Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator

NCT ID: NCT05571072

Last Updated: 2024-06-21

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-02

Study Completion Date

2024-02-17

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.

Detailed Description

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Conditions

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Post Operative Pain Opioid Use Prolapse Genital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Group Type ACTIVE_COMPARATOR

Standard opioid prescription

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Opioid calculator

Intervention Type OTHER

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.

Intervention Type OTHER

Standard opioid prescription

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

Intervention Type OTHER

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:

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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David Sheyn

OTHER

Sponsor Role lead

Responsible Party

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David Sheyn

Associate Professor of Urology

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 40570353 (View on PubMed)

Other Identifiers

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STUDY20221287

Identifier Type: -

Identifier Source: org_study_id

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