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AzTrials

Kidney StonePhase 4NCT03872843

Opioid Free Management After Ureteroscopy

A Phase 4 study testing Norco 5milligram-325milligram Tablet and Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED in people with Kidney Stone, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Stone
What is being tested?
Norco 5milligram-325milligram Tablet and Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
19 Sep 2019to 26 Feb 2020
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Kidney Stone
Being tested
Norco 5milligram-325milligram Tablet, Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED
Keywords
Ureteroscopy, Opioid, Non-Opioid, Stent Placement, Nephrolithiasis
Medical subject headings
Kidney Calculi, Nephrolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Norco 5milligram-325milligram TabletDrug

    Also called Opioid

    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

    Also called Non-Opioid

    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.

Study groups in NCT03872843
Study groupRoleWhat they receive
Opioid GroupActive comparatorThis 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.
Receives: Drug: Norco 5milligram-325milligram Tablet
Non-Opioid GroupActive comparatorThis 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.
Receives: Drug: Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of Pain Medication Used

    Number of tablets taken after surgery

    Measured: between baseline through day 7

  2. Number of Subjects Who Need Additional Pain Medication and/or Refill

    Number of Subjects Who Need Additional Pain medication and/or Refill

    Measured: baseline through day 7

Secondary outcomes (1)

  1. Urinary Index

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

    Measured: day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2019
  2. Study start19 Sep 2019
  3. Primary completion26 Feb 2020
  4. Study completion26 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03872843
Sponsor's protocol ID
IRB00056720
Status last verified
Feb 2021
First submitted
11 Mar 2019
Last updated
11 Mar 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: We will not share.

Publications

  • Finney RP. Experience with new double J ureteral catheter stent. J Urol. 1978 Dec;120(6):678-81. doi: 10.1016/s0022-5347(17)57326-7.

    PubMed 731804

  • Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART II. J Urol. 2016 Oct;196(4):1161-9. doi: 10.1016/j.juro.2016.05.091. Epub 2016 May 27.

    PubMed 27238615

  • Joshi HB, Okeke A, Newns N, Keeley FX Jr, Timoney AG. Characterization of urinary symptoms in patients with ureteral stents. Urology. 2002 Apr;59(4):511-6. doi: 10.1016/s0090-4295(01)01644-2.

    PubMed 11927301

  • Mosli HA, Farsi HM, al-Zimaity MF, Saleh TR, al-Zamzami MM. Vesicoureteral reflux in patients with double pigtail stents. J Urol. 1991 Oct;146(4):966-9. doi: 10.1016/s0022-5347(17)37976-4.

    PubMed 1895452

  • Chew BH, Knudsen BE, Nott L, Pautler SE, Razvi H, Amann J, Denstedt JD. Pilot study of ureteral movement in stented patients: first step in understanding dynamic ureteral anatomy to improve stent comfort. J Endourol. 2007 Sep;21(9):1069-75. doi: 10.1089/end.2006.0252.

    PubMed 17941789

  • Al-Kandari AM, Al-Shaiji TF, Shaaban H, Ibrahim HM, Elshebiny YH, Shokeir AA. Effects of proximal and distal ends of double-J ureteral stent position on postprocedural symptoms and quality of life: a randomized clinical trial. J Endourol. 2007 Jul;21(7):698-702. doi: 10.1089/end.2007.9949.

    PubMed 17705753

  • Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003 Mar;169(3):1060-4. doi: 10.1097/01.ju.0000049198.53424.1d.

    PubMed 12576846

  • Theisen K, Jacobs B, Macleod L, Davies B. The United States opioid epidemic: a review of the surgeon's contribution to it and health policy initiatives. BJU Int. 2018 Nov;122(5):754-759. doi: 10.1111/bju.14446. Epub 2018 Jul 26.

    PubMed 29896932

  • Large T, Heiman J, Ross A, Anderson B, Krambeck A. Initial Experience with Narcotic-Free Ureteroscopy: A Feasibility Analysis. J Endourol. 2018 Oct;32(10):907-911. doi: 10.1089/end.2018.0459. Epub 2018 Sep 12.

    PubMed 30039709

  • Sobel DW, Cisu T, Barclay T, Pham A, Callas P, Sternberg K. A Retrospective Review Demonstrating the Feasibility of Discharging Patients Without Opioids After Ureteroscopy and Ureteral Stent Placement. J Endourol. 2018 Nov;32(11):1044-1049. doi: 10.1089/end.2018.0539. Epub 2018 Oct 23.

    PubMed 30244594

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Norco 5milligram-325milligram Tablet and Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED in people with Kidney Stone, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of Pain Medication Used (time frame: between baseline through day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03872843, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.

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