Study Results
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View full resultsBasic Information
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COMPLETED
NA
135 participants
INTERVENTIONAL
2014-03-31
2016-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Interventions
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Infiniti Plus needle guidance system
The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks.
Conventional block needle
conventional block needle used for insertion of femoral nerve catheters.
Eligibility Criteria
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Inclusion Criteria
* Scheduled for elective knee surgery and expected to receive a femoral nerve block and catheter
* Written informed consent
Exclusion Criteria
* Pregnancy
* Preexisting neuropathy involving the surgical limb
18 Years
85 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Principal Investigators
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Alparslan Turan
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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References
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Turan A, Babazade R, Elsharkawy H, Esa WA, Maheshwari K, Farag E, Zimmerman NM, Soliman LM, Sessler DI. Novel needle guide reduces time to perform ultrasound-guided femoral nerve catheter placement: A randomised controlled trial. Eur J Anaesthesiol. 2017 Mar;34(3):135-140. doi: 10.1097/EJA.0000000000000584.
Other Identifiers
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13-1299
Identifier Type: -
Identifier Source: org_study_id
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