Nonopioid pain management after surgery for traumatic fractures
Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures
This study tests whether a nonopioid pain management plan can help adults recovering from surgery for traumatic fractures feel better and have fewer side effects than using opioids.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Henry Ford Health System Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT06113211 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a nonopioid pain control regimen compared to standard opioid pain management in patients undergoing open reduction and internal fixation (ORIF) for traumatic fractures. The study involves a randomized, single-blinded design where adult patients will be assigned to either a nonopioid treatment group or a control group receiving opioids. The aim is to assess postoperative pain control and minimize the side effects associated with opioid use. The trial is conducted at Henry Ford Hospital and West Bloomfield Hospital by fellowship-trained trauma surgeons.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for primary ORIF following a traumatic fracture.
Not a fit: Patients with known allergies to the study medications, a history of narcotics use within the last six months, or certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce reliance on opioids for pain management, thereby minimizing the risk of opioid-related side effects and addiction.
How similar studies have performed: Other studies have shown promise in using multimodal pain control strategies, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All adult patients over age eighteen and scheduled for primary open reduction internal fixation following a traumatic fracture at Henry Ford Hospital (Detroit, Michigan, United States), and Henry Ford West Bloomfield Hospital (West Bloomfield, Michigan, United States) will be eligible for inclusion in this study. All patients will be met in our abulatory orthopedic clinics. All surgeries will be performed by a fellowship trained truama surgeons. Exclusion Criteria: * patients with a medical history of known allergies or intolerance to allergies or intolerance to Motrin, Lyrica, Tylenol, tramadol, Zanaflex * substantial alcohol or drug abuse * pregnancy * history of narcotics within 6 months of surgery * renal impairment, peptic ulcer disease, GI bleeding.
Where this trial is running
Detroit, Michigan
- Henry Ford Hospital System — Detroit, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: William Hakeos
- Email: whakeos1@hfhs.org
- Phone: 3132055349
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.