NCT07754916尚未招募不适用
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
Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2026年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Coefficient of Variation of Blood Glucose
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
- •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).
研究组 & 干预措施
treatment group
Experimental
干预措施: Paravertebral nerve block (Procedure)
control group
Active Comparator
干预措施: Intercostal nerve block (Procedure)
结局指标
主要结局
Coefficient of Variation of Blood Glucose
时间窗: 48 hours post-surgery
次要结局
- Fasting Serum Insulin(Preoperatively and on the first postoperative day)
- 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)
- Numerical Rating Scale (NRS) Pain Score(Preoperatively and on the first postoperative day, the second postoperative day, and the third postoperative day)
- Cortisol(Preoperatively and on the first postoperative day)
- Fasting C peptide(Preoperatively and on the first postoperative day)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
The Effect of Liposomal Bupivacaine Erector Spinae Plane BlockLiposome BupivacaineErector Spinae Plane BlockPostoperative AnalgesiaRandomized Controlled TrialNCT07667439Second Affiliated Hospital, School of Medicine, Zhejiang University148
Enrolling By Invitation
不适用
Effect of Liposomal Bupivacaine and Bupivacaine Hydrochloride for Superior Trunk Block of the Interscalene Brachial Plexus on Postoperative Diaphragmatic Function and AnalgesiaProximal Humerus SurgeryRotator Cuff SurgeryShoulder ArthroplastyShoulder ArthroscopyNCT07587203Nanjing First Hospital, Nanjing Medical University184
尚未招募
4 期
Effect of Liposomal Bupivacaine on Rebound Pain After Peripheral Nerve Block in Orthopedic Surgery.Acute PainOrthopaedic SurgeryNCT07606911Shanghai Jiao Tong University Affiliated Sixth People's Hospital668
尚未招募
4 期
Bupivacaine Liposome Suspension Administration to Decreasre Peri-procedural Pain in Interventional Radiology (IR) ProceduresAnalgesia AssessmentNCT07535411Massachusetts General Hospital10
尚未招募
4 期
The Effect of Bupivacaine Liposomes on Postoperative Pain in Lung Transplant Patients After Intercostal Nerve Block: a Randomized Controlled StudyLung TransplantationPain ManagementLiposomal BupivacaineNCT07641647Second Affiliated Hospital, School of Medicine, Zhejiang University88