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

NCT01122693 | Completed DMC

• 1 other identifier: eZono
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Anesthesia

Keywords

Regional Anesthesia; Pain Medicine; Ultrasound; Nerve Blocks

Outcome Measures

Primary Outcomes (1)

• Reduction in time to perform the catheter placement in regional anesthesia

  first three days

Secondary Outcomes (2)

• Improvement in performance: Incidence of complications

  first three days

• Improvement of success rate regarding correct catheter placement

  first three days

Study Arms (3)

standard 2D ultrasound images

ACTIVE COMPARATOR

Device: eZono - high-quality 2D ultrasound images; Device: standard 2D ultrasound images

high-quality 2D ultrasound images

EXPERIMENTAL

Device: eZono - high-quality 2D ultrasound images; Device: standard 2D ultrasound images

nerve stimulation techniques

ACTIVE COMPARATOR

Device: eZono - high-quality 2D ultrasound images; Device: standard 2D ultrasound images

Interventions

eZono - high-quality 2D ultrasound images DEVICE

higher ultrasound frequencies, better image resolution, better post-processing and user-friendliness.

high-quality 2D ultrasound images; nerve stimulation techniques; standard 2D ultrasound images

standard 2D ultrasound images DEVICE

current standard in two-dimensional (2D) ultrasound images

high-quality 2D ultrasound images; nerve stimulation techniques; standard 2D ultrasound images

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (2)

Charité - Universitätsmedizin Berlin, Klinik für Anästhesiologie

Berlin, State of Berlin, 10117, Germany

Location

Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum

Berlin, State of Berlin, 10117, Germany

Location

Study Officials

• Claudia Spies, MD Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ. Prof. Dr. med. Claudia Spies, Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 13, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 4, 2016

Record last verified: 2016-02

Locations

DE (2)