Trial Outcomes & Findings for Needle Guidance in Ultrasound Guided Nerve Blocks (NCT NCT02080481)

NCT ID: NCT02080481

Last Updated: 2017-05-15

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 135 participants
• Primary outcome timeframe: time elapsed from beginning the block procedure (after prepping and draping) until the catheter was successfully inserted or the end of the day of surgery.
• Results posted on: 2017-05-15

Participant Flow

Participant milestones

Measure	Infiniti Plus Needle Guidance System ultrasound guidance with the InfinitiPlus (TM) needle guidance system Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks.	Conventional Block Needle ultrasound guidance with a conventional block needle Conventional block needle: conventional block needle used for insertion of femoral nerve catheters.
Overall Study STARTED	68	67
Overall Study COMPLETED	67	67
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Infiniti Plus Needle Guidance System ultrasound guidance with the InfinitiPlus (TM) needle guidance system Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks.	Conventional Block Needle ultrasound guidance with a conventional block needle Conventional block needle: conventional block needle used for insertion of femoral nerve catheters.
Overall Study Never received a block.	1	0

Baseline Characteristics

Needle Guidance in Ultrasound Guided Nerve Blocks

Baseline characteristics by cohort

Measure	Infiniti Plus Needle Guidance System n=67 Participants ultrasound guidance with the InfinitiPlus (TM) needle guidance system Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks.	Conventional Block Needle n=67 Participants ultrasound guidance with a conventional block needle Conventional block needle: conventional block needle used for insertion of femoral nerve catheters.	Total n=134 Participants Total of all reporting groups
Intraoperative management strategy Spinal anesthesia	23 Participants n=5 Participants	31 Participants n=7 Participants	54 Participants n=5 Participants
Age, Continuous	64.7 years STANDARD_DEVIATION 10.6 • n=5 Participants	63.8 years STANDARD_DEVIATION 9.1 • n=7 Participants	64.3 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	44 Participants n=7 Participants	81 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	23 Participants n=7 Participants	53 Participants n=5 Participants
Intraoperative management strategy General anesthesia	42 Participants n=5 Participants	36 Participants n=7 Participants	78 Participants n=5 Participants
Intraoperative management strategy Other	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: time elapsed from beginning the block procedure (after prepping and draping) until the catheter was successfully inserted or the end of the day of surgery.

Outcome measures

Measure	Infiniti Plus Needle Guidance System n=67 Participants ultrasound guidance with the InfinitiPlus (TM) needle guidance system Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks.	Conventional Block Needle n=67 Participants ultrasound guidance with a conventional block needle Conventional block needle: conventional block needle used for insertion of femoral nerve catheters.
Time Spent in Performing Ultrasound Guided Femoral Nerve Blocks With InfinitiPlusTM Needle Guidance System	118 seconds Interval 100.0 to 150.0	177 seconds Interval 130.0 to 236.0

SECONDARY outcome

Timeframe: start of surgery until femoral nerve block completion

Number of patients who had block failure

Outcome measures

Measure	Infiniti Plus Needle Guidance System n=67 Participants ultrasound guidance with the InfinitiPlus (TM) needle guidance system Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks.	Conventional Block Needle n=67 Participants ultrasound guidance with a conventional block needle Conventional block needle: conventional block needle used for insertion of femoral nerve catheters.
Block Failure	5 Participants	3 Participants

SECONDARY outcome

Timeframe: from start of block procedure until block placement

Number of block attempts was collected for each patient as > 1 block attempt versus 1 attempt. A block attempt was defined as pulling the block needle back to skin and redirecting it.

Outcome measures

Measure	Infiniti Plus Needle Guidance System n=67 Participants ultrasound guidance with the InfinitiPlus (TM) needle guidance system Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks.	Conventional Block Needle n=67 Participants ultrasound guidance with a conventional block needle Conventional block needle: conventional block needle used for insertion of femoral nerve catheters.
> 1 Block Attempt	1 Participants	7 Participants

SECONDARY outcome

Timeframe: From start of block procedure until block placement

Percentage of time that perfect needle visibility was visualized on ultrasound.

Outcome measures

Measure	Infiniti Plus Needle Guidance System n=67 Participants ultrasound guidance with the InfinitiPlus (TM) needle guidance system Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks.	Conventional Block Needle n=67 Participants ultrasound guidance with a conventional block needle Conventional block needle: conventional block needle used for insertion of femoral nerve catheters.
Percentage of Time With Perfect Needle Visibility	59 percentage of time Standard Deviation 28	55 percentage of time Standard Deviation 24

Adverse Events

Infiniti Plus Needle Guidance System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Block Needle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aplarslan Turan, MD

Cleveland Clinic

Phone: 216-445-9857

Email: turana@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place