Prospective Post-market Evaluation of an Echogenic Catheter (EchoCath)

Prospective Post-market Evaluation of an Echogenic Catheter Used in a Peripheral Nerve Block Procedure

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Nerve Block Procedure
• Intervention / Treatment: Device: EchoGlo Nerve Block Catheter; Device: Pajunk® Nerve Block Catheter

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simeon West, MBChB FRCA; Phone Number: +07919205965; Email: simeon.west@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, NW14 5BU
    • Recruiting
    • University College Hospital
    • Contact: Simeon West, MBChB FRCA; Phone Number: +07919205965; Email: simeon.west@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled to undergo breast surgery requiring use of a peripheral nerve block catheter for establishing a paravertebral block
• Patients classified as ASA (American Society of Anesthesiologists) physical status I, II or III
• Patients at least 18 years old
• Patient is willing and able to provide informed consent for study participation
• Patient has a good understanding of written and verbal English

Exclusion Criteria:

• Patient with contraindications to regional anesthesia technique (e.g. allergy to local anesthetic or other medications used in study)
• Patient with known coagulopathy
• Patient whose target nerve cannot be seen with linear ultrasound probe in a pre-procedure scan. All patients who need a curvilinear probe to visualize the target nerve will be excluded from the study.
• Patients having mastectomy and immediate reconstruction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EchoGlo™ Peripheral Nerve Block Catheter; Echogenic nerve block catheter (test)	Device: EchoGlo Nerve Block Catheter; Catheter used for a paravertebral anesthesia block; Other Names: EchoGlo™ Peripheral Nerve Block Catheter
Active Comparator: Pajunk® EpiLong Catheter; Non-echogenic nerve block catheter (control)	Device: Pajunk® Nerve Block Catheter; Nerve Block Catheter; Other Names: Pajunk® EpiLong Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visibility of entire catheter length	Demonstrate superior ultrasound visibility of the entire length of the test catheter compared to the control, as graded by a blinded investigator	Day 1, time of procedure
Visibility of catheter tip	Demonstrate superior ultrasound visibility of the test catheter tip compared to the control, as graded by a blinded investigator	Day 1, time of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of the block	Mean rating of block quality as assessed by the clinician on a 4 point scale per treatment group	Day 1, time of procedure
Block failure rate	Number of failed blocks per treatment group	Day 1, time of procedure

Collaborators and Investigators

• Sponsor: Smiths Medical, ASD, Inc.
• Investigators: Study Director: Peter R Kratz, MS, Smiths Medical

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: May 7, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimate): May 13, 2014

Study Record Updates

• Last Update Posted (Estimate): May 19, 2015
• Last Update Submitted That Met QC Criteria: May 18, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Post-operative pain; Mastectomy; Paravertebral block; Echogenic; Peripheral nerve block catheter
• Other Study ID Numbers: ECHOCATH