IV Acetaminophen for Postoperative Analgesia
2017年5月30日 更新者：Northwell Health
IV Acetaminophen for Postoperative Analgesia After Laparoscopic Cholecystectomy
The purpose of this study is to evaluate the use of IV acetaminophen for postoperative pain management after laparoscopic cholecystectomy to determine if its use to supplement standard of care pain management decreases the incidence of post-operative nausea and vomiting.
研究概览
详细说明
The recent clinical development of an intravenous (IV) acetaminophen formulation for use in the US has important implications for the management of postoperative pain given its safety profile and suitability for use in the early phase of the postoperative period.
In clinical studies a significant opioid-sparing effect has been documented with a substantial percentage of patients avoiding the need for opioid rescue medication altogether.
This avoidance or delay in the use of opioids has been shown to reduce undesirable side effects.
It is proposed that the use of IV acetaminophen in the post anesthesia care unit (PACU) for postoperative analgesia after laparoscopic cholecystectomy will result in decreased incidence of post operative nausea and vomiting (PONV) and decreased use of narcotics.
研究类型
介入性
注册 (实际的)
105
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
-
-
New York
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Manhasset、New York、美国、11030
- North Shore University Hospital
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New Hyde Park、New York、美国、11040
- Long Island Jewish Medical Center
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Syosset、New York、美国、11791
- Syosset Hospital
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-
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
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Subject is undergoing pre-scheduled laparoscopic cholecystectomy;
- American Society of Anesthesiology patient classification status I-II
Exclusion Criteria:
- Regular preoperative use of or opioids,
- Subjects admitted after surgery for postoperative complications other than postoperative pain or PONV.
- Subjects converted to open laparoscopic cholecystectomy
- Known allergy/hypersensitivity to acetaminophen
- Use of opioids prior to commencement of the study (<7 days)
- Patients with chronic pain conditions or disease requiring pain control
- Abnormal liver function
- Known or suspected alcohol, drug or opiate abuse or dependence
- Patients with a BMI of greater than 35
- Other physical, mental or medical conditions that could effect participation.
- Abnormal renal function; serum creatinine>2gm/dl
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：IV Acetaminophen
IV Acetaminophen administered on admission to post-anesthesia care unit
|
Single dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen
其他名称：
|
|
有源比较器：Standard of care
Standard of care pain management regimen including opioids administered on admission to post-anesthesia care unit
|
Standard of care pain management regimen, no IV Acetaminophen,
其他名称：
|
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 |
|---|---|---|
|
Number of Participants With Postoperative Nausea and Vomiting (PONV).
大体时间：4 hours plus/minus 30 minutes
|
Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay. PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching. |
4 hours plus/minus 30 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Post Discharge Nausea and Vomiting (PDNV)
大体时间：Up to two days following surgery
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Number of participants reporting post discharge nausea and vomiting (PDNV) documented up to 2 days following surgery. PDNV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching following discharge. |
Up to two days following surgery
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Highest Pain Intensity Score Using Numeric Rating Scale (NRS)
大体时间：4 hours plus/minus 30 minutes
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Highest pain intensity reported during PACU stay using a 11-point (0-10) pain intensity numeric rating scale (NRS).
Higher values represent higher pain intensities.
|
4 hours plus/minus 30 minutes
|
|
Patient Satisfaction on a 5 Point Likert Scale
大体时间：Up to one week following surgery
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Number of patients very satisfied or satisfied with pain and PONV management during hospital stay
|
Up to one week following surgery
|
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Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale
大体时间：1 hour following surgery
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Pain intensity score reported by participants 1 hour following surgery using an 11-point, 0-10 Numeric Rating Scale (NRS).
Higher scores indicate higher pain intensities
|
1 hour following surgery
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Patients Requiring Rescue Analgesia for Breakthrough Pain
大体时间：1 hour following surgery
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Number of patients requiring rescue analgesia medication during first hour of PACU stay
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1 hour following surgery
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Narcotic Use During PACU Stay
大体时间：4 hours plus/minus 30 minutes
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Narcotic medication administered during PACU stay in morphine milligram equivalents
|
4 hours plus/minus 30 minutes
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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。
调查人员
- 首席研究员：Frank J Overdyk, MD、Northwell Health
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
2013年3月1日
初级完成 (实际的)
2015年9月1日
研究完成 (实际的)
2015年9月1日
研究注册日期
首次提交
2013年2月5日
首先提交符合 QC 标准的
2013年2月21日
首次发布 (估计)
2013年2月25日
研究记录更新
最后更新发布 (实际的)
2017年5月31日
上次提交的符合 QC 标准的更新
2017年5月30日
最后验证
2017年5月1日
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.