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The purpose of this study is to compare opioid prescribing practices by either routine provider prescribing practices, or with the use of a calculator, i.e., the Opioid Calculator, published by the University of Michigan (www.opioidcalculator.org), with the intent of decreasing the number of pills.
The intent of this study is to validate the use of the Opioid Calculator, published at University of Michigan (www.opioidcalculator.org), which takes several variables into account, including age, risk factors (history of depression, alcohol abuse, others) to determine in a more scientific way the number of pills sufficient to prescribe. The sample size was determined by the number of routine post-op laparoscopic patients seen in our practice. The estimated necessary sample size is 6 participants per group (12 total). Patients will be randomized using 3 block groups of size 4 each. Patients will be approached at in clinic at the time they are consenting to laparoscopic hysterectomy and will be counseled about postoperative pain medication management. Randomization to either standard practice or calculator will be performed using computer-generated, permuted blocks of 4 participants. Sealed randomization envelopes will be opened for each subject on the day of surgery, after anesthesia is initiated. The study will be singled-blinded to the participant. Patients will be contacted on day 2 and day 7 to inquire where they are on the Visual Analog Scale (VAS) and how many pills they have taken. Two weeks after surgery patients will be seen in office for VAS and requested to bring unused pills for accounting purposes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 Doses | Experimental | Participants will receive 5 doses of prescription opioids following surgery. |
|
| 16 Doses | Active Comparator | Participants will receive 16 doses of prescription opioids following surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5x Oxycodone Oral Tablets | Other | Participants will be prescribed 5 doses of 5mg tablets of oxycodone for postoperative pain relief. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of pills used | All participants will be contacted on postoperative days 2 and 7 to inquire how many pills they have taken | Within 1 week following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | All participants will be contacted on postoperative days 2 and 7, and at their two-week follow-up visit to inquire where their pain level is on the Visual Analog Scale (VAS). This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain. | Within 2 weeks following surgery |
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Inclusion Criteria:
Exclusion Criteria:
Women who are biologically female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Health Science Center | Recruiting | Memphis | Tennessee | 38103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36716511 | Background | Straubhar AM, Stroup C, de Bear O, Dalton L, Rolston A, McCool K, Reynolds RK, McLean K, Siedel JH, Uppal S. Provider compliance with a tailored opioid prescribing calculator in gynecologic surgery. Gynecol Oncol. 2023 Mar;170:229-233. doi: 10.1016/j.ygyno.2023.01.018. Epub 2023 Jan 28. | |
| 30837064 | Background |
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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 | Jul 25, 2024 | Jul 25, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 12, 2024 | Jul 15, 2024 | ICF_001.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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| 16x Oxycodone Oral Tablets | Other | Participants will be prescribed 16 doses of 5mg tablets of oxycodone for postoperative pain relief. |
|
| Wong M, Vogell A, Wright K, Isaacson K, Loring M, Morris S. Opioid use after laparoscopic hysterectomy: prescriptions, patient use, and a predictive calculator. Am J Obstet Gynecol. 2019 Mar;220(3):259.e1-259.e11. doi: 10.1016/j.ajog.2018.10.022. Epub 2018 Oct 25. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |