search
Back to results

Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator

Primary Purpose

Post Operative Pain, Opioid Use, Prolapse Genital

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opioid calculator
Standard opioid prescription
Sponsored by
David Sheyn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring post operative pain, opioid use, urogynecologic surgery

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Cleveland Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Opioid Prescription

Opioid Calculator Prescription

Arm Description

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.

Patients will be a given a prescription for opioid pain medication based on the opioid calculator.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 4, 2022
Last Updated
January 16, 2023
Sponsor
David Sheyn
search

1. Study Identification

Unique Protocol Identification Number
NCT05571072
Brief Title
Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator
Official Title
Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Sheyn

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Opioid Use, Prolapse Genital
Keywords
post operative pain, opioid use, urogynecologic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Opioid Prescription
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Opioid Calculator Prescription
Arm Type
Experimental
Arm Description
Patients will be a given a prescription for opioid pain medication based on the opioid calculator.
Intervention Type
Other
Intervention Name(s)
Opioid calculator
Intervention Description
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
Intervention Name(s)
Standard opioid prescription
Intervention Description
Patients will receive prescription for post-operative opioids based on what the attending surgeon usually provides.
Primary Outcome Measure Information:
Title
Change in pain scores measured by team-created pain questionnaires
Description
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.
Time Frame
baseline, 1 week post-op, 2 weeks post-op
Secondary Outcome Measure Information:
Title
Change in satisfaction scores measured by team-created questionnaire
Description
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.
Time Frame
1 week post-op, 2 weeks post-op
Title
Change in number of opioid tablets remaining measured by team-created questionnaire
Description
Patients will be asked the number of tablets remaining from their opioid prescriptions.
Time Frame
1 week post-op, 2 weeks post-op

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hope Bauer, MD
Phone
989-464-2537
Email
hope.bauer@uhhospitals.org
First Name & Middle Initial & Last Name or Official Title & Degree
David Sheyn, MD
Email
david.sheyn@uhhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Sheyn, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Sheyn, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator

We'll reach out to this number within 24 hrs