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Reducing Opioid Prescription After Kidney Stone Removal Surgery

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05353478
Collaborator
(none)
100
Enrollment
1
Location
4.9
Anticipated Duration (Months)
20.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to implement and assess a standard way of prescribing opioid pain medication following PCNL (a kidney stone removal surgery) to ensure patients are being discharged with an appropriate quantity of pain management medication.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Participants in this study will have their opioid pain medication prescription at discharge following PCNL (Percutaneous Nephrolithotomy, a kidney stone removal surgery) determined by an algorithm in addition to physician judgement. The goal of the algorithm is help physicians refine pain medication prescribing patterns for patients who have undergone PCNL in order to discharge patients with an appropriate quantity of pain management medication. The effectiveness of the algorithm will be assessed through participant surveys. Participants will complete a brief online survey on Days 3, 7, and 14 following hospital discharge and another phone-based survey 26-30 days after hospital discharge.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Reducing Opioids After Percutaneous Stone Surgery
    Actual Study Start Date :
    Jun 6, 2022
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Nov 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Unused opioid prescriptions [30 days]

      Number of unused opioids following recovery from percutaneous nephrolithotomy

    Secondary Outcome Measures

    1. Unfilled opioid prescriptions [30 days]

      Number of unfilled opioid prescriptions following recovery from percutaneous nephrolithotomy

    2. Opioid prescription refills [30 days]

      Number of opioid prescription refills following recovery from percutaneous nephrolithotomy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergoing percutaneous nephrolithotomy at Mayo Clinic Rochester.
    Exclusion Criteria:

    • Unable or unwilling to provide informed consent.

    • Patients who require Intensive Care Unit admission after surgery.

    • Patients who have Clavien grade III or greater postoperative complications requiring additional intervention < 30 days after index procedure.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Kevin Koo, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Kevin Koo, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05353478
    Other Study ID Numbers:
    • 22-000494
    First Posted:
    Apr 29, 2022
    Last Update Posted:
    Jun 27, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kevin Koo, Principal Investigator, Mayo Clinic
    Percutaneous Nephrolithotomy (PCNL)
    Additional relevant MeSH terms:
    Kidney Calculi
    Nephrolithiasis

    Study Results

    No Results Posted as of Jun 27, 2022