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CompletedNCT03596190Updated Apr 6, 2020

Diaphragmatic Dysfunction After Supraclavicular Brachial Plexus Block

An interventional study of ultrasonographic diaphragmatic assessment in Anesthesia, sponsored by Nova Scotia Health Authority. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-06.

Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Anesthesia
03

In context

Lead sponsor

Nova Scotia Health Authority is the lead sponsor of 264 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Known Chronic Obstructive Pulmonary Disease
  • Pregnancy
  • Any significant neurologic dysfunction, or inability to visualize the diaphragm during baseline sonographic assessment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Other
    Assessment arm

    Diagnostic Test: ultrasonographic diaphragmatic assessment

Interventions

  • Diagnostic testultrasonographic diaphragmatic assessment

    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).

06

What researchers measure

Primary outcomes

  1. Frequency of hemi-diaphragmatic paresis

    Number of participants in which hemi-diaphragmatic paresis is detected using ultrasound measurement of diaphragmatic thickening

    Time frame: Relative change in ultrasound assessment of diaphragmatic thickening (Baseline vs 30 min after supraclavicular block)

  2. Onset time of hemi-diaphragmatic paresis

    The average time at which hemi-diaphragmatic paresis is detected using ultrasound measurement of diaphragmatic thickening

    Time frame: Baseline, 5, 10, 15, 20, 25, and 30 minutes after block

Secondary outcomes

  1. The correlation of subjective dyspnea

    Using the modified Borg dyspnea scale ranging from 0 (no breathlessness at all to 10 (maximal breathlessness)

    Time frame: Baseline, 5, 10, 15, 20, 25, and 30 minutes after block

  2. Incidence of HDP after surgical procedure under supraclavicular brachial plexus block (in post recovery unit).

    Based upon sonographic assessment

    Time frame: Post-operatively up to 24 hours

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Study locations

1 site
  • NSHA
    Halifax, Nova Scotia B3H 2Y9, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03596190
Responsible party
Vishal Uppal (Principal Investigator, Nova Scotia Health Authority) — Principal investigator
First posted
Jul 23, 2018
Start date
Aug 21, 2018
Primary completion
Mar 6, 2019
Completion
Aug 8, 2019
Last update
Apr 6, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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