- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05353478
Reducing Opioid Prescription After Kidney Stone Removal Surgery
April 18, 2024 updated by: Kevin Koo, Mayo Clinic
Reducing Opioids After Percutaneous Stone Surgery
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Katie Barthels
- Phone Number: 507-538-5772
- Email: Barthels.Kathryn@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Subjects undergoing percutaneous nephrolithotomy at Mayo Clinic Rochester.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unused opioid prescriptions
Time Frame: 30 days
|
Number of unused opioids following recovery from percutaneous nephrolithotomy
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unfilled opioid prescriptions
Time Frame: 30 days
|
Number of unfilled opioid prescriptions following recovery from percutaneous nephrolithotomy
|
30 days
|
Opioid prescription refills
Time Frame: 30 days
|
Number of opioid prescription refills following recovery from percutaneous nephrolithotomy
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kevin Koo, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2022
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
April 25, 2022
First Submitted That Met QC Criteria
April 25, 2022
First Posted (Actual)
April 29, 2022
Study Record Updates
Last Update Posted (Actual)
April 22, 2024
Last Update Submitted That Met QC Criteria
April 18, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-000494
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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