Diaphragmatic Dysfunction After Supraclavicular Brachial Plexus Block
1 other identifier
interventional
35
1 country
1
Brief 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. The hypothesis is HDP following supraclavicular brachial plexus block occurs with-in 15 minutes of block performance and is not associated with subjective dyspnea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2018
CompletedFirst Posted
Study publicly available on registry
July 23, 2018
CompletedStudy Start
First participant enrolled
August 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2019
CompletedApril 6, 2020
April 1, 2020
7 months
June 4, 2018
April 3, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Frequency of hemi-diaphragmatic paresis
Number of participants in which hemi-diaphragmatic paresis is detected using ultrasound measurement of diaphragmatic thickening
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
Baseline, 5, 10, 15, 20, 25, and 30 minutes after block
Secondary Outcomes (2)
The correlation of subjective dyspnea
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).
Post-operatively up to 24 hours
Study Arms (1)
Assessment arm
OTHERInterventions
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).
Eligibility Criteria
You may qualify if:
- 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
- years old and over
- Weight 50kg or greater
- English speaking
- American Society of Anesthesiologists physical status 1-3
You may not qualify if:
- Known Chronic Obstructive Pulmonary Disease
- Pregnancy
- Any significant neurologic dysfunction, or inability to visualize the diaphragm during baseline sonographic assessment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NSHA
Halifax, Nova Scotia, B3H 2Y9, Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 4, 2018
First Posted
July 23, 2018
Study Start
August 21, 2018
Primary Completion
March 6, 2019
Study Completion
August 8, 2019
Last Updated
April 6, 2020
Record last verified: 2020-04