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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA055848 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound Shear Wave Elastography Examination - Lower | Experimental | 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. |
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| Ultrasound Shear Wave Elastography Examination - Mid | Experimental | 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. |
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| Ultrasound Shear Wave Elastography Examination - Higher | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl Injection | Drug | Three different fentanyl doses (used for sedation) will be evaluated on their effects on shear wave elastography (SWE) and breathing |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Young's modulus (derived from shear wave speed) | Measured by the ultrasound elastography of the diaphragm muscle reported in KPa | Baseline, 10 min post-opioid |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Mantilla, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Recruiting | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42414111 | Derived | Gransee HM, Urban MW, Martin BA, Stoltenberg AD, Knoll KM, Jahanian S, Anderson BK, Panchamia JK, Schroeder DR, Mantilla CB. Effects of fentanyl on diaphragm muscle force in patients undergoing knee arthroplasty: a randomised double-blind clinical trial. Br J Anaesth. 2026 Jul 7:S0007-0912(26)00418-6. doi: 10.1016/j.bja.2026.06.004. Online ahead of print. |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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