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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

This study will prospectively compare the preventive effect of liposomal bupivacaine combined with plain bupivacaine versus plain bupivacaine alone on rebound pain after nerve block in patients undergoing orthopedic extremity surgery. The primary aim is to assess whether the combination reduces the incidence or severity of rebound pain (i.e., more effectively covers the postoperative inflammatory peak on days 2-3 and provides a smoother regression curve of sensory blockade). Secondary aims include evaluation of upper limb functional scores, occurrence of chronic pain, and health-related quality of life. All aims will be assessed over 72 hours or the duration of hospitalization if shorter.

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

介入性

注册 (估计的)

668

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200233
        • Shanghai Sixth People's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
实验性的:liposomal bupivacaine
5 ml of plain bupivacaine 0.75% will be mixed with 10 ml liposomal bupivacaine (133mg)
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.
安慰剂比较:normal saline
5 ml of plain bupivacaine 0.75% will be combined with 10 ml of normal saline
Prepare a local anesthetic by combining normal saline (10 mL) and bupivacaine hydrochloride (75 mg/10 mL) in a 2:1 volume ratio.

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
incidence of rebound pain
大体时间:the first 24 hours after surgery
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.
the first 24 hours after surgery

次要结果测量

结果测量
措施说明
大体时间
Area under the pain intensity-time curve
大体时间:up to 72 hours
Area under the pain intensity-time curve (0-72 hours) at rest / with movement
up to 72 hours
Total postoperative opioid consumption
大体时间:24, 48, 72 hours
Total postoperative opioid consumption (IV morphine mg equivalents) at 24, 48, and 72 hours
24, 48, 72 hours

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年7月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年5月19日

首先提交符合 QC 标准的

2026年5月19日

首次发布 (实际的)

2026年5月26日

研究记录更新

最后更新发布 (实际的)

2026年9月2日

上次提交的符合 QC 标准的更新

2026年8月31日

最后验证

2026年5月1日

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)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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