Diaphragmatic Dysfunction After Supraclavicular Brachial Plexus Block

NCT ID: NCT03596190

Last Updated: 2020-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-21
• Study Completion Date: 2019-08-08

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.

Conditions

Anesthesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Assessment arm

Group Type: OTHER

ultrasonographic diaphragmatic assessment

Intervention Type: 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).

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Vishal Uppal

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NSHA

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

6447

Identifier Type: -

Identifier Source: org_study_id