Post Operative Pain, Ureteroscopy
Conditions
Brief summary
The purpose of this research is to evaluate if corticosteroid (prednisone) after ureteroscopy and placement of the stent will help alleviate postoperative pain control in addition to other normal postoperative pain medications
Interventions
DRUGCorticosteroid
In addition to the standard of care postoperative ureteroscopy medication, participants will be given prednisone 25 mg orally, once a day for 5 days post-surgery.
OTHERPlacebo
In addition to the standard of care postoperative ureteroscopy medication, participants will be given a placebo pill orally, once a day for 5 days post-surgery.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are diagnosed with kidney or ureteral stones confirmed on imaging (CT of the abdomen or pelvis) and who elect for definitive treatment via ureteroscopy with placement of ureteral stent. * Age 18 years or older * Patients of either gender * Patients of all ethnic backgrounds * Cable of giving informed consent * Capable and willing to fulfill the requirements of the study.
Exclusion criteria
* History of chronic pain * Chronic use of opioids or other pain medication (\>12 weeks) * Known allergies to corticosteroids. * Known or suspected pregnancy * Inability to give informed consent or unable to meet requirements of the study for any reason. * Bilateral ureteroscopy * Current Corticosteroid Use * Diabetic patients who are insulin dependent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Scale Pain Score | Baseline, Day 1 (Post-operatively), Day 2, Day 3 | Pain values reported by participants will be assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of times non-opioid analgesics medication used | 3 days | Total number of times participants used non-opioid analgesics medication |
| Cumulative usage of non-opioid analgesics medication | 3 days | Total use of non-opioid analgesics medication of any kind, reported in mg |
| Change in Wisconsin Stone Quality of Life Questionnaire (WISQOL) score | Day 2 (Post-operatively), Day 3 | The Wisconsin Stone Quality of Life (WISQOL) questionnaire is a 29 item survey that assesses quality of life for participants with kidney stones and covers four domains: social impact, emotional impact, stone-related symptom impact, and vitality. Questions are answered on a 5-point Likert scale, (1 = Very true, 5 = Not at all true), with a total maximum score of 140. Higher scores indicate a better quality of life. |
| Change in Canadian Endourology Group Stent Symptom Score (CEGSSS) score | Day 1 (Post-operatively), Day 2, Day 3 | The Canadian Endourology Group Stent Symptom Score (CEGSSS) is a 11-item questionnaire that assesses ureteral stent symptoms through three domains: urination, pain, and quality of life. Scoring is based on participant responses to the individual questions, with higher scores indicating a greater symptom burden. |
Countries
United States
Contacts
CONTACTRev V. Vilasan Shylaja
PRINCIPAL_INVESTIGATORKaren L. Stern, MD
Mayo Clinic
Outcome results
None listed