Comparison of Liposomal Bupivacaine Paravertebral Nerve Block Versus Intercostal Nerve Block on Postoperative Glycemic Variability in Patients Undergoing Minimally Invasive Pulmonary Resection: A Randomized Controlled Non-Inferiority Trial

Starting soon · Not applicable

Conditions studied: Thoracic Surgery, Glycemic Variability

In brief

In this randomized controlled non-inferiority trial, we will test whether liposomal bupivacaine intercostal nerve block is non-inferior to paravertebral nerve block for the coefficient of variation (CV) of glucose during the 0- to 48-hour postoperative period, using a non-inferiority margin of Δ = 0.025 for the absolute CV difference. We will also compare the two blocks regarding their effects on postoperative glucose, autonomic function, stress, insulin resistance, acute pain, recovery quality, procedure duration, complications, and hemodynamic stability.

Key facts

Study ID

NCT07754916

Run by

Xiangya Hospital of Central South University

People needed

64

Starts

2026-08-01

Expected to finish

2027-02-28

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18-70 years, with American Society of Anesthesiologists (ASA) physical status I-III, scheduled for uniportal or multiportal video-assisted thoracoscopic (VATS) minimally invasive pulmonary resection under general anesthesia.
• Planned to receive liposomal bupivacaine regional block analgesia under direct thoracoscopic visualization.
• Body mass index (BMI) 18-30 kg/m².
• Willing and able to cooperate with the study procedures and provide written informed consent.

You may not qualify if…

• Regularly taking beta-blockers (for ≥2 weeks) or long-term use of high-dose glucocorticoids (prednisone ≥20 mg/day for >2 weeks).
• Known history of diabetes mellitus, or regular use of glucose-lowering agents (oral agents or insulin) before surgery.
• Planned postoperative admission to the intensive care unit (ICU).
• Concurrent severe cardiac (New York Heart Association class III or higher), hepatic (e.g., cirrhosis), or renal insufficiency (glomerular filtration rate <30 mL/min/1.73 m²), or neuropsychiatric disorders.
• Contraindications to regional block or to any study medication, including but not limited to infection or tumor invasion at the puncture site, coagulation disorders, or allergy to any drug used in the study.
• Alcohol dependence: meeting the DSM-5 criteria for severe alcohol use disorder (AUD), or clinically judged as alcohol dependence (regardless of liver function status).
• Pregnancy or lactation (for men and women of childbearing potential, effective contraception is required until 3 months after surgery, and donation of sperm or eggs is prohibited).
• Participation in another interventional drug trial.
• Regular use of analgesics for acute or chronic pain within 2 weeks before surgery.
• Concurrent severe infection.
• Prior ipsilateral intrathoracic surgery or severe pleural adhesions (estimated to preclude successful thoracoscopic visualization and completion of the block).
• Psychiatric or cognitive disorders that would impair the ability to cooperate with postoperative follow-up.
• Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in the trial (for medical or safety reasons).

Where it is running

• Department of Anesthesiology, Xiangya Hospital, Central South University — Changsha, Hunan, China

Full record on ClinicalTrials.gov

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