Opioid-Free Anesthesia for Opiate Dependence
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new methods to manage pain during surgery without opioids, which can lead to dependency issues. Researchers will compare outcomes of opioid-free anesthesia with traditional opioid-based anesthesia in surgical patients. The focus is on patients undergoing a single knee replacement surgery who are expected to stay in the recovery area after their procedure. Participants will help determine if opioid-free methods can effectively manage pain and reduce dependency risk. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to experience innovative pain management strategies.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using anesthesia without opioids can be safe for surgeries. Studies have found it reduces the risk of postoperative nausea and provides effective pain relief. Patients who underwent lung surgery with this method experienced less pain during movement after surgery and had fewer issues with pain-control devices.
In contrast, anesthesia with opioids, such as fentanyl, effectively relieves pain but carries risks like addiction and other side effects.
Since this trial is in its early stages, it's important to note that while the safety of opioid-free anesthesia appears promising, it remains under study. Prospective participants should consider the potential benefits and risks and discuss any concerns with their doctor.12345Why are researchers excited about this trial's treatments?
Researchers are excited about opioid-free anesthesia (OFA) for opiate dependence because it offers a way to manage anesthesia without using opioids, which can be crucial for individuals with a history of addiction. Unlike traditional opioid-based anesthesia that uses fentanyl, OFA employs alternatives like IV-acetaminophen, IV-lidocaine, dexmedetomidine, and ketamine, reducing the risk of relapse or dependency. This approach not only targets pain management effectively but also minimizes the potential for opioid-related side effects and complications. By using a combination of non-opioid medications, OFA provides a promising option for safer surgical procedures for those with opiate dependence.
What evidence suggests that this trial's treatments could be effective for opiate dependence?
This trial will compare opioid-free anesthesia (OFA) with opioid-based anesthesia (OBA) for individuals with opiate dependence. Research has shown that OFA can effectively manage pain without using opioids. Studies have found that OFA reduces common side effects like nausea and vomiting after surgery. Specifically, patients who underwent video-assisted lung surgery with OFA experienced less severe pain from movement post-surgery and had fewer negative reactions to pain control methods. Although OFA does not significantly reduce pain compared to opioid-based methods in the first 24 hours after surgery, it improves overall well-being the next day by reducing side effects. Overall, OFA presents a promising option for those concerned about the risks associated with opioids.12346
Who Is on the Research Team?
Jacques Chelly, MD, PhD, MBA
Principal Investigator
University of Pittsburgh, UPMC
Are You a Good Fit for This Trial?
This trial is for surgical patients at risk of developing opioid dependency after surgery. It's designed to compare the outcomes of those receiving opioid-free anesthesia (OFA) with non-opioid analgesics versus traditional opioid-based anesthesia (OBA).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Opioid-Free Anesthesia (OFA) or Opioid-Based Anesthesia (OBA) during surgery
Postoperative Monitoring
Participants' pain scores and medication use are monitored up to Postoperative Day 5
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Opioid-based anesthesia
- Opioid-free anesthesia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jacques E. Chelly
Lead Sponsor