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This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an orthopaedic injury requiring surgery. Patients who consent to study participation will be randomized to receive either the multimodal pain management protocol or standard oral hydrocodone-acetaminophen for post-operative pain management. Data on opioid usage, pain control, and functional status will be collected for each participant. After 3 years of data collection, investigators will analyze this data to provide further insight in determining appropriateness of pain regimens that reduce the overall opioid consumption. Given the widespread opioid epidemic, it is imperative to develop alternative means to appropriately manage pain in orthopaedic surgery patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard oral hydrocodone-acetaminophen post-op management | No Intervention | ||
| Multimodal pain post-op management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal Pain Management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine) | Drug | Multimodal Pain Management to minimize patients' reliance on opioids. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine equivalents used | Morphine equivalents used over 1 year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score (0-10, 0=no pain, 10=most severe pain) | 1 year | |
| Number of Complications | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Polytrauma
Any not medically managed severe systemic disease
Their doctor has decided that it is in the patient's best interest to receive pain management regimen of one type vs. the other.
The patient prefers one type of pain management protocol and is not willing to be randomized.
Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment or confound pain control
Pregnancy or women planning to conceive within the subject participation period (1 year)
o Pregnancy will be self-reported and no test will be performed to test for it.
Prisoner
Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | San Diego | California | 92093 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 5, 2026 | Feb 23, 2026 | 4 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |