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Completed

NCT Number: NCT05571072

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.

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Opioid Use Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prolapse Genital Signs and Symptoms

Age range

18 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard opioid prescription

Other

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

Primary outcomes

  1. Change in pain scores measured by team-created pain questionnaires

    Time frame: baseline, 1 week post-op, 2 weeks post-op

    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 outcomes

  1. Change in satisfaction scores measured by team-created questionnaire

    Time frame: 1 week post-op, 2 weeks post-op

    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.

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

    Time frame: 1 week post-op, 2 weeks post-op

    Patients will be asked the number of tablets remaining from their opioid prescriptions.

Sponsors and collaborators

Lead sponsor

David Sheyn

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 7, 2022
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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