Opioid-free pain management after orthopedic surgery
A Double-Blinded Randomized Controlled Trial Examining Multimodal Opioid-Free Orthopaedic Procedures
This study is testing a new way to manage pain after orthopedic surgery without using opioids to see if it helps patients feel better and reduces the need for painkillers.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 3 sites (Atlanta, Georgia and 2 other locations) |
| Trial ID | NCT04659317 on ClinicalTrials.gov |
What this trial studies
This investigation aims to evaluate the effectiveness of a multimodal pain control regimen that minimizes or eliminates the need for opioids following orthopedic surgery. The study is a prospective double-blinded randomized controlled trial where patients will be assigned to receive either encapsulated opioids or a placebo, alongside standard multimodal pain management strategies. Researchers will monitor various outcomes including pain levels, patient satisfaction, opioid consumption, side effects, and complications to assess the regimen's efficacy. The findings could pave the way for future opioid-free surgical approaches and help identify patients at risk for prolonged opioid use post-surgery.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with advanced arthritis or those undergoing specific orthopedic procedures who have not responded to nonoperative treatments.
Not a fit: Patients with significant concurrent injuries, recent opioid use, or certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce opioid dependency and improve postoperative pain management for orthopedic patients.
How similar studies have performed: Other studies have shown promise in multimodal pain management approaches, but this specific opioid-free strategy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any patient with advanced arthritis undergoing a total joint replacement (e.g. total shoulder arthroplasty, anatomic or reverse), in the primary setting. * Any patient undergoing an orthopaedic procedure or surgery of their finger, hand, wrist, forearm, or elbow * Any patient undergoing an orthopaedic procedure or surgery for their hip, knee, ankle or foot * Patients who have exhausted 3+ months of nonoperative treatment to include activity modifications, optional corticosteroid injections, and physical therapy. * Patients over the age of 18 years old that are willing to participate in the study and mentally capable to consent Exclusion Criteria: * Patients with concurrent and significant injuries to other bones or organs, local infections, history of alcohol or medical abuse, preoperative opioid use within 3 months of the surgery, advanced renal or liver disease, contraindication to receiving a nerve block, uncontrolled diabetes mellitus (HbA1C \>9.0), or if a prior gastric ulcer precludes Aspirin and anti-inflammatory medications.i. Prior to inclusion, the patient will undergo blood testing to evaluate both kidney and liver function, including estimated glomerular filtration rate (GFR) as well as alanine aminotransferase (ALT) and aspartate aminotransferase (AST). * Workman's compensation status, minors, vulnerable subjects, women who are pregnant, or those who are not willing to consent to participate in the study. * Patients who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
Where this trial is running
Atlanta, Georgia and 2 other locations
- The Emory Clinic — Atlanta, Georgia, United States (Recruiting)
- Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
- Emory Orthopedic and Spine Hospital — Tucker, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Eric Wagner, MD — Emory University
- Study coordinator: Alexander Dawes
- Email: adawes@emory.edu
- Phone: 404-784-2402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.