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

NCT ID: NCT02380183

Last Updated: 2019-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-06-30

Brief 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.

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)

Conditions

Needle Guidance; Nerve Blocks

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

Civco needle guidance device will be used while the nerve block is performed.

Group Type: EXPERIMENTAL

Civco Needle Guidance Device

Intervention Type: DEVICE

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

Standard of Care

Needle guidance device will not be used while nerve block is performed; nerve block is performed by hand alone.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Civco Needle Guidance Device

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CIVCO Medical Solutions

UNKNOWN

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Amaresh Vydynathan

Assoc. Prof. Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amaresh Vydyanathan, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

2014-3414

Identifier Type: -

Identifier Source: org_study_id