Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator

Study Overview
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Brief Summary
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The purpose of this study is to determine if the investigators can precisely predict how much pain medication the subjects will need after surgery using a special calculator that was developed for this purpose.

Official Title
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Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator

Conditions
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Post Operative Pain, Opioid Use, Prolapse Genital

Intervention / Treatment
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* Other: Opioid calculator
* Other: Standard opioid prescription


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-89 Able to provide informed consent Patients undergoing any of below urogynecologic procedures Included urogynecologic procedures: Sacrocolpopexy - robotic or laparoscopic With or without hysterectomy With or without salpingo-oophorectomy With or without anterior colporrhaphy With or without posterior colporrhaphy/perineorrhaphy With or without midurethral sling Sacrospinous ligament fixation With or without hysterectomy With or without salpingo-oophorectomy With or without anterior colporrhaphy With or without posterior colporrhaphy/perineorrhaphy With or without midurethral sling Uterosacral ligament suspension - robotic, laparoscopic, or vaginal With or without hysterectomy With or without salpingo-oophorectomy With or without anterior colporrhaphy With or without posterior colporrhaphy/perineorrhaphy With or without midurethral sling Colpocleisis Lefort colpocleisis Complete colpectomy with colpocleisis Isolated anterior and/or posterior colporrhaphy Exclusion Criteria: Non-English speakers 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Opioid Prescription<br>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. | Other: Standard opioid prescription<br>* Patients will receive prescription for post-operative opioids based on what the attending surgeon usually provides.<br>|
| Experimental: Opioid Calculator Prescription<br>Patients will be a given a prescription for opioid pain medication based on the opioid calculator. | Other: Opioid calculator<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain scores measured by team-created pain questionnaires | Pain questionnaire is a 2 question survey that ask patients to rate pain on scale of 0 (no pain) to 10 (worst pain) immediately post-op and current. Baseline will be calculated by asking patient's expected post-op pain score. | baseline, 1 week post-op, 2 weeks post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in satisfaction scores measured by team-created questionnaire | Questionnaire is a 1 question survey that ask patients to rate their satisfaction with their pain control on scale of 0 (totally unsatisfied) to 10 (totally satisfied) immediately post-op and current. | 1 week post-op, 2 weeks post-op | 
| Change in number of opioid tablets remaining measured by team-created questionnaire | Patients will be asked the number of tablets remaining from their opioid prescriptions. | 1 week post-op, 2 weeks post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post operative pain, opioid use, urogynecologic surgery