Pulmonary Function Changes and Diaphragmatic Paralysis Following Ultrasound Guided Supraclavicular Brachial Plexus Blockade: The Effects of Decreased Local Anesthetic Volume

NCT01048021 | Completed

• 1 other identifier: B2008:061
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is being conducted to study lung function and movement of the major muscle involved in breathing (the diaphragm) after a brachial plexus nerve block (nerve "freezing"). The purpose of this study is to find out what effects (good and bad) ultrasound guided nerve freezing has on the movement of the patient's diaphragm and their lung function. The potential advantage of ultrasound guidance will be a lesser chance of freezing the nerves that innervate the diaphragm and thus having less of an effect on lung function.

Conditions

Diaphragmatic Function; Lung Function

Keywords

Measurement of lung mechanics (FEV1, FVC and PEF)

Outcome Measures

Primary Outcomes (3)

• Forced expiratory volume in one second (FEV1)

  60 minutes

• Forced vital capacity (FVC)

  60 minutes

• Peak expiratory flow (PEF)

  60 minutes

Study Arms (1)

Supraclavicular Block

Procedure: Supraclavicular Block

Interventions

Supraclavicular Block PROCEDURE

Baseline values of forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and peak expiratory flow rates (PEFR) will be measured in both the sitting and supine position. Ultrasound-guided supraclavicular brachial plexus blocks will be performed in the supine position with a Pajunk 22g block needle and nerve stimulator. The patients will receive local anesthetic injection with 15 mL of 0.75% Bupivicaine. A maximum of 3 cc of 5% Dextrose will be utilized as contrast to confirm needle tip placement and fluid spread prior to injection of the local anesthetic. At 60 minutes post-injection, FEV1, FVC, and PEFR measurements will be taken in the sitting and supine position.

Supraclavicular Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pateints at the HSC Pain Management Centre

You may qualify if:

• eligible patients undergoing Supraclavicular blockade

You may not qualify if:

• \< 18 years of age,
• mental illness precluding informed consent,
• infection at the injection site,
• coagulopathy,
• allergy to local anesthetics,
• inability to comprehend English,
• pulmonary disease, and
• pregnancy

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

HSC Pain Management Centre

Winnipeg, Manitoba, Canada

Location

Study Officials

• Patricia Mykytiuk, MD

  Department of Anesthesia, University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Patricia Mykytiuk

Study Record Dates

• First Submitted: November 6, 2009
• First Posted: January 13, 2010
• Study Start: October 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

CA (1)