Clinical trial NCT03872843: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Stone
Keywords: Ureteroscopy
Opioid
Non-Opioid
Stent Placement
Nephrolithiasis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Amount of Pain Medication Used
timeFrame: between baseline through day 7
measure: Number of Subjects Who Need Additional Pain Medication and/or Refill
timeFrame: baseline through day 7
Secondary outcomes:
measure: Urinary Index
timeFrame: day 7
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jorge Gutierrez-Aceves, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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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.
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.
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.
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.
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.