Elective Knee SurgeryNCT02080481
Needle Guidance in Ultrasound Guided Nerve Blocks
A study testing Infiniti Plus needle guidance system and Conventional block needle in people with Elective Knee Surgery, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Elective Knee Surgery
- What is being tested?
- Infiniti Plus needle guidance system and Conventional block needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women 18-85 years old
- Scheduled for elective knee surgery and expected to receive a femoral nerve block and catheter
- Written informed consent
Who cannot join
- Contraindications to femoral block such as coagulopathy, infection at the needle insertion site and allergy to local anesthetics
- Pregnancy
- Preexisting neuropathy involving the surgical limb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of InfinitiPlusTM Needle Guidance in Ultrasound Guided Regional Anesthesia
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
- Being tested
- Infiniti Plus needle guidance system, Conventional block needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infiniti Plus needle guidance systemDevice
The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks.
Conventional block needleDevice
conventional block needle used for insertion of femoral nerve catheters.
| Study group | Role | What they receive |
|---|---|---|
| Infiniti Plus needle guidance system | Experimental | ultrasound guidance with the InfinitiPlus (TM) needle guidance system Receives: Device: Infiniti Plus needle guidance system |
| conventional block needle | Other | ultrasound guidance with a conventional block needle Receives: Device: Conventional block needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Spent in Performing Ultrasound Guided Femoral Nerve Blocks With InfinitiPlusTM Needle Guidance System
Measured: 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.
Secondary outcomes (3)
Block Failure
Number of patients who had block failure
Measured: start of surgery until femoral nerve block completion
> 1 Block Attempt
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.
Measured: from start of block procedure until block placement
Percentage of Time With Perfect Needle Visibility
Percentage of time that perfect needle visibility was visualized on ultrasound.
Measured: From start of block procedure until block placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elective Knee SurgeryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alparslan Turan, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080481
- Sponsor's protocol ID
- 13-1299
- Status last verified
- Apr 2017
- First submitted
- 21 Feb 2014
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 28009637
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of InfinitiPlusTM Needle Guidance in Ultrasound Guided Regional Anesthesia
- ClinicalTrials.gov ID
- NCT02080481
- Acronym / sponsor ID
- 13-1299
- Conditions
- Elective Knee Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Posted 15 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infiniti Plus needle guidance system | Experimental | Device: Infiniti Plus needle guidance systemultrasound guidance with the InfinitiPlus (TM) needle guidance system |
| conventional block needle | Other | Device: Conventional block needleultrasound guidance with a conventional block needle |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women 18-85 years old
- Scheduled for elective knee surgery and expected to receive a femoral nerve block and catheter
- Written informed consent
Key exclusion criteria (3 listed)
- Contraindications to femoral block such as coagulopathy, infection at the needle insertion site and allergy to local anesthetics
- Pregnancy
- Preexisting neuropathy involving the surgical limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infiniti Plus needle guidance systemThe Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks. | Device | Infiniti Plus needle guidance system |
| Conventional block needleconventional block needle used for insertion of femoral nerve catheters. | Device | conventional block needle |
Primary outcome
Time Spent in Performing Ultrasound Guided Femoral Nerve Blocks With InfinitiPlusTM Needle Guidance System
Time frame: 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.
3 secondary outcomes
Block Failure
Time frame: start of surgery until femoral nerve block completion
> 1 Block Attempt
Time frame: from start of block procedure until block placement
Percentage of Time With Perfect Needle Visibility
Time frame: From start of block procedure until block placement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28009637Turan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alparslan Turan principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infiniti Plus needle guidance system and Conventional block needle in people with Elective Knee Surgery, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Spent in Performing Ultrasound Guided Femoral Nerve Blocks With InfinitiPlusTM Needle Guidance System (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02080481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.