Onset and Duration of Forearm Nerve Blockade
perjantai 22. helmikuuta 2019 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
36
Vaihe
- Vaihe 4
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
Limburg
-
Genk, Limburg, Belgia, B-3600
- Ziekenhuis Oost-Limburg
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 80 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: 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
|
|
Active Comparator: 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
|
|
Active Comparator: 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
|
|
Active Comparator: 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
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
postoperative Numeric Rating Scale (NRS)
Aikaikkuna: 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)
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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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: Day 30
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 30
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
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Keskiviikko 7. maaliskuuta 2018
Ensisijainen valmistuminen (Todellinen)
Maanantai 31. joulukuuta 2018
Opintojen valmistuminen (Todellinen)
Maanantai 31. joulukuuta 2018
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 1. elokuuta 2018
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Perjantai 24. elokuuta 2018
Ensimmäinen Lähetetty (Todellinen)
Tiistai 28. elokuuta 2018
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Tiistai 26. helmikuuta 2019
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 22. helmikuuta 2019
Viimeksi vahvistettu
Perjantai 1. helmikuuta 2019
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