Effect of Different Fentanyl Doses on Diaphragm Muscle Strength During Orthopedic Surgery

What this Trial Is About

Researchers are evaluating how different doses of opioids affect the strength of the diaphragm muscle during elective lower extremity orthopedic surgery. This study focuses on measuring the diaphragms ability to generate stronger breathing efforts under varying opioid exposure. It is a Phase 4, randomized, and triple-blinded trial conducted to understand opioid impacts on respiratory function. Participants will be assigned to one of three groups receiving low, mid, or higher doses of fentanyl injections as part of their standard sedation during surgery. Each group will undergo an ultrasound shear wave elastography examination to assess diaphragm muscle stiffness while performing various breathing techniques. The study measures changes in Youngs modulus derived from shear wave speed before and 10 minutes after opioid administration. During the study, participants will have ultrasound exams to monitor diaphragm function and breathing patterns. Researchers will collect data on diaphragm muscle strength changes related to opioid dose. The study involves monitoring at baseline and post-opioid dosing to understand respiratory muscle response. Participants will be tracked through the surgery and immediate postoperative period, with overall study completion expected by 2027.

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