Patient Satisfaction and Postoperative Analgesia Between Subarachnoid Block With 2-chloroprocaine Versus General Anesthesia for Knee Arthroscopy
2018年8月6日 更新者：Jenna Walters、Vanderbilt University Medical Center
Randomized Controlled Trial Evaluating Patient Satisfaction and Postoperative Analgesia Between Subarachnoid Block With 2-chloroprocaine Versus General Anesthesia for Knee Arthroscopy
The study evaluates the efficacy of two different anesthetic techniques in patients undergoing unilateral knee arthroscopy.
Participants will be randomized to receive either subarachnoid block with 2-chloroprocaine or general anesthesia plus intravenous fentanyl.
研究概览
详细说明
The study evaluates the efficacy of two different anesthetic techniques in patients undergoing unilateral knee arthroscopy.
Participants will be randomized to receive either subarachnoid block with 2-chloroprocaine or general anesthesia plus intravenous fentanyl.
The study evaluates pain scores, opioid utilization and patient satisfaction.
研究类型
介入性
注册 (实际的)
1
阶段
- 不适用
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
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Tennessee
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Nashville、Tennessee、美国、37212
- Vanderbilt University Medical Center
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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
30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:
- Patients with ASA physical status classification of I, II, or III
- Patients without a current diagnosis of chronic pain or chronic opioid use for > 1-month prior to knee arthroscopy
- Patients who are scheduled to undergo unilateral knee arthroscopy
- Patients do not have a contraindication to receiving regional anesthesia
Exclusion Criteria:
- Preexisting sensory or motor deficit in operative extremity
- Patients with a contraindication to general anesthesia
- Patient undergoing meniscal or ligamentous repair
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Subarachnoid block
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Neuraxial anesthesia will be performed at the L2-3 or L3-4 interspace with a 25-gauge Whitacre needle in the sitting position.
After free flow of cerebrospinal fluid (CSF), 40-45mg of 2-chloroprocaine will be injected based on patient's height and discretion of attending anesthesiologist, needle withdrawn and the patient placed supine.
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有源比较器：全身麻醉
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General anesthesia will be delivered per standard procedure.
General anesthesia will include induction with propofol 1-3mg/kg followed by placement of a laryngeal mask airway with maintenance anesthesia of sevoflurane 0.5-1 minimum alveolar concentration (MAC).
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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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Pain score
大体时间：Discharge from post anesthesia care unit (PACU) (usually one hour)
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Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable.
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Discharge from post anesthesia care unit (PACU) (usually one hour)
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Pain score
大体时间：Post operative day one
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Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable.
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Post operative day one
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Pain score
大体时间：One month postoperatively
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Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable.
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One month postoperatively
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Pain score
大体时间：Three months postoperatively
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Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable.
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Three months postoperatively
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Opioid utilization
大体时间：Surgical completion to PACU discharge (usually one hour)
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Opioid utilization based on amount of opioid medications administered
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Surgical completion to PACU discharge (usually one hour)
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Opioid utilization
大体时间：Postoperative day one
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Opioid utilization based on number of pain pills taken
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Postoperative day one
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Opioid utilization
大体时间：One month postoperatively
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Opioid utilization based on average number of pain pills taken per day
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One month postoperatively
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Opioid utilization
大体时间：Three months postoperatively
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Opioid utilization based on average number of pain pills taken per day
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Three months postoperatively
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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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Patient satisfaction with anesthetic
大体时间：24 hours after PACU discharge
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Patient satisfaction with anesthetic based on 10-item patient satisfaction survey validated for regional and general anesthesia
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24 hours after PACU discharge
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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：Jenna Walters, M.D.、Vanderbilt University Medical Center
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 (实际的)
2017年6月16日
初级完成 (实际的)
2018年4月20日
研究完成 (实际的)
2018年4月20日
研究注册日期
首次提交
2017年5月29日
首先提交符合 QC 标准的
2017年5月29日
首次发布 (实际的)
2017年6月1日
研究记录更新
最后更新发布 (实际的)
2018年8月8日
上次提交的符合 QC 标准的更新
2018年8月6日
最后验证
2018年8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.
Subarachnoid block的临床试验
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Queen Mary University of LondonNational Health Service, United Kingdom未知
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University of PennsylvaniaUniversity of Wisconsin, Madison; Philips Healthcare; National Aeronautics and Space Administration...完全的