Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery
Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery: A Prospective Randomized Trial
研究概览
详细说明
Primary Objective To assess efficacy of EXPAREL TAP blocks in improving pain scores for 48 hours postoperatively, and in reducing total oral morphine equivalents (OME) use, compared to standard Intrathecal opioid administration (IT).
Secondary Objective Assess the length of stay (LOS), postoperative ileus (POI) incidence, and the use of intravenous patient controlled analgesia (PCA) in patients that had EXPAREL TAP blocs compared to IT.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Florida
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Jacksonville、Florida、美国、32224
- Mayo Clinic Florida
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
• All patients undergoing elective laparoscopic or open colorectal resections who are eligible for IT
- Age >18 years
- BMI <40
- Ability to understand and read English
Exclusion Criteria:
• Not able or unwilling to sign consent.
- Currently pregnant or lactating.
- Patients with chronic pain, requiring daily opiate use at time of surgery.
- Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.
- Patients requiring emergent surgery.
- Abdominoperineal resections
- Any contraindications to neuraxial analgesia (coagulopathy, localized infection at the potential site of injection, pre-existing spinal canal pathology)
- Patients with a diagnosis of inflammatory bowel disease
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:TAP block (EXPAREL)
After induction of anesthesia, the patients will receive a single injection with 133 mg of EXPAREL in the transversus abdominis plane (TAP), on each side, suspended in 20 milliliters (mL) of injectable saline.
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transversus abdominis plane injection
其他名称:
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有源比较器:Intrathecal opioid (IT)
single injection intrathecal hydromorphone analgesia given preoperatively
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Intrathecal opioid administration
其他名称:
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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 |
---|---|---|
Mean Pain Score
大体时间:First 48 hours post operative
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Postoperative mean pain score for 48 hours after surgery.
Pain was assessed on a 0 to 10 point visual analog scale (VAS), with 0 indicating no pain and 10 indicating severe pain.
The mean pain score was summarized as the area under the curve (AUC) of the observed pain score, normalized for the total time of observation.
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First 48 hours post operative
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Total Morphine Milligram Equivalents Use (MME)
大体时间:First 48 hours post operative
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The total cumulative use of opioids administered within 48 hours after surgery.
MME is a standard value based on morphine and its potency assigned to all opioids to represent relative potencies.
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First 48 hours post operative
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Total Length of Hospital Stay
大体时间:post-operative to discharge
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Length of stay was defined as the total number of nights spent in the hospital after surgery.
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post-operative to discharge
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Number of Participants With Post-operative Ileus
大体时间:24 hours post-operatively
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Post-operative ileus was defined as the inability to tolerate oral diet and/or the absence of flatus over 24 hours after surgery.
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24 hours post-operatively
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Use of Intravenous Patient-controlled Analgesia
大体时间:First 48 hours post-operative
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The total number of patients that used patient-controlled analgesia within 48 hours after surgery.
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First 48 hours post-operative
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合作者和调查者
赞助
调查人员
- 首席研究员:Dorin Colibaseanu, MD、Mayo Clinic
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
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
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.
EXPAREL的临床试验
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OrthoCarolina Research Institute, Inc.Pacira Pharmaceuticals, Inc完全的
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University of California, San DiegoPacira Pharmaceuticals, Inc完全的