Recruiting

Opioid Exposure

Sponsor:

Mayo Clinic

Code:

NCT05856136

Conditions

Respiratory Function Loss

Respiratory Complication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fentanyl Injection

Study Details

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.

Conditions

Respiratory Function Loss

Respiratory Complication

Study ID

NCT05856136

Start date

Jun 19, 2023

Status verified date

Jun, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Dec 8, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

69 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Ultrasound Shear Wave Elastography Examination - Lower

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.

experimental: Ultrasound Shear Wave Elastography Examination - Mid

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.

experimental: Ultrasound Shear Wave Elastography Examination - Higher

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.

Interventions

Fentanyl Injection

Three different fentanyl doses (used for sedation) will be evaluated on their effects on shear wave elastography (SWE) and breathing

Primary outcome measure

  • Change in Young's modulus (derived from shear wave speed) [ Time Frame: Baseline, 10 min post-opioid ]

Central Contacts and Locations

Locations

Mayo Clinic Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Beth Martin

866-265-9263martin.elizabeth@mayo.edu

Brenda Anderson

866-265-9263anderson.brenda@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • elastography
  • ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-23.