Department of Anesthesiology, Xiangya Hospital, Central South University
Changsha, Hunan, 410000, China
Location contact
Hongying Zhu
CONTACT
Yingqi Weng, MD
CONTACT
NCT Number: NCT07754916
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
Changsha, Hunan, 410000, China
Hongying Zhu
CONTACT
Yingqi Weng, MD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 48 hours post-surgery
Time frame: Preoperatively and on the first postoperative day
Time frame: Preoperatively and on the first postoperative day, the second postoperative day, and the third postoperative day
Time frame: Preoperatively and on the first postoperative day
Time frame: 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.
Time frame: Preoperatively and on the first postoperative day
Time frame: Preoperatively and on the first postoperative day
Contact information is provided by the study sponsor or research team.
Hongying Zhu
CONTACT
Yingqi Weng, MD
CONTACT
Xiangya Hospital of Central South University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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