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Onset and Duration of Forearm Nerve Blockade

22 februari 2019 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

36

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv 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.
Läkemedel: Lidocaine
lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total
Läkemedel: Lidocaine
lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total
Aktiv 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.
Läkemedel: Bupivacaine
Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total
Aktiv 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
Läkemedel: Lidocaine
lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total
Läkemedel: Lidocaine
lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total
Aktiv 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.
Läkemedel: Bupivacaine
Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
postoperative Numeric Rating Scale (NRS)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Day 30
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
Day 30

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

New York School of Regional Anesthesia

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 mars 2018

Primärt slutförande (Faktisk)

31 december 2018

Avslutad studie (Faktisk)

31 december 2018

Studieregistreringsdatum

Först inskickad

1 augusti 2018

Först inskickad som uppfyllde QC-kriterierna

24 augusti 2018

Första postat (Faktisk)

28 augusti 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 februari 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 februari 2019

Senast verifierad

1 februari 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1801

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