A Phase 4 interventional study of Narcotic pain medication and Nonnarcotic pain medications in Opioid Use, Fractures, Bone and Trauma, sponsored by Henry Ford Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Henry Ford Health System · Phase 4, Interventional, and Treatment
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.
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 Truama 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.
The traditional narcotic intervention is: 60 pills of Norco 5-325 q4 hours PRN.
Patients in the nonnarcotic and narocotic intervention will be given the following pre-operative pain protocol:
Celebrex 400mg PO, Lyrica 75mg x1 dose pre-op, Tramadol 50mg x 1
Patients in the non-narcotic and narcotic intervention will be given the following intraoperative pain injection:
Epinephrine 1mg (1mL), 0.5% ropivacaine (60mL), Acetaminophen 1000mg IV, Toradol 30mg (1ml)
Postoperative day 1:
Motrin - also known as ibuprofen 800 mg every 6 hours; not to exceed 3200 mg/day
Lyrica - also known as pregabalin 75mg q12hr
Tylenol - also known as acetaminophen 1000mg PO q8hr PRN pain
Zanaflex - also know as tizanidine 4mg PO q6hr
The Postoperative pain control will be as follows:
Weeks 1 and 2:
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.
723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
This study's planned enrollment of 75 is close to the median of 80 across 458 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 26 (70%) have results posted.
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Exclusion Criteria:
Standard of care control group given standard opioid pain control regimen.
Drug: Narcotic pain medication
Experimental group given nonopioid pain control regimen.
Drug: Nonnarcotic pain medications
Primary intervention is pain medication received postoperatively. Control group will receive the standard of care which is opioid medications. Experimental group will receive a nonopioid pain control regimen.
Primary intervention is pain medication received postoperatively. Control group will receive the standard of care which is opioid medications. Experimental group will receive a nonopioid pain control regimen.
Pain Score
Analog pain score 0-10. A pain score of 10 represents maximum pain and a pain score of 0 represents no pain.
Time frame: Pain scores will be recorded daily for the first 2 weeks, and then once a week until the 6 week post operative clinic visit.
Patient reported function score
Patient reported function questionnaire will be administered to patients during postoperative visits.
Time frame: Preoperative visit and postoperative visits up to 1 year.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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