Opioid Free Management After Ureteroscopy

Study Overview
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Brief Summary
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The purpose of this research study is to compare how well two medications work to control post-operative pain.

Detailed Description
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This will be a randomized double blinded control trial with subjects randomized to either opioid group (Norco 5-325 milligram) or a non-opioid group (Ibuprofen 400 milligram). Subjects with a renal stones who are consented for a ureteroscopy will be eligible for the study. Subjects eligible for the study will have a discussion with the study team member about treatment options. Subjects can either elect not to be in the study and actively choose which treatment is preferable, or the subject can choose to enter the study and be randomized to one of these treatment arms. The ureteroscopy will be performed using standard of care instruments and techniques. No changes to operative technique will be performed for subjects in the study vs regular patients undergoing the same procedure. Post operatively; investigators plan to discharge all subjects home from the recovery unit. All subjects will be seen one week after surgery for follow up, questioner filling and stent removal.

Official Title
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A Prospective Double Blind Randomized Control Trial Comparing Opioid to Non-Opioid Protocol in Managing Postoperative Pain After Ureteroscopy With Stent Placement

Conditions
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Kidney Stone

Intervention / Treatment
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* Drug: Norco 5milligram-325milligram Tablet
* Drug: Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ureteroscopy performed for renal stones Age over 18 years Two kidneys Exclusion Criteria: Solitary Kidney Poor kidney function (GFR<30) Allergy to either Ibuprofen or Norco Pelvic Kidney

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Opioid Group<br>This group includes subjects with renal stones who are consented for a ureteroscopy. They will be randomized to Norco 5milligram-325milligram Tablet for postoperative pain after ureteroscopy with stent placement. | Drug: Norco 5milligram-325milligram Tablet<br>* Designated coated 7 days supply of pain medication (Norco 5 milligram-325milligram Tablet) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times per day until the stent will be removed in clinic a week later.<br>* Other names: Opioid;|
| Active Comparator: Non-Opioid Group<br>This group includes subjects with renal stones who are consented for a ureteroscopy. They will be randomized to Ibuprofen 400 milligram for postoperative pain after ureteroscopy with stent placement. | Drug: Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED<br>* Designated coated 7 days supply of pain medication (Ibuprofen 400 milligram) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times a day as needed until the stent will be removed in clinic a week later.<br>* Other names: Non-Opioid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Pain Medication Used | Number of tablets taken after surgery | between baseline through day 7 | 
| Number of Subjects Who Need Additional Pain Medication and/or Refill | Number of Subjects Who Need Additional Pain medication and/or Refill | baseline through day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Index | Ureteral stent symptom questionnaire Urinary Symptom score ranges from 11 to 56 with a higher score denoting a worse outcome. | day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ureteroscopy, Opioid, Non-Opioid, Stent Placement, Nephrolithiasis