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The investigators will evaluate the effect of preoperative education on postoperative opioid.
The investigators propose a randomized trial to be performed at the Cleveland Clinic. Patients will be assigned to: 1) an educational video focused on postoperative analgesia modalities, opioids, and realistic pain expectations (analgesic education); or, 2) an educational video focused on other aspects of the perioperative experience.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Analgesic education | Active Comparator |
| |
| General perioperative education | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video on analgesic education | Other | A four minute video informing the patient about opioids. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Opioid consumption (morphine milligrams equivalent) during the initial 72 hours after surgery. | 72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted Average Pain Scores | Time-weighted average of pain scores obtained from electronic medical records. Pain scores were measured using the numeric rating scale ranging from 0-10, with 0 indicating the lowest pain (better) and 10 the highest pain (worse). Pain scores were recorded approximately every 15 minutes in the post-anesthesia care unit and then every 4 hours in the ward. | 72 hours after surgery, or until discharge, whichever was earlier |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alparslan Turan, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Analgesic Education | Video on analgesic education: A four minute video informing the patient about opioids. |
| FG001 | General Perioperative Education | Video on general perioperative education: A four minute video informing the patient about general perioperative process. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Analgesic Education | Video on analgesic education: A four minute video informing the patient about opioids. |
| BG001 | General Perioperative Education | Video on general perioperative education: A four minute video informing the patient about general perioperative process. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors. |
| 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 | Opioid Consumption | Opioid consumption (morphine milligrams equivalent) during the initial 72 hours after surgery. | Modified intention to treat analysis population | Posted | Median | Inter-Quartile Range | Morphine milligrams equivalent | 72 hours after surgery |
|
72 hours after surgery or until discharge, whichever was earlier.
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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 | Analgesic Education | Video on analgesic education: A four minute video informing the patient about opioids. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alparslan Turan | Cleveland Clinic | 2162172312 | turana@ccf.org |
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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 | Jan 4, 2023 | Jun 7, 2024 | Prot_SAP_000.pdf |
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| 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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| Video on general perioperative education | Other | A four minute video informing the patient about general perioperative process. |
|
| Satisfaction With Post Operative Pain Management | Patient satisfaction measured using Likert scale 0-10 with 0 meaning not satisfied and 10 meaning completely satisfied. | 3 days after surgery |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| History of chronic pain | Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors. | Count of Participants | Participants |
|
| Type of surgery | Excludes patients not analyzed due to surgical cancellations/reschedule, and randomization errors. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Time-weighted Average Pain Scores | Time-weighted average of pain scores obtained from electronic medical records. Pain scores were measured using the numeric rating scale ranging from 0-10, with 0 indicating the lowest pain (better) and 10 the highest pain (worse). Pain scores were recorded approximately every 15 minutes in the post-anesthesia care unit and then every 4 hours in the ward. | Modified intention to treat population | Posted | Median | Inter-Quartile Range | score on a scale | 72 hours after surgery, or until discharge, whichever was earlier |
|
|
|
|
| Secondary | Satisfaction With Post Operative Pain Management | Patient satisfaction measured using Likert scale 0-10 with 0 meaning not satisfied and 10 meaning completely satisfied. | Posted | Median | Inter-Quartile Range | score on a scale | 3 days after surgery |
|
|
|
|
| 0 |
| 483 |
| 0 |
| 483 |
| 181 |
| 483 |
| EG001 | General Perioperative Education | Video on general perioperative education: A four minute video informing the patient about general perioperative process. | 2 | 474 | 0 | 474 | 176 | 474 |
| Nausea and vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Urinary catheterization | Renal and urinary disorders | Non-systematic Assessment |
|
| Anti-emetic use | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |