Effect of Liposomal Bupivacaine and Bupivacaine Hydrochloride for Superior Trunk Block of the Interscalene Brachial Plexus on Postoperative Diaphragmatic Function and Analgesia in Shoulder Surgery: A Multicenter, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 184
- 试验地点
- 3
- 主要终点
- The incidence of hemi-diaphragmatic paralysis( Partial plus complete diaphragmatic paralysis) after superior trunk block of the interscalene brachial plexus
研究概览
简要总结
To compare the effects of 1.33% liposomal bupivacaine versus 0.375% bupivacaine hydrochloride for superior trunk block of the interscalene brachial plexus on postoperative diaphragmatic function and analgesic efficacy in shoulder surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, 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 unilateral proximal humerus surgery, rotator cuff surgery, shoulder arthroplasty, or shoulder arthroscopy;
- •Visible diaphragmatic movement on the surgical side under ultrasound before anesthesia;
- •Patient provides informed consent;
- •Age 18-80 years, any gender;
- •ASA physical status I-III;
- •18 kg/m² ≤ BMI ≤ 30 kg/m².
排除标准
- •Coagulopathy;
- •Allergy to local anesthetics;
- •Infection at the puncture site;
- •History of chronic pain or opioid use;
- •Severe respiratory disease;
- •Pregnancy;
- •Diabetes and peripheral neuropathy;
- •Inability to understand assessment scales.
研究组 & 干预措施
Liposomal Bupivacaine
When performing a superior trunk block of the interscalene brachial plexus, the local anesthetic used is 1.33% liposomal bupivacaine.
干预措施: Liposomal bupivacaine (Drug)
Bupivacaine Hydrochloride
When performing the superior trunk block of the interscalene brachial plexus, 0.375% bupivacaine hydrochloride is used as the local anesthetic.
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
The incidence of hemi-diaphragmatic paralysis( Partial plus complete diaphragmatic paralysis) after superior trunk block of the interscalene brachial plexus
时间窗: Before block and before leaving the PACU after surgery
Observe diaphragmatic movement through the hepatic or splenic acoustic window and measure the amplitude of diaphragmatic excursion on the anesthetized side using M-mode (average of 3 waveforms). Diaphragmatic Function Evaluation\[4,5\]: A decrease in diaphragmatic excursion amplitude during deep breathing of \<25% compared to pre-block is defined as normal diaphragmatic movement. A decrease of 25%-75% is defined as partial diaphragmatic paralysis. A decrease of \>75% is defined as complete diaphragmatic paralysis.
次要结局
- The incidence of hemi-diaphragmatic paralysis( Partial plus complete diaphragmatic paralysis) after superior trunk block of the interscalene brachial plexus(Postoperative 24 hours)
研究者
Hongwei Shi
Director, Department of Anesthesia, Pain and Perioperative Medicine
Nanjing First Hospital, Nanjing Medical University