Prospective Post-market Evaluation of an Echogenic Catheter

Study Overview
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Brief Summary
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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.

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

Conditions
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Peripheral Nerve Block Procedure

Intervention / Treatment
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* Device: EchoGlo Nerve Block Catheter
* Device: Pajunk® Nerve Block Catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paravertebral block, Mastectomy, Post-operative pain, Echogenic, Peripheral nerve block catheter