Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator
NCT ID: NCT05571072
Last Updated: 2024-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2023-01-02
2024-02-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard Opioid Prescription
Patients will be given a prescription for opioid pain medication to use for acute postoperative pain as would be typical for the attending surgeon performing the surgery.
Standard opioid prescription
Patients will receive prescription for post-operative opioids based on what the attending surgeon usually provides.
Opioid Calculator Prescription
Patients will be a given a prescription for opioid pain medication based on the opioid calculator.
Opioid calculator
Our research group previously created an Opioid calculator that can be used to predict the number of opioids needed post-operatively based on patient health history and characteristics.
Interventions
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Opioid calculator
Our research group previously created an Opioid calculator that can be used to predict the number of opioids needed post-operatively based on patient health history and characteristics.
Standard opioid prescription
Patients will receive prescription for post-operative opioids based on what the attending surgeon usually provides.
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
* Patients undergoing any of below urogynecologic procedures
Included urogynecologic procedures:
1. Sacrocolpopexy - robotic or laparoscopic
1. With or without hysterectomy
2. With or without salpingo-oophorectomy
3. With or without anterior colporrhaphy
4. With or without posterior colporrhaphy/perineorrhaphy
5. With or without midurethral sling
2. Sacrospinous ligament fixation
1. With or without hysterectomy
2. With or without salpingo-oophorectomy
3. With or without anterior colporrhaphy
4. With or without posterior colporrhaphy/perineorrhaphy
5. With or without midurethral sling
3. Uterosacral ligament suspension - robotic, laparoscopic, or vaginal
1. With or without hysterectomy
2. With or without salpingo-oophorectomy
3. With or without anterior colporrhaphy
4. With or without posterior colporrhaphy/perineorrhaphy
5. With or without midurethral sling
4. Colpocleisis
1. Lefort colpocleisis
2. Complete colpectomy with colpocleisis
5. Isolated anterior and/or posterior colporrhaphy
Exclusion Criteria
* pre-operative diagnosis of cancer
* scheduled for any concurrent non-urogynecologic procedure (ex: abdominoplasty)
* \<18 years or \>89 years of age
* unable to provide informed consent
18 Years
89 Years
FEMALE
No
Sponsors
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David Sheyn
OTHER
Responsible Party
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David Sheyn
Associate Professor of Urology
Principal Investigators
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David Sheyn, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Countries
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References
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Bauer HH, Schlussel MA, Hoffberg EA, Palm KM, Rhodes SP, Wherley SD, Le Neveu M, Sears SB, Rustia GM, Hijaz AK, Mahajan ST, Sammarco AG, Sheyn D. Personalized Prediction of Opioid Demand After Surgery for Pelvic Organ Prolapse: A Randomized Controlled Trial. Obstet Gynecol. 2025 Jun 26;146(2):285-292. doi: 10.1097/AOG.0000000000005969.
Other Identifiers
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STUDY20221287
Identifier Type: -
Identifier Source: org_study_id
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