A Study to Investigate of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle

Study Overview
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Brief Summary
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The purpose of this study is to evaluate opioid dose effects on the ability of the diaphragm muscle to generate higher force behaviors.

Official Title
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Investigation of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle to Generate Higher Force Behaviors

Conditions
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Respiratory Function Loss, Respiratory Complication

Intervention / Treatment
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* Drug: Fentanyl Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Adult male and female patients undergoing lower extremity orthopedic surgery at the study institutions (St. Mary Hospital and Rochester Methodist Hospital within the Mayo Clinic Rochester hospital system). Exclusion Criteria: Patients who refuse research participation. Patients who are pregnant. Patients with known pulmonary pathology (COPD, asthma requiring routine treatment).

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound Shear Wave Elastography Examination - Lower<br>Subjects identified as being administered low dose opioids during an elective lower extremity orthopedic surgery per standard of care will undergo an ultrasound shear wave elastography examination while performing different breathing techniques. | Drug: Fentanyl Injection<br>* Three different fentanyl doses (used for sedation) will be evaluated on their effects on shear wave elastography (SWE) and breathing<br>|
| Experimental: Ultrasound Shear Wave Elastography Examination - Mid<br>Subjects identified as being administered mid dose opioids during an elective lower extremity orthopedic surgery per standard of care will undergo an ultrasound shear wave elastography examination while performing different breathing techniques. | Drug: Fentanyl Injection<br>* Three different fentanyl doses (used for sedation) will be evaluated on their effects on shear wave elastography (SWE) and breathing<br>|
| Experimental: Ultrasound Shear Wave Elastography Examination - Higher<br>Subjects identified as being administered higher dose opioids during an elective lower extremity orthopedic surgery per standard of care will undergo an ultrasound shear wave elastography examination while performing different breathing techniques. | Drug: Fentanyl Injection<br>* Three different fentanyl doses (used for sedation) will be evaluated on their effects on shear wave elastography (SWE) and breathing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in shear wave speed | Measured by the ultrasound elastography of the diaphragm muscle reported in m/sec | Baseline, 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elastography, ultrasound