Opioid Free Management After Ureteroscopy

March 10, 2021 updated by: Wake Forest University Health Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Opioid Group
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
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.
Other Names:
  • Opioid
ACTIVE_COMPARATOR: Non-Opioid Group
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
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.
Other Names:
  • Non-Opioid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of Pain Medication Used
Time Frame: between baseline through day 7
Number of tablets taken after surgery
between baseline through day 7
Number of Subjects Who Need Additional Pain Medication and/or Refill
Time Frame: baseline through day 7
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
Time Frame: day 7
Ureteral stent symptom questionnaire Urinary Symptom score ranges from 11 to 56 with a higher score denoting a worse outcome.
day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Jorge Gutierrez-Aceves, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 19, 2019

Primary Completion (ACTUAL)

February 26, 2020

Study Completion (ACTUAL)

February 26, 2020

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (ACTUAL)

March 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00056720

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will not share.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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