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

NCT ID: NCT05856136

Last Updated: 2026-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-19

Study Completion Date

2026-06-01

Brief Summary

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The purpose of this study is to evaluate opioid dose effects on the ability of the diaphragm muscle to generate higher force behaviors.

Detailed Description

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Conditions

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Respiratory Function Loss Respiratory Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Fentanyl Injection

Intervention Type 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 - 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.

Group Type EXPERIMENTAL

Fentanyl Injection

Intervention Type 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

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.

Group Type EXPERIMENTAL

Fentanyl Injection

Intervention Type DRUG

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

Interventions

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Fentanyl Injection

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

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Carlos B Mantilla, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos Mantilla, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Beth Martin

Role: primary

866-265-9263

Brenda Anderson

Role: backup

866-265-9263

Other Identifiers

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R21DA055848

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-007084

Identifier Type: -

Identifier Source: org_study_id

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