The Effect of Intravenous Lidocaine on Normal Sensation and Pain in Healthy Volunteers
2017年4月11日 更新者：Michael Froelich、University of Alabama at Birmingham
The Effect of Intravenous Lidocaine on Normal Sensation and Pain in Healthy Volunteers (Carl Koller Grant) (The Effect of Intravenous Lidocaine on Allodynia)
The purpose of this study is to study if lidocaine, given intravenously, reduces pain.
調査の概要
詳細な説明
Clinicians use lidocaine intravenously in a fashion that suggests that it might have analgesic effects.
Therefore, we test the hypothesis that lidocaine reduces pain intensity in response to experimental pain.
研究の種類
介入
入学 (実際)
22
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Alabama
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Birmingham、Alabama、アメリカ、35233
- University of Alabama at Birmingham
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
19年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Healthy Adult Volunteers, age >19 years
Exclusion Criteria:
- History of Substance Abuse
- Coronary Artery Disease (CAD): unstable
- Congestive Heart Failure (CHF): unstable
- Heart Arrhythmia: symptomatic
- Chronic Obstructive Pulmonary Disease (COPD)
- Lidocaine Allergy
- Diagnostic and Statistical Manual of Mental Disorders (Rev IV): Axis I: Common Axis I disorders include depression, anxiety disorders,bipolar disorder, ADHD, and schizophrenia. Axis II: borderline personality disorder, schizotypal personality disorder, antisocial personality disorder, and mild mental retardation.
- Presence of Contraindications for MRI
- Presence of electronically, magnetically, and mechanically activated implants
- Electronically, magnetically, and mechanically activated implants
- Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators
- Cardiac pacemakers
- Metallic splinters in the eye
- Ferromagnetic haemostatic clips in the central nervous system (CNS)
- Claustrophobia
- Pregnancy
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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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実験的：Lidocaine
Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
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Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
他の名前：
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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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Ischemic Pain
時間枠：baseline, during 20 minute lidocaine infusion, and 30 minutes after discontinuation of lidocaine infusion
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The right arm was exsanguinated by elevating it above heart level for 30 seconds, after which the arm was occluded with a standard blood pressure cuff positioned proximal to the elbow inflated to twice the participant's mean arterial pressure.
Participants then performed 20 handgrip exercises of 2-second duration at 4-second intervals at 50% of their maximum grip strength.
Pain was rated on a scale from 0 - 10 with 0 being no pain to 10 being the worst pain imaginable.
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baseline, during 20 minute lidocaine infusion, and 30 minutes after discontinuation of lidocaine infusion
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Electrical Pain
時間枠：Baseline, during 20 minutes lidocaine infusion, and 30 minutes after completion of lidocaine infusion
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Peripheral nerve stimulation electrodes were attached to the base and the tip of the third digit and connected to a constant current stimulator (DS7A, Digitimer Ltd, Hertfordshire, England).
Ascending electrical stimuli of 2000 mu duration, ranging from 0.5 to 35 mA (ampere) was administered one per second in 0.5 mA increments.
Participants were instructed to indicate when they first felt the slightest sense of pain (electrical pain threshold, EPTh) and when they were unable to tolerate a further increase (electrical pain tolerance, EPTo).
For each measure, the average of three trials was computed for use in subsequent analyses.
Each of the three electrical pain stimuli were presented three times and balanced in order using a Graeco-Latin square design.
The pain scale is between 0 and 10, with 0 being no pain and 10 being the worst pain imaginable
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Baseline, during 20 minutes lidocaine infusion, and 30 minutes after completion of lidocaine infusion
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Heat Pain
時間枠：baseline, during 20 minute lidocaine infusion, and 30 minutes after completion of lidocaine infusion
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The thermal procedure involved a baseline assessment of heat pain threshold and tolerance.
Contact heat stimuli were delivered using a computer-controlled Medoc Thermal Sensory Analyzer (TSA-II; Ramat Yishai, Israel), which is a peltier elementbased stimulator.
Temperature levels were monitored by a thermistor and returned to a preset baseline of 32°C by active cooling at a rate of 10°C/s.
The 3 × 3 cm contact probe was applied to the right forearm.
The pain scale is between 0 and 10 with 1 being no pain and 10 being the worst pain imaginable
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baseline, during 20 minute lidocaine infusion, and 30 minutes after completion of lidocaine infusion
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Cold Pain
時間枠：baseline, during 20 minute infusion, and 30 minutes after lidocaine infusion
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The participant's foot was immersed up to the ankle into a container filled with ice water of 3°C.
Participants were instructed to maintain their foot in the container until the cold pain became intolerable (cold pain tolerance).
The length of time was recorded in seconds.
This procedure was repeated once with a gap of at least fifteen minutes in-between repeated tests.
The range was 0 seconds to 120 seconds
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baseline, during 20 minute infusion, and 30 minutes after lidocaine infusion
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Tactile Sensation
時間枠：baseline, during 20 minute infusion, and 30 minutes after completion of infusion
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Pin prick sensory thresholds (PPT) were obtained by touching the skin in-between the first and second metacarpal bone with a 23-gauge needles which moved freely out of a 10 mL plastic syringe barrel.
The pin prick sensation was modified by adding small weights to the 23-gauge needles (from 0.2 to 5.2 mg).
A syringe barrel of tuberculin (TB) needles that were cut to different lengths to add the desired weight to the 23-gauge needle.
The PPT was determined using the weighted 23-gauge needle in ascending order, according to the method of limits.
This assessment was to evaluate whether participants were able to feel the touch of the needle.
The participant's arm was placed on a tray table.
A linen sheet was suspended in-between two IV poles in such a fashion that the subject's view of his/her hand was blocked.
Normal values are between 0.21mg and 5mg.
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baseline, during 20 minute infusion, and 30 minutes after completion of infusion
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Michael Froelich, MD、University of Alabama at Birmingham
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2008年4月1日
一次修了 (実際)
2012年1月1日
研究の完了 (実際)
2012年1月1日
試験登録日
最初に提出
2008年4月9日
QC基準を満たした最初の提出物
2008年4月11日
最初の投稿 (見積もり)
2008年4月14日
学習記録の更新
投稿された最後の更新 (実際)
2017年5月17日
QC基準を満たした最後の更新が送信されました
2017年4月11日
最終確認日
2017年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- F061204013
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