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Onset and Duration of Forearm Nerve Blockade

22 février 2019 mis à jour par: Catherine Vandepitte, M.D., New York School of Regional Anesthesia

Onset and Duration of Forearm Nerve Blockade Performed With a Single Distal Injection Versus Sequential Injections at Distal and Proximal Locations Alongside the Nerves: A Blinded Randomized

This pilot study will evaluate the latency of onset and duration of sensory-motor block in patients undergoing hand surgery. Patients will be randomized to receive nerve blocks of the distal forearm or of the distal and proximal forearm. Local anesthetic will be injected to anesthetise the median and ulnar nerves in the distal forearm (1-injection site group) or the median and ulnar nerves in the distal and proximal forearm (2-sequential injection sites group) to accomplish anesthesia for surgery on the hand.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

36

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Belgique
    • Limburg
      • Genk, Limburg, Belgique, B-3600
        • Ziekenhuis Oost-Limburg

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Scheduled to undergo daycare surgery for carpal tunnel syndrome under peripheral nerve blocks
  • American Society of Anesthesiologists (ASA) physical status I, II or III
  • Able to demonstrate sensory function in the ulnar and median nerve distribution by exhibiting sensitivity to cold, pinprick and light touch
  • Scheduled to undergo primary hand surgery
  • Able to understand the Dutch language, purpose and risks of the study
  • Able to provide informed consent and authorization to use protected health information, adhere to the study visit schedule, and complete all study assessments

Exclusion Criteria:

  • Currently pregnant or nursing
  • History of hypersensitivity to local anesthetics
  • Contraindication to lidocaine, bupivacaine, paracetamol
  • Medical condition that will make it difficult to assess sensory distributions of the upper extremity peripheral nerves or to communicate with staff
  • Suspected or known recent history (< 3 months) of drug or alcohol abuse
  • Concurrent physical condition that may require analgesic treatment (such as NSAID or opioid) in the postsurgical period for pain that is not strictly related to Carpal Tunnel Syndrome and which may confound the postsurgical assessments
  • Infection at the planned block site(s)
  • Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®)
  • Body weight <40 kg or body mass index >44 kg/m2
  • Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
  • Any chronic neuromuscular deficit affecting the Ulnar and Median nerves or muscles of the surgical extremity
  • Any chronic condition or disease that would compromise neurological
  • Presence of pre-existing coagulation disorders
  • Baseline neurological deficits

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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
Comparateur actif: Lidocaine distal forearm
Lidocaine 1% - Ultrasound-guided specific blocks of the DISTAL median and ulnar nerves with perineural injections of Lidocaine1%. Volume injected is 6 mL/nerve; 12 mL total.
Médicament: Lidocaine
lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total
Médicament: Lidocaine
lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total
Comparateur actif: Bupivacaine distal forearm
Bupivacaine 0.5%-Ultrasound-guided specific blocks of the DISTAL median and ulnar nerves with perineural injections of Bupivacaine0.5%. Volume injected is 6 mL/nerve; 12 mL total.
Médicament: Bupivacaine
Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total
Comparateur actif: Lidocaine distal and proximal forearm
Lidocaine 1%- Ultrasound-guided specific blocks of the DISTAL and PROXIMAL median and ulnar nerves with perineural injections of Lidocaine 1%. Volume injected is 3 mL/nerve; 12 mL total
Médicament: Lidocaine
lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total
Médicament: Lidocaine
lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total
Comparateur actif: Bupivacaine distal and proximal forearm
Bupivacaine 0.5%- Ultrasound-guided specific blocks of the DISTAL and PROXIMAL median and ulnar nerves with perineural injections of Bupivacaine 0.5 %. Volume injected is 3 mL/nerve; 12 mL total.
Médicament: Bupivacaine
Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Délai: 5-minute beginning at the end of the last injection
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
5-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Délai: 10-minute beginning at the end of the last injection
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
10-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Délai: 15-minute beginning at the end of the last injection
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
15-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Délai: 20-minute beginning at the end of the last injection
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
20-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Délai: 25-minute beginning at the end of the last injection
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
25-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Délai: 30-minute beginning at the end of the last injection
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
30-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Délai: 45-minute beginning at the end of the last injection
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
45-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Délai: 60-minute beginning at the end of the last injection
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
60-minute beginning at the end of the last injection
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Délai: Post Anesthesia Care Unit arrival
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
Post Anesthesia Care Unit arrival
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Délai: 15-minute after Post Anesthesia Care Unit arrival
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
15-minute after Post Anesthesia Care Unit arrival
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Délai: 30-minute after Post Anesthesia Care Unit arrival
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
30-minute after Post Anesthesia Care Unit arrival
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Délai: Post Anesthesia Care Unit discharge
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
Post Anesthesia Care Unit discharge

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
postoperative Numeric Rating Scale (NRS)
Délai: screening Day0 (prior to the nerve block), post block, PACU arrival, Day0 evening, Day1 morning and evening, Day2 morning and evening, Day3 morning and evening, Day4, Day5, Day6, Day7
pain rating(numeric rating scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
screening Day0 (prior to the nerve block), post block, PACU arrival, Day0 evening, Day1 morning and evening, Day2 morning and evening, Day3 morning and evening, Day4, Day5, Day6, Day7
postoperative Numeric Rating Scale (NRS)
Délai: post block
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
post block
postoperative Numeric Rating Scale (NRS)
Délai: Post Anesthesia Care Unit arrival
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Post Anesthesia Care Unit arrival
postoperative Numeric Rating Scale (NRS)
Délai: Day 0 evening
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Day 0 evening
postoperative Numeric Rating Scale (NRS)
Délai: Day 1 morning
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Day 1 morning
postoperative Numeric Rating Scale (NRS)
Délai: Day 1 evening
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Day 1 evening
postoperative Numeric Rating Scale (NRS)
Délai: Day 2 morning
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Day 2 morning
postoperative Numeric Rating Scale (NRS)
Délai: Day 2 evening
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Day 2 evening
postoperative Numeric Rating Scale (NRS)
Délai: Day 3 morning
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Day 3 morning
postoperative Numeric Rating Scale (NRS)
Délai: Day 3 evening
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Day 3 evening
postoperative Numeric Rating Scale (NRS)
Délai: Day 4
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Day 4
postoperative Numeric Rating Scale (NRS)
Délai: Day 5
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Day 5
postoperative Numeric Rating Scale (NRS)
Délai: Day 6
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Day 6
postoperative Numeric Rating Scale (NRS)
Délai: Day 7
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Day 7
postoperative Numeric Rating Scale (NRS)
Délai: Day 30
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Day 30

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

New York School of Regional Anesthesia

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

7 mars 2018

Achèvement primaire (Réel)

31 décembre 2018

Achèvement de l'étude (Réel)

31 décembre 2018

Dates d'inscription aux études

Première soumission

1 août 2018

Première soumission répondant aux critères de contrôle qualité

24 août 2018

Première publication (Réel)

28 août 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 février 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 février 2019

Dernière vérification

1 février 2019

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 1801

Plan pour les données individuelles des participants (IPD)

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Indécis

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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