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Onset and Duration of Forearm Nerve Blockade

2019. február 22. frissítette: 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.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

36

Fázis

  • 4. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

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

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Négyszeres

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Aktív összehasonlító: 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.
Drog: Lidocaine
lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total
Drog: Lidocaine
lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total
Aktív összehasonlító: 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.
Drog: Bupivacaine
Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total
Aktív összehasonlító: 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
Drog: Lidocaine
lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total
Drog: Lidocaine
lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total
Aktív összehasonlító: 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.
Drog: Bupivacaine
Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
postoperative Numeric Rating Scale (NRS)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: Day 30
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Day 30

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

New York School of Regional Anesthesia

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2018. március 7.

Elsődleges befejezés (Tényleges)

2018. december 31.

A tanulmány befejezése (Tényleges)

2018. december 31.

Tanulmányi regisztráció dátumai

Először benyújtva

2018. augusztus 1.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2018. augusztus 24.

Első közzététel (Tényleges)

2018. augusztus 28.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2019. február 26.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2019. február 22.

Utolsó ellenőrzés

2019. február 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

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Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

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Nem

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

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