AnesthesiaNCT03596190
Diaphragmatic Dysfunction After Supraclavicular Brachial Plexus Block
A study testing ultrasonographic diaphragmatic assessment in people with Anesthesia, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The investigators plan to determine the onset time and incidence of hemidiaphragmatic paresis (HDP) with a double injection supraclavicular nerve block in patients presenting for upper extremity surgery below the elbow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- ultrasonographic diaphragmatic assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 21 Aug 2018to 8 Aug 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting for unilateral upper extremity surgery below the level of the elbow (the forearm or hand) who are having a double injection regional block for anesthesia
- 18 years old and over
- Weight 50kg or greater
- English speaking
- American Society of Anesthesiologists physical status 1-3
Who cannot join
- Known Chronic Obstructive Pulmonary Disease
- Pregnancy
- Any significant neurologic dysfunction, or inability to visualize the diaphragm during baseline sonographic assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diaphragmatic Dysfunction After Ultrasound-guided Supraclavicular Brachial Plexus Block With the Double Injection Technique
The investigators plan to determine the onset time and incidence of hemidiaphragmatic paresis (HDP) with a double injection supraclavicular nerve block in patients presenting for upper extremity surgery below the elbow.
The hypothesis is HDP following supraclavicular brachial plexus block occurs with-in 15 minutes of block performance and is not associated with subjective dyspnea.
Read the detailed description
This study will be an observational trial to assess the onset time and incidence of hemidiaphragmatic paresis in patients who undergo the double injection ultrasound-guided supraclavicular block. Diaphragmatic dysfunction will be determined by intercostal diaphragm thickening measured using ultrasound. The available image will be saved.
Patients having below the elbow surgery will be be approached by someone from the research team for consent and possible inclusion in the study. This will be done in the anesthesia preoperative assessment clinic, or in the pre-op area on the day of surgery (if a patient was not seen in clinic).
A baseline ultrasonographic diaphragmatic assessment will be completed. Study participants will then receive supraclavicular brachial plexus block as per standard of care. Ultrasonographic diaphragmatic assessment and dyspnea score (using modified Borg dyspnea scale) will be performed every 5 minutes for 30 minutes, or until the patient is transferred to the operating room, whatever comes first. Patients will also undergo an ultrasonographic diaphragmatic assessment and dyspnea score in the recovery room after their surgery.
- Conditions
- Anesthesia
- Being tested
- ultrasonographic diaphragmatic assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographic diaphragmatic assessmentDiagnostic test
Diaphragmatic dysfunction will be determined by intercostal diaphragm thickening. The available image will be saved.
Diaphragmatic motion assessments will be conducted on the side to be blocked both at baseline, and then every 5 minutes until patient leaves for operating room or 30 minutes (whatever is earlier).
| Study group | Role | What they receive |
|---|---|---|
| Assessment arm | Other | Not described Receives: Diagnostic Test: ultrasonographic diaphragmatic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of hemi-diaphragmatic paresis
Number of participants in which hemi-diaphragmatic paresis is detected using ultrasound measurement of diaphragmatic thickening
Measured: Relative change in ultrasound assessment of diaphragmatic thickening (Baseline vs 30 min after supraclavicular block)
Onset time of hemi-diaphragmatic paresis
The average time at which hemi-diaphragmatic paresis is detected using ultrasound measurement of diaphragmatic thickening
Measured: Baseline, 5, 10, 15, 20, 25, and 30 minutes after block
Secondary outcomes (2)
The correlation of subjective dyspnea
Using the modified Borg dyspnea scale ranging from 0 (no breathlessness at all to 10 (maximal breathlessness)
Measured: Baseline, 5, 10, 15, 20, 25, and 30 minutes after block
Incidence of HDP after surgical procedure under supraclavicular brachial plexus block (in post recovery unit).
Based upon sonographic assessment
Measured: Post-operatively up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start21 Aug 2018
- Primary completion6 Mar 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vishal Uppal, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596190
- Sponsor's protocol ID
- 6447
- Status last verified
- Apr 2020
- First submitted
- 4 Jun 2018
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Dysfunction After Ultrasound-guided Supraclavicular Brachial Plexus Block With the Double Injection Technique
- ClinicalTrials.gov ID
- NCT03596190
- Acronym / sponsor ID
- 6447
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 23 Jul 2018 (actual)
- 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.
The investigators plan to determine the onset time and incidence of hemidiaphragmatic paresis (HDP) with a double injection supraclavicular nerve block in patients presenting for upper extremity surgery below the elbow.
The hypothesis is HDP following supraclavicular brachial plexus block occurs with-in 15 minutes of block performance and is not associated with subjective dyspnea.
Detailed description
This study will be an observational trial to assess the onset time and incidence of hemidiaphragmatic paresis in patients who undergo the double injection ultrasound-guided supraclavicular block. Diaphragmatic dysfunction will be determined by intercostal diaphragm thickening measured using ultrasound. The available image will be saved.
Patients having below the elbow surgery will be be approached by someone from the research team for consent and possible inclusion in the study. This will be done in the anesthesia preoperative assessment clinic, or in the pre-op area on the day of surgery (if a patient was not seen in clinic).
A baseline ultrasonographic diaphragmatic assessment will be completed. Study participants will then receive supraclavicular brachial plexus block as per standard of care. Ultrasonographic diaphragmatic assessment and dyspnea score (using modified Borg dyspnea scale) will be performed every 5 minutes for 30 minutes, or until the patient is transferred to the operating room, whatever comes first. Patients will also undergo an ultrasonographic diaphragmatic assessment and dyspnea score in the recovery room after their surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment arm | Other | Diagnostic Test: ultrasonographic diaphragmatic assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients presenting for unilateral upper extremity surgery below the level of the elbow (the forearm or hand) who are having a double injection regional block for anesthesia
- 18 years old and over
- Weight 50kg or greater
- English speaking
- American Society of Anesthesiologists physical status 1-3
Key exclusion criteria (3 listed)
- Known Chronic Obstructive Pulmonary Disease
- Pregnancy
- Any significant neurologic dysfunction, or inability to visualize the diaphragm during baseline sonographic assessment
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 |
|---|---|---|
| ultrasonographic diaphragmatic assessmentDiaphragmatic dysfunction will be determined by intercostal diaphragm thickening. The available image will be saved. Diaphragmatic motion assessments will be conducted on the side to be blocked both at baseline, and then every 5 minutes until patient leaves for operating room or 30 minutes (whatever is earlier). | Diagnostic test | Assessment arm |
Primary outcome
Frequency of hemi-diaphragmatic paresis
Time frame: Relative change in ultrasound assessment of diaphragmatic thickening (Baseline vs 30 min after supraclavicular block)
Number of participants in which hemi-diaphragmatic paresis is detected using ultrasound measurement of diaphragmatic thickening
Onset time of hemi-diaphragmatic paresis
Time frame: Baseline, 5, 10, 15, 20, 25, and 30 minutes after block
The average time at which hemi-diaphragmatic paresis is detected using ultrasound measurement of diaphragmatic thickening
2 secondary outcomes
The correlation of subjective dyspnea
Time frame: Baseline, 5, 10, 15, 20, 25, and 30 minutes after block
Incidence of HDP after surgical procedure under supraclavicular brachial plexus block (in post recovery unit).
Time frame: Post-operatively up to 24 hours
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 6 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonographic diaphragmatic assessment in people with Anesthesia, run by Nova Scotia Health Authority 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 5 inclusion and 3 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 6 Apr 2020. 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?
Frequency of hemi-diaphragmatic paresis (time frame: Relative change in ultrasound assessment of diaphragmatic thickening (Baseline vs 30 min after supraclavicular block)). The study lists 2 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 6 Apr 2020.