NCT05353478

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jun 2022Aug 2026

First Submitted

Initial submission to the registry

April 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 6, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

2.2 years

First QC Date

April 25, 2022

Last Update Submit

August 5, 2025

Conditions

Kidney Stone

Keywords

Percutaneous Nephrolithotomy (PCNL)

Outcome Measures

Primary Outcomes (1)

  • Unused opioid prescriptions

    Number of unused opioids following recovery from percutaneous nephrolithotomy

    30 days

Secondary Outcomes (2)

  • Unfilled opioid prescriptions

    30 days

  • Opioid prescription refills

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects undergoing percutaneous nephrolithotomy at Mayo Clinic Rochester.

You may qualify if:

  • \- Patients undergoing percutaneous nephrolithotomy at Mayo Clinic Rochester.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Kevin Koo, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2022

First Posted

April 29, 2022

Study Start

June 6, 2022

Primary Completion

August 14, 2024

Study Completion (Estimated)

August 1, 2026

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)