Diaphragmatic Dysfunction After Supraclavicular Brachial Plexus Block

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03596190
• Other study ID #: 6447
• Status: Completed
• Phase: N/A
• Start date: August 21, 2018
• Est. completion date: August 8, 2019

Study information

• Verified date: April 2020
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

The hypothesis is HDP following supraclavicular brachial plexus block occurs with-in 15 minutes of block performance and is not associated with subjective dyspnea.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 8, 2019
• Est. primary completion date: March 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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).

Locations

Country	Name	City	State
Canada	NSHA	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	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