Evaluation of a Nonopioid Recovery Pathway Following Surgery for Kidney Stones

Evaluation of a Nonopioid Recovery Pathway After Percutaneous Nephrolithotomy

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.

Study Overview

• Status: Completed
• Conditions: Nephrolithiasis
• Intervention / Treatment: Other: Novel Nonopioid Pathway

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Miriam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre-Implementation Cohort; Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway
Experimental: Implementation Cohort; Cohort undergoing PCNL with implementation of the novel nonopioid pathway	Other: Novel Nonopioid Pathway; 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.

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

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: Rhode Island Hospital; National Institute of General Medical Sciences (NIGMS); Brown Physicians, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): May 11, 2022
• Study Completion (Actual): June 11, 2022

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; Kidney Calculi; Nephrolithotomy, Percutaneous
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Calculi; Nephrolithiasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic
• Other Study ID Numbers: 1574642; P20GM125507 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No