Opioid-free pain management after orthopedic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.