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Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures
Who can join
Ages 18 to 80 · All sexes
Full eligibility 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.
About the study
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.
What is being tested
- Narcotic pain medication (drug)
- Nonnarcotic pain medications (drug)
Sponsor: Henry Ford Health System · Participants: 75 · Started: Oct 1, 2024
Contact the study team
- William Hakeos · Phone: 3132055349
Official record on ClinicalTrials.gov — NCT06113211
Locations in the U.S.
| Michigan | Henry Ford Hospital System, Detroit |
Conditions
From ClinicalTrials.gov, data retrieved Oct 3, 2026. Each study sets its own eligibility; the study team decides who can join.