Opioid-Free Pain Treatment for Trauma Patients
Peri-operative Opioid-free Analgesic Protocol for Orthopedic Trauma Patients
This study is testing whether pain management without opioids works better than traditional opioid pain relief for orthopedic patients recovering from certain types of fractures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT06078371 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares pain outcomes between opioid analgesia and opioid-free analgesia in post-operative orthopedic patients with specific types of fractures. It is a single-center randomized trial conducted at the University of Kansas Medical Center, utilizing block randomization for patient enrollment. Patients will be assigned to either a standard pain management protocol that includes opioids or an opioid-free protocol, with crossover for those with contraindications to NSAIDs or acetaminophen. The study aims to evaluate the effectiveness of pain management strategies in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have undergone surgical treatment for specific types of femoral fractures at the University of Kansas Medical Center.
Not a fit: Patients with chronic opioid use, those under 18, or individuals with certain medical conditions like CKD or cirrhosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer pain management alternative for trauma patients, reducing reliance on opioids.
How similar studies have performed: Other studies have shown promising results with opioid-free pain management approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient is over the age of 18 years old * Underwent surgical treatment for the injuries of interest (stated elsewhere) by an Orthopedic Traumatology Attending Physician at the University of Kansas Hospital Exclusion Criteria: * Patients that are unable to provide informed consent due to sustaining a head injury or incoherence from narcotics given to them post-injury * Chronic opioid use * Under the age of 18 years old * Undergoing revision surgery * Did not undergo surgical fixation * Pregnant/nursing women * Vulnerable populations as defined by the University of Kansas Medical Center IRB * Did not experience one of the following fractures listed in D.1. above. * Patients with CKD and/or cirrhosis will be excluded from the opioid-free pain block (block 2) and will only qualify for the standard of care opioid group (Block 1)
Where this trial is running
Kansas City, Kansas
- The University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Study coordinator: Archie Heddings, MD
- Email: aheddings@kumc.edu
- Phone: 913-588-6164
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.