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NCT06113211 · ClinicalTrials.gov registry record · Phase 4
Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures
A Phase 4 study of Opioid Use and Trauma, sponsored by Henry Ford Health System.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT06113211 is a Phase 4 study of Opioid Use and Trauma that is actively recruiting participants, run by Henry Ford Health System. The registered enrollment target is 75 participants, below the 148,259-participant average among 105 other Opioid Use trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06113211, a Phase 4 study of Opioid Use and Trauma, is actively recruiting participants, sponsored by Henry Ford Health System.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Conditions Studied
Interventions
- DRUG Narcotic pain medication
- DRUG Nonnarcotic pain medications
Study Locations (1)
Michigan
- Henry Ford Hospital System - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2026-09-15 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06113211
The ClinicalTrials.gov registry entry for NCT06113211 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 148,259-participant average among 105 other Opioid Use trials with a reported enrollment target (100% lower). The listed sponsor is Henry Ford Health System, which has 234 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Opioid Use appearing as the primary indexed condition, and to 2 interventions - of which Narcotic pain medication is the first listed.
NCT06113211 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT06113211 about?
NCT06113211 is a clinical study titled "Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures". 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 ...
What is the current status of trial NCT06113211?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 75 participants. The study started on 2024-10-01. Estimated completion is 2026-09-15.
What conditions does trial NCT06113211 study?
This clinical trial studies the following conditions: Opioid Use, Trauma, Fractures, Bone.
What interventions are being tested in trial NCT06113211?
The interventions under investigation include: Narcotic pain medication (DRUG), Nonnarcotic pain medications (DRUG).
Who is sponsoring clinical trial NCT06113211?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06113211 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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