Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use; Post Operative Pain; Prolapse Genital
• Intervention / Treatment: Other: Standard opioid prescription; Other: Opioid calculator

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: David Sheyn
• Investigators: Principal Investigator: David Sheyn, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Actual): February 17, 2024
• Study Completion (Actual): February 17, 2024

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: post operative pain; opioid use; urogynecologic surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Pain, Postoperative; Prolapse; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: STUDY20221287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No