Clinical Trials Directory

Trials / Completed

CompletedNCT06855641

Effect of Patient Preference for Intraoperative Opioid Use on Early Postoperative Quality of Recovery

Patient Preference for Intraoperative Opioid Use and Early Recovery Following Non-Cardiac Surgery: Protocol for a Randomized Factorial Design Trial of Opioid-Free vs Opioid-Based Anesthesia (PERFECT TRIAL)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
240 (actual)
Sponsor
University of California, Los Angeles · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Substituting the administration of opioids with a combination of alternative analgesics, known as opioid-free anesthesia (OFA), is gaining in popularity today and is typically administered as part of a larger multimodal strategy. However, OFA adoption is not as common today as one could expect from the potential benefits of limiting opioid use and patient involvement in the decision may impact its adoption. Relevant shared decision-making process with patients concerning the use or limited use of opioids could improve patient autonomy and empowerment. There have been no studies that have evaluated patient preference regarding opioid use and its potential impact on the quality of recovery. The aim of this study is to compare the effect of patient preference on intraoperative opioid use on early postoperative quality of recovery following moderate risk laparoscopic/robotic abdominal surgery.

Detailed description

Although opioid analgesic drugs are commonly used to relieve pain associated with surgery, they are not consequence free. Respiratory depression, postoperative nausea and vomiting (PONV), impaired gastrointestinal function, urinary retention are frequent concerns associated with their use. Moreover, the United States and many western countries are currently experiencing a significant health problem with opioid addiction and deaths due to overdose. Some opioid addiction pathways can trace their origin back to when a patient was first admitted to a hospital and received opioids in the setting of acute pain or surgery. As a result of this, there is likely a potential iatrogenic component to the current opioid abuse epidemic. Questioning the role of opioids is part of enhanced recovery after surgery programs, and good practice to reduce the risk of developing addiction and other side effects. Substituting the administration of opioids with a combination of alternative analgesics, known as opioid-free anesthesia (OFA), is gaining in popularity today and is typically administered as part of a larger multimodal strategy. However, OFA adoption is not as common today as one could expect from the potential benefits of limiting opioid use and patient involvement in the decision may impact its adoption. Relevant shared decision-making process with patients concerning the use or limited use of opioids could improve patient autonomy and empowerment. There have been no studies that have evaluated patient preference regarding opioid use and its potential impact on the quality of recovery. The aim of this study is to compare the effect of patient preference on intraoperative opioid use on early postoperative quality of recovery following moderate risk laparoscopic/robotic abdominal surgery.

Conditions

Interventions

TypeNameDescription
PROCEDUREOpioid based Anesthesiain this group, patient will receive standard of care at UCLA including fentanyl administration during surgery
PROCEDUREopioid free anesthesiaIn this group, patients will not receive any opioids intraoperatively

Timeline

Start date
2025-03-24
Primary completion
2025-06-18
Completion
2025-06-18
First posted
2025-03-04
Last updated
2025-06-27

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT06855641. Inclusion in this directory is not an endorsement.