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Lidocaine and Neuroma Pain Related Modalities

21 november 2014 uppdaterad av: Adriana Miclescu, Uppsala University

Differential Analgesic Effects of Subanesthetic Concentrations of Lidocaine on Spontaneous and Evoked Pain in Human Painful Neuroma

Background Subanesthetics concentrations of lidocaine are able to produce a differential block of the ectopic discharges, but not propagation of impulses, suppressing differentially the associated neuropathic pain symptoms. The aim of this study was to investigate the differences between the analgesic effects of lidocaine 0.5% and a control group of lidocaine 0.1% on several neuroma related pain modalities.

Methods Sixteen patients with neuropathic pain due to painful neuromas caused by nerve injury participated in this randomized, double-blind experiment. The patterns of sensory changes were compared before and after injection of 1 ml lidocaine 0.5% and 0.1% close to the neuroma, the sessions being 1-2 weeks apart. Spontaneous and evoked pains were assessed using a visual analogue scale (VAS), quantitative and qualitative sensory testing.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

Patients were recruited by using a postal follow up questionnaire . The number of enrolled subjects in this study- 16 patients, Study design

  • The patients visited the Pain Clinic twice.
  • The same investigator (AM) performed all study procedure assessments.
  • Neuroma was localized by Tinel's sign 14 and when possible (7 patients out of 16), the localization of a neuroma was verified by ultrasound.

Administration of study drug The patients were randomized by a computer generated random list to receive either 1ml lidocaine 0.5% (A) or 1 ml 0.1% (B-control) injected perineuromally.

Pain assessments Duration of the present pain condition was recorded. The patients were asked to rate the mean, maximum, minimum pain intensity of their spontaneous and evoked pain in the week prior to both visits. The pain score was measured from baseline until 60 min after injection. Assessments of pain were done post injection at 15 s, 30 s, 1 min, and at 5-min intervals for the first 30-min post injection and then every 10-min to 1 hr post injection. The assessments of pain were performed between the limbs in the following order: spontaneous pain, then assessment of dynamic mechanical allodynia and then pinprick hyperalgesia.

Spontaneous pain Evaluation of sensory function was performed in the affected limb using bedside examination according to EFNS (European Federation of Neurological Societies)guidelines: light touch, pinprick sense, warmth (40°) and cold (25°) temperature stimuli were tested.

Studietyp

Interventionell

Inskrivning (Faktisk)

16

Fas

  • Inte tillämpbar

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

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • 18 years or older,
  • with a history of persistent spontaneous and/or evoked pain (by e.g. touch, movement),
  • who scored an average daily pain intensity of at least 4 on a 0-10 point numerical pain scale (NRS) interfering with daily activities and who had pain at least 3 months duration.
  • They all had neuromas after upper extremity surgery or other trauma affecting the radial, ulnar, median or digital nerves and were eligible to participate in the study after giving written informed consent.

Exclusion Criteria:

  • Patients with other conditions that might confound assessment of pain attributed to posttraumatic upper limb pain or
  • any condition/disease that could interfere with the study measurements, such as drug abuse, diabetes, vascular disease, polyneuropathy or psychiatric diseases were excluded.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Lidocaine (Xylocaine) 0.5%
Injection of 1ml after mixing Lidocaine 10 mg/ml 1 ml +1 ml NaCl was administrated perineuromally
perineuromally administration of 1 ml lidocaine
Andra namn:
  • Lidokain
  • Xylokain
perineuromally administration of NaCL
Andra namn:
  • Natriumklorid
  • salt-
Placebo-jämförare: Lidocaine (Xylocaine) 10 mg/ml 0.01%
Injection of 1 ml from 10 mg/ml 1 ml lidocaine Xylocaine +10 ml Nacl was adminsitrated perineuromally
perineuromally administration of 1 ml lidocaine
Andra namn:
  • Lidokain
  • Xylokain
perineuromally administration of NaCL
Andra namn:
  • Natriumklorid
  • salt-

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
The primary end-point measure was defined as the change in pain score measured from baseline until 60 min after injection
Tidsram: 60 min
60 min

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

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 2010

Primärt slutförande (Faktisk)

1 augusti 2013

Avslutad studie (Faktisk)

1 september 2014

Studieregistreringsdatum

Först inskickad

16 november 2014

Först inskickad som uppfyllde QC-kriterierna

21 november 2014

Första postat (Uppskatta)

24 november 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

24 november 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 november 2014

Senast verifierad

1 november 2014

Mer information

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 .

Kliniska prövningar på Neuropatisk smärta

Kliniska prövningar på Lidocaine (Xylocaine)

3
Prenumerera