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Completed

NCT Number: NCT03596190

Diaphragmatic Dysfunction After Supraclavicular Brachial Plexus Block

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NSHA

Halifax, Nova Scotia, B3H 2Y9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

ultrasonographic diaphragmatic assessment

Diagnostic 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).

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. The correlation of subjective dyspnea

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

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

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

    Time frame: Post-operatively up to 24 hours

    Based upon sonographic assessment

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

Diaphragmatic Dysfunction After Ultrasound-guided Supraclavicular Brachial Plexus Block With the Double Injection Technique

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2018
Registry last updated
Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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