Opioid UsePhase 4NCT06113211
Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures
A Phase 4 study testing Narcotic pain medication and Nonnarcotic pain medications in people with Opioid Use and Fractures, Bone, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Opioid Use, Fractures, Bone, Trauma
- What is being tested?
- Narcotic pain medication and Nonnarcotic pain medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 15 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Henry Ford Hospital System
Detroit, Michigan, 48226
William Hakeos, MD, whakeos1@hfhs.org
About this 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.
Read more
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.
Read the detailed description
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:
- Motrin - also known as Ibuprofen (for 2 weeks) 800 mg every 6 hours; not to exceed 3200 mg/day
- Lyrica (also known as pregabalin) 75mg twice per day for 5 days then wean off as described below. Dispense: 30 tablets at discharge (75mg/tablet). Days 6-7: morning-75mg; evening- 75mg. Days 8-9: morning-75mg. Days 10: No more Lyrica
- Tylenol (also known as acetaminophen) 1000 mg three times per day. Do not exceed a total of 4 grams of Acetaminophen per day.
- Zanaflex (also known as tizanidine) 4 mg every 6-12 hours for 2 weeks. Weeks 2 - 4: 1. Tylenol (also known as acetaminophen) 1000 mg three times per day. Do Not exceed a total of 4 grams of Acetaminophen per day.
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.
- Conditions
- Opioid Use, Fractures, Bone, Trauma
- Being tested
- Narcotic pain medication, Nonnarcotic pain medications
- Medical subject headings
- Fractures, Bone, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narcotic pain medicationDrug
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.
Nonnarcotic pain medicationsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Narcotic Postoperative Pain Control | Active comparator | Standard of care control group given standard opioid pain control regimen. Receives: Drug: Narcotic pain medication |
| Nonnarcotic Postoperative Pain Control | Experimental | Experimental group given nonopioid pain control regimen. Receives: Drug: Nonnarcotic pain medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Analog pain score 0-10. A pain score of 10 represents maximum pain and a pain score of 0 represents no pain.
Measured: Pain scores will be recorded daily for the first 2 weeks, and then once a week until the 6 week post operative clinic visit.
Secondary outcomes (1)
Patient reported function score
Patient reported function questionnaire will be administered to patients during postoperative visits.
Measured: Preoperative visit and postoperative visits up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Oct 2024
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Hakeos, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113211
- Sponsor's protocol ID
- 15315
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures
- ClinicalTrials.gov ID
- NCT06113211
- Acronym / sponsor ID
- 15315
- Conditions
- Opioid Use, Fractures, Bone, Trauma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Motrin - also known as Ibuprofen (for 2 weeks) 800 mg every 6 hours; not to exceed 3200 mg/day
- Lyrica (also known as pregabalin) 75mg twice per day for 5 days then wean off as described below. Dispense: 30 tablets at discharge (75mg/tablet). Days 6-7: morning-75mg; evening- 75mg. Days 8-9: morning-75mg. Days 10: No more Lyrica
- Tylenol (also known as acetaminophen) 1000 mg three times per day. Do not exceed a total of 4 grams of Acetaminophen per day.
- Zanaflex (also known as tizanidine) 4 mg every 6-12 hours for 2 weeks. Weeks 2 - 4: 1. Tylenol (also known as acetaminophen) 1000 mg three times per day. Do Not exceed a total of 4 grams of Acetaminophen per day.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narcotic Postoperative Pain Control | Active comparator | Drug: Narcotic pain medicationStandard of care control group given standard opioid pain control regimen. |
| Nonnarcotic Postoperative Pain Control | Experimental | Drug: Nonnarcotic pain medicationsExperimental group given nonopioid pain control regimen. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narcotic pain medicationPrimary 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. | Drug | Narcotic Postoperative Pain Control |
| Nonnarcotic pain medicationsPrimary 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. | Drug | Nonnarcotic Postoperative Pain Control |
Primary outcome
Pain Score
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.
Analog pain score 0-10. A pain score of 10 represents maximum pain and a pain score of 0 represents no pain.
1 secondary outcome
Patient reported function score
Time frame: Preoperative visit and postoperative visits up to 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Narcotic pain medication and Nonnarcotic pain medications in people with Opioid Use and Fractures, Bone, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Hakeos (3132055349, whakeos1@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.