Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06113211 |
| Other study ID # |
15315 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2024 |
| Est. completion date |
September 15, 2025 |
Study information
| Verified date |
January 2024 |
| Source |
Henry Ford Health System |
| Contact |
William Hakeos |
| Phone |
3132055349 |
| Email |
whakeos1[@]hfhs.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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-narocotic 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:
Mortin - 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:
1. Motrin - also known as Ibuprofen (for 2 weeks) 800 mg every 6 hours; not to exceed 3200
mg/day
2. 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
3. Tylenol (also known as acetaminophen) 1000 mg three times per day. Do not exceed a total
of 4 grams of Acetaminophen per day.
4. 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.
