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The utilization of arthroscopic surgery to treat meniscus injuries has continued to increase in recent years, partly due to a younger, more active population, and improved technology and technique. However, pain management in the post-operative period is critical to the ability to perform this procedure as an outpatient surgery. Traditionally, oral narcotic agents have been the preferred analgesic postoperatively in orthopaedic surgery. However, these agents are associated with several side effects, including nausea/vomiting, constipation, and somnolence. In addition, opioid agents have a significant potential for abuse in comparison to non-narcotic analgesics. In light of the rising opioid epidemic and nationwide initiatives to limit narcotic usage, surgeons must explore alternate pain modalities in the acute postoperative period. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory properties.1 Multiple prior studies have examined the beneficial effect of oral and intravenous (IV) ketorolac as an analgesic in the postoperative period,1-3 including arthroscopic meniscus surgery. However, the beneficial effects of this agent following arthroscopic meniscus surgery have not been extensively described.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental | Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery |
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| Ketorolac | Experimental | Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Levels Recorded With a Visual Analogue Scale | Patients will record pain levels post-operatively using a visual analogue scale (VAS) ranging from 0 as the minimum value to 100 as the maximum value. A smaller VAS value will be considered a lower pain level. | 2 weeks postoperatively |
| Narcotic Medication Consumed | Number of oxycodone- acetaminophen tablets consumed | up to 5 days postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Karns, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery Oxycodone-Acetaminophen: Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery. |
| FG001 | Ketorolac |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2019 |
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| Oxycodone-Acetaminophen | Drug | Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery. |
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Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery. Ketorolac: Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery Oxycodone-Acetaminophen: Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery. |
| BG001 | Ketorolac | Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery. Ketorolac: Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Levels Recorded With a Visual Analogue Scale | Patients will record pain levels post-operatively using a visual analogue scale (VAS) ranging from 0 as the minimum value to 100 as the maximum value. A smaller VAS value will be considered a lower pain level. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks postoperatively |
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| Primary | Narcotic Medication Consumed | Number of oxycodone- acetaminophen tablets consumed | 9 subjects, including 4 in the control group and 5 in the ketorolac group, failed to report complete data on postoperative number of oxycodone-acetaminophen tablets consumed and were therefore excluded from data analysis. | Posted | Mean | Standard Deviation | tablets | up to 5 days postoperatively |
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6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery Oxycodone-Acetaminophen: Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG001 | Ketorolac | Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery. Ketorolac: Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac. | 0 | 23 | 0 | 23 | 0 | 23 |
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single institution study not blinded
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Karns | University Hospitals Cleveland Medical Center | 216-844-7200 | michael.karns@uhhospitals.org |
| Sep 12, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 25, 2020 | Sep 12, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000070600 | Tibial Meniscus Injuries |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| C514822 | oxycodone-acetaminophen |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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