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

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 Overview

• Status: Not yet recruiting
• Conditions: Thoracic Surgery; Glycemic Variability
• Intervention / Treatment: Procedure: Paravertebral nerve block; Procedure: Intercostal nerve block

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yingqi Weng, MD; Phone Number: +86-15074834690; Email: 651922615@qq.com
• Study Contact Backup: Name: Hongying Zhu; Phone Number: +86-15970330540; Email: 2506627021@qq.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410000
      • Department of Anesthesiology, Xiangya Hospital, Central South University
      • Contact: Yingqi Weng, MD; Phone Number: +86-15074834690; Email: 651922615@qq.com
      • Contact: Hongying Zhu; Phone Number: +86-15970330540; Email: 2506627021@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group	Procedure: Intercostal 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.
Experimental: treatment group	Procedure: Paravertebral 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Coefficient of Variation of Blood Glucose	48 hours post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Numerical Rating Scale (NRS) Pain Score Scale range: 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate more severe pain.	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	Preoperatively and on the first postoperative day
Cortisol	Serum cortisol concentration measured by chemiluminescent immunoassay	Preoperatively and on the first postoperative day

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University
• Investigators: Principal Investigator: Yingqi Weng, MD, Department of Anesthesiology, Xiangya Hospital, Central South University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: July 28, 2026
• First Submitted That Met QC Criteria: August 4, 2026
• First Posted (Actual): August 10, 2026

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Ethics Approval No. 202606086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared externally. All raw data are restricted to the research team to protect participants' privacy. Data sharing plans have not been established at this stage.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No