Needle Guidance; Nerve BlocksNCT02380183
Needle-Guided vs Free-Hand Technique in Performing Brachial Plexus Blockade
A study testing Civco Needle Guidance Device in people with Needle Guidance; Nerve Blocks, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This is an openly randomized controlled parallel group study evaluating the effectiveness of using a guided approach and free-hand approach in performing upper extremity regional blocks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Needle Guidance; Nerve Blocks
- What is being tested?
- Civco Needle Guidance Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jun 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years old
- ASA 1-3 for upper extremity surgery receiving interscalene or supraclavicular blockade
- Able to understand and sign the informed consent
Who cannot join
- Patient refusal of regional anesthesia
- Any contraindications to regional anesthesia
- Any anatomical or neurological disorders (also applicable to the diagnosis made by the anesthesiologist prior to randomization of the patient)
- Any other condition /diagnosis by the anesthesiologist that could compromise performing the block
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Randomized Controlled Study Comparing Needle-Guided vs Free-Hand Technique in Performing Brachial Plexus Blockade
This is an openly randomized controlled parallel group study evaluating the effectiveness of using a guided approach and free-hand approach in performing upper extremity regional blocks. Potential subjects for this study are the patients who are scheduled for upper extremity surgeries requiring supraclavicular and interscalene brachial plexus blocks at Montefiore Medical Center.
Rotating residents who are participating in the study will be randomly assigned either to perform block under guided approach (with the help of needle guidance) or free-hand without the needle guidance. All the blocks will be single injection blocks utilizing the in-plane technique for needle insertion which is the usual protocol in our institution. Each resident will be performing one interscalene block with the device and one without the device and one supraclavicular block with device and one without the device. An independent observer will be present during the case and will be responsible for recording the time taken to perform the block, number of times the needle has been redirected and the number of times the needle is reinserted. This observer will also administer the satisfaction questionnaire. Number of time needle is redirected and number of times reinserted is also a self reported assessment by the physician who is performing the block. Efficacy of the block will be assessed by the standard of care practiced at our center.
Read the detailed description
Objectives
- The primary end point of the study is to evaluate the time taken to complete blocks with and without the use of the needle guidance device. (Start time is considered as the first skin touch by the needle until the completion of the block. Completion of the block is defined as withdrawing the needle completely out of the body). The principal investigator/co-investigator and an independent observer will be recording the time taken to complete the block.
- Ease of the technique- (Will be assessed with a short questionnaire survey at the end of the procedure). Immediately after the block is finished, the performing physician will be requested to fill out the questionnaire.
- Number of times needle needs to be re-directed. This is self a reported measurement. The person performing the block, investigators (attending physician) and an independent observer will be recording number of times the needle was manipulated.
- Number of times needle was pulled out entirely out of the body and reinserted. This is also a self reported measurement.
- Efficacy of the blocks performed will be assessed (This is part of the routine standard of care assessing the blocks.)
- Total amount of time taken to complete the whole procedure (Starting from the first time the ultrasound probe was placed on the patient to the withdrawal of the needle after completing the procedure)
- Conditions
- Needle Guidance; Nerve Blocks
- Being tested
- Civco Needle Guidance Device
- Keywords
- anesthesia, nerve block, needle guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Civco Needle Guidance DeviceDevice
Needle guidance device will be used while nerve block is performed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Civco needle guidance device will be used while the nerve block is performed. Receives: Device: Civco Needle Guidance Device |
| Standard of Care | No intervention | Needle guidance device will not be used while nerve block is performed; nerve block is performed by hand alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needle Time;
needle insertion to needle withdrawal
Measured: Needle insertion to needle withdrawal, up to 20 minutes
Secondary outcomes (1)
Nerve Block Procedure Time
How long the procedure takes in minutes, starting from ultrasound contact with skin to needle withdrawal.
Measured: time from ultrasound contact with skin to needle withdrawal, up to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionJun 2015
- Study completionJun 2015
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.
- Other trials for Needle Guidance; Nerve BlocksStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- CIVCO Medical Solutions
- Responsible party
- Principal investigator, Amaresh Vydynathan, Montefiore Medical Center
- Investigators
- Amaresh Vydyanathan, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380183
- Sponsor's protocol ID
- 2014-3414
- Status last verified
- Feb 2019
- First submitted
- 30 Jan 2015
- Last updated
- 12 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Comparing Needle-Guided vs Free-Hand Technique in Performing Brachial Plexus Blockade
- ClinicalTrials.gov ID
- NCT02380183
- Acronym / sponsor ID
- 2014-3414
- Conditions
- Needle Guidance; Nerve Blocks
- Keywords
- anesthesia, nerve block, needle guidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- CIVCO Medical Solutions
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Posted 12 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an openly randomized controlled parallel group study evaluating the effectiveness of using a guided approach and free-hand approach in performing upper extremity regional blocks. Potential subjects for this study are the patients who are scheduled for upper extremity surgeries requiring supraclavicular and interscalene brachial plexus blocks at Montefiore Medical Center.
Rotating residents who are participating in the study will be randomly assigned either to perform block under guided approach (with the help of needle guidance) or free-hand without the needle guidance. All the blocks will be single injection blocks utilizing the in-plane technique for needle insertion which is the usual protocol in our institution. Each resident will be performing one interscalene block with the device and one without the device and one supraclavicular block with device and one without the device. An independent observer will be present during the case and will be responsible for recording the time taken to perform the block, number of times the needle has been redirected and the number of times the needle is reinserted. This observer will also administer the satisfaction questionnaire. Number of time needle is redirected and number of times reinserted is also a self reported assessment by the physician who is performing the block. Efficacy of the block will be assessed by the standard of care practiced at our center.
Detailed description
Objectives
- The primary end point of the study is to evaluate the time taken to complete blocks with and without the use of the needle guidance device. (Start time is considered as the first skin touch by the needle until the completion of the block. Completion of the block is defined as withdrawing the needle completely out of the body). The principal investigator/co-investigator and an independent observer will be recording the time taken to complete the block.
- Ease of the technique- (Will be assessed with a short questionnaire survey at the end of the procedure). Immediately after the block is finished, the performing physician will be requested to fill out the questionnaire.
- Number of times needle needs to be re-directed. This is self a reported measurement. The person performing the block, investigators (attending physician) and an independent observer will be recording number of times the needle was manipulated.
- Number of times needle was pulled out entirely out of the body and reinserted. This is also a self reported measurement.
- Efficacy of the blocks performed will be assessed (This is part of the routine standard of care assessing the blocks.)
- Total amount of time taken to complete the whole procedure (Starting from the first time the ultrasound probe was placed on the patient to the withdrawal of the needle after completing the procedure)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Civco Needle Guidance DeviceCivco needle guidance device will be used while the nerve block is performed. |
| Standard of Care | No intervention | –Needle guidance device will not be used while nerve block is performed; nerve block is performed by hand alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years old
- ASA 1-3 for upper extremity surgery receiving interscalene or supraclavicular blockade
- Able to understand and sign the informed consent
Key exclusion criteria (4 listed)
- Patient refusal of regional anesthesia
- Any contraindications to regional anesthesia
- Any anatomical or neurological disorders (also applicable to the diagnosis made by the anesthesiologist prior to randomization of the patient)
- Any other condition /diagnosis by the anesthesiologist that could compromise performing the block
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 |
|---|---|---|
| Civco Needle Guidance DeviceNeedle guidance device will be used while nerve block is performed. | Device | Intervention |
Primary outcome
Needle Time;
Time frame: Needle insertion to needle withdrawal, up to 20 minutes
needle insertion to needle withdrawal
1 secondary outcome
Nerve Block Procedure Time
Time frame: time from ultrasound contact with skin to needle withdrawal, up to 20 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Amaresh Vydyanathan, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Civco Needle Guidance Device in people with Needle Guidance; Nerve Blocks, run by Montefiore Medical Center 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 4 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 12 Mar 2019. 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 12 Mar 2019). 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?
Needle Time; (time frame: Needle insertion to needle withdrawal, up to 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2019.