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
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Zapisy (Rzeczywisty)
Zapisy
Faza
Faza
- Faza 4
Kontakty i lokalizacje
Lokalizacje studiów
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Limburg
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Genk, Limburg, Belgia, B-3600
- Ziekenhuis Oost-Limburg
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
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Aktywny 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.
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lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total
lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total
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Aktywny 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.
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Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total
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Aktywny 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
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lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total
lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total
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Aktywny 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.
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Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Ramy czasowe: 5-minute beginning at the end of the last injection
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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.
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5-minute beginning at the end of the last injection
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onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Ramy czasowe: 10-minute beginning at the end of the last injection
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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
Ramy czasowe: 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
Ramy czasowe: 20-minute beginning at the end of the last injection
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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
|
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onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Ramy czasowe: 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
|
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onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Ramy czasowe: 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.
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30-minute beginning at the end of the last injection
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onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Ramy czasowe: 45-minute beginning at the end of the last injection
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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
|
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onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Ramy czasowe: 60-minute beginning at the end of the last injection
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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.
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60-minute beginning at the end of the last injection
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onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Ramy czasowe: Post Anesthesia Care Unit arrival
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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
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onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Ramy czasowe: 15-minute after Post Anesthesia Care Unit arrival
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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.
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15-minute after Post Anesthesia Care Unit arrival
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onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Ramy czasowe: 30-minute after Post Anesthesia Care Unit arrival
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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.
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30-minute after Post Anesthesia Care Unit arrival
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onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Ramy czasowe: Post Anesthesia Care Unit discharge
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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.
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Post Anesthesia Care Unit discharge
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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postoperative Numeric Rating Scale (NRS)
Ramy czasowe: 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
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postoperative Numeric Rating Scale (NRS)
Ramy czasowe: post block
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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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post block
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postoperative Numeric Rating Scale (NRS)
Ramy czasowe: Post Anesthesia Care Unit arrival
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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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Post Anesthesia Care Unit arrival
|
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postoperative Numeric Rating Scale (NRS)
Ramy czasowe: Day 0 evening
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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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Day 0 evening
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postoperative Numeric Rating Scale (NRS)
Ramy czasowe: Day 1 morning
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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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Day 1 morning
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postoperative Numeric Rating Scale (NRS)
Ramy czasowe: Day 1 evening
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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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Day 1 evening
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postoperative Numeric Rating Scale (NRS)
Ramy czasowe: Day 2 morning
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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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Day 2 morning
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postoperative Numeric Rating Scale (NRS)
Ramy czasowe: 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)
Ramy czasowe: Day 3 morning
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 3 morning
|
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postoperative Numeric Rating Scale (NRS)
Ramy czasowe: Day 3 evening
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
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Day 3 evening
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postoperative Numeric Rating Scale (NRS)
Ramy czasowe: Day 4
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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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Day 4
|
|
postoperative Numeric Rating Scale (NRS)
Ramy czasowe: Day 5
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 5
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postoperative Numeric Rating Scale (NRS)
Ramy czasowe: Day 6
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 6
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postoperative Numeric Rating Scale (NRS)
Ramy czasowe: Day 7
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pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 7
|
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postoperative Numeric Rating Scale (NRS)
Ramy czasowe: Day 30
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pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 30
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Współpracownicy i badacze
Sponsor
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
Ukończenie studiów (Rzeczywisty)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby Układu Nerwowego
- Rany i urazy
- Choroby nerwowo-mięśniowe
- Mononeuropatie
- Choroby obwodowego układu nerwowego
- Neuropatia medianowa
- Zespoły ucisku nerwów
- Skumulowane zaburzenia traumy
- Skręcenia i naciągnięcia
- Zespół cieśni nadgarstka
- Fizjologiczne skutki leków
- Molekularne mechanizmy działania farmakologicznego
- Środki antyarytmiczne
- Depresanty ośrodkowego układu nerwowego
- Agenty obwodowego układu nerwowego
- Agenci systemu sensorycznego
- Środki znieczulające
- Modulatory transportu membranowego
- Środki znieczulające, miejscowe
- Blokery kanału sodowego bramkowane napięciem
- Blokery kanałów sodowych
- Lidokaina
- Bupiwakaina
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 1801
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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