Bupivacaine Liposome Versus Bupivacaine for Ultrasound-Guided Suprascapular Nerve Combined With Axillary Nerve Block in Analgesia After Arthroscopic Shoulder Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Opioid consumption after surgery
研究概览
简要总结
This trial is designed to compare the post-operative analgesic efficacy and safety of liposomal bupivacaine versus plain bupivacaine when both are used for ultrasound-guided combined suprascapular and axillary nerve block in patients undergoing elective arthroscopic shoulder surgery.
详细描述
Most liposomal bupivacaine data come from ultrasound-guided brachial-plexus blocks; evidence for its safety and efficacy when used specifically for a combined ultrasound-guided suprascapular-plus-axillary block after arthroscopic shoulder surgery is still missing. This trial fills that gap by comparing liposomal bupivacaine with bupivacaine along, aiming to advance multimodal analgesia and enhanced-recovery pathways, cut postoperative pain and stress, and shorten hospital stay.
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)
盲法说明
Because liposomal bupivacaine is a milky-white suspension that cannot be disguised, the investigator who performs the block cannot be blinded; the study therefore uses a double-blind design in which both participants and outcome assessors remain unaware of group allocation.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-60 years
- •ASA physical status I-II
- •Undergoing unilateral arthroscopic shoulder surgery
- •The Operative time between 1and 4 hours
排除标准
- •Anticipated operative time < 1 h or > 4 h
- •Severe cardiopulmonary insufficiency
- •Hepatic or renal dysfunction
- •Coagulopathy
- •Diabetic peripheral neuropathy
- •History of nerve injury on the operative side
- •Skin infection at the block site
- •Allergy to amide local anesthetics
- •Refusal to participate or any other condition deemed unsuitable.
研究组 & 干预措施
Group A (liposomal bupivacene）
In the experimental group, 15 mL of a mixture containing liposomal bupivacaine plus plain bupivacaine is deposited around each target nerve (20 mL liposomal bupivacene, 266 mg, combined with 10 mL 0.75 % plain bupivacaine, total 30 mL).
干预措施: Group A（ liposomal bupivacene） (Drug)
Group B（bupivacene）
The control group receives 15 mL of 0.25 % plain bupivacaine around each nerve. Unlike the clear solution of plain bupivacaine, liposomal bupivacaine has a distinctive milky-white appearance.
干预措施: Group B（bupivacene） (Drug)
结局指标
主要结局
Opioid consumption after surgery
时间窗: The outcome will be monitored and recorded within 72 hours postoperatively.
The primary outcome entails tracking and assessing the total opioid consumption by participants following arthroscopic shoulder surgery. The consumption of Opioid via patient-controlled analgesia will be recorded within 72h postoperatively.
次要结局
- Analgesic efficacy after surgery(The outcome will be monitored and recorded within 72 hours postoperatively)
- Operative time(Intraoperative)
- Length of hospital stay(Through study completion, up to 7 days)
- Incidence of Allergic Reactions(From first dose to 3 days postoperatively)
- Incidence of Nerve Injury(From time of nerve block procedure to 7 days postoperatively)
- Incidence of Respiratory Depression(within 24 hours postoperatively)
- Incidence of Local Anesthetic Systemic Toxicity (LAST)(From time of nerve block injection to 6 hours post-procedure)
- Incidence and Severity of Postoperative Nausea and Vomiting (PONV)(From Post-Anesthesia Care Unit admission to 72 hours postoperatively)
研究者
Wei Mei
clinical professor
Huazhong University of Science and Technology