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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01048021
First received: November 6, 2009
Last updated: January 12, 2010
Last verified: November 2009
  Purpose

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.


Condition Intervention
Diaphragmatic Function
Lung Function
Procedure: Supraclavicular Block

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmonary Function Changes and Diaphragmatic Paralysis Following Ultrasound Guided Supraclavicular Brachial Plexus Blockade: The Effects of Decreased Local Anesthetic Volume

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Forced expiratory volume in one second (FEV1) [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • Forced vital capacity (FVC) [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • Peak expiratory flow (PEF) [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Supraclavicular Block Procedure: Supraclavicular Block

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.


Detailed Description:

The supraclavicular approach to brachial plexus blockade was first described by Kulenkampf in 1911. With classic "blind" techniques, an incidence of pneumothorax has been reported ranging from 0.5-6.0%, limiting its widespread use, despite the belief that the supraclavicular approach is the most consistent, effective technique for anesthetizing the brachial plexus. With the advent of ultrasound guidance and real time visualization this risk has been minimized and a resurgence in utilization of this approach has occurred. Increased block success, diminished performance times, and lower anesthetic volumes have been observed with this technique when compared to nerve stimulator techniques. Despite these advantages, brachial plexus anesthesia above the clavicle is associated with diaphragmatic dysfunction and caution must be demonstrated in patients with respiratory disease. Interscalene brachial plexus blockade has been widely documented to produce a 100% incidence of hemidiaphragmatic paresis and an associated 25% mean reduction in forced vital capacity (FVC) with local anesthetic volumes ranging from 20 - 45mL 8-10, these parameters for supraclavicular brachial plexus blockage are not as well defined. Previous investigations report an incidence of hemidiaphragmatic paresis of 1-75% with supraclavicular brachial plexus blockade. This study will address whether diaphragmatic function and respiratory mechanics can be preserved with lower anesthetic volumes in ultrasound guided supraclavicular brachial plexus blockade.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pateints at the HSC Pain Management Centre

Criteria

Inclusion Criteria:

  • eligible patients undergoing Supraclavicular blockade

Exclusion Criteria:

  • < 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01048021

Locations
Canada, Manitoba
HSC Pain Management Centre
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Patricia Mykytiuk, MD Department of Anesthesia, University of Manitoba
  More Information

No publications provided

Responsible Party: Dr. Patricia Mykytiuk, Department of Anesthesia, University of Manitoba
ClinicalTrials.gov Identifier: NCT01048021     History of Changes
Other Study ID Numbers: B2008:061
Study First Received: November 6, 2009
Last Updated: January 12, 2010
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
Measurement of lung mechanics (FEV1, FVC and PEF)

Additional relevant MeSH terms:
Respiratory Paralysis
Paralysis
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014