About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Paravertebral nerve block
Procedure/SurgeryFollowing induction of general anesthesia, a T3-T8 paravertebral nerve block will be performed by the surgeon under thoracoscopic guidance. Liposomal bupivacaine (6.65 mg/mL) will be diluted with normal saline (20 mL + 20 mL = 40 mL total). Under direct vision, 4.0 mL of the diluted solution will be injected evenly at each level, lateral to the sympathetic chain, for a total liposomal bupivacaine dose of 159.6 mg (24 mL). Injections will be slow and fractionated, with aspiration for blood or cerebrospinal fluid prior to each injection, and care will be taken to prevent overdose and systemic toxicity.
Intercostal nerve block
Procedure/SurgeryFollowing induction of general anesthesia, the surgeon will perform thoracoscopic intercostal nerve blocks using liposomal bupivacaine (prepared as 20 mL of 6.65 mg/mL solution diluted with 20 mL normal saline to 40 mL total) to cover the surgical incision and pleural irritation areas, typically at the 3rd-8th intercostal spaces. Under direct vision, 4.0 mL of the diluted solution will be injected at each space at a site 3-5 cm lateral to the spine, for a total liposomal bupivacaine dose of 159.6 mg (24 mL). Injections will be slow and fractionated, with aspiration for blood or CSF before each injection, and care will be taken to prevent overdose and systemic toxicity.
Treatment groups
Trial outcomes
Primary outcomes
Coefficient of Variation of Blood Glucose
Secondary outcomes
Glycated Serum Protein (GSP)
Heart Rate Variability
Fasting Serum Insulin
Numerical Rating Scale (NRS) Pain Score
Numerical Rating Scale (NRS) Pain Score Scale range: 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate more severe pain.
Sponsors and contacts
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