Opioid Exposure for Respiratory Complications

Phase 4

Recruiting

Led By Carlos Mantilla, MD, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 hour

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests how opioids affect the strength of the diaphragm muscle, which helps with breathing.

Who is the study for?

This trial is for adult men and women who are having lower limb orthopedic surgery at St. Mary Hospital or Rochester Methodist within the Mayo Clinic in Rochester. It's not for those with lung conditions like COPD or asthma, anyone who doesn't want to participate in research, or pregnant individuals.

What is being tested?

The study is looking into how different doses of an opioid called Fentanyl affect the diaphragm muscle's ability to work harder and generate force during breathing, especially after surgery.

What are the potential side effects?

While not explicitly listed, common side effects of Fentanyl can include drowsiness, nausea, confusion, constipation, sedation, respiratory depression (slowed breathing), and potential dependency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 hour

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 hour

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 hour for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in shear wave speed

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Ultrasound Shear Wave Elastography Examination - MidExperimental Treatment1 Intervention

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.

Group II: Ultrasound Shear Wave Elastography Examination - LowerExperimental Treatment1 Intervention

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.

Group III: Ultrasound Shear Wave Elastography Examination - HigherExperimental Treatment1 Intervention

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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