Thoracic SurgeryNCT07754916
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
A study testing Paravertebral nerve block and Intercostal nerve block in people with Thoracic Surgery and Glycemic Variability, run by Xiangya Hospital of Central South University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thoracic Surgery, Glycemic Variability
- What is being tested?
- Paravertebral nerve block and Intercostal nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 28 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Anesthesiology, Xiangya Hospital, Central South University
Changsha, Hunan, 410000
Yingqi Weng, MD, +86-15074834690, 651922615@qq.com
Hongying Zhu, +86-15970330540, 2506627021@qq.com
About this study
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.
- Conditions
- Thoracic Surgery, Glycemic Variability
- Being tested
- Paravertebral nerve block, Intercostal nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral nerve blockProcedure or surgery
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.
Intercostal nerve blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Not described Receives: Procedure: Paravertebral nerve block |
| control group | Active comparator | Not described Receives: Procedure: Intercostal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of Variation of Blood Glucose
Measured: 48 hours post-surgery
Secondary outcomes (6)
Glycated Serum Protein (GSP)
Measured: Preoperatively and on the first postoperative day
Heart Rate Variability
Measured: Preoperatively and on the first postoperative day, the second postoperative day, and the third postoperative day
Fasting Serum Insulin
Measured: 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.
Measured: 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
Measured: Preoperatively and on the first postoperative day
Cortisol
Serum cortisol concentration measured by chemiluminescent immunoassay
Measured: Preoperatively and on the first postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingqi Weng, MD, Principal investigator, Department of Anesthesiology, Xiangya Hospital, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754916
- Sponsor's protocol ID
- Ethics Approval No. 202606086
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.