncontrolled bleeding or coagulation disorders, insulin-treated diabetes, or those on unpaused anticoagulants are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could provide longer-lasting incision-site pain relief after VATS, reduce opioid use, and speed recovery.

How similar studies have performed: Some prior studies have reported improved analgesia with liposomal bupivacaine versus standard local anesthetics, but results have been mixed and heterogeneous.

Eligibility criteria

Inclusion Criteria:

1. Patients scheduled for elective video-assisted thoracoscopic lobectomy or wedge resection under general anesthesia;
2. Ages 18 to 64 years old；
3. American Society of Anesthesiologists (ASA) physical status of I-III；
4. Glasgow Coma Scale (GCS) score of 15；
5. Patients must be able to understand the nature and potential personal consequences of the clinical trial, signing of the informed consent form.

Exclusion Criteria:

1. History of chronic pain syndrome of any cause.
2. Patients with heart conduction block (sinus block or atrioventricular block).
3. Patients with unstable coronary artery disease.
4. Patients with gastric ulcer or gastric bleeding.
5. Patients with diabetes and are being treated with insulin.
6. Subjects with coagulation dysfunction (prothrombin time or activated partial thromboplastin time is higher than the normal threshold) or patients who are taking oral anticoagulants for other medical reasons and have not stopped it before surgery, such as warfarin or new anticoagulants rivaroxaban or dabigatran.
7. Patients with abnormal liver function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 2× the upper limit of normal (ULN) or total bilirubin (TBIL) ≥ 1.5×ULN.
8. Patients with renal impairment (serum creatinine \> 176 µmol/L) or receiving dialysis treatment within 28 days before surgery.
9. Patients with a history of diagnosed mental illness or currently taking psychotropic medication.
10. Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 h before surgery.
11. Pregnancy or breastfeeding.
12. Extreme body mass index (BMI) (\< 15 or \> 35).
13. Participation in another interventional trial that interferes with the intervention or outcome of this trial.
14. Patients with a history of allergy to local anaesthetics or one of the study drugs.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Fang Luo

Conditions Video-assisted Thoracoscopic Surgery; Pain Management; Liposomal Bupivacaine; Local Injection