A Study Of Corticosteroid On Postoperative Pain After Ureteroscopy For Urinary Calculi

Phase 4RecruitingNCT07223580

Mayo Clinic90 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Ureteroscopy Post Operative Pain

Interventions

CorticosteroidDRUG

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.

PlaceboOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

RECRUITING

Outcomes

Primary Outcomes

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 3

Secondary Outcomes

Number of times non-opioid analgesics medication used

Total number of times participants used non-opioid analgesics medication

Time frame: 3 days

Cumulative usage of non-opioid analgesics medication

Total use of non-opioid analgesics medication of any kind, reported in mg

Time frame: 3 days

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 3

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.

Central Contacts

Rev V. Vilasan Shylaja

CONTACT

480-574-1466

Data from ClinicalTrials.gov

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