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Femoral Nerve Block With Bupivacaine and Adjuvant Dexamethasone in Patients With Hip Fracture

11 september 2015 uppdaterad av: University of Aarhus

Analgesic Duration af a Preoperative Single-shot Femoral Nerve Block With Bupivacaine and Adjuvant Dexamethasone in Patients With Hip Fracture

Prolongation of the analgesic effect of a femoral nerve block from the present 15 hours to 24 hours in patients with hip fracture would have a major impact in order to provide better preoperative analgesia for this group.

In other trials concerning other nerves then the femoral nerve the addition of Dexamethasone to the local anesthetics doubled the analgesic duration. No studies has investigated the effect of the addition of Dexamethasone to the femoral nerve block in patients with hip fracture.

The aim of our study is to investigate if more patients with hip fracture experience lasting preoperative analgesia until the time of operation or 20 hours after a femoral nerve block with the addition of Dexamethasone compared to the same nerve block done without Dexamethasone.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Patients with hip fractures are most often old, have multiple comorbidities and suffer severe pain.

Femoral nerve block as a means of preoperative analgesia for these patients has proven effective in multiple trials for the majority of the patients. Still some issues remains to be investigated in order to optimize the preoperative analgesia for this group.

One of the issues that reduces the feasibility of the femoral nerve block is the relatively shorter analgesic duration of the nerve block compared to the often longer time from the hospital admission to the actual operation. From the literature and our own experience the mean analgesic duration of a femoral nerve block approximates 15 hours.

Many studies have shown a prolonged analgesic duration of different nerve blocks when Dexamethasone was added to the local anesthetics. Some studies show a 100 percent increase in duration.

To our knowledge no studies have been published regarding prolongation of the analgesic effect of the femoral nerve block with Dexamethasone, and also none regarding the group of patients with hip fracture.

The clinical impact of a femoral nerve block with an analgesic duration of 20 hours compared to the present 15 hours would be less patients waking up in wards during the night time with pain and a terminated femoral nerve block.

The purpose of this study is to investigate if more patients with hip fracture experience a lasting preoperative analgesic duration of at least 20 hours or until the time of operation after a femoral nerve block with Bupivacaine with adrenaline and the addition of Dexamethasone compared to the same nerve block done with only Bupivacaine with adrenaline.

Studietyp

Interventionell

Inskrivning (Faktisk)

7

Fas

  • Fas 4

Kontakter och platser

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Studieorter

  • Danmark
      • Aarhus, Danmark, 8000
        • Aarhus University Hospital

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

55 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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 pain score (0-10) ≥ 7 with passive leg raise of the fractured leg at the time of inclusion
  • Patients informed consent

Exclusion Criteria:

  • Hip fracture not confirmed by x-ray
  • Weight < 40 kg
  • Verbal pain score > 3, 30 minutes after the nerve block
  • Verbal pain score > 5 with passive leg raise, 30 minutes after the nerve block
  • Patient has previously been included in this trial
  • Ongoing pre traumatic treatment with parenteral or intravenous adrenocortical hormone
  • Verbal pain score > 3 from other locations than the fractured hip
  • 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
  • Acute inability to comprehend and use verbal pain score

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
Placebo-jämförare: Saline
Bupivacaine with adrenaline with 2 ml. of Saline added
Läkemedel: Saline
Saline is added as a placebo to Bupivacaine with adrenaline for perineural injection
Andra namn:
  • Lösning av natriumklorid
Experimentell: Dexamethasone
Bupivacaine with adrenaline with 2 ml. of Dexamethasone added
Läkemedel: Dexamethasone
Dexamethasone is added to Bupivacaine with Adrenaline for perineural injection

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Frequency of analgesia at the time of operation or at 20 hours
Tidsram: Until the start of the operation or at 20 hours, average 18 hours
Frequency of analgesia at the time of operation or at 20 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine
Until the start of the operation or at 20 hours, average 18 hours

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Frequency of analgesia at the time of operation or at 22 hours
Tidsram: Until the start of the operation or at 22 hours, average 20 hours
Frequency of analgesia at the time of operation or at 22 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine
Until the start of the operation or at 22 hours, average 20 hours
Frequency of analgesia at the time of operation or at 24 hours
Tidsram: Until the start of the operation or at 24 hours, average 22 hours
Frequency of analgesia at the time of operation or at 24 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine
Until the start of the operation or at 24 hours, average 22 hours
Frequency of satisfactory analgesia
Tidsram: Until the start of the operation or at 20 hours, average 18 hours
Frequency of patients with satisfactory analgesia i the period from the nerve block until the time of operation or at 20 hours compared between the groups
Until the start of the operation or at 20 hours, average 18 hours
Time to wish for opioid analgesia
Tidsram: Until the start of the operation or at 24 hours, average 22 hours
Mean time fra nerve block to wish for opioid analgesia compared between groups
Until the start of the operation or at 24 hours, average 22 hours
Use of opioid analgesia until 20 hours
Tidsram: Until the start of the operation or at 20 hours, average 18 hours
Mean use of opioid analgesia until the time of operation or at 20 hours compared between groups
Until the start of the operation or at 20 hours, average 18 hours
Use of opioid analgesia until 22 hours
Tidsram: Until the start of the operation or at 22 hours, average 20 hours
Mean use of opioid analgesia until the time of operation or at 22 hours compared between groups
Until the start of the operation or at 22 hours, average 20 hours
Use of opioid analgesia until 24 hours
Tidsram: Until the start of the operation or at 24 hours, average 22 hours
Mean use of opioid analgesia until the time of operation or at 24 hours compared between groups
Until the start of the operation or at 24 hours, average 22 hours
Time to analgesic effect with patient at rest
Tidsram: 30 minutes
Mean time from nerve block to verbal pain score ≤3 at rest
30 minutes
Time to analgesic effect measured while doing passive leg raise
Tidsram: 30 minutes
Mean time from nerve block to verbal pain score ≤5 while doing passive leg raise
30 minutes
Frequency of insufficient analgesia
Tidsram: 30 minutes
Frequency of patients with hip fracture with insufficient analgesia after femoral nerve block at 30 minutes
30 minutes
Frequency of absent analgesia
Tidsram: 30 minutes
Frequency of patients with hip fracture with absent analgesia after femoral nerve block at 30 minutes
30 minutes
Frequency of patients without sufficient analgesia
Tidsram: 30 minutes
Frequency of patients with hip fracture without sufficient analgesia after femoral nerve block at 30 minutes
30 minutes
Skin sensation in saphenous area
Tidsram: 30 minutes
Frequency of reduced cold sensation in the skin area innervated by the saphenous nerve when sufficient analgesia versus insufficient analgesia of the fractured hip is experienced 30 minutes after the femoral nerve block
30 minutes
Skin sensation in area of the anterior cutaneous branches of the femoral nerve
Tidsram: 30 minutes
Frequency of reduced cold sensation in the skin area innervated by the anterior cutaneous branches of the femoral nerve when sufficient analgesia versus insufficient analgesia of the fractured hip is experienced 30 minutes after the femoral nerve block
30 minutes
Sufficient analgesia Dexamethasone vs. plain
Tidsram: 30 minutes
Success rate of sufficient analgesia after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain bupivacaine
30 minutes
Nerve visualization
Tidsram: Just before injection, which is within an expected average of 10 minutes after inclusion
Frequency of possible ultrasound visualization of the femoral nerve
Just before injection, which is within an expected average of 10 minutes after inclusion

Samarbetspartners och utredare

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

Sponsor

University of Aarhus

Utredare

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

Publikationer och användbara länkar

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Allmänna publikationer

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

1 mars 2015

Primärt slutförande (Faktisk)

1 september 2015

Avslutad studie (Faktisk)

1 september 2015

Studieregistreringsdatum

Först inskickad

18 september 2014

Först inskickad som uppfyllde QC-kriterierna

23 september 2014

Första postat (Uppskatta)

25 september 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

14 september 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 september 2015

Senast verifierad

1 mars 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • protocol1tdn

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