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临床试验/NCT07221019
NCT07221019招募中4 期

Single-Shot Exparel Versus Catheters for Lower Extremity Orthopedic Trauma Patients

George Washington University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年9月12日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
招募中
入组人数
90
试验地点
1
主要终点
Postoperative Pain Score

研究概览

简要总结

This study will compare the use of single-shot Exparel, a long-acting local anesthestic, with the use of catheters that deliver a continuous flow of the short-acting local anesthetic ropivacaine. The comparison will be done in patients who receive preoperative adductor and sciatic nerve blocks prior to orthopedic surgery for traumatic lower extremity injury. The patients' pain will then be monitored for up to 72 hours after injection, measuring every 12 hours after injection until the 72-hour mark. Opioid consumption (measured in morphine milligram equivalents) will also be tracked over this time period.

详细描述

The use of Exparel has been widely criticized over the past few years with regard to its efficacy compared to perineural catheters and whether or not it truly lasts 72 hours, as is often advertised. However, it is still used in many centers for the proposed increased duration of action and ease of use compared to indwelling catheters, which require a greater degree of monitoring and follow-up for removal. Various studies conducted have looked at the efficacy of Exparel and have found no superiority over nerve blocks with other local anesthetic agents. However, nerve blocks with catheters have never been directly compared to exparel injections for pain control. As such, the goal of this study is to elucidate whether there truly is a difference between the two. In this study, the study team will compare preoperative adductor and sciatic nerve blocks with exparel versus catheters in orthopedic surgery patients who present with a traumatic lower extremity injury. Exparel has been documented to increase the duration of a nerve block by up to 72 hours. Studies comparing exparel single shot versus bupivacaine single shot have favored for the latter, which pharmacodynamically makes sense. A liposomal compound which slowly denatures to present an active component would seemingly be unlikely to match up against the higher concentration of said active component flood the desired site of action. In our study, the study team plans to measure the duration of the block with the addition of exparel in comparison to the duration of the block with a catheter which is connected to a pump continuously infusing a set rate of local anesthetics. Our primary research question is whether there is a statistically significant difference in pain control for 72 hours post-op in lower extremity orthopedic trauma when using Exparel versus a short-acting local anesthetic supplied via continuous infusion, in this case ropivacaine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Closed lower extremity orthopedic injury
  • Opioid naive patients
  • No other significant surgical injuries on admission as determined by study physician

排除标准

  • Allergy to local anesthetics
  • Multiple traumatic injuries
  • Weight less than 60 kg
  • Prior opioid use or risk of increased pain control needs as determined by PI
  • Chronic opioid use
  • Open fractures
  • Plastic surgery needed for complete closure
  • Patient has intraoperative cardiac arrest

研究组 & 干预措施

Exparel + Bupivacaine

Experimental

干预措施: Exparel + Bupivacaine (Drug)

Bupivacaine

Active Comparator

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Postoperative Pain Score

时间窗: 72 hours

Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)

次要结局

  • Morphine equivalents(Day 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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