- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03649763
Onset and Duration of Forearm Nerve Blockade
22. Februar 2019 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
36
Phase
- Phase 4
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Limburg
-
Genk, Limburg, Belgien, B-3600
- Ziekenhuis Oost-Limburg
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
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
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / 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
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
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
|
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)
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
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
7. März 2018
Primärer Abschluss (Tatsächlich)
31. Dezember 2018
Studienabschluss (Tatsächlich)
31. Dezember 2018
Studienanmeldedaten
Zuerst eingereicht
1. August 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
24. August 2018
Zuerst gepostet (Tatsächlich)
28. August 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
26. Februar 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
22. Februar 2019
Zuletzt verifiziert
1. Februar 2019
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
- 1801
Plan für individuelle Teilnehmerdaten (IPD)
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Unentschieden
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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