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Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures

StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated April 13, 2026 (before its estimated September 15, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Re-verified, no change to tracked fieldsv6
  2. Notable Primary and study completion dates: Sep 15, 2025 to Sep 15, 2026v5
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Study description revised
    v4
  4. Notable Start date: Jun 15, 2024 to Oct 1, 2024v3
  5. Notable Start date: Dec 15, 2023 to Jun 15, 2024
    • Eligibility criteria shortened, about 5 words
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
An open reduction and internal fixation is a painful procedure requiring intensive postoperative pain management. Traditionally, opioid analgesia has been the gold standard for postoperative pain control. However, given the harmful side effect profile and opioid epidemic in the United States, it is advantageous to use alternate forms of analgesia. Multimodal pain control captures the effectiveness of different analgesic modalities and maximizes analgesia while minimizing side effects. The theory behind their use is that agents with different mechanisms of action work synergistically in preventing acute pain. Objective: To measure postoperative pain control in patients in two treatment arms of ORIF of the clavicle: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen. Study Design: A randomized single blinded standard of care controlled clinical trial comparing pain management interventions. All adult patients scheduled for an ORIF following a traumatic fracture by fellowship trained Trauma surgeons will be eligible for inclusion. Patients will be excluded if their medical history presents known allergies or intolerance to Motrin, Lyrica, Tylenol, Zanaflex, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. On the day of surgery, patients will be randomized to receive a nonopioid pain control regimen or an opioid regimen using a computer-generated sequence. If pain is uncontrolled, patients will also be sent home with a prescription with 10 pills of 5 mg of Oxycodone for breakthrough pain. The amount of oxycodone taken will be recorded. Patients can call the resident on call, available 24-hours per day, if additional pain control is needed. Treatment: All patients will undergo previously scheduled ORIF of the clavicle in standard fashion and be randomized to the non-narcotic pain regimen vs the narcotic pain regimen.
Trial Details
NCT Number NCT06113211
Lead Sponsor Henry Ford Health System
Conditions
(from sponsor)
Opioid Use, Fractures, Bone, Trauma
Related terms Fractures, Bone, Wounds and Injuries
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov