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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorXiangya Hospital of Central South University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Paravertebral nerve block

    Procedure/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 block

    Procedure/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.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: treatment groupExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Coefficient of Variation of Blood Glucose

Time frame
48 hours post-surgery

Secondary outcomes

1

Glycated Serum Protein (GSP)

Time frame
Preoperatively and on the first postoperative day
2

Heart Rate Variability

Time frame
Preoperatively and on the first postoperative day, the second postoperative day, and the third postoperative day
3

Fasting Serum Insulin

Time frame
Preoperatively and on the first postoperative day
4

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

Other outcomes

Sponsors and contacts

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