Acupuncture for Post-Operative Pain Control for Patients Undergoing Gynecological Surgery
2019年6月18日 更新者:Icahn School of Medicine at Mount Sinai
The Role of Acupuncture in Post-Operative Pain Management in Gynecological Patients
This study investigates the role of acupuncture in controlling post-operative pain in patients who have undergone gynecological surgery.
研究概览
详细说明
The goal of the study is to investigate acupuncture at the time of gynecological surgery as a way to decrease post-operative pain which would decrease narcotic intake and hospitalization time.
To do this, the researchers will recruit non-pregnant patients over the age of 18 who are undergoing laparoscopic surgery for a benign gynecological indication.
These patients will be randomized using a computer generated randomization system to receive either acupuncture or sham acupuncture pre-operatively after the induction of anesthesia.
The acupuncture points used will be points proven in the literature to be associated with decreasing general pain, pelvic pain and nausea and vomiting.
The needles will be placed by a anesthesiologist trained in acupuncture and they will be left in place for 15 minutes while the patient is prepped for the surgery.
The sham points will be on the hands and feet and chosen at random by the gynecologic surgeon who is not trained in acupuncture.
For both groups, the acupuncture needles will be removed before the first incision of the surgery.
All patients will be blinded to their group allocation.
研究类型
介入性
注册 (实际的)
110
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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New York
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New York、New York、美国、10029
- Icahn School of Medicine at Mount Sinai
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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 80年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- female patients
- over the age of 18
- scheduled for laparoscopic gynecological procedures for benign conditions of the uterus, fallopian tubes and/or adnexa
Exclusion Criteria:
- male patients
- pregnancy
- suspected or known malignant disease
- immunocompromised
- known or persistent abuse of medications, drugs or alcohol
- chronic pain for greater than 3 months
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:Acupuncture
Receives acupuncture during gynecological surgery at 5 known points for pain control.
Needles will be placed prior to the start of surgery by an anesthesiologist trained in acupuncture after induction of anesthesia and while the patient is prepped for surgery.
They will be in place for 15 minutes.
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Acupuncture needles (29 and 30 gauge) used to perform the acupuncture
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假比较器:Sham acupuncture
Receives acupuncture during gynecological surgery at sham points not associated with pain control.
Needles will be placed by the gynecologic surgeon who is not trained in acupuncture after induction of anesthesia and prior to the start of the surgery.
The needles will be removed immediately after placement.
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Acupuncture needles (29 and 30 gauge) used to perform the acupuncture
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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 |
---|---|---|
Morphine Equivalent Usage While in the Hospital
大体时间:Intra-operative and 24 hours post-operatively
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Effectiveness of intra-operative acupuncture in post-operative pain control as measured by narcotic use in the 24 hours post-operatively.
Narcotic use monitored either through hospital records if patient is still admitted to the hospital or over the phone if the patient is discharged home prior to 24 hours post-operative.
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Intra-operative and 24 hours post-operatively
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of Pain Medication Tablets Used at Home Post-Operatively
大体时间:7 days post-operatively
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Patients kept a log of pain medication use once they were discharged from the hospital for first 7 days post operatively.
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7 days post-operatively
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Number of Patients Readmitted to the Hospital
大体时间:2 weeks post-operatively
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Effectiveness of intra-operative acupuncture in post-operative pain control as measured by re-admission to the hospital for pain management.
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2 weeks post-operatively
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Pain Score
大体时间:up to 4 hours post operatively
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Pain Score.
Patients asked to rate pain score total from 0-10 with higher score indicating more pain
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up to 4 hours post operatively
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Pain Score at Home Post-Operatively
大体时间:up to 7 days post operatively
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Pain Score from 0-10 with higher score indicating more pain
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up to 7 days post operatively
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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:Charles Ascher-Walsh, MD、Icahn School of Medicine at Mount Sinai
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)
2016年8月6日
初级完成 (实际的)
2017年12月5日
研究完成 (实际的)
2017年12月5日
研究注册日期
首次提交
2016年7月29日
首先提交符合 QC 标准的
2016年8月1日
首次发布 (估计)
2016年8月4日
研究记录更新
最后更新发布 (实际的)
2019年6月25日
上次提交的符合 QC 标准的更新
2019年6月18日
最后验证
2019年6月1日
更多信息
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