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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EchoGlo™ Peripheral Nerve Block Catheter | Experimental | Echogenic nerve block catheter (test) |
|
| Pajunk® EpiLong Catheter | Active Comparator | Non-echogenic nerve block catheter (control) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EchoGlo Nerve Block Catheter | Device | Catheter used for a paravertebral anesthesia block |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simeon West, MBChB FRCA | Contact | +07919205965 | simeon.west@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Peter R Kratz, MS | Smiths Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College Hospital | Recruiting | London | NW14 5BU | United Kingdom |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 14, 2016 | |
| Reset | May 19, 2016 | |
| Release | Apr 24, 2017 | |
| Reset | Aug 3, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 14, 2016 | May 19, 2016 | |||
| Apr 24, 2017 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Pajunk® Nerve Block Catheter | Device | Nerve Block Catheter |
|
|
| Day 1, time of procedure |
| Aug 3, 2017 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |