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Opioids are commonly used after orthopedic surgery for pain control but have been shown to increase complications, surgeries, readmissions, and risk for opioid use disorder. The purpose of this study is to investigate the impact of adding a methylprednisolone taper to the pain regimen after ACL repair surgery to determine if this results in decreased postoperative pain and opioid use without increasing complications.
The study is to include consecutive patients who undergo ACL repair by fellowship trained surgeons at a single institution with minimum 12 week follow up. All patients between the ages of 13-50 who are willing and able to provide informed consent will be included. Patients will be assessed preoperatively and then at 2 weeks, 6 weeks,12 weeks, and 1 year clinic visits, which is standard of care. The patient will fill out 2 questions on the MyCap app the day of surgery and for 14 days following surgery for pain scores and 15 days for amount of opioid pills consumed the day prior. Patient demographic, comorbidity, and surgical data will be collected from the medical record, including age, sex, BMI, smoking status, and diabetic status.
Patients will be randomized to the treatment or control group. The treatment group will receive the following pain regimen after surgery: Medrol dose pack, Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin. The control group will be prescribed: Ketoralac, Hydrocodone/Acetaminophen, and Gabapentin. Pain reporting and opioid consumption will be assessed via the MyCap app for two weeks following surgery.
Patients will be followed at standard of care clinic appointments for 1 year. PROMs data will be collected at that time, in addition to any complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medrol group | Active Comparator | Patients will receive Medrol dose pack, Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery. |
|
| No Medrol group | Active Comparator | Patients will receive Ketorolac, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam 15 mg | Drug | PO once/day for 1 week |
| |
| Medrol 4 MG Oral Tablet Includes Medrol Dosepak |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale (NRS) pain scores | Zero is equivalent to no pain and 10 indicates the worst possible pain | Post-op days 0-14, 2 weeks, 6 weeks, and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption after surgery | Calculated using Morphine milligram equivalents (MME) | 0-14 days postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Scott Kaar | Contact | 314-617-3405 | scott.kaar@ssmhealth.com | |
| Allison Gruender | Contact | 314-617-3406 | allison.gruender@health.slu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Scott Kaar, MD | St. Louis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Louis University | Recruiting | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| D008775 | Methylprednisolone |
| D000077206 | Gabapentin |
| D006853 | Hydrocodone |
| D000082 | Acetaminophen |
| D020910 | Ketorolac |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
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| Drug |
PO 6 day taper |
|
| Gabapentin 300 mg | Drug | PO every 8 hours for 1 week |
|
| Hydrocodone 5Mg/Acetaminophen 325Mg Tab | Drug | PO 1-2 tabs every 4 hours as needed (total of 28 pills) |
|
| Ketorolac 10 Mg Oral Tablet | Drug | PO every 6 hours for 5 days |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000588 | Amines |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |