Effect of Liposomal Bupivacaine on Rebound Pain After Peripheral Nerve Block in Orthopedic Surgery.
Liposomal Bupivacaine Combined With Plain Bupivacaine for Peripheral Nerve Block to Reduce Rebound Pain After Orthopedic Extremity Surgery: A Multicenter Randomized Controlled Trial
研究概览
详细说明
Rebound pain (RP) after nerve block occurs in up to 50% of patients, presenting as acute severe pain that impairs recovery and is associated with chronic pain. Risk factors include female sex, younger age, orthopedic surgery, and lack of perioperative dexamethasone use. Even with dexamethasone, approximately one-third of patients show a poor response, suggesting the limitations of a single-agent anti-inflammatory strategy.
RP is associated with an imbalance in perioperative inflammation management. The postoperative inflammatory peak occurs on days 2-3 and is accompanied by central sensitization, with pain rebounding after block resolution. Prolonged sensory blockade may reduce RP; however, continuous nerve block techniques are complex and associated with higher complication rates, which limits their clinical application.
Liposomal bupivacaine provides up to 72 hours of analgesia with a single injection, prolongs sensory blockade, and may theoretically reduce RP. Nevertheless, existing evidence is inconsistent: some studies support its efficacy, whereas others fail to demonstrate clinically important differences. Moreover, one animal study suggests that it may only delay, rather than eliminate, RP, albeit with limited evidence quality. This study aims to evaluate the preventive effect of liposomal bupivacaine combined with plain bupivacaine on RP after nerve block in orthopedic extremity surgery, thereby providing evidence to inform clinical strategies.
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200233
- Shanghai Sixth People's Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 18-65 years old;
- ASA Physical Status 1-3;
- Scheduled for elective unilateral orthopedic surgery of the upper or lower extremity.
Exclusion Criteria:
- Women who are pregnant or breastfeeding;
- Bupivacaine sensitivity or known allergy;
- Contraindication for nerve blocks;
- Enrollment in another clinical trial that could confound pain evaluation;
- Other conditions that preclude study participation.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:liposomal bupivacaine
5 ml of plain bupivacaine 0.75% will be mixed with 10 ml liposomal bupivacaine (133mg)
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Prepare a local anesthetic by combining liposomal bupivacaine (133 mg/10 mL) and bupivacaine hydrochloride (75 mg/10 mL) in a 2:1 volume ratio.
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安慰剂比较:normal saline
5 ml of plain bupivacaine 0.75% will be combined with 10 ml of normal saline
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Prepare a local anesthetic by combining normal saline (10 mL) and bupivacaine hydrochloride (75 mg/10 mL) in a 2:1 volume ratio.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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incidence of rebound pain
大体时间:the first 24 hours after surgery
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Rebound pain was defined as initial mild pain (<4/ 10) when the patient left the recovery room, progressing to severe pain (>7/10) (NRS, 0-10) occurring within the first 24 hours after the procedure.
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the first 24 hours after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Area under the pain intensity-time curve
大体时间:up to 72 hours
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Area under the pain intensity-time curve (0-72 hours) at rest / with movement
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up to 72 hours
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Total postoperative opioid consumption
大体时间:24, 48, 72 hours
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Total postoperative opioid consumption (IV morphine mg equivalents) at 24, 48, and 72 hours
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24, 48, 72 hours
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- BLOC trial
- Grant No. 20240814 (其他赠款/资助编号:the Shanghai Jiao Tong University School of Medicine Double Hundred Talent Program)
- Grant No. 82525022 (其他赠款/资助编号:National Natural Science Foundation of China (NSFC) Project)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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