Kidney StoneNCT05353478
Reducing Opioid Prescription After Kidney Stone Removal Surgery
An observational study of Kidney Stone, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2022to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects undergoing percutaneous nephrolithotomy at Mayo Clinic Rochester.
Who may be able to join
- Patients undergoing percutaneous nephrolithotomy at Mayo Clinic Rochester.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Stone
- Keywords
- Percutaneous Nephrolithotomy (PCNL)
- Medical subject headings
- Kidney Calculi
What is being measured
The primary outcome is the main question the study is designed to answer.
Unused opioid prescriptions
Number of unused opioids following recovery from percutaneous nephrolithotomy
Measured: 30 days
Secondary outcomes (2)
Unfilled opioid prescriptions
Number of unfilled opioid prescriptions following recovery from percutaneous nephrolithotomy
Measured: 30 days
Opioid prescription refills
Number of opioid prescription refills following recovery from percutaneous nephrolithotomy
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start6 Jun 2022
- Primary completion14 Aug 2024
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Koo, Mayo Clinic
- Investigators
- Kevin Koo, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353478
- Sponsor's protocol ID
- 22-000494
- Status last verified
- Sep 2026
- First submitted
- 25 Apr 2022
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Opioids After Percutaneous Stone Surgery
- ClinicalTrials.gov ID
- NCT05353478
- Acronym / sponsor ID
- 22-000494
- Conditions
- Kidney Stone
- Keywords
- Percutaneous Nephrolithotomy (PCNL)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing percutaneous nephrolithotomy at Mayo Clinic Rochester.
Key inclusion criteria (1 listed)
- Patients undergoing percutaneous nephrolithotomy at Mayo Clinic Rochester.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Unused opioid prescriptions
Time frame: 30 days
Number of unused opioids following recovery from percutaneous nephrolithotomy
2 secondary outcomes
Unfilled opioid prescriptions
Time frame: 30 days
Opioid prescription refills
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Koo, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stone, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unused opioid prescriptions (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.