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Comparison Between Two Ultrasound Technologies for Ultrasound-guided Catheter Placement in Regional Anesthesia (eZono)

3. februar 2016 oppdatert av: Claudia Spies, Charite University, Berlin, Germany

A Prospective, Randomized Comparison Between Two Ultrasound Technologies for Ultrasound-guided Catheter Placement in Regional Anesthesia

The use of ultrasound imaging techniques in regional anaesthesia is rapidly becoming an area of increasing interest. It represents one of the largest changes that the field of regional anaesthesia has seen. For the first time, the operator is able to view an image of the target nerve directly, guide the needle under real-time observation, navigate away from sensitive anatomy, and monitor the spread of local anaesthetic (LA).The key to successful regional anaesthesia is deposition of LA accurately around the nerve structures.

In the past, electrical stimulation which relied on surface landmark identification, was used for this. However, landmark techniques have limitations; variations in anatomy and nerve physiology , as well as equipment accuracy have had an effect on success rates and complications.

However, alongside the enthusiasm of ultrasound guidance in regional anaesthesia, there should be a degree of informed scepticism. The widespread use of the various techniques of ultrasound-guided regional blocks without adequate training raises the danger of malpractice and subsequent impaired outcome.

Adequate education in the use of regional block techniques under ultrasound guidance is essential. Recent technical developments have achieved higher ultrasound frequencies and better image resolution, as well as better post-processing and user-friendliness.

The purpose of this study is to determine whether new technical features such as reference images, higher ultrasound frequencies, better image resolution and smaller size and weight of the ultrasound probes may improve outcome (clinical benefits) and may show an increased efficacy and safety. And if the new technology of ultrasound images improves the training quality of trainees and novices in the art of ultrasound-guided blocks.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

90

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Berlin, Tyskland, 10117
        • Charité - Universitätsmedizin Berlin, Klinik für Anästhesiologie
      • Berlin, Tyskland, 10117
        • Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients at the age of 18 and above who need a regional anesthesia catheter for postoperative pain management after elective orthopedic surgery

Exclusion Criteria:

  • Participation in another trial according to the German Drug Law 30 days to and during the study
  • Lacking willingness to save and hand out data within the study
  • Accommodation in an institution due to an official or judicial order
  • (Unclear) history of alcohol or substances disabuse
  • Absent knowledge of German language
  • Analphabetism
  • Allergy to local anesthesia or other ingredients of the intravenous solutions
  • For women: Pregnancy or positive pregnancy test within the preoperative screening
  • Operation due to case of emergency, polytrauma or pathologic fracture
  • American Society of Anaesthesiologists (ASA) classification greater than III
  • Peripheral or central edema
  • AIDS (according to the CDC-classification of HIV-infection: category C)
  • Immunosuppression therapy
  • History of bleeding tendency (e.g. von-Willebrand-disease, thrombocytopenia)
  • Derailed metabolic disorder (e.g. Diabetes mellitus (Glucose > 300 mg/dl) during the preoperative screening)
  • Known history of electrolyte disturbance (e.g. Hyperkalemia > 5.8 mmol/l, Hypernatraemia > 155 mmol/l)
  • Known history of acid-base-dysbalances
  • History of intracranial hemorrhage within one year of participation in the study
  • Neurological or psychiatric disease with limited contractual capability
  • CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV
  • Liver disease (CHILD B or C cirrhosis, end-stage liver disease (MELD-score greater than 10)
  • Renal insufficiency (serum creatinine greater than 2.0 mg/dl or greater than 150 µmol/l or dependency of haemodialysis)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: standard 2D ultrasound images
higher ultrasound frequencies, better image resolution, better post-processing and user-friendliness.
current standard in two-dimensional (2D) ultrasound images
Eksperimentell: high-quality 2D ultrasound images
higher ultrasound frequencies, better image resolution, better post-processing and user-friendliness.
current standard in two-dimensional (2D) ultrasound images
Aktiv komparator: nerve stimulation techniques
higher ultrasound frequencies, better image resolution, better post-processing and user-friendliness.
current standard in two-dimensional (2D) ultrasound images

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Reduction in time to perform the catheter placement in regional anesthesia
Tidsramme: first three days
first three days

Sekundære resultatmål

Resultatmål
Tidsramme
Improvement in performance: Incidence of complications
Tidsramme: first three days
first three days
Improvement of success rate regarding correct catheter placement
Tidsramme: first three days
first three days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2010

Primær fullføring (Faktiske)

1. juni 2011

Studiet fullført (Faktiske)

1. juli 2011

Datoer for studieregistrering

Først innsendt

10. mai 2010

Først innsendt som oppfylte QC-kriteriene

11. mai 2010

Først lagt ut (Anslag)

13. mai 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

4. februar 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. februar 2016

Sist bekreftet

1. februar 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • eZono

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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