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Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator

Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05571072
Enrollment
110
Registered
2022-10-07
Start date
2023-01-02
Completion date
2024-02-17
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use, Post Operative Pain, Prolapse Genital

Keywords

post operative pain, opioid use, urogynecologic surgery

Brief summary

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.

Interventions

OTHEROpioid 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.

Patients will receive prescription for post-operative opioids based on what the attending surgeon usually provides.

Sponsors

David Sheyn
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
No

Inclusion criteria

* Age 18-89 * 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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in pain scores measured by team-created pain questionnairesbaseline, 1 week post-op, 2 weeks post-opPain 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.

Secondary

MeasureTime frameDescription
Change in satisfaction scores measured by team-created questionnaire1 week post-op, 2 weeks post-opQuestionnaire 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.
Change in number of opioid tablets remaining measured by team-created questionnaire1 week post-op, 2 weeks post-opPatients will be asked the number of tablets remaining from their opioid prescriptions.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026