Evaluation of a Nonopioid Recovery Pathway Following Surgery for Kidney Stones

Study Overview
=================
Brief Summary
-----------------
Evaluation of a nonopioid recovery pathway after percutaneous nephrolithotomy is a pragmatic pilot study that will apply the knowledge and experience gained with development of an outpatient opioid reduction protocol to percutaneous nephrolithotomy (PCNL). We have previously demonstrated that outpatient ureteroscopy and stent placement without postoperative opioid prescriptions is possible in the vast majority of patients. The success of this is dependent upon a multimodal approach to the patient's experience of undergoing endoscopic kidney stone surgery (ureteroscopy) and focuses on the preoperative, perioperative, and postoperative stages of intervention. Our hypothesis is that a novel nonopioid pathway after PCNL is both feasible and safe and will reduce postoperative prescriptions for opioids without impacting clinical outcomes, patient satisfaction or outpatient resources.

Detailed Description
-----------------
Evaluation of a nonopioid recovery pathway after percutaneous nephrolithotomy is a pragmatic pilot study which will prospectively compare a cohort undergoing PCNL prior to implementation of the novel nonopioid pathway undergoing the same procedure utilizing the novel nonopioid pathway. Current standard of care following PCNL remains the routine prescription of opioid medications for pain control. Evaluation of a nonopioid recovery pathway after percutaneous nephrolithotomy has three specific aims: Demonstrate feasibility and acceptability of the novel nonopioid protocol and describe the barriers to enrollment and reasons for drop out. The feasibility of the protocol will be measured by dropout of enrolled patients and the acceptability of protocol will be measured by number of enrolled patients / patients approached and patient satisfaction via a validated questionnaire. Describe what adverse events occur to those on the nonopioid protocol as compared to the standard of care. Adverse events occurring as an inpatient will be measured by nursing and physician reporting, and as an outpatient via patient self-reporting, electronic medical records of emergency department visits and telephone calls to clinic. Begin to reduce overall opioid prescription writing for patients undergoing PCNL at the academic institution. The electronic medical records will be queried for prescriptions written at discharge. The state Opioid Prescription Monitoring Program (PMP) will be queried for a 30-day period following surgery. After written consent and enrollment, patients will undergo preoperative counseling regarding pain after PCNL in the preoperative holding area prior to surgery. The patient will then undergo percutaneous nephrolithotomy. No procedural changes will be made for study participants. Postoperatively, patients will be admitted to the post-anesthesia care unit and standard of care adjunctive and analgesic medications will be administered. The patient will be admitted to the floor following surgery and postoperative specialized nonopioid PCNL pathway orders will be communicated to nursing staff. The patient's pain will be treated with multimodal nonopioid analgesic agents. Opioid medications will not be withheld for patients with severe pain. On postoperative day one, the patient will be assessed for discharge as in standard of care. They will be asked about their perceived need for a prescription for opioids. If requested, the patient will be given a prescription for a limited quantity of opioids. Nursing staff will complete specialized discharge instructions and patients will be given written instructions regarding medications and activity. Patients will be seen in 7-10 days for stent removal in the office per standard of care, and will complete a validated quality of life survey for pain after kidney stone surgery.

Official Title
-----------------
Evaluation of a Nonopioid Recovery Pathway After Percutaneous Nephrolithotomy

Conditions
-----------------
Nephrolithiasis

Intervention / Treatment
-----------------
* Other: Novel Nonopioid Pathway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing primary percutaneous nephrolithotomy at a single academic hospital site. Exclusion Criteria: Patients will be excluded if currently taking opioids for chronic pain, undergoing concurrent non-PCNL procedure, second-look PCNL (subsequent PCNL after primary PCNL), or present with Chronic Kidney Disease Stage >3 or glomerular filtration rate < 50 mL/min/1.73m2 at time of surgery. Patients with allergy to NSAIDs or have history of NSAID related GI bleeding or ulcers will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Pragmatic Pilot Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-Implementation Cohort<br>Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway | |
| Experimental: Implementation Cohort<br>Cohort undergoing PCNL with implementation of the novel nonopioid pathway | Other: Novel Nonopioid Pathway<br>* The novel nonopioid pathway consists of preoperative counseling, postoperative standardized orders and standard of care adjunctive and analgesic medications, specialized discharge instructions and written patient instructions regarding medications and activity.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protocol Feasibility | Number of enrolled patients / patients approached | 1 year or until subject accrual is complete | 
| Adherence to the Protocol | Dropout of enrolled patients | 30 days after procedure | 
| Adverse Events | Adverse events (AEs) while inpatient and following discharge | Day of procedure to 30 days after procedure | 
| Opioid Free Discharge | Whether subject is discharged with prescription for opioids or not | Within 24 hours of discharge from hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Inpatient Opioid Utilization | Postoperative inpatient intravenous opioid utilization (morphine milliEquivalents / kg / day) | 24-48 hours | 
| Discharge Opioid Prescriptions | Opioid prescriptions written at time of discharge (morphine milliEquivalents / kg / day) | At time of discharge, average of postoperative day 1 | 
| Nonopioid Discharge Medications | Nonopioid medications given for pain | At time of discharge, average of postoperative day 1 | 
| Length of Stay (Hours) | Length of inpatient stay (hours) | 24-48 hours | 
| Clinic Calls | Quantitative number of telephone calls to clinic for pain / discomfort within 30 days via documentation in electronic medical record | 30 days | 
| Refill Requests | Quantitative number of requests for refills of opioid prescriptions within 30 days via documentation in EMR | 30 days | 
| Emergency Department Visits | Quantitative number of subject presentations to emergency department for pain within 30 days via documentation in EMR | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery, Kidney Calculi, Nephrolithotomy, Percutaneous