Opioid-Free Anesthesia for Opiate Dependence

AM
CR
Overseen ByCarly Riedmann, MPH
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Jacques E. Chelly
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

JC

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

I will be receiving general anesthesia for my procedure.
I am 18 years old or older.
I am scheduled for knee replacement surgery on one knee.
See 2 more

Exclusion Criteria

I was given pain medication other than fentanyl during surgery.
I was admitted to the ICU during my hospital stay.
I am scheduled for knee replacement surgery on both knees.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Opioid-Free Anesthesia (OFA) or Opioid-Based Anesthesia (OBA) during surgery

Surgery duration

Postoperative Monitoring

Participants' pain scores and medication use are monitored up to Postoperative Day 5

5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Opioid-based anesthesia
  • Opioid-free anesthesia
Trial Overview The study tests whether OFA supplemented with non-opioid painkillers can reduce the transition from acute post-surgical pain to chronic pain and Opioid Use Disorder, compared to conventional OBA.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Opioid-free anesthesia (OFA) GroupExperimental Treatment1 Intervention
Group II: Opioid-based anesthesia (OBA) GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jacques E. Chelly

Lead Sponsor

Trials
10
Recruited
710+

Citations

Effectiveness and safety of opioid-free anesthesia compared ...No OFA regimens showed a statistically significant effect over OBA in reducing postoperative pain within the first 24 h following surgery.
Pain Opioid-free versus opioid-sparing anaesthesia in ...This trial identified no beneficial effect of opioid-free anaesthesia compared to opioid-sparing anaesthesia. Both strategies provide early recovery and ...
Effect of opioid-free anesthesia on the incidence of...Opioid-free anesthesia reduces the incidence of postoperative nausea and vomiting while providing adequate analgesia without interfering with postoperative ...
Opioid-free anesthesia reduces the severity of acute ...OFA in patients who received video-assisted lung surgery led to lower severity of acute postoperative motion-induced pain and fewer PCEA-related adverse events.
The progress in the clinical application of opioid-free anesthesiaThe results showed that the OFA group was significantly better than the OA group in terms of adverse events, such as improved quality of life the next day, ...
Opioid Use and Opioid Use Disorder in PregnancyMore research is needed to assess the safety (particularly regarding maternal relapse), efficacy, and long-term outcomes of medically supervised withdrawal.
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