- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00657358
The Effect of Intravenous Lidocaine on Normal Sensation and Pain in Healthy Volunteers
11 april 2017 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
22
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35233
- University of Alabama at Birmingham
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
19 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Ischemic Pain
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Michael Froelich, MD, University of Alabama at Birmingham
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2008
Primärt slutförande (Faktisk)
1 januari 2012
Avslutad studie (Faktisk)
1 januari 2012
Studieregistreringsdatum
Först inskickad
9 april 2008
Först inskickad som uppfyllde QC-kriterierna
11 april 2008
Första postat (Uppskatta)
14 april 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 maj 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 april 2017
Senast verifierad
1 april 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Medel mot arytmi
- Depressiva medel i centrala nervsystemet
- Agenter från det perifera nervsystemet
- Sensoriska systemagenter
- Bedövningsmedel
- Membrantransportmodulatorer
- Anestesimedel, lokal
- Spänningsstyrda natriumkanalblockerare
- Natriumkanalblockerare
- Lidokain
Andra studie-ID-nummer
- F061204013
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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