Opioid Free Management After Ureteroscopy

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT03872843
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.3
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Stone	Drug: Norco 5milligram-325milligram Tablet; Drug: Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Double-blinded
• Primary Purpose: Treatment
• Official Title: A Prospective Double Blind Randomized Control Trial Comparing Opioid to Non-Opioid Protocol in Managing Postoperative Pain After Ureteroscopy With Stent Placement
• Actual Study Start Date: Sep 19, 2019
• Actual Primary Completion Date: Feb 26, 2020
• Actual Study Completion Date: Feb 26, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Amount of Pain Medication Used [between baseline through day 7]

   Number of tablets taken after surgery

2. 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

1. Urinary Index [day 7]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

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

Study Documents (Full-Text)

• Informed Consent Form - Apr 29, 2020
• Study Protocol and Statistical Analysis Plan - Sep 9, 2019

More Information

Publications

• 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.
• 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.
• 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.
• Finney RP. Experience with new double J ureteral catheter stent. J Urol. 1978 Dec;120(6):678-81.
• 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.
• 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.
• 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.
• 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.
• 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. Review.
• 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. Review.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT03872843
• Other Study ID Numbers: IRB00056720
• First Posted: Mar 13, 2019
• Last Update Posted: Mar 11, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Wake Forest University Health Sciences: Ureteroscopy; Opioid; Non-Opioid; Stent Placement; Nephrolithiasis
• Additional relevant MeSH terms: Kidney Calculi; Ibuprofen

Study Results

Participant Flow

Arm/Group Title	Opioid Group	Non-Opioid Group
Arm/Group 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. 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.	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. 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.
Period Title: Overall Study
STARTED	12	10
COMPLETED	7	3
NOT COMPLETED	5	7

Baseline Characteristics

Arm/Group Title	Opioid Group	Non-Opioid Group	Total
Arm/Group 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. 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.	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. 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.	Total of all reporting groups
Overall Participants	7	3	10
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	57	53	56
Sex: Female, Male (Count of Participants)
Female	2 28.6%	1 33.3%	3 30%
Male	5 71.4%	2 66.7%	7 70%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	7 100%	3 100%	10 100%

Outcome Measures

1. Primary Outcome

Title	Amount of Pain Medication Used
Description	Number of tablets taken after surgery
Time Frame	between baseline through day 7

Outcome Measure Data

Analysis Population Description

12 subjects out of total 22 enrolled were lost to follow up

Arm/Group Title	Opioid Group	Non-Opioid Group
Arm/Group 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. 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.	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. 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.
Measure Participants	7	3
Mean (Full Range) [tablets]	7.3	6.67

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

12 subjects out of total 22 enrolled were lost to follow up

Arm/Group Title	Opioid Group	Non-Opioid Group
Arm/Group 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. 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.	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. 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.
Measure Participants	7	3
Count of Participants [Participants]	0 0%	0 0%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

12 subjects out of total 22 enrolled were lost to follow up

Arm/Group Title	Opioid Group	Non-Opioid Group
Arm/Group 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. 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.	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. 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.
Measure Participants	7	3
Mean (Full Range) [score on a scale]	29.2	22.3

Adverse Events

Time Frame	baseline through month 6
Arm/Group Title	Opioid Group		Non-Opioid Group
Arm/Group 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. 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.		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. 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.
All Cause Mortality
	Opioid Group		Non-Opioid Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/3 (0%)
Serious Adverse Events
	Opioid Group		Non-Opioid Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Opioid Group		Non-Opioid Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.