Investigating how opioids affect diaphragm muscle function
Investigation of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle to Generate Higher Force Behaviors
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 |
| Enrollment | 69 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05856136 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult patients undergoing lower extremity orthopedic surgery who are willing to participate in the research.
Not a fit: Patients with known pulmonary pathology such as COPD or asthma requiring routine treatment may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rochester, Minnesota
- Mayo Clinic Minnesota — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Carlos Mantilla, MD, PhD — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.