Prospective Post-market Evaluation of an Echogenic Catheter

Not Applicable

• Conditions: Peripheral Nerve Block Procedure
• Interventions: Device: EchoGlo Nerve Block Catheter; Device: Pajunk® Nerve Block Catheter

• Registration Number: NCT02136446
• Lead Sponsor: Smiths Medical, ASD, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-13
• Study Start: 2014-09
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-18
• Last Update Posted: 2015-05-19
• Primary Completion: 2015-09
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EchoGlo™ Peripheral Nerve Block Catheter	EchoGlo Nerve Block Catheter	Echogenic nerve block catheter (test)
Pajunk® EpiLong Catheter	Pajunk® Nerve Block Catheter	Non-echogenic nerve block catheter (control)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University College Hospital; 🇬🇧 London, United Kingdom