Diaphragmatic Dysfunction After Supraclavicular Brachial Plexus Block

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Diagnostic test: ultrasonographic diaphragmatic assessment

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • NSHA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Assessment arm	Diagnostic test: ultrasonographic 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation of subjective dyspnea	Using the modified Borg dyspnea scale ranging from 0 (no breathlessness at all to 10 (maximal breathlessness)	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	Post-operatively up to 24 hours

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2018
• Primary Completion (Actual): March 6, 2019
• Study Completion (Actual): August 8, 2019

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 6447 (Saskatchewan Health Research Foundation)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No