Clinical trial NCT04597619: Evaluation of a Nonopioid Recovery Pathway Following Surgery for Kidney Stones
Official title: Evaluation of a Nonopioid Recovery Pathway After Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nephrolithiasis
Keywords: Kidney Calculi
Surgery
Nephrolithotomy, Percutaneous
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
name: Rhode Island Hospital
name: Brown Physicians, Inc.
First posted: 2020-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Pragmatic Pilot Study
Primary purpose: TREATMENT

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:

1. 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.
2. 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.
3. 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.

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.

Primary outcomes:
measure: Protocol Feasibility
timeFrame: 1 year or until subject accrual is complete
measure: Adherence to the Protocol
timeFrame: 30 days after procedure
measure: Adverse Events
timeFrame: Day of procedure to 30 days after procedure
measure: Opioid Free Discharge
timeFrame: Within 24 hours of discharge from hospital
Secondary outcomes:
measure: Postoperative Inpatient Opioid Utilization
timeFrame: 24-48 hours
measure: Discharge Opioid Prescriptions
timeFrame: At time of discharge, average of postoperative day 1
measure: Nonopioid Discharge Medications
timeFrame: At time of discharge, average of postoperative day 1
measure: Length of Stay (Hours)
timeFrame: 24-48 hours
measure: Clinic Calls
timeFrame: 30 days
measure: Refill Requests
timeFrame: 30 days
measure: Emergency Department Visits
timeFrame: 30 days
Other outcomes:
Locations:
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
Study officials:
References: