CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
Civco Needle Guidance Devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02380183
NCT02380183N/ACompleted

A Randomized Controlled Study Comparing Needle-Guided vs Free-Hand Technique in Performing Brachial Plexus Blockade

Montefiore Medical Center·interventional·Posted Mar 5, 2015·Updated Mar 12, 2019

In Brief

A clinical study evaluating Civco Needle Guidance Device for Needle Guidance; Nerve Blocks. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 5, 2015
Enrollment StartOct 1, 2014
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.3 years ago

Interventions

Civco Needle Guidance Devicedevice

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