Evaluation of Diaphragm Movement After an Interscalene Block

Phrenic Nerve Paralysis Clinical Trial

Official title:

Evaluation of Diaphragm Movement After an Interscalene Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636542
• Other study ID #: ANES-2018-26543
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2018
• Est. completion date: June 3, 2020

Study information

• Verified date: November 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the movement of the diaphragm after an interscalene block with liposome bupivacaine (LB) compared to interscalene block (IB) with bupivacaine. This study will evaluate if there is a possible prolonged phrenic nerve paralysis when using liposome bupivacaine in an interscalene block, using ultrasound.

Description:

This study will be run concurrently with two other studies comparing bupivacaine to Liposomal Bupivacaine in shoulder surgeries. We will use already randomized patients for our randomization process. For this study in particular we will use an ultrasound machine to scan the diaphragm of any patient who had an Interscalene Block for Total Shoulder Arthroplasy or Rotator Cuff Repair. Patients are to be scanned in an upright sitting position and scanned from a low intercostal or subcostal approach using the liver or spleen as an acoustic window. M Mode will be applied and the range of diaphragmatic movement from the resting expiratory position to deep inspiration (sigh test) will be recorded as was the range of diaphragmatic movement from resting expiratory position when quickly inspiring through the nose (sniff test). The blocks will be done regardless of the study as they are standard of care for pain control. The only intervention is ultrasound examination of the patient's diaphragm at baseline, 3 hours post block in recovery room and on post-operative day 1, and basic spirometry to record FEV1 and FVC via a portable spirometer at the same time points. If patients did stay in hospital on postoperative day 2 we would also evaluate their diaphragm function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 3, 2020
• Est. primary completion date: June 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients age 18 years and older who are scheduled for shoulder surgery with interscalene block and remain in the hospital for more than 24 hours that are being randomized into a bupivacaine versus liposomal bupivacaine interscalene block study.

Exclusion Criteria:

• Non English speaking patients.

Related Conditions & MeSH terms

• Paralysis
• Phrenic Nerve Paralysis

Intervention

Drug:
• liposomal bupivacaine
Experimental
• bupivacaine
Active comparator

Locations

Country	Name	City	State
United States	Univeristy of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragm Excursion With Sigh	Evaluation of diaphragm excursion (movement in cm) from rest to sigh in a sitting position.	change from baseline to 24 hours after block
Secondary	Diaphragm Excursion With Quick Inspiratory Breath	Evaluation of diaphragm excursion (movement in cm) from rest to a quick inspiratory breath.	change from baseline to 24 hours after block
Secondary	Forced Expiratory Volume in 1 Second (FEV1)	Evaluation of FEV1 via spirometry.	change from baseline to 24 hours after block
Secondary	Forced Vital Capacity (FVC)	Evaluation of FVC via spirometry.	change from baseline to 24 hours after block
Secondary	FEV1/FVC	Evaluation of FEV1/FVC percent via spirometry.	change from baseline to 24 hours after block