Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator

NCT05571072 | Completed

• 1 other identifier: STUDY20221287
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain; Opioid Use; Prolapse Genital

Keywords

post operative pain; opioid use; urogynecologic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in satisfaction scores measured by team-created questionnaire

  1 week post-op, 2 weeks post-op

• Change in number of opioid tablets remaining measured by team-created questionnaire

  1 week post-op, 2 weeks post-op

Study Arms (2)

Standard Opioid Prescription

ACTIVE COMPARATOR

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

Opioid Calculator Prescription

EXPERIMENTAL

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

Other: Opioid calculator

Interventions

Opioid calculator 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.

Opioid Calculator Prescription

Standard opioid prescription OTHER

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

Standard Opioid Prescription

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• David Sheyn: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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.

  PMID: 40570353 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• David Sheyn, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Urology

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 7, 2022
• Study Start: January 2, 2023
• Primary Completion: February 17, 2024
• Study Completion: February 17, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)