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The Effect of Intravenous Lidocaine on Normal Sensation and Pain in Healthy Volunteers

11. april 2017 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

22

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35233
        • University of Alabama at Birmingham

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

19 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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.
Andre navn:
  • Lokalbedøvelse

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Ischemic Pain
Tidsramme: baseline, during 20 minute lidocaine infusion, and 30 minutes after discontinuation of lidocaine infusion
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.
baseline, during 20 minute lidocaine infusion, and 30 minutes after discontinuation of lidocaine infusion
Electrical Pain
Tidsramme: Baseline, during 20 minutes lidocaine infusion, and 30 minutes after completion of lidocaine infusion
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
Baseline, during 20 minutes lidocaine infusion, and 30 minutes after completion of lidocaine infusion
Heat Pain
Tidsramme: baseline, during 20 minute lidocaine infusion, and 30 minutes after completion of lidocaine infusion
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
baseline, during 20 minute lidocaine infusion, and 30 minutes after completion of lidocaine infusion
Cold Pain
Tidsramme: baseline, during 20 minute infusion, and 30 minutes after lidocaine infusion
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
baseline, during 20 minute infusion, and 30 minutes after lidocaine infusion
Tactile Sensation
Tidsramme: baseline, during 20 minute infusion, and 30 minutes after completion of infusion
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.
baseline, during 20 minute infusion, and 30 minutes after completion of infusion

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Alabama at Birmingham

Samarbeidspartnere

American Society of Regional Anesthesia

Etterforskere

  • Hovedetterforsker: Michael Froelich, MD, University of Alabama at Birmingham

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2008

Primær fullføring (Faktiske)

1. januar 2012

Studiet fullført (Faktiske)

1. januar 2012

Datoer for studieregistrering

Først innsendt

9. april 2008

Først innsendt som oppfylte QC-kriteriene

11. april 2008

Først lagt ut (Anslag)

14. april 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. mai 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. april 2017

Sist bekreftet

1. april 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • F061204013

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