Thoracic Surgery, Glycemic Variability
Conditions
Brief summary
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.
Interventions
PROCEDUREParavertebral nerve block
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.
PROCEDUREIntercostal nerve block
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.
Sponsors
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Planned to receive liposomal bupivacaine regional block analgesia under direct thoracoscopic visualization. 3. Body mass index (BMI) 18-30 kg/m². 4. Willing and able to cooperate with the study procedures and provide written informed consent.
Exclusion criteria
1. Regularly taking beta-blockers (for ≥2 weeks) or long-term use of high-dose glucocorticoids (prednisone ≥20 mg/day for \>2 weeks). 2. Known history of diabetes mellitus, or regular use of glucose-lowering agents (oral agents or insulin) before surgery. 3. Planned postoperative admission to the intensive care unit (ICU). 4. 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. 5. 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. 6. Alcohol dependence: meeting the DSM-5 criteria for severe alcohol use disorder (AUD), or clinically judged as alcohol dependence (regardless of liver function status). 7. 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). 8. Participation in another interventional drug trial. 9. Regular use of analgesics for acute or chronic pain within 2 weeks before surgery. 10. Concurrent severe infection. 11. Prior ipsilateral intrathoracic surgery or severe pleural adhesions (estimated to preclude successful thoracoscopic visualization and completion of the block). 12. Psychiatric or cognitive disorders that would impair the ability to cooperate with postoperative follow-up. 13. Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in the trial (for medical or safety reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coefficient of Variation of Blood Glucose | 48 hours post-surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycated Serum Protein (GSP) | Preoperatively and on the first postoperative day | — |
| Heart Rate Variability | Preoperatively and on the first postoperative day, the second postoperative day, and the third postoperative day | — |
| Fasting Serum Insulin | Preoperatively and on the first postoperative day | — |
| Numerical Rating Scale (NRS) Pain Score | Preoperatively and on the first postoperative day, the second postoperative day, and the third postoperative day | Numerical Rating Scale (NRS) Pain Score Scale range: 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate more severe pain. |
| Fasting C peptide | Preoperatively and on the first postoperative day | Serum fasting C-peptide concentration measured by chemiluminescent immunoassay |
| Cortisol | Preoperatively and on the first postoperative day | Serum cortisol concentration measured by chemiluminescent immunoassay |
Countries
China
Contacts
CONTACTYingqi Weng, MD
CONTACTHongying Zhu
PRINCIPAL_INVESTIGATORYingqi Weng, MD
Department of Anesthesiology, Xiangya Hospital, Central South University
Outcome results
None listed