NCT02080481

Needle Guidance in Ultrasound Guided Nerve Blocks

Effect of InfinitiPlusTM Needle Guidance in Ultrasound Guided Regional Anesthesia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

An FDA-approved product, InfinitiPlus (TM), is a needle guidance system that has been recently developed to guide clinicians in performing ultrasound guided nerve blocks. This system helps the clinician to align the needle with ultrasound beam while performing an ultrasound guided nerve block. InfinitiPlus (TM) has a unique open channel design allowing efficient needle movement while having improved needle shaft and tip visualization. This is a disposable system specifically designed for improving success rate of ultrasound guided block and patient safety. This study will be done with patients having elective knee surgery and a femoral nerve block with a catheter. The nerve block procedure will be performed under ultrasound guidance to help improve safety and efficacy of the injection. InfinitiPlus (TM) has been recently developed to try to improve needle guidance in the ultrasound guided nerve block procedure. This study will determine whether femoral nerve block procedures performed under ultrasound guidance with InfinitiPlus (TM) take less time than procedures performed with ultrasound guidance and a conventional block needle. The study will also determine whether the InfinitiPlus (TM) needle reduces the number of times the clinician attempts the procedure, reduces the cost of the procedure, increases the procedure success rate, and improves ultrasound visibility of the needle. Participants will be randomly assigned to either ultrasound guidance with the InfinitiPlus (TM) needle guidance system or ultrasound guidance with a conventional block needle. After surgery, pain will be rated every 30 minutes for the first 2 hours, then every 4 hours while awake for 24 hours. 24 hours after surgery, participants will be given a survey about pain treatment satisfaction and a questionnaire about recovery.

Conditions

• Elective Knee Surgery

Interventions

Type	Name	Description
DEVICE	Infiniti Plus needle guidance system	The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks.
DEVICE	Conventional block needle	conventional block needle used for insertion of femoral nerve catheters.

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-12-01
• Completion: 2016-12-01
• First posted: 2014-03-06
• Last updated: 2017-05-15
• Results posted: 2017-05-15

Locations

1 site across 1 country: United States