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Opioid Free Management After Ureteroscopy

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ClinicalTrials.gov Identifier: NCT03872843
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones
Drug Information available for: Ibuprofen

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 Name: 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 Name: Non-Opioid




Primary Outcome Measures :
  1. Amount of pain medication in each arm [ Time Frame: up to 7 days ]
  2. Amount of additional pain medication [ Time Frame: up to 7 days ]
  3. Number of pain medication refills [ Time Frame: up to 7 days ]

Secondary Outcome Measures :
  1. Number of Emergency Department visits for postoperative Genitourinary Symptoms [ Time Frame: up to 7 days ]
  2. Number of Phone Calls to Clinic [ Time Frame: up to 7 days ]
  3. Urinary Index [ Time Frame: up to 7 days ]
    Ureteral stent symptom questionnaire: Urinary Index Score (11-55). Higher scores indicates worse outcomes.

  4. Pain Index [ Time Frame: up to 7 days ]
    Ureteral stent symptom questionnaire: Pain Index Score (6-30) Higher scores indicates worse outcomes.

  5. General Health Index [ Time Frame: up to 7 days ]
    Ureteral stent symptom questionnaire: General Health Index Score (6-30). Higher scores indicates worse outcomes.

  6. Work Performance questionnaire [ Time Frame: up to 7 days ]
    Ureteral stent symptom questionnaire: Work Performance Score (3-15). Higher scores indicates worse outcomes.

  7. Sexual Matters questionnaire [ Time Frame: up to 7 days ]
    Ureteral stent symptom questionnaire:Sexual Matters( 2-10) Higher scores indicates worse outcomes.

  8. Additional Problems with the stent in situ questionnaire [ Time Frame: up to 7 days ]
    Ureteral stent symptom questionnaire: Additional Problems with the stent in situ (4-17) Higher scores indicates worse outcomes.

  9. Global Quality of life with the stent in situ questionnaire [ Time Frame: up to 7 days ]
    Ureteral stent symptom questionnaire: Global Quality of life with the stent in situ (1-7). Higher scores indicates worse outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872843


Contacts
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Contact: Taylor Peak, MD 336-716-5710 tpeak@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest University Health Sciences Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Taylor Peak, MD       tpeak@wakehealth.edu   
Principal Investigator: Jorge Gutierrez-Aceves, MD         
Sub-Investigator: Ilan Klein, MD         
Sub-Investigator: Teresa Biles, MD         
Sub-Investigator: Taylor Peak, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Jorge Gutierrez-Aceves, MD Wake Forest University Health Sciences

Publications:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03872843     History of Changes
Other Study ID Numbers: IRB00056720
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not share.

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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:
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Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Ibuprofen
Analgesics, Opioid
Analgesics, Non-Narcotic
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action