Opioid Free Management After Ureteroscopy

Wake Forest University Health Sciences22 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Kidney Stone

Interventions

Norco 5milligram-325milligram TabletDRUG

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.

Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATEDDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Amount of Pain Medication Used

Number of tablets taken after surgery

Time frame: 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

Time frame: baseline through day 7

Secondary Outcomes

Urinary Index

Ureteral stent symptom questionnaire Urinary Symptom score ranges from 11 to 56 with a higher score denoting a worse outcome.

Time frame: day 7

Data from ClinicalTrials.gov

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