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

11 settembre 2015 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

7

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Danimarca
      • Aarhus, Danimarca, 8000
        • Aarhus University Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

55 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Saline
Bupivacaine with adrenaline with 2 ml. of Saline added
Droga: Saline
Saline is added as a placebo to Bupivacaine with adrenaline for perineural injection
Altri nomi:
  • Soluzione di cloruro di sodio
Sperimentale: Dexamethasone
Bupivacaine with adrenaline with 2 ml. of Dexamethasone added
Droga: Dexamethasone
Dexamethasone is added to Bupivacaine with Adrenaline for perineural injection

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Frequency of analgesia at the time of operation or at 20 hours
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Frequency of analgesia at the time of operation or at 22 hours
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 30 minutes
Mean time from nerve block to verbal pain score ≤5 while doing passive leg raise
30 minutes
Frequency of insufficient analgesia
Lasso di tempo: 30 minutes
Frequency of patients with hip fracture with insufficient analgesia after femoral nerve block at 30 minutes
30 minutes
Frequency of absent analgesia
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 30 minutes
Success rate of sufficient analgesia after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain bupivacaine
30 minutes
Nerve visualization
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Aarhus

Investigatori

  • Direttore dello studio: Thomas F. Bendtsen, MD, Ph.d., Aarhus University Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2015

Completamento primario (Effettivo)

1 settembre 2015

Completamento dello studio (Effettivo)

1 settembre 2015

Date di iscrizione allo studio

Primo inviato

18 settembre 2014

Primo inviato che soddisfa i criteri di controllo qualità

23 settembre 2014

Primo Inserito (Stima)

25 settembre 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

14 settembre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 settembre 2015

Ultimo verificato

1 marzo 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • protocol1tdn

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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