Evaluation of Diaphragm Movement After an Interscalene Block

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Diaphragm Movement After an Interscalene Block

Conditions
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Phrenic Nerve Paralysis

Intervention / Treatment
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* Drug: liposomal bupivacaine
* Drug: bupivacaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: liposomal bupivacaine<br>These patients receive an interscalene block with liposomal bupivacaine. | Drug: liposomal bupivacaine<br>* Experimental<br>|
| Active Comparator: bupivacaine<br>These patients receive an interscalene block with bupivacaine. | Drug: bupivacaine<br>* Active comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Forced Expiratory Volume in 1 Second (FEV1) | Evaluation of FEV1 via spirometry. | change from baseline to 24 hours after block | 
| Forced Vital Capacity (FVC) | Evaluation of FVC via spirometry. | change from baseline to 24 hours after block | 
| FEV1/FVC | Evaluation of FEV1/FVC percent via spirometry. | change from baseline to 24 hours after block |