NCT02136446

Prospective Post-market Evaluation of an Echogenic Catheter

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Smiths Medical, ASD, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	EchoGlo Nerve Block Catheter	Catheter used for a paravertebral anesthesia block
DEVICE	Pajunk® Nerve Block Catheter	Nerve Block Catheter

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-09-01
• Completion: 2015-10-01
• First posted: 2014-05-13
• Last updated: 2015-05-19

Locations

1 site across 1 country: United Kingdom