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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Charite University, Berlin, Germany.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01122693
First received: May 10, 2010
Last updated: May 11, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention
Anesthesia
 Device: eZono - high-quality 2D ultrasound images
Device: standard 2D ultrasound images

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Prospective, Randomized Comparison Between Two Ultrasound Technologies for Ultrasound-guided Catheter Placement in Regional Anesthesia

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Reduction in time to perform the catheter placement in regional anesthesia [ Time Frame: first three days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in performance: Incidence of complications [ Time Frame: first three days ] [ Designated as safety issue: Yes ]
  • Improvement of success rate regarding correct catheter placement [ Time Frame: first three days ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: May 2010
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard 2D ultrasound images Device: eZono - high-quality 2D ultrasound images
higher ultrasound frequencies, better image resolution, better post-processing and user-friendliness.
Device: standard 2D ultrasound images
current standard in two-dimensional (2D) ultrasound images
Experimental: high-quality 2D ultrasound images Device: eZono - high-quality 2D ultrasound images
higher ultrasound frequencies, better image resolution, better post-processing and user-friendliness.
Device: standard 2D ultrasound images
current standard in two-dimensional (2D) ultrasound images
Active Comparator: nerve stimulation techniques Device: eZono - high-quality 2D ultrasound images
higher ultrasound frequencies, better image resolution, better post-processing and user-friendliness.
Device: standard 2D ultrasound images
current standard in two-dimensional (2D) ultrasound images

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122693

Contacts
Contact: Claudia Spies, MD Prof. + 4930450551001 claudia.spies@charite.de

Locations
Germany
Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum Not yet recruiting
Berlin, Germany, 10117
Contact: Claudia Spies Prof., MD     004930450531001     claudia.spies@charite.de    
Principal Investigator: Claudia Spies, MD Prof. Dr.            
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Director: Claudia Spies, MD Prof. Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Univ. Prof. Dr. med. Claudia Spies, Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum Charité - Universitätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT01122693     History of Changes
Other Study ID Numbers: EA 1/012/10
Study First Received: May 10, 2010
Last Updated: May 11, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Regional Anesthesia
Pain Medicine
Ultrasound
Nerve Blocks

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013