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

Anesthesia Clinical Trial

— eZono  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122693
• Other study ID #: eZono
• Status: Completed
• Phase: N/A
• First received: May 10, 2010
• Last updated: February 3, 2016
• Start date: January 2010
• Est. completion date: July 2011

Study information

• Verified date: February 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• eZono - high-quality 2D ultrasound images
higher ultrasound frequencies, better image resolution, better post-processing and user-friendliness.
• standard 2D ultrasound images
current standard in two-dimensional (2D) ultrasound images

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin, Klinik für Anästhesiologie	Berlin
Germany	Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in time to perform the catheter placement in regional anesthesia		first three days	No
Secondary	Improvement in performance: Incidence of complications		first three days	Yes
Secondary	Improvement of success rate regarding correct catheter placement		first three days	No