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Prospective Post-market Evaluation of an Echogenic Catheter

NCT02136446 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-05-19

No results posted yet for this study

Summary

Patients scheduled for mastectomy and suitable for paravertebral block will be randomized to one of 2 groups.

Group 1 will have the nerve block performed using a standard non-echogenic needle and catheter under ultrasound guidance. Group 2 will have the block performed using the control needle and an echogenic catheter, all under ultrasound (US) guidance.

The clinician will be blinded to the catheter type and will assess the quality of catheter visualisation of the US image during the procedure, along with adequacy of spread of local anesthetic. The primary outcome will be needle visibility, and secondary outcomes will be block success rate and block quality. An assessment of the patient's pain levels after the procedure will also be conducted.

Conditions

  • Peripheral Nerve Block Procedure

Interventions

DEVICE

EchoGlo Nerve Block Catheter

Catheter used for a paravertebral anesthesia block

DEVICE

Pajunk® Nerve Block Catheter

Nerve Block Catheter

Sponsors & Collaborators

  • Smiths Medical, ASD, Inc.

    lead INDUSTRY

Principal Investigators

  • Peter R Kratz, MS · Smiths Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-09-30
Completion
2015-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02136446 on ClinicalTrials.gov