Remote Ischemic Preconditioning Mechanism Study
Remote Ischemic Preconditioning Effects on Central and Peripheral Sensitization in Healthy Volunteers-A Pilot Study
This research is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not relieve all types of pain or may relieve pain only at doses that produce side effects and potential complications.
Although Remote Ischemic Preconditioning (RIPC) appears promising, there remain several unanswered questions about how it works. This research trial will help determine how RIPC may activate the bodies natural pain control system. The goals of this study are to see if RIPC has any effect 1) on a small area of skin that will be expose to a small amount of UV- B radiation (a mild sunburn), 2) on acute thermal heat temperatures that will be applied to skin, and 3) on the sunburn-like sensation to light touch after putting capsaicin cream (the active ingredient in hot chili peppers) on skin.
Remote ischemic preconditioning is done by inflating a balloon (very similar to a blood pressure cuff) on the leg until it blocks blood flow for a few minutes. The cuff is then deflated and blood flow resumes. The process is repeated up to three times. This procedure causes the body to increase its natural pain relief system that may help to decrease the amount of postsurgical pain.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 第一阶段早期
联系人和位置
学习地点
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North Carolina
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Winston-Salem、North Carolina、美国、27157
- WakeForestUBMC
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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:
- healthy volunteers of both sexes ASA 1 or II classification
- between the ages of 18-55
- weighing less than 250 pounds
- without chronic pain
- not taking analgesics
- off caffeine for 2 days.
Exclusion Criteria:
- pregnancy
- allergy to capsaicin
- lower extremity vascular insufficiency
- active treatment for DVT
- severe thigh pain
- taking psychotropic medications, including anti-depressants.
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 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：Capsaicin, UV-B, RIPC
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The participants will have one disposable tourniquet applied to the left mid thigh by research personnel.
The participants will then be randomized to the treatment group or sham group.
The treatment group will receive 3 cycles of RIPC to the left lower leg by occluding blood flow at the thigh with a pneumatic cuff.
Each cycle will consist of 5 minutes of ischemia by inflating the cuff to 300 mmHg followed by 5 minutes of reperfusion.
The sham group will have the cuff inflated to no more than 15mmHg for three cycles as described above.
Areas of hypersensitivity and allodynia will be obtained every 40 min for 280 min following the end of capsaicin application.
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假比较器：Capsaicin, UV-B
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The participants will have one disposable tourniquet applied to the left mid thigh by research personnel.
The participants will then be randomized to the treatment group or sham group.
The treatment group will receive 3 cycles of RIPC to the left lower leg by occluding blood flow at the thigh with a pneumatic cuff.
Each cycle will consist of 5 minutes of ischemia by inflating the cuff to 300 mmHg followed by 5 minutes of reperfusion.
The sham group will have the cuff inflated to no more than 15mmHg for three cycles as described above.
Areas of hypersensitivity and allodynia will be obtained every 40 min for 280 min following the end of capsaicin application.
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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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Areas of hyperalgesia and allodynia to mechanical stimuli.
大体时间：24 hours
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Hyperalgesia will be measured with vonFrey fibers and allodynia will be measured with a cotton wisp.
The area will be measured in cm2.
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24 hours
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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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Pain intensity and unpleasantness to mechanical stimuli
大体时间：24 hours
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Using a Visual Analog Sliding Scale the intensity and unpleasantness will be measured in centimeters.
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24 hours
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Presence of parathesias where RIPC was used
大体时间：24 hours
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After a brief tourniquet application I fully expect participants to have some degree of parasthesias.
Using a standard rating scale I will record and report this.
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24 hours
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合作者和调查者
调查人员
- 首席研究员：Scott A Miller, MD、Wake Forest University Health Sciences
研究记录日期
研究主要日期
学习开始 (实际的)
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
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