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It is well recognized that a multimodal analgesia program targeting multiple pain pathways, is more effective for controlling pain during the hospital stay and in the acute postoperative period than monotherapy-based regimens, such as opioids only. This multimodal analgesic regimen also leads to reduce opioid consumption and its related side effects after hip and knee joint replacement procedures. One potential strategy to reduce the use of opioids after TKA is to administer a prolonged oral multimodal pain regimen that targets multiple pain pathways in the post hospital discharge period. This can be equal or more effective than the regimen of opioid prescriptions used after TKA. To the best of our knowledge, there have been no studies conducted that directly examine the effect of prolonged multimodal pain regimen after hospital discharge in primary TKA patients.
PURPOSE:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid Regimen | Active Comparator | Weeks 1-4
|
|
| Multimodal pain regimen with PRN opioids | Experimental | Weeks 1-4
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug | Patients are given, for up to 4 weeks, Oxycodone 5m PRN every four hours (up to 30 tablets) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain | Measured via Visual Analog scale (0-100mm) | Postsurgery days 1-30 |
| Opioid related side effects | Severity measured via Visual Analog scale (0-100mm) | post-surgery days 1-30 |
| Measure | Description | Time Frame |
|---|---|---|
| opioid consumption | morphine milligram equivalent | post-surgery weeks 1-4 |
| opioid consumption | number of pills consumed | post-surgery weeks 1-4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothman Institute | Philadelphia | Pennsylvania | 19148 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33036845 | Derived | Li WT, Bell KL, Yayac M, Barmann JA, Star AM, Austin MS. A Postdischarge Multimodal Pain Management Cocktail Following Total Knee Arthroplasty Reduces Opioid Consumption in the 30-Day Postoperative Period: A Group-Randomized Trial. J Arthroplasty. 2021 Jan;36(1):164-172.e2. doi: 10.1016/j.arth.2020.07.060. Epub 2020 Jul 30. |
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| Tramadol | Drug | Patients are given, for up to 4 weeks, Tramadol 50mg PRN every 6 hours (up to 30 tablets) |
|
| Tylenol | Drug | Tylenol 1000 mg: take as needed every 8 hours |
|
| Meloxicam | Drug | Meloxicam 15 mg as need once per day |
|
| Gabapentin | Drug | •Gabapentin 200 mg with morning and evening Tylenol dose |
|
| Metaxalone | Drug | Metaxalone 800mg TID |
|
| Esomeprazole 20mg | Drug | Esomeprazole 20mg daily |
|
| number of opioid refills | number of times subjects asked to have an opioid prescription refilled during post-operative period | post-surgery weeks 1-4 |
| 90 day complications | collection of all post-operative medical complications within the first 90 days after surgery | post-surgery 90 days |
| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D014147 | Tramadol |
| D000082 | Acetaminophen |
| D000077239 | Meloxicam |
| D000077206 | Gabapentin |
| C011301 | metaxalone |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| 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 |
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
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