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

Mayo Clinic

Status and phase: Enrolling; Phase 4

Conditions: Respiratory Complication; Respiratory Function Loss

Treatments: Drug: Fentanyl Injection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05856136

20-007084

R21DA055848 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 69 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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69 participants in 3 patient groups

Ultrasound Shear Wave Elastography Examination - Lower

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Injection

Ultrasound Shear Wave Elastography Examination - Mid

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Injection

Ultrasound Shear Wave Elastography Examination - Higher

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Injection