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Does Perineural Dexmedetomidine Prolong Duration of a Nerve Block?

4 januari 2016 uppdaterad av: Jakob Hessel Andersen, Zealand University Hospital

Does Perineural Dexmedetomidine Prolong the Duration of an Adductor Canal Block When Controlling for a Systemic Effect? - A Randomised Paired Trial in Healthy Volunteers.

Brief Summary: The aim of this trial is to investigate if dexmedetomidine prolongs the duration of an adductor canal block. By using healthy volunteers the investigators can perform a bilateral adductor canal block and thereby control for a systemic effect to clarify if the effect is actually peripheral or systemic. The investigators hypothesis is that dexmedetomidine as an adjunct to a local anaesthetic prolongs the duration of a peripheral nerve block by a peripheral mechanism.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Background:

Efficient pain management promoting mobilization and convalescence is essential in an ideal perioperative course. Regional nerve blocks are a central element in postoperative regimes for many patients and it is therefore important that these nerve blocks are both long lasting and efficient. This trial will investigate whether it is possible to optimize the postoperative pain management when adding dexmedetomidine to the local anaesthetic ropivacaine in peripheral nerve blocks.

The prolonging effect of using dexmedetomidine as adjunct in peripheral nerve blocks have been investigated in several studies. However, it remains uncertain whether the effect is mediated by a systemic-, a peripheral- or a combined systemic/peripheral mechanism. In this trial the adjuvating effect of dexmedetomidine will be investigated using the adductor canal block. This is a nerve block that besides being efficient as pain treatment after knee surgery, is primarily sensory, and therefore augments mobilization after total knee arthroplasty.

Method:

On the trial day the volunteers will receive bilateral adductor canal blocks. In one thigh they will receive the local anaesthetic ropivacaine 20ml 5mg/ml and placebo (saline) and in the other thigh ropivacaine 20ml 5mg/ml and dexmedetomidine 100μg. The allocation is blinded to volunteer and investigator.

The duration of the nerve block will be measured by five different tests: Temperature test, Pinprick, Pain during tonic heat stimulation, Warmth detection threshold and pain detection threshold. All tests are validated within pain research.

Studietyp

Interventionell

Inskrivning (Faktisk)

21

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Danmark
      • Koege, Danmark, 4600
        • Department of Anesthesiology Koege Hospital

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 till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Manlig

Beskrivning

Inclusion Criteria:

  • American Society of Anesthesiologists class 1
  • Body Mass Index 18-30

Exclusion Criteria:

  • Allergy to study medication
  • Earlier trauma or surgery to lower limb
  • Diabetes Mellitus
  • Alcohol or drug abuse
  • Daily intake of opioids or steroids last 4 weeks
  • Daily intake of any analgesics last 48 hours Heart block Sick sinus node.

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: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Ropivacaine + Dexmedetomidine
Adductor Canal Block 20 ml Ropivacaine 5mg/ml + 1 ml Dexmedetomidine 100ug/ml
Läkemedel: Dexmedetomidine
100 ug dexmedetomidine added to the ropivacaine nerveblock
Andra namn:
  • Dexdor
Läkemedel: Ropivacaine
20 ml Ropivacaine 5mg/ml
Placebo-jämförare: Ropivacaine + Placebo
Adductor Canal Block 20 ml Ropivacaine 5mg/ml + 1 ml Saline
Läkemedel: Ropivacaine
20 ml Ropivacaine 5mg/ml
Läkemedel: Isotonic Saline
Placebo

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Difference in duration of sensory block between dexmedetomidine and placebo assessed as cold sensation with an alcohol swab
Tidsram: 0-36 hours
Duration is defined as time from block performance until recovery of cold sensation to an alcohol swab, assessed every hour post-block (and every half hour when pain scores during the tonic heat stimulation test is above 0) Time for sleep will be provided.
0-36 hours

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Difference between dexmedetomidine and placebo in the duration of a sensory block assessed by pin-prick
Tidsram: 0-36 hours
Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block Time for sleep will be provided.
0-36 hours
Difference between dexmedetomidine and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test
Tidsram: 0-36 hours
Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block.Time for sleep will be provided. Recovery of normal sensation is defined as VAS pain scores ± 10 mm of the pre-block value. A Linear 100mm visual analogue scale (VAS) will be used.
0-36 hours
Difference between dexmedetomidine and placebo in the duration of a sensory block assessed as warmth detection threshold
Tidsram: 0-36 hours
Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block Time for sleep will be provided. Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value. Time for sleep will be provided
0-36 hours
Difference between dexmedetomidine and placebo in the duration of a sensory block assessed as heat pain detection threshold
Tidsram: 0-36 hours
Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block. Time for sleep will be provided. Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.
0-36 hours
Difference in maximum pain scores between dexmedetomidine and placebo during block and after recovery of normal sensation.
Tidsram: 0-36 hours
Pain scores during a tonic heat stimulation will be compared every hour post block and 1 h after pain scores have returned to the pre-block values. Time for sleep will be provided.
0-36 hours

Samarbetspartners och utredare

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

Sponsor

Zealand University Hospital

Utredare

  • Huvudutredare: Jakob H Andersen, MD, Department of Anesthesiology Koege Hospital

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 augusti 2015

Primärt slutförande (Faktisk)

1 september 2015

Avslutad studie (Faktisk)

1 september 2015

Studieregistreringsdatum

Först inskickad

30 juni 2015

Först inskickad som uppfyllde QC-kriterierna

30 juni 2015

Första postat (Uppskatta)

2 juli 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

5 januari 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 januari 2016

Senast verifierad

1 augusti 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • SM2-JH-14
  • 2014-005651-89 (EudraCT-nummer)

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