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Obturator and Femoral Nerve Block in Patients With Hip Fracture

13. maj 2016 opdateret af: University of Aarhus

Analgesic Effect of an Obturator Nerve Block Combined With a Femoral Nerve Block Compared With Femoral Nerve Block Alone in Patients With Hip Fracture

A higher number than expected of patients with hip fracture have only insufficient analgesic effect of a femoral nerve block, which is the nerve block commonly used for this group of patients. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve.

With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve.

The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A higher number than expected of all patients with hip fracture have only insufficient analgesic effect of a femoral nerve block. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve. Earlier it was believed that the so called '3-in-1-block' or the iliac fascia compartment block would anesthetize also the obturator nerve, and these two nerve blocks have been uses extensively in the emergency ward for preoperative analgesia. Today that is not believed to be true and consequently is the part of the obturator nerve in patients with hip fracture unknown.

With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve before it branches into an anterior and a posterior branch. A selective nerve block of the obturator nerve to access its effect in patients with hip fracture has to our knowledge never been done.

The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

90

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Aarhus, Danmark, 8000
        • Rekruttering
        • Aarhus University Hospital
        • Kontakt:
        • Kontakt:
          • Thomas F. Bendtsen, MD, Ph.d.
          • Telefonnummer: +45 51542997
          • E-mail: tfb@dadlnet.dk

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

55 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Clinical suspicion of hip fracture
  • Age ≥ 55 years
  • Mentally capable of comprehending and using verbal pain score
  • Mentally capable of differentiating between pain from the fractured hip and pain from other locations
  • Mentally capable of understanding the given information
  • Arrival in the emergency room at times when one of the doctors who do the nerve blocks for this investigation are on call
  • Verbal numeric pain scale score (NRS 0-10) > 5 with a dynamic test OR NRS > 3 at rest
  • Patients informed consent

Exclusion Criteria:

  • Hip fracture not confirmed by x-ray
  • Weight < 40 kg
  • Patient has previously been included in this trial
  • If the patient wishes to be excluded
  • Allergy to local anesthetics or adrenocortical hormone
  • Visible infection in the area of the point of needle injection

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Bupivacaine
Obturator nerve block
Medicin: Bupivacaine
Obturator nerve block
Andre navne:
  • Active nerve block
Placebo komparator: Saline
Saline is injected as a placebo
Medicin: Saline
Obturator nerve block with saline(placebo)
Andre navne:
  • Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Success rate of successful analgesia, measured with numeric rating scale(NRS) 0-10 with 0=no pain and 10=worst pain. Successful analgesia = NRS<4 at rest and NRS <6 with passive movement of the fractured leg.
Tidsramme: 30 minutes
Success rate of successful analgesia compared between the groups
30 minutes

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Median pain score (NRS 0-10)
Tidsramme: 30 minutes
Median pain score 30 minutes after the nerve blocks compared between the groups
30 minutes
Median change in pain score (NRS 0-10)
Tidsramme: 30 minutes
Median change in pain score 30 minutes after the nerve blocks compared between the groups
30 minutes
Course in pain reduction
Tidsramme: 30 minutes
Course in pain reduction during the 30 minutes after the nerve blocks
30 minutes
Time to sufficient analgesia
Tidsramme: 30 minutes
Time from ended injection until sufficient analgesia
30 minutes
Frequency of anesthesia in the skin area of the saphenous nerve
Tidsramme: 30 minutes
Frequency of anesthesia in the skin area innervated by the saphenous nerve
30 minutes
Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
Tidsramme: 30 minutes
Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
30 minutes
Localization of the worst pain before block
Tidsramme: 0 minutes
Localization of the worst pain before any nerve blocks
0 minutes
Localization of the worst pain after block
Tidsramme: 30 minutes
Localization of the worst pain 30 minutes after the nerve blocks
30 minutes
Discomfort during nerve block procedures (score 0-10, 0=no discomfort)
Tidsramme: 5 minutes
Discomfort during the nerve block procedures compared between procedures
5 minutes
Satisfaction (0-10, 0= very unsatisfactory)
Tidsramme: 30 minutes
Patient satisfaction with the pain treatment
30 minutes
Frequency of ultrasound visualization of femoral nerve
Tidsramme: 5 minutes
Frequency of patients with possible ultrasound visualization af the femoral nerve
5 minutes
Frequency of ultrasound visualization of obturator injection site
Tidsramme: 5 minutes
Frequency of patients with possible ultrasound visualization of the obturator nerve block injection site
5 minutes
Time spend on femoral nerve block
Tidsramme: 5 minutes
Time spend on conducting the femoral nerve block
5 minutes
Time spend on obturator nerve block
Tidsramme: 5 minutes
Time spend on conducting the obturator nerve block
5 minutes
Total morphine equivalent dose of opioid from the time of nerve block to operation
Tidsramme: Approximately 24 hours in average
Total morphine equivalent dose of opioid from the time of nerve block until the time of operation
Approximately 24 hours in average
Total morphine equivalent dose of opioid/time from the time of nerve block to operation
Tidsramme: Approximately 24 hours in average
Total morphine equivalent dose of opioid/time from the time of nerve block until the time of operation
Approximately 24 hours in average
Total morphine equivalent dose of opioid in the first 10 hours after nerve block
Tidsramme: 10 hours
Total morphine equivalent dose of opioid given in the first 10 hours after nerve block
10 hours
Total morphine equivalent dose of opioid/time in the first 10 hours after nerve block
Tidsramme: 10 hours
Total morphine equivalent dose of opioid/time given in the first 10 hours after nerve block
10 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Aarhus

Efterforskere

  • Studieleder: Thomas F. Bendtsen, Ph.d., Aarhus University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2015

Primær færdiggørelse (Forventet)

1. april 2017

Studieafslutning (Forventet)

1. april 2017

Datoer for studieregistrering

Først indsendt

27. august 2015

Først indsendt, der opfyldte QC-kriterier

1. september 2015

Først opslået (Skøn)

4. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. maj 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2016

Sidst verificeret

1. maj 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • protocol2_2tdn

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