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.
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
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North Carolina
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Winston-Salem、North Carolina、アメリカ、27157
- WakeForestUBMC
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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偽コンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Areas of hyperalgesia and allodynia to mechanical stimuli.
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain intensity and unpleasantness to mechanical stimuli
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Scott A Miller, MD、Wake Forest University Health Sciences
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 00019284
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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