CompletedNCT02380183Updated Mar 12, 2019Results posted

Needle-Guided vs Free-Hand Technique in Performing Brachial Plexus Blockade

An interventional study of Civco Needle Guidance Device in Needle Guidance; Nerve Blocks, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-12.

Sponsored by Montefiore Medical Center · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 70
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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. 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.

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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 studied

Needle Guidance; Nerve Blocks

Keywords

anesthesia
nerve block
needle guidance

In context

Lead sponsor

Montefiore Medical Center is the lead sponsor of 414 studies on the registry; 69 are open to participants now.

Of its 86 completed or terminated interventional studies of FDA-regulated products, 76 (88%) have results posted.

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age ≥18 years old
ASA 1-3 for upper extremity surgery receiving interscalene or supraclavicular blockade
Able to understand and sign the informed consent

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 70 participants (actual)

Study arms

Experimental
Intervention
Civco needle guidance device will be used while the nerve block is performed.
Device: Civco Needle Guidance Device
No intervention
Standard of Care
Needle guidance device will not be used while nerve block is performed; nerve block is performed by hand alone.

Interventions

DeviceCivco Needle Guidance Device
Needle guidance device will be used while nerve block is performed.

What researchers measure

Primary outcomes

Needle Time;
needle insertion to needle withdrawal
Time frame: Needle insertion to needle withdrawal, up to 20 minutes

Secondary outcomes

Nerve Block Procedure Time
How long the procedure takes in minutes, starting from ultrasound contact with skin to needle withdrawal.
Time frame: time from ultrasound contact with skin to needle withdrawal, up to 20 minutes

Results

Posted Mar 12, 2019

Limitations and caveats

A limitation of this study was that most of the clinicians using the device were either senior residents (CA-3's), or fellows. It is possible that this device could provide more or less benefit in newer trainees.

Participant flow

Participant flow — Overall Study
Milestone	Intervention	Standard of Care
Started	36	34
Completed	36	34
Not completed	0	0

Outcome measures

PrimaryNeedle Time;

needle insertion to needle withdrawal

Time frame:: Needle insertion to needle withdrawal, up to 20 minutes
Reported as:: Median · seconds

Needle Time;
seconds	Intervention	Standard of Care
Needle Time;	106 (92 to 162)	197 (140 to 278)

SecondaryNerve Block Procedure Time

How long the procedure takes in minutes, starting from ultrasound contact with skin to needle withdrawal.

Time frame:: time from ultrasound contact with skin to needle withdrawal, up to 20 minutes
Reported as:: Median · seconds

Nerve Block Procedure Time
seconds	Intervention	Standard of Care
Nerve Block Procedure Time	86 (76 to 146)	126 (94 to 126)

Adverse events

Collected over There were no adverse events reported throughout the duration of our study.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Intervention	0/36 (0%)	0/36 (0%)	0/36 (0%)
Standard of Care	0/34 (0%)	0/34 (0%)	0/34 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Intervention	Standard of Care	Total
Mean	56 (41 to 71)	50 (34 to 66)	53 (34 to 71)

Sex: Female, Male
Sex: Female, Male(Participants)	Intervention	Standard of Care	Total
Female	18	20	38
Male	18	14	32

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Intervention	Standard of Care	Total
Count of participants	—	—	0

Region of Enrollment
Region of Enrollment(Participants)	Intervention	Standard of Care	Total
United States	36	34	70

Study locations

1 site

Montefiore Medical Center
The Bronx, New York 10467, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02380183
Lead sponsor: Montefiore Medical Center
Collaborators: CIVCO Medical Solutions
Responsible party: Amaresh Vydynathan (Assoc. Prof. Anesthesiology, Montefiore Medical Center) — Principal investigator
First posted: Mar 5, 2015
Start date: Oct 2014
Primary completion: Jun 2015
Completion: Jun 2015
Results posted: Mar 12, 2019
Last update: Mar 12, 2019

Study contacts

Amaresh Vydyanathan, MD

principal investigator · Montefiore Medical Center

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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