Clinical trial NCT03596190: Diaphragmatic Dysfunction After Supraclavicular Brachial Plexus Block
Official title: Diaphragmatic Dysfunction After Ultrasound-guided Supraclavicular Brachial Plexus Block With the Double Injection Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of hemi-diaphragmatic paresis
timeFrame: Relative change in ultrasound assessment of diaphragmatic thickening (Baseline vs 30 min after supraclavicular block)
measure: Onset time of hemi-diaphragmatic paresis
timeFrame: Baseline, 5, 10, 15, 20, 25, and 30 minutes after block
Secondary outcomes:
measure: The correlation of subjective dyspnea
timeFrame: Baseline, 5, 10, 15, 20, 25, and 30 minutes after block
measure: Incidence of HDP after surgical procedure under supraclavicular brachial plexus block (in post recovery unit).
timeFrame: Post-operatively up to 24 hours
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: NSHA
state: Nova Scotia
Study officials:
References: