Diaphragmatic FunctionNCT01048021
Pulmonary Function Changes and Diaphragmatic Paralysis Following Ultrasound Guided Supraclavicular Brachial Plexus Blockade: The Effects of Decreased Local Anesthetic Volume
An observational study of Diaphragmatic Function and Lung Function, run by University of Manitoba at 1 site in Canada.
Trial 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"). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diaphragmatic Function, Lung Function
- What is being tested?
- Supraclavicular Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pateints at the HSC Pain Management Centre
Who may be able to join
- eligible patients undergoing Supraclavicular blockade
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diaphragmatic Function, Lung Function
- Being tested
- Supraclavicular Block
- Keywords
- Measurement of lung mechanics (FEV1, FVC and PEF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraclavicular BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Supraclavicular Block | Not described Receives: Procedure: Supraclavicular Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in one second (FEV1)
Measured: 60 minutes
Forced vital capacity (FVC)
Measured: 60 minutes
Peak expiratory flow (PEF)
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragmatic FunctionStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Patricia Myktiuk, University of Manitoba
- Investigators
- Patricia Mykytiuk, MD, Principal investigator, Department of Anesthesia, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048021
- Sponsor's protocol ID
- B2008:061
- Status last verified
- May 2017
- First submitted
- 6 Nov 2009
- Last updated
- 8 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Function Changes and Diaphragmatic Paralysis Following Ultrasound Guided Supraclavicular Brachial Plexus Blockade: The Effects of Decreased Local Anesthetic Volume
- ClinicalTrials.gov ID
- NCT01048021
- Acronym / sponsor ID
- B2008:061
- Conditions
- Diaphragmatic Function, Lung Function
- Keywords
- Measurement of lung mechanics (FEV1, FVC and PEF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supraclavicular Block | – | Procedure: Supraclavicular Block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pateints at the HSC Pain Management Centre
Key inclusion criteria (1 listed)
- eligible patients undergoing Supraclavicular blockade
Key exclusion criteria (8 listed)
- < 18 years of age,
- mental illness precluding informed consent,
- infection at the injection site,
- coagulopathy,
- allergy to local anesthetics,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supraclavicular BlockBaseline 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. | Procedure or surgery | Supraclavicular Block |
Primary outcome
Forced expiratory volume in one second (FEV1)
Time frame: 60 minutes
Forced vital capacity (FVC)
Time frame: 60 minutes
Peak expiratory flow (PEF)
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Mykytiuk, MD principal investigator
Department of Anesthesia, University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragmatic Function and Lung Function, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume in one second (FEV1) (time frame: 60 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.