Actively Recruiting
Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures
Led by Henry Ford Health System · Updated on 2026-04-13
75
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating pain control methods after open reduction and internal fixation (ORIF) surgery for traumatic clavicle fractures. This study compares a nonopioid pain control regimen to the standard opioid pain control regimen to determine how well each manages postoperative pain. The goal is to find effective pain relief options while reducing opioid use due to their side effects and the ongoing opioid epidemic. The study is a randomized, single-blinded clinical trial involving adult patients undergoing ORIF by specialized trauma surgeons. Participants will all receive ORIF surgery and be randomly assigned on the day of surgery to either a nonopioid or an opioid pain management group. Both groups receive a preoperative pain protocol including Celebrex, Lyrica, and Tramadol, and an intraoperative injection with epinephrine, ropivacaine, acetaminophen, and Toradol. Postoperative pain control in both groups includes scheduled Motrin, Lyrica, Tylenol, and Zanaflex, with detailed dosing schedules over the first four weeks. Patients with uncontrolled pain may receive a prescription for a limited number of oxycodone pills for breakthrough pain. Participants will have their pain scores recorded daily for the first two weeks after surgery and then weekly until their six-week postoperative clinic visit. Functional outcomes will be assessed before surgery and at follow-up visits up to one year. Additional monitoring includes recording the amount of oxycodone taken if prescribed. Patients can contact a 24-hour on-call resident for additional pain management. The total participation includes surgery, medication regimens, pain and function assessments, and follow-up over several months.
CONDITIONS
Brief Title
Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years old scheduled for primary open reduction internal fixation following a traumatic fracture
- Surgery performed by fellowship trained trauma surgeons
- Patients presenting at designated Henry Ford Health System hospitals
You will not qualify if you...
- Known allergies or intolerance to Motrin, Lyrica, Tylenol, tramadol, or Zanaflex
- History of substantial alcohol or drug abuse
- Pregnancy
- Use of narcotics within 6 months before surgery
- Renal impairment, peptic ulcer disease, or gastrointestinal bleeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants undergo open reduction and internal fixation surgery and receive either a nonopioid or opioid postoperative pain control regimen.
1 surgery day visit and weekly visits for up to 4 weeks
Duration - Up to 1 year
Participants have follow-up visits to monitor pain scores and function, with assessments continuing up to 1 year after surgery.
Weekly visits until 6 weeks post surgery and additional visits up to 1 year
Trial Site Locations
Total: 1 location
1
Henry Ford Hospital System
Detroit, Michigan, United States, 48226
Actively Recruiting
Research Team
W
William Hakeos
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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