Does Perineural Dexmedetomidine Prolong Duration of a Nerve Block?
Does Perineural Dexmedetomidine Prolong the Duration of an Adductor Canal Block When Controlling for a Systemic Effect? - A Randomised Paired Trial in Healthy Volunteers.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Koege, Danemark, 4600
- Department of Anesthesiology Koege Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Ropivacaine + Dexmedetomidine
Adductor Canal Block 20 ml Ropivacaine 5mg/ml + 1 ml Dexmedetomidine 100ug/ml
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100 ug dexmedetomidine added to the ropivacaine nerveblock
Autres noms:
20 ml Ropivacaine 5mg/ml
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Comparateur placebo: Ropivacaine + Placebo
Adductor Canal Block 20 ml Ropivacaine 5mg/ml + 1 ml Saline
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20 ml Ropivacaine 5mg/ml
Placebo
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Difference in duration of sensory block between dexmedetomidine and placebo assessed as cold sensation with an alcohol swab
Délai: 0-36 hours
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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.
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0-36 hours
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Difference between dexmedetomidine and placebo in the duration of a sensory block assessed by pin-prick
Délai: 0-36 hours
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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.
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0-36 hours
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Difference between dexmedetomidine and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test
Délai: 0-36 hours
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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.
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0-36 hours
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Difference between dexmedetomidine and placebo in the duration of a sensory block assessed as warmth detection threshold
Délai: 0-36 hours
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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
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0-36 hours
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Difference between dexmedetomidine and placebo in the duration of a sensory block assessed as heat pain detection threshold
Délai: 0-36 hours
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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.
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0-36 hours
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Difference in maximum pain scores between dexmedetomidine and placebo during block and after recovery of normal sensation.
Délai: 0-36 hours
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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.
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0-36 hours
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jakob H Andersen, MD, Department of Anesthesiology Koege Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Effets physiologiques des médicaments
- Agents adrénergiques
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Dépresseurs du système nerveux central
- Agents du système nerveux périphérique
- Analgésiques
- Agents du système sensoriel
- Anesthésiques
- Analgésiques, non narcotiques
- Agonistes des récepteurs adrénergiques alpha-2
- Alpha-agonistes adrénergiques
- Agonistes adrénergiques
- Hypnotiques et sédatifs
- Anesthésiques locaux
- Dexmédétomidine
- Ropivacaïne
Autres numéros d'identification d'étude
- SM2-JH-14
- 2014-005651-89 (Numéro EudraCT)
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