NCT07667439尚未招募不适用
The Effect of Liposomal Bupivacaine Erector Spinae Plane Block on Postoperative Pain in Patients Undergoing Open Upper Abdominal Surgery: A Randomized, Controlled, Double-Blind Trial
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2026年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 148
- 试验地点
- 1
研究概览
简要总结
This is a single-center, randomized, controlled, double-blind clinical trial. A total of 148 patients undergoing elective open upper abdominal surgery will be included and randomly assigned 1:1 to receive ultrasound-guided erector spinae plane block with liposome bupivacaine plus bupivacaine hydrochloride or bupivacaine hydrochloride alone. The primary outcome is the AUC of resting pain scores from 0 to 72 hours postoperatively. This study aims to evaluate the analgesic efficacy and safety of liposome bupivacaine and provide a long-acting and safe postoperative analgesia strategy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective open upper abdominal surgery, including open liver, gastric and pancreatic surgery.
- •Patients receiving general anesthesia with tracheal intubation.
- •Aged from 18 to 80 years old.
- •Patients with American Society of Anesthesiologists (ASA) physical status class Ⅰ-Ⅲ.
- •Patients who can understand the trial content, are willing to strictly follow the clinical research protocol and complete the trial, and voluntarily sign the informed consent form.
排除标准
- •Pregnant or lactating women.
- •Patients complicated with severe primary diseases of the lung, liver, kidney, cardiovascular system and hematopoietic system.
- •Bleeding tendency or coagulation dysfunction, defined as international normalized ratio (INR) ≥ 1.4, activated partial thromboplastin time > 38 s, or platelet count < 80×10⁹/L.
- •Patients with aggravated cardiac diseases (complex congenital heart disease, heart failure and valvular disease) or pulmonary insufficiency.
- •Skin infection at the puncture site for erector spinae plane block (ESPB).
- •Previous history of neurological or psychiatric diseases, with inability to read, understand and communicate.
- •Current obstructive or restrictive pulmonary disease.
- •Patients with BMI greater than 30 kg/m².
- •Drug abuse, long-term regular use of analgesics, or allergy to the study drugs.
- •Patients who refuse to provide informed consent.
- •Those enrolled in other randomized controlled trials simultaneously or with other conditions unsuitable for participation in this trial.
研究者
研究点 (1)
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