Actively Recruiting
Investigation of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle to Generate Higher Force Behaviors
Led by Mayo Clinic · Updated on 2026-02-27
69
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how different doses of opioids affect the diaphragm muscle's ability to generate stronger breathing efforts. This study focuses on adult patients undergoing lower extremity orthopedic surgery and aims to understand how opioid exposure changes diaphragm muscle function during breathing. Participants will be grouped based on receiving low, mid, or high doses of fentanyl, an opioid used for sedation during surgery. They will undergo ultrasound shear wave elastography examinations while performing various breathing techniques to measure muscle stiffness and response at different opioid dose levels. During the study, researchers will measure changes in muscle stiffness using Young's modulus derived from shear wave speed before and 10 minutes after opioid administration. Participants will have these assessments performed during surgery, and the study will monitor respiratory function to evaluate the effects of opioid doses on diaphragm strength and breathing mechanics.
CONDITIONS
Brief Title
A Study to Investigate of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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).
You will not qualify if you...
- Patients who refuse research participation.
- Patients who are pregnant.
- Patients with known pulmonary pathology (COPD, asthma requiring routine treatment).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day
Participants receive different doses of fentanyl during elective lower extremity orthopedic surgery as part of standard care. Ultrasound shear wave elastography examinations are performed while participants perform different breathing techniques to assess diaphragm muscle function.
1 visit (in-person, on surgery day)
Trial Site Locations
Total: 1 location
1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here