A Study to Investigate of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle

NCT05856136 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: 20-007084R21DA055848
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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 Complication; Respiratory Function Loss

Keywords

elastography; ultrasound

Outcome Measures

Primary Outcomes (1)

• Change in Young's modulus (derived from shear wave speed)

  Measured by the ultrasound elastography of the diaphragm muscle reported in KPa

  Baseline, 10 min post-opioid

Study Arms (3)

Ultrasound Shear Wave Elastography Examination - Lower

EXPERIMENTAL

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.

Drug: Fentanyl Injection

Ultrasound Shear Wave Elastography Examination - Mid

EXPERIMENTAL

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.

Drug: Fentanyl Injection

Ultrasound Shear Wave Elastography Examination - Higher

EXPERIMENTAL

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.

Drug: Fentanyl Injection

Interventions

Fentanyl Injection DRUG

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

Ultrasound Shear Wave Elastography Examination - Higher; Ultrasound Shear Wave Elastography Examination - Lower; Ultrasound Shear Wave Elastography Examination - Mid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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 may not qualify if:

• Patients who refuse research participation.
• Patients who are pregnant.
• Patients with known pulmonary pathology (COPD, asthma requiring routine treatment).

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Carlos Mantilla, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 12, 2023
• Study Start: June 19, 2023
• Primary Completion: December 8, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)