Non-Opioid Analgesia for Pain Management
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to manage pain after hip replacement surgery without heavily relying on opioids. Researchers aim to determine if using fewer opioids can still effectively control pain and maintain patient satisfaction with recovery. One group will receive a standard opioid prescription, while the other will follow a mostly non-opioid plan (opioid-sparing regimen). Candidates may qualify if they have osteoarthritis, plan a hip replacement, and have not recently used opioids. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used opioids in the 4 weeks before surgery. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that non-opioid pain treatments are generally easy for people to handle. In one study, 71% of patients using non-opioid methods reported satisfaction with their pain management, and 86% felt their pain was very well controlled. These findings suggest that non-opioid treatments can effectively manage pain without the usual side effects of opioids.
Another study examined pain management in orthopedic surgeries, comparing opioid and non-opioid methods. It found that non-opioid options were safe and effective. Patients using non-opioid treatments were less likely to feel they received too much medication compared to those using opioids.
Overall, this evidence suggests that the non-opioid approach in this trial is likely to be well-tolerated and effective for managing pain.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the opioid-sparing regimen because it offers a non-opioid alternative for pain management, which could significantly reduce the risk of addiction associated with traditional opioid prescriptions. Unlike standard treatments that rely heavily on opioids, this regimen uses a multimodal non-opioid approach with counseling from a Life Care Specialist, aiming to manage pain effectively without the side effects of opioids. Additionally, participants receive a limited supply of rescue hydromorphone for severe pain, ensuring that breakthrough pain can still be addressed without defaulting to full opioid reliance. This innovative approach could pave the way for safer pain management strategies post-surgery.
What evidence suggests that this opioid-sparing regimen could be effective for pain management in osteoarthritis?
Research shows that using fewer opioids can effectively manage pain after surgery. In this trial, participants in the Opioid-Sparing Regimen arm will receive a standardized multimodal non-opioid analgesic regimen and placebo tablets instead of a standard opioid prescription. Studies have found that these methods can greatly reduce the need for morphine and improve pain levels. A review of multiple studies found that non-opioid pain relievers work well for controlling pain and help lessen the use of opioids. Additionally, surgeries using fewer opioids have shown good results, especially in common procedures, highlighting their potential in managing pain after surgery. Overall, evidence suggests that treatments using fewer opioids can provide effective pain relief while reducing opioid use.13678
Who Is on the Research Team?
Ajay Premkumar, MD
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
This trial is for adults with hip osteoarthritis who need a primary arthroplasty. Participants must be scheduled for anterior total hip replacement, able to follow the study's procedures and attend follow-up visits, and provide informed consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Perioperative Treatment
Participants receive a standardized multimodal non-opioid analgesic regimen throughout the perioperative period, along with counseling from a Life Care Specialist.
Postoperative Monitoring
Pain scores, nausea, opioid consumption, and patient-reported outcomes are collected during the first postoperative week.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 3 weeks and 3 months.
What Are the Treatments Tested in This Trial?
Interventions
- Opioid-Sparing Regimen
Trial Overview
The trial tests if an opioid-sparing pain management approach after hip surgery can reduce opioid use while still controlling pain effectively. It compares standard opioid prescriptions with both a placebo and non-opioid analgesia regimen.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants receive a standardized multimodal non-opioid analgesic regimen throughout the perioperative period and are discharged with placebo tablets instead of a standard opioid prescription. All participants receive counseling from a Life Care Specialist and a limited supply of rescue hydromorphone for severe breakthrough pain.
Participants receive the same standardized multimodal non-opioid analgesic regimen and Life Care Specialist counseling as the experimental group, but are discharged with a standard opioid prescription.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
Citations
The Impact of Opioid-Sparing Analgesia on Postoperative ...
Effective postoperative analgesia allows patients to begin rehabilitation sooner and reduces adverse outcomes. Opioids play an essential role in ...
2.
cureus.com
cureus.com/articles/448472-navigating-the-post-opioid-era-a-focus-on-non-opioid-perioperative-analgesicsNavigating the Post-opioid Era: A Focus on Non- ...
The evidence strongly supports their analgesic efficacy and opioid-sparing role. A meta-analysis by De Oliveira et al. (2012) established that ...
Opioid-Sparing Analgesia Linked to Reduced ...
Opioid-sparing analgesia may significantly reduce morphine consumption, pain scores, and adverse effects following surgery, according to a ...
4.
sportsmedicine.mayoclinic.org
sportsmedicine.mayoclinic.org/news/opioid-sparing-surgeries-show-promising-results-in-pain-management/Opioid-sparing surgeries show promising results in pain ...
Opioid-sparing surgeries show promising results in pain management ... “We've found that [non-opioid pain-management] is effective in common sports surgeries…
Biochemical strategies for opioid-sparing pain ...
This review explores non-opioid approaches for managing pain in the ever-changing operating room. The review examines the molecular basis of pain perception.
Efficacy and Safety of Opioid Versus Non- ...
This study compared opioid-based and non-opioid multimodal analgesia strategies in 75 patients undergoing common orthopaedic procedures. Our ...
Impact of opioid-free analgesia on pain severity and patient ...
Overall, 14.8% of patients prescribed opioid analgesia felt that they were prescribed too much pain relief medication, compared with 3.7% of ...
Patient-Reported Satisfaction with Non-opioid and ...
About 86% of the patients in the non-opioid usage group reported pain levels that were very well controlled, and 71% reported that they were ...
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