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In the midst of the opioid crisis, the use of non-narcotic pain medication has garnered increased interest, particularly in the field of orthopaedic surgery, where narcotic medications are routinely prescribed postoperatively. Nonsteroidal anti-inflammatory drugs (NSAIDs) have the potential to serve as an adjunct analgesic, but many orthopaedic surgeons have viewed NSAIDs with hesitancy because of evidence that they can lead to delayed bone healing.
When evaluating bone healing across different NSAID formulas, ketorolac was found to cause no delay and lead to better union rates when compared to controls and other NSAIDs, respectively. Previous studies in the orthopaedic spine and trauma literature have suggested a detrimental effect of NSAIDs, specifically ketorolac, with regards to bone healing, while others have reported no delay in healing. A recent study from our institution found no detrimental effects on the healing of ankle fractures with the use of ketorolac in the immediate postoperative period. Additionally, the use of ketorolac was associated with less reliance on narcotic pain medications.
The purpose of this prospective randomized study is to evaluate the use of ketorolac on postoperative pain, opioid requirements, patient satisfaction, complication/reoperation rates, and delayed and/or nonunion rates in patients undergoing fusion of their first metatarsophalangeal joint (1st MTPJ) for treatment of end-stage arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac administration | Active Comparator | Participants who have surgery for great toe (1st metatarsophalangeal joint) fusion will receive 30 mg of IV ketorolac during surgery as well as 20 mg ketorolac pills to take after surgery for pain |
|
| No Ketorolac administration | Active Comparator | Participants who have surgery for great toe (1st metatarsophalangeal joint) fusion will receive the standard treatment of 30 tablets of oxycodone-acetaminophen to take as needed for pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| great toe (1st metatarsophalangeal joint) fusion | Procedure | Great Toe joint fusion surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | Participants will be asked to complete the Visual Analog Scale for Pain Survey to measure postoperative pain | 7 days |
| Satisfaction with pain management | This will be measured using the 6-point Likert scale (very dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, very satisfied) | 7 days |
| Participant Perception of Pain | This will be measured using a 5-point Likert scale (never, almost never, often, almost always, always) | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothman Orthopaedic Institute | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D000844 | Ankylosis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D050939 | Gene Fusion |
| D020910 | Ketorolac |
| C514822 | oxycodone-acetaminophen |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D011995 | Recombination, Genetic |
| D055614 | Genetic Phenomena |
| D007213 | Indomethacin |
| D007211 | Indoles |
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Patients will be blinded at enrollment and first made aware to which intervention they were randomized when receiving their postoperative pain medication at outside pharmacies
| IV Ketorolac | Drug | Participants will receive 30mg of intravenous (IV) ketorolac will be given during surgery |
|
| Ketorolac Pill | Drug | Participants will receive 20 tablets of 10mg ketorolac, with instructions to take 1 tablet orally every 6 hours for pain |
|
| 5/325mg Oxycodone-Acetaminophen | Drug | Participants will receive 30 tablets of 5/325mg oxycodone-acetaminophen with instructions to take 1 or 2 tablets by mouth every 4 to 6 hours as needed for pain |
|
| Aspirin 81Mg Ec Tab | Drug | Participants will receive 81 mg aspirin twice daily as a preventive measure against deep venous thrombosis (DVT) |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |