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| Name | Class |
|---|---|
| Orthopedic Research and Education Foundation | OTHER |
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As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons must revisit pain management protocols to reduce unnecessary opioid prescriptions. The long-term goal is to reduce opioid use and residual opioids in circulation.
As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons must revisit pain management protocols to reduce unnecessary opioid prescriptions. The long-term goal is to reduce opioid use and residual opioids in circulation. The purposes are to 1) conduct a double-blinded randomized controlled trial to determine the effectiveness of opioid versus non-opioid medications on post-surgical pain, and 2) examine predictors of opioid usage in individuals following Anterior Cruciate ligament (ACL) reconstruction. Patients will use an innovative Smartphone application to track pain and medication usage. Additionally, patients will complete quality of life and pain catastrophizing questionnaires, as well as undergo pain threshold testing, to be used in a model to determine predictors of greater post-surgical opioid use. This study will provide information on non-opioid alternatives and specific predictors of post-surgical opioid use that can be used to develop prescribing protocols. These findings will help orthopaedic surgeons make informed decisions when tailoring individualized prescriptions for patients following ACL reconstruction. Importantly, findings will be readily translatable into research to reduce opioid use in other orthopaedic surgical cohorts as well. Our ultimate goal is to lessen the burden of the opioid epidemic on not only our orthopaedic patients, but also society, by minimizing the number of opioids left in circulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone Arm | Experimental | Patients in this opioid group will receive 15 oral opioid tablets (5 mg oxycodone) Patients will also receive 8 "rescue" medications, in the Oxycodone arm will be placebo "rescue" medications. All participants will also receive the following as part of standard of care:
|
|
| Placebo Arm | Placebo Comparator | Patients in placebo group will receive 15 placebo tablets. All patients will also receive 8 "rescue" medications: Patients who randomize to the non-opioid arm will receive 5mg oxycodone "rescue" tablets. All participants will also receive the following as part of standard of care:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug | 5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Level: Numeric Rating Scale | Patients will record pain levels on Numeric Rating Scale 1-10, where 1 is minimal pain and 10 is associated with highest level of pain (worse outcome). | Postoperative days 0-6 |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Threshold Testing | will be conducted with digital pressure dolorimeter (Wagner Force One Model FDIX 50TM, Wagner Instruments). Pressure dolorimeters are devices that measure pressure/pain threshold. The device will be held perpendicular to the areas to be tested. The force will be increased at a constant rate of 1 kg/cm2. Patients will be instructed to express pain either by saying "ouch" or raising their hand when pain is felt. The force read on the digital dolorimeters will be recorded. This procedure will be repeated 3 times. Both right and left sides will be tested. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Xerogeanes, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Emory Clinic | Atlanta | Georgia | 30324 | United States | ||
| Emory clinic at Executive Park |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxycodone Arm | Patients in this opioid group will receive 15 oral opioid tablets (5 mg oxycodone) Patients will also receive 8 "rescue" medications, in the Oxycodone arm will be placebo "rescue" medications. All participants will also receive the following as part of standard of care:
Oxycodone: 5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10 |
| FG001 | Placebo Arm | Patients in placebo group will receive 15 placebo tablets. All patients will also receive 8 "rescue" medications: Patients who randomize to the non-opioid arm will receive 5mg oxycodone "rescue" tablets. All participants will also receive the following as part of standard of care:
Placebo oral tablet: Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxycodone Arm | Patients in this opioid group will receive 15 oral opioid tablets (5 mg oxycodone) Patients will also receive 8 "rescue" medications, in the Oxycodone arm will be placebo "rescue" medications. All participants will also receive the following as part of standard of care:
Oxycodone: 5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Level: Numeric Rating Scale | Patients will record pain levels on Numeric Rating Scale 1-10, where 1 is minimal pain and 10 is associated with highest level of pain (worse outcome). | Number analyzed in one or more rows differs from overall number analyzed depending on the number of patients that were able to provide data about their level of pain. | Posted | Mean | 95% Confidence Interval | score on a scale | Postoperative days 0-6 |
|
Up to 6 weeks post-operatively
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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 | Oxycodone Arm | Patients in this opioid group will receive 15 oral opioid tablets (5 mg oxycodone) Patients will also receive 8 "rescue" medications, in the Oxycodone arm will be placebo "rescue" medications. All participants will also receive the following as part of standard of care:
Oxycodone: 5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Euphoria | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Xerogeanes | Emory University | 404-778-7202 | jxeroge@emory.edu |
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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 4, 2022 | Sep 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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Prospective, double-blind, randomized controlled clinical trial
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Both participants and PI (orthopaedic surgeon) will be blinded. Placebo pills will be closely matched to oxycodone pills, so patients will not know to which group they are allocated. The PI will be blinded to group allocation.
| Placebo oral tablet | Drug | Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets. |
|
| Postoperative days 0-6, 6 weeks post-surgery |
| Change in Pain Catastrophizing Scale (PCS) | It will be determined with the Pain Catastrophizing Scale (PCS). Pain catastrophizing is described as "an exaggerated negative mental set brought to bear during actual or anticipated painful experience." In other words, it is a feeling of helplessness. The PCS is a 13-item questionnaire that inquires about thoughts and feelings a patient experiences when in pain. Responses are recorded on a 5-point Likert scale ("not at all" to "all the time"). A total score is yielded ranging from 0-52. Higher score is associated with worse outcome. | Postoperative days 0-6, 6 weeks post-surgery |
| Change in Quality of Life: Euro Quality of Life Index (Euro QoL 5-D 5-L) EQ-5D | Quality of life will be measured with the instrument Euro Quality of Life Index (Euro QoL 5-D 5-L) EQ-5D is a standardized measure of health status that measures five dimensions, Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression. Each dimension can be rated at five levels: from no problems to major problems. The five dimensions can be summed into a descriptive health state with 11111 representing no problems in any of the five health dimensions and 55555 indicating major problems in any of the five health dimensions. | Postoperative days 0-6, 6 weeks post-surgery |
| Atlanta |
| Georgia |
| 30329 |
| United States |
| Emory Orthopedic and spine Hospital | Tucker | Georgia | 30084 | United States |
| BG001 | Placebo Arm | Patients in placebo group will receive 15 placebo tablets. All patients will also receive 8 "rescue" medications: Patients who randomize to the non-opioid arm will receive 5mg oxycodone "rescue" tablets. All participants will also receive the following as part of standard of care:
Placebo oral tablet: Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
| Smoking status | Count of Participants | Participants |
|
| Current use of alcohol | Count of Participants | Participants |
|
| Currently on treatment for depression | Count of Participants | Participants |
|
| ADHD treatment | Count of Participants | Participants |
|
| Preoperative opioid use | Count of Participants | Participants |
|
| OG001 | Placebo Arm | Patients in placebo group will receive 15 placebo tablets. All patients will also receive 8 "rescue" medications: Patients who randomize to the non-opioid arm will receive 5mg oxycodone "rescue" tablets. All participants will also receive the following as part of standard of care:
Placebo oral tablet: Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets. |
|
|
| Other Pre-specified | Change in Pain Threshold Testing | will be conducted with digital pressure dolorimeter (Wagner Force One Model FDIX 50TM, Wagner Instruments). Pressure dolorimeters are devices that measure pressure/pain threshold. The device will be held perpendicular to the areas to be tested. The force will be increased at a constant rate of 1 kg/cm2. Patients will be instructed to express pain either by saying "ouch" or raising their hand when pain is felt. The force read on the digital dolorimeters will be recorded. This procedure will be repeated 3 times. Both right and left sides will be tested. | Not Posted | Postoperative days 0-6, 6 weeks post-surgery | Participants |
| Other Pre-specified | Change in Pain Catastrophizing Scale (PCS) | It will be determined with the Pain Catastrophizing Scale (PCS). Pain catastrophizing is described as "an exaggerated negative mental set brought to bear during actual or anticipated painful experience." In other words, it is a feeling of helplessness. The PCS is a 13-item questionnaire that inquires about thoughts and feelings a patient experiences when in pain. Responses are recorded on a 5-point Likert scale ("not at all" to "all the time"). A total score is yielded ranging from 0-52. Higher score is associated with worse outcome. | Not Posted | Postoperative days 0-6, 6 weeks post-surgery | Participants |
| Other Pre-specified | Change in Quality of Life: Euro Quality of Life Index (Euro QoL 5-D 5-L) EQ-5D | Quality of life will be measured with the instrument Euro Quality of Life Index (Euro QoL 5-D 5-L) EQ-5D is a standardized measure of health status that measures five dimensions, Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression. Each dimension can be rated at five levels: from no problems to major problems. The five dimensions can be summed into a descriptive health state with 11111 representing no problems in any of the five health dimensions and 55555 indicating major problems in any of the five health dimensions. | Not Posted | Postoperative days 0-6, 6 weeks post-surgery | Participants |
| 0 |
| 49 |
| 0 |
| 49 |
| 15 |
| 49 |
| EG001 | Placebo Arm | Patients in placebo group will receive 15 placebo tablets. All patients will also receive 8 "rescue" medications: Patients who randomize to the non-opioid arm will receive 5mg oxycodone "rescue" tablets. All participants will also receive the following as part of standard of care:
Placebo oral tablet: Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets. | 0 | 49 | 0 | 49 | 8 | 49 |
| Nausea and vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Other | General disorders | Non-systematic Assessment |
|
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| 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 |