Investigating how opioids affect diaphragm muscle function
Official title: Investigation of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle to Generate Higher Force Behaviors
Run by Mayo Clinic · NCT05856136 · Data updated 2026-11-12
This study tests how different doses of fentanyl affect the diaphragm muscle's ability to work properly in adults having lower limb surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 69 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | June 19, 2023 |
| Main results expected | December 8, 2025 |
| Study ends | January 1, 2027 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT05856136 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult patients undergoing lower extremity orthopedic surgery who are willing to participate in the research.
✕Probably not a fit
Patients with known pulmonary pathology such as COPD or asthma requiring routine treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the impact of opioid exposure, specifically fentanyl, on the diaphragm muscle's ability to generate force during respiratory activities. It focuses on adult patients undergoing lower extremity orthopedic surgery and utilizes elastography and ultrasound techniques to assess diaphragm performance. By measuring the effects of different opioid doses, the study aims to understand how opioids may influence respiratory function and complications post-surgery.
Why it matters
Potential benefit: If successful, this study could lead to improved management of respiratory function in patients receiving opioids, enhancing postoperative recovery.
How similar studies have gone: While the specific approach of this study may be novel, there have been other studies examining the effects of opioids on respiratory function, indicating a growing interest in this area.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
-
Mayo Clinic Minnesota
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Carlos Mantilla, MD, PhD — Mayo Clinic
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study is testing if a new ultrasound method can better measure how well the diaphragm works compared to standard breathing tests in healthy adults.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.