Evaluation of a Nonopioid Recovery Pathway Following Surgery for Kidney Stones

Sponsor

The Miriam Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04597619

Collaborator

National Institute of General Medical Sciences (NIGMS) (NIH), Center of Biomedical Research Excellence (COBRE) on Opioids and Overdose (Other), Minimally Invasive Urology Institute, The Miriam Hospital (Other), Brown Urology Inc., Brown Physicians Inc. (Other)

Enrollment

Location

Arms

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nephrolithiasis	Other: Novel Nonopioid Pathway	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Pragmatic Pilot StudyPragmatic Pilot Study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of a Nonopioid Recovery Pathway After Percutaneous Nephrolithotomy

Actual Study Start Date :

Dec 10, 2020

Actual Primary Completion Date :

May 11, 2022

Actual Study Completion Date :

Jun 11, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Protocol Feasibility [1 year or until subject accrual is complete]
Number of enrolled patients / patients approached
Adherence to the protocol [30 days after procedure]
Dropout of enrolled patients
Acceptability of the protocol [30 days after procedure]
Patient satisfaction via validated questionnnaire
Adverse events [Day of procedure to 30 days after procedure]
Adverse events (AEs) while inpatient and following discharge
Opioid free discharge [Within 24 hours of discharge from hospital]
Whether subject is discharged with prescription for opioids or not

Secondary Outcome Measures

Postoperative inpatient opioid utilization [24-48 hours]
Postoperative inpatient opioid utilization (morphine mEq / kg / day)
Discharge opioid prescriptions [At time of discharge, average of postoperative day 1]
Opioid prescriptions written at time of discharge (morphine mEq / kg / day)
USSQ symptom scoring [7-10 days postoperatively]
Ureteral Stent Symptom Questionnaire (USSQ) scores at postoperative visit
Nonopioid discharge medications [At time of discharge, average of postoperative day 1]
Nonopioid medications given for pain
Length of stay (hours) [24-48 hours]
Length of inpatient stay (hours)
Clinic calls [30 days]
Quantitative number of telephone calls to clinic for pain / discomfort within 30 days via documentation in EMR
Refill requests [30 days]
Quantitative number of requests for refills of opioid prescriptions within 30 days via documentation in EMR
ED visits [30 days]
Quantitative number of subject presentations to emergency department for pain within 30 days via documentation in EMR

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 eGFR < 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.