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

3. februar 2016 opdateret af: 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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

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

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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
Eksperimentel: 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

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

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

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. januar 2010

Primær færdiggørelse (Faktiske)

1. juni 2011

Studieafslutning (Faktiske)

1. juli 2011

Datoer for studieregistrering

Først indsendt

10. maj 2010

Først indsendt, der opfyldte QC-kriterier

11. maj 2010

Først opslået (Skøn)

13. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. februar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • eZono

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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