Onset and Duration of Forearm Nerve Blockade
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
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Studientyp
Studientyp
Einschreibung (Tatsächlich)
Einschreibung
Phase
Phase
- Phase 4
Kontakte und Standorte
Studienorte
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-
Limburg
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Genk, Limburg, Belgien, B-3600
- Ziekenhuis Oost-Limburg
-
-
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
|
Aktiver Komparator: 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.
|
lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total
lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total
|
|
Aktiver Komparator: 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.
|
Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total
|
|
Aktiver Komparator: 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
|
lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total
lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total
|
|
Aktiver Komparator: 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.
|
Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total
|
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
postoperative Numeric Rating Scale (NRS)
Zeitfenster: 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
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pain rating(numeric rating scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
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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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Day 30
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 30
|
Mitarbeiter und Ermittler
Sponsor
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Tatsächlich)
Primärer Abschluss
Studienabschluss (Tatsächlich)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Nervensystems
- Wunden und Verletzungen
- Neuromuskuläre Erkrankungen
- Mononeuropathien
- Erkrankungen des peripheren Nervensystems
- Mediane Neuropathie
- Nervenkompressionssyndrome
- Kumulative Traumastörungen
- Verstauchungen und Zerrungen
- Karpaltunnelsyndrom
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Anti-Arrhythmie-Mittel
- Depressiva des zentralen Nervensystems
- Agenten des peripheren Nervensystems
- Agenten des sensorischen Systems
- Anästhetika
- Membrantransportmodulatoren
- Anästhetika, lokal
- Spannungsgesteuerte Natriumkanalblocker
- Natriumkanalblocker
- Lidocain
- Bupivacain
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- 1801
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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