Pre-induction Analgesia: Multimodel Regimen vs Aceteminophen for Post Ureteroscopy Pain

Study Overview
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Brief Summary
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Adult patients with kidney stones undergoing surgical intervention with ureteroscopy with laser lithotripsy will be randomized to receive one of two different regimens of oral medications administered prior to induction of general anesthesia. Postoperatively, patients will receive automated daily text messages to assess pain and opioid consumption and subsequently determine which which treatment regimen is superior.

Detailed Description
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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 Acetaminophen 975mg Gabapentin 800mg Oxycodone 10mg 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 Tylenol 650 every 6 hours x 7 day Oxybutynin 5mg three times daily as needed for x 7 days Flomax 0.4mg daily x 7 days Oxycodone, 5mg as needed 15 pills 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

Official Title
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Randomized Comparison of Two Pre-induction Analgesia Regimens: Multimodal vs Acetaminophen in the Reduction of Post-operative Pain Following Ureteroscopy With Lithotripsy for Kidney Stones Evaluated With Text Messaging

Conditions
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Kidney Calculi, Pain, Postoperative

Intervention / Treatment
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* Drug: Multimodal Oral Drug Regimen
* Drug: Acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Patient (greater than 18 years old) Possesses or has access to cell phone with text message capability Undergoing ureteroscopy with lithotripsy for a ureteral or kidney stones Exclusion Criteria: Does not possess or have access to a cell phone with text message capability Non-English speaking Incarcerated individuals undergoing planned secondary procedure pregnancy intellectual disability History of, anaphylactic, rash, or other hypersensitivity reaction to any of the study agents Patients with history of CABG, myocardial infarction, endovascular cardiac stent, gastrointestinal bleed, or gastric ulcer disease will not receive Celecoxib. They may still participate in the study otherwise, it will be documented that they did not receive an NSAID component.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimodel Drug Regimen<br>The patients randomized to this arm will receive the following multimodal oral drug regimen administered shortly before induction of general anesthesia Tylenol, 975mg (3 tabs) 800mg Gabapentin 400mg Celecoxib 10mg Oxycodone | Drug: Multimodal Oral Drug Regimen<br>* Regimen of 4 pharmacologic agents that provides analgesia by acting on 4 different physiologic pain pathways<br>* Other names: Celecoxib 400mg;|
| Active Comparator: Acetaminophen Only<br>The patients randomized to this arm will receive oral acetaminophen only administered shortly before induction of general anesthesia 1. Tylenol, 975mg (3 tabs) | Drug: Acetaminophen<br>* Acetaminophen 975mg<br>* Other names: Tylenol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative day 0 Pain | The magnitude of pain (0-10) that the patient experiences in the evening after their surgery concludes | 4-6 hours after conclusion of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to pain resolution | The amount of time (days) that it takes for patients to report a pain level of less than 4 (0-10 scale) | Approximately the first 72-96 hours | 
| Opioid Consumption | The number of total opioid pills a patient consumes following surgery | 14 days following surgery | 
| Time to complete pain resolution | The amount of time (days) that it takes for patients to report a pain level of 0 (0-10 scale) | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ureteroscopy, opioids, narcotics, text messaging, real time data acquisition, ecologic momentary assessments, pre-emptive analgesia, gabapentin, meloxicam, tamsulosin, kidney stones, lithotripsy, nephrolithiasis