Opioid Free Management After Ureteroscopy

Phase 4

Completed

• Conditions: Kidney Stone
• Interventions: Drug: Norco 5milligram-325milligram Tablet; Drug: Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED

• Registration Number: NCT03872843
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-13
• Study Start: 2019-09-19
• Primary Completion: 2020-02-26
• Study Completion: 2020-02-26
• Status Verified: 2021-02
• Results First Submitted: 2021-02-15
• Results First Submitted QC: 2021-03-10
• Last Update Submitted: 2021-03-10
• Results First Posted: 2021-03-11
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Ureteroscopy performed for renal stones
• Age over 18 years
• Two kidneys

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Exclusion Criteria

• Solitary Kidney
• Poor kidney function (GFR<30)
• Allergy to either Ibuprofen or Norco
• Pelvic Kidney

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid Group	Norco 5milligram-325milligram Tablet	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.
Non-Opioid Group	Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED	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.

Primary Outcome Measures

Name	Time	Method
Amount of Pain Medication Used	between baseline through day 7	Number of tablets taken after surgery
Number of Subjects Who Need Additional Pain Medication and/or Refill	baseline through day 7	Number of Subjects Who Need Additional Pain medication and/or Refill

Secondary Outcome Measures

Name	Time	Method
Urinary Index	day 7	Ureteral stent symptom questionnaire Urinary Symptom score ranges from 11 to 56 with a higher score denoting a worse outcome.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States