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

Phase 4

Recruiting

• Conditions: Respiratory Function Loss; Respiratory Complication
• Interventions: Drug: Fentanyl Injection

• Registration Number: NCT05856136
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-04
• Study First Posted: 2023-05-12
• Study Start: 2023-06-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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).

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Exclusion Criteria

• Patients who refuse research participation.
• Patients who are pregnant.
• Patients with known pulmonary pathology (COPD, asthma requiring routine treatment).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound Shear Wave Elastography Examination - Lower	Fentanyl Injection	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.
Ultrasound Shear Wave Elastography Examination - Mid	Fentanyl Injection	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.
Ultrasound Shear Wave Elastography Examination - Higher	Fentanyl Injection	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.

Primary Outcome Measures

Name	Time	Method
Change in shear wave speed	Baseline, 1 hour	Measured by the ultrasound elastography of the diaphragm muscle reported in m/sec

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States