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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05353478
Other study ID # 22-000494
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 6, 2022
Est. completion date July 2024

Study information

Verified date April 2024
Source Mayo Clinic
Contact Katie Barthels
Phone 507-538-5772
Email Barthels.Kathryn@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mayo Clinic Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Unused opioid prescriptions Number of unused opioids following recovery from percutaneous nephrolithotomy 30 days
Secondary Unfilled opioid prescriptions Number of unfilled opioid prescriptions following recovery from percutaneous nephrolithotomy 30 days
Secondary Opioid prescription refills Number of opioid prescription refills following recovery from percutaneous nephrolithotomy 30 days
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