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We would like to evaluate and optimize opioid prescribing after minimally invasive hysterectomy. Currently, our standard prescribing is 150 oral morphine equivalents. However, recent studies show that half of the opioids prescribed are not used. We would like to include the patient in the decision making of the opioid prescribing.
We have designed a randomized controlled trial to prescribe standard (150 oral morphine equivalents) or patient directed (less than or equal to 150 oral morphine equivalents) for pain control.
We hypothesize that with patient input, there will be a higher utilization of the opioids prescribed. Also, we anticipate a lower number of opioids used overall.
This study will help us optimize opioid prescribe and evaluate whether patient input can help in this important measure.
There is an emphasis in patient centered care in medicine and part of this effort has evaluated the success of shared decision making in the care of the patient. Currently, there is strong research and clinical emphasis trying to determine how, as surgeons, we can assist in minimizing the misuse of opioid medications. Several studies have shown significant over-prescribing and under-utilizing of the pain medications that are prescribed to patients after surgery. One such study by As-Sanie et al showed that about half of medications were utilized for pain after surgery, with typically 200 oral morphine equivalents prescribed.
A recent prospective cohort study by Prabhu et al showed that shared decision making in the prescription of narcotic pain medications after cesarean section decreased opioid use without impacting patient satisfaction.
We propose a randomized controlled trial evaluating the impact of shared decision making in the prescribing of pain medications after minimally invasive gynecologic surgery. For adult female patients who are undergoing minimally invasive hysterectomy, we will randomize them to either standard care or patient directed treatment. Our standard arm will receive 150 oral morphine equivalents, or 30 tablets of oxycodone, whereas our patient directed arm will receive a prescription with as many pills is determined after discussion with the patient.
We hope to contribute to identifying the optimized opioid prescription for post surgical patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. |
|
| Patient Directed Care | Experimental | Subject directed arm will be prescribed the number of opioids that the patient decides to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physician directed opioid prescribing | Drug | Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. |
|
| Measure | Description | Time Frame |
|---|---|---|
| # of Opioid Pills Consumed | Percent utilization of opioids consumed (consumed/prescribed) | 6 weeks postop |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Pills Prescribed | Number of opioids prescribed | preoperative visit |
| Patient Satisfaction | Patients were asked if they were satisfied with the # of oxycodone pills prescribed. |
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Inclusion criteria
Exclusion criteria
Non-English speaking
Combined surgical cases with other surgical departments
Planned laparotomy
Surgery planned to last >4 hours
Postoperative hospitalization planned for >7 days
Planned use of oral opioids other than oxycodone postoperatively
Pre-existing chronic pain conditions including: chronic pelvic pain, migraines, temporomandibular joint dysfunction syndrome, fibromyalgia, and interstitial cystitis
Preoperative diagnosis of pelvic pain
Chronic preoperative opioid use
History of or current diagnosis of narcotic or alcohol dependence
o Screening question asked at preoperative appointment: Have you or are you currently dependent on narcotic medications or alcohol?
Desire for more opioids than standard therapy
Postoperative decision of surgeon to prescribed more than standard therapy
Allergy or contraindication to taking opioids, ibuprofen, or acetaminophen
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| Name | Affiliation | Role |
|---|---|---|
| Johnny Yi | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Ambulatory Gynecologic Surgery Clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. Physician directed opioid prescribing: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. |
| FG001 | Patient Directed Care | Subject directed arm will be prescribed the number of opioids that the patient decides based on shared decision making model to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care. Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. Physician directed opioid prescribing: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | # of Opioid Pills Consumed | Percent utilization of opioids consumed (consumed/prescribed) | Posted | Mean | Standard Error | % oxycodone used | 6 weeks postop |
|
Patients were followed up to 6 weeks postoperative visit.
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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 | Standard of Care | Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. Physician directed opioid prescribing: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator, Dr Johnny Yi | Mayo Clinic Arizona | 14803420612 | yi.johnny@mayo.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 | Oct 29, 2018 | Jan 29, 2021 | Prot_SAP_000.pdf |
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| Patient directed opioid prescribing | Drug | Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care. |
|
| 6 weeks post-operative |
| BG001 |
| Patient Directed Care |
Subject directed arm will be prescribed the number of opioids that the patient decides based on a shared decision making model to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care. Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Median | Inter-Quartile Range | kg/m2 |
|
|
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| Secondary | Opioid Pills Prescribed | Number of opioids prescribed | Posted | Median | Inter-Quartile Range | pills | preoperative visit |
|
|
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| Secondary | Patient Satisfaction | Patients were asked if they were satisfied with the # of oxycodone pills prescribed. | Posted | Count of Participants | Participants | 6 weeks post-operative |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Patient Directed Care | Subject directed arm will be prescribed the number of opioids that the patient decides based on shared decision making model to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care. Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care. | 0 | 33 | 0 | 33 | 0 | 33 |
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