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

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.

Study Overview

• Status: Completed
• Conditions: Needle Guidance; Nerve Blocks
• Intervention / Treatment: Device: Civco Needle Guidance Device

Detailed Description

Objectives

1. 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.
2. 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.
3. 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.
4. Number of times needle was pulled out entirely out of the body and reinserted. This is also a self reported measurement.
5. Efficacy of the blocks performed will be assessed (This is part of the routine standard of care assessing the blocks.)
6. 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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Needle Time;	needle insertion to needle withdrawal	Needle insertion to needle withdrawal, up to 20 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: CIVCO Medical Solutions
• Investigators: Principal Investigator: Amaresh Vydyanathan, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: January 30, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: anesthesia; nerve block; needle guidance
• Other Study ID Numbers: 2014-3414

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes