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

NCT02380183 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-03-12

Study results available
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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.

Conditions

  • Needle Guidance; Nerve Blocks

Interventions

DEVICE

Civco Needle Guidance Device

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

Sponsors & Collaborators

  • CIVCO Medical Solutions

    collaborator UNKNOWN

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Amaresh Vydyanathan, MD · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-06-30
Completion
2015-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02380183 on ClinicalTrials.gov