Authors
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University of Iowa -More
Category
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Primary study
Registry of Trials»clinicaltrials.gov
Year
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2018
Adult patients undergoing ureteroscopy for kidney stones will be screened and those who meet initial study criteria (adult, English speaking, non‐pregnant, non‐intellectually disabled patients), will be sent an information letter outlining the study. Interested patients, who possess a phone capable of text messaging will be consented to enroll in the study and randomized to one of two preoperative analgesic treatment arms (see below) that will be administered in the preoperative area prior to induction of general anesthesia. Multimodal Analgesia Arm 1. Acetaminophen 975mg 2. Gabapentin 800mg 3. Oxycodone 10mg 4. Celecoxib 400mg Acetaminophen Only Analgesia Arm a. Acetaminophen 975mg Consenting patients will fill out a baseline demographics questionnaire as well as provide baseline levels of pain and opioid consumption prior to surgery. They will also be enrolled to receive automated postoperative pain assessments and opioid consumption inquiries via text message. The patients will be blinded to the treatment they are receiving. The research team will not be blinded. The patient will then proceed with their planned ureteroscopy. The patient will then undergo their planned ureteroscopy with lithotripsy for kidney stone disease; the study does not change any parameters about the surgery itself. The general anesthesia regimen will be standardized to one particular standard of care method so as to minimize the potential effect of confounders. All patients (patients in both preoperative analgesia treatment regimen arms) will be monitored in the post‐anesthesia recovery unit for pain, blood pressure, sedation level monitored by the Ramsey Sedation Scale. Once they have recovered appropriately and met standard discharge criteria they will be discharged with the following analgesic regimen 1. Tylenol 650 every 6 hours x 7 day 2. Oxybutynin 5mg three times daily as needed for x 7 days 3. Flomax 0.4mg daily x 7 days 4. Oxycodone, 5mg as needed 15 pills 5. Celecoxib daily for 7 days Patients will receive a pain assessment via text message the evening of postoperative day 0, and then twice a day for 14 days. Patients will also receive an opioid consumption inquiry once a day for 14 days. On postoperative day 15 patients will be asked if they were happy with their postoperative pain control. During the study period the research team will access the patients electronic medical record to review and record the following information ‐ Current medications ‐ height, weight, age, gender, marital status, city, state of residence ‐ Co‐morbid medical conditions ‐ insurance ‐ stone parameters: size (mmm), location, laterality, number of stones, ‐ Operative factors: instruments used, operative time, operative complications ‐ post‐operative course: emergency department visits, unexpected phone calls, unexpected clinic visits, other 30‐day complications
Epistemonikos ID: a0b6acf5b63da71f49728c7c31eec08ee05ac0ee
First added on: May 21, 2024