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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
Following 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.
Following 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.
Department of Anesthesiology, Xiangya Hospital, Central South University
Changsha, Hunan, China
Coefficient of Variation of Blood Glucose
Time frame: 48 hours post-surgery
Glycated Serum Protein (GSP)
Time frame: Preoperatively and on the first postoperative day
Heart Rate Variability
Time frame: Preoperatively and on the first postoperative day, the second postoperative day, and the third postoperative day
Fasting Serum Insulin
Time frame: Preoperatively and on the first postoperative day
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.
Time frame: Preoperatively and on the first postoperative day, the second postoperative day, and the third postoperative day
Fasting C peptide
Serum fasting C-peptide concentration measured by chemiluminescent immunoassay
Time frame: Preoperatively and on the first postoperative day
Cortisol
Serum cortisol concentration measured by chemiluminescent immunoassay
Time frame: Preoperatively and on the first postoperative day
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