Kidney Stone
Conditions
Keywords
Ureteroscopy, Opioid, Non-Opioid, Stent Placement, Nephrolithiasis
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.
Interventions
DRUGNorco 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.
DRUGIbuprofen 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Pain Medication Used | between baseline through day 7 | Number of tablets taken after surgery |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Urinary Index | day 7 | Ureteral stent symptom questionnaire Urinary Symptom score ranges from 11 to 56 with a higher score denoting a worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 7 |
| 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.
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. | 3 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 7 |
Baseline characteristics
| Characteristic | Non-Opioid Group | Total | Opioid Group |
|---|---|---|---|
| Age, Continuous | 53 years | 56 years | 57 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 3 participants | 10 participants | 7 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 3 |
| other Total, other adverse events | 0 / 7 | 0 / 3 |
| serious Total, serious adverse events | 0 / 7 | 0 / 3 |
Outcome results
Primary
Amount of Pain Medication Used
Number of tablets taken after surgery
Time frame: between baseline through day 7
Population: 12 subjects out of total 22 enrolled were lost to follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Opioid Group | Amount of Pain Medication Used | 7.3 tablets |
| Non-Opioid Group | Amount of Pain Medication Used | 6.67 tablets |
Primary
Number of Subjects Who Need Additional Pain Medication and/or Refill
Number of Subjects Who Need Additional Pain medication and/or Refill
Time frame: baseline through day 7
Population: 12 subjects out of total 22 enrolled were lost to follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Opioid Group | Number of Subjects Who Need Additional Pain Medication and/or Refill | 0 Participants |
| Non-Opioid Group | Number of Subjects Who Need Additional Pain Medication and/or Refill | 0 Participants |
Secondary
Urinary Index
Ureteral stent symptom questionnaire Urinary Symptom score ranges from 11 to 56 with a higher score denoting a worse outcome.
Time frame: day 7
Population: 12 subjects out of total 22 enrolled were lost to follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Opioid Group | Urinary Index | 29.2 score on a scale |
| Non-Opioid Group | Urinary Index | 22.3 score on a scale |