A Study Of Corticosteroid On Postoperative Pain After Ureteroscopy For Urinary Calculi
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
History of chronic pain
Chronic use of opioids or other pain medication (>12 weeks)
Known allergies to corticosteroids.
Known or suspected pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Corticosteroid
DrugIn 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.
Placebo
Other interventionIn 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Standard of care plus CorticosteroidExperimental treatment 1 intervention
Group B: Standard of CarePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Visual Analog Scale Pain Score
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.
Time frame
Baseline, Day 1 (Post-operatively), Day 2, Day 3Secondary outcomes
1
Number of times non-opioid analgesics medication used
Total number of times participants used non-opioid analgesics medication
Time frame
3 days2
Cumulative usage of non-opioid analgesics medication
Total use of non-opioid analgesics medication of any kind, reported in mg
Time frame
3 days3
Change in Wisconsin Stone Quality of Life Questionnaire (WISQOL) score
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.
Time frame
Day 2 (Post-operatively), Day 34
Change in Canadian Endourology Group Stent Symptom Score (CEGSSS) score
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.
Time frame
Day 1 (Post-operatively), Day 2, Day 3Sponsors and contacts
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Source ClinicalTrials.gov