Opioid Free Management After Ureteroscopy
Primary Purpose
Kidney Stone
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Norco 5milligram-325milligram Tablet
Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Stone focused on measuring Ureteroscopy, Opioid, Non-Opioid, Stent Placement, Nephrolithiasis
Eligibility Criteria
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
Sites / Locations
- Wake Forest University Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Opioid Group
Non-Opioid Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Amount of Pain Medication Used
Number of tablets taken after surgery
Number of Subjects Who Need Additional Pain Medication and/or Refill
Number of Subjects Who Need Additional Pain medication and/or Refill
Secondary Outcome Measures
Urinary Index
Ureteral stent symptom questionnaire Urinary Symptom score ranges from 11 to 56 with a higher score denoting a worse outcome.
Full Information
NCT ID
NCT03872843
First Posted
March 11, 2019
Last Updated
March 10, 2021
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03872843
Brief Title
Opioid Free Management After Ureteroscopy
Official Title
A Prospective Double Blind Randomized Control Trial Comparing Opioid to Non-Opioid Protocol in Managing Postoperative Pain After Ureteroscopy With Stent Placement
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
February 26, 2020 (Actual)
Study Completion Date
February 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone
Keywords
Ureteroscopy, Opioid, Non-Opioid, Stent Placement, Nephrolithiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blinded
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Opioid Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non-Opioid Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Norco 5milligram-325milligram Tablet
Other Intervention Name(s)
Opioid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED
Other Intervention Name(s)
Non-Opioid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Amount of Pain Medication Used
Description
Number of tablets taken after surgery
Time Frame
between baseline through day 7
Title
Number of Subjects Who Need Additional Pain Medication and/or Refill
Description
Number of Subjects Who Need Additional Pain medication and/or Refill
Time Frame
baseline through day 7
Secondary Outcome Measure Information:
Title
Urinary Index
Description
Ureteral stent symptom questionnaire Urinary Symptom score ranges from 11 to 56 with a higher score denoting a worse outcome.
Time Frame
day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Gutierrez-Aceves, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We will not share.
Citations:
PubMed Identifier
731804
Citation
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.
Results Reference
background
PubMed Identifier
27238615
Citation
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.
Results Reference
background
PubMed Identifier
11927301
Citation
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.
Results Reference
background
PubMed Identifier
1895452
Citation
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.
Results Reference
background
PubMed Identifier
17941789
Citation
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.
Results Reference
background
PubMed Identifier
17705753
Citation
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.
Results Reference
background
PubMed Identifier
12576846
Citation
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.
Results Reference
background
PubMed Identifier
29896932
Citation
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.
Results Reference
background
PubMed Identifier
30039709
Citation
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.
Results Reference
background
PubMed Identifier
30244594
Citation
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.
Results Reference
background
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Opioid Free Management After Ureteroscopy
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