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Total knee arthroplasty (TKA) is one the most common surgical treatments performed for end stage degenerative arthritis of the knee. More than 700,000 procedures are currently performed yearly in the United States. This procedure usually results in moderate-to-severe pain in the immediate post-operative period. Optimal pain control may allow early mobilization, accelerate rehabilitation, improve patient satisfaction, decrease length-of-stay, and optimize functional outcomes. The challenge, however, is to manage pain with alternative methods, reducing the role of opiate medications, which are highly addictive with myriad side effects.
In this prospective randomized double-blinded controlled study, the investigators aim to evaluate the benefits of an over-the-counter (OTC) transdermal CBD preparation in patients undergoing primary total knee arthroplasty as a novel adjunct to the standard multi-modal analgesic regimen, to reduce postoperative pain and reduce the need for opiates after total knee arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: (CBD + MO cohort) | Active Comparator | Roll on stick containing CBD and mineral oils (CBD + MO cohort) |
|
| Group 2: (MO cohort) | Active Comparator | Roll on stick containing mineral oils only (MO cohort) |
|
| Group 3: (CBD Cohort) | Active Comparator | Roll on stick containing CBD only (CBD cohort) |
|
| Group 4: (Roll-on stick only with NO CBD or MO-placebo cohort) | Placebo Comparator | Roll on stick with neither CBD nor essential oils (Roll-on stick only with NO CBD or MO-placebo cohort) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBD | Drug | CBD oil Roll-On Stick |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative change in pain and change the need for opiates after total knee arthroplasty. | opioid consumption after surgery will be calculated in morphine equivalents | 14 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 |
|---|---|
| D018771 | Arthralgia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D008899 | Mineral Oil |
| ID | Term |
|---|---|
| D010577 | Petrolatum |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Mineral Oil |
| Drug |
Mineral Oil- Roll on Stick |
|
| Placebo | Drug | Roll- On stick with no CBD and no Mineral Oil |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |