Trial Outcomes & Findings for Opioid Free Management After Ureteroscopy (NCT NCT03872843)
NCT ID: NCT03872843
Last Updated: 2021-03-11
Results Overview
Number of tablets taken after surgery
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
between baseline through day 7
Results posted on
2021-03-11
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
COMPLETED
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Opioid Group
n=7 Participants
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.
|
Non-Opioid Group
n=3 Participants
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
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=7 Participants
|
53 years
n=3 Participants
|
56 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=7 Participants
|
2 Participants
n=3 Participants
|
7 Participants
n=10 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
7 participants
n=7 Participants
|
3 participants
n=3 Participants
|
10 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: between baseline through day 7Population: 12 subjects out of total 22 enrolled were lost to follow up
Number of tablets taken after surgery
Outcome measures
| Measure |
Opioid Group
n=7 Participants
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.
|
Non-Opioid Group
n=3 Participants
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.
|
|---|---|---|
|
Amount of Pain Medication Used
|
7.3 tablets
Interval 3.0 to 25.0
|
6.67 tablets
Interval 0.0 to 11.0
|
PRIMARY outcome
Timeframe: baseline through day 7Population: 12 subjects out of total 22 enrolled were lost to follow up
Number of Subjects Who Need Additional Pain medication and/or Refill
Outcome measures
| Measure |
Opioid Group
n=7 Participants
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.
|
Non-Opioid Group
n=3 Participants
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.
|
|---|---|---|
|
Number of Subjects Who Need Additional Pain Medication and/or Refill
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: day 7Population: 12 subjects out of total 22 enrolled were lost to follow up
Ureteral stent symptom questionnaire Urinary Symptom score ranges from 11 to 56 with a higher score denoting a worse outcome.
Outcome measures
| Measure |
Opioid Group
n=7 Participants
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.
|
Non-Opioid Group
n=3 Participants
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.
|
|---|---|---|
|
Urinary Index
|
29.2 score on a scale
Interval 20.0 to 42.0
|
22.3 score on a scale
Interval 16.0 to 27.0
|
Adverse Events
Opioid Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Opioid Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place