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Evaluation of a Nonopioid Recovery Pathway Following Surgery for Kidney Stones

Evaluation of a Nonopioid Recovery Pathway After Percutaneous Nephrolithotomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04597619
Enrollment
30
Registered
2020-10-22
Start date
2020-12-01
Completion date
2022-06-11
Last updated
2023-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrolithiasis

Keywords

Kidney Calculi, Surgery, Nephrolithotomy, Percutaneous

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.

Interventions

OTHERNovel 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.

Sponsors

National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
Rhode Island Hospital
CollaboratorOTHER
Brown Physicians, Inc.
CollaboratorOTHER
The Miriam Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Pragmatic Pilot Study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Adherence to the Protocol30 days after procedureDropout of enrolled patients
Adverse EventsDay of procedure to 30 days after procedureAdverse events (AEs) while inpatient and following discharge
Opioid Free DischargeWithin 24 hours of discharge from hospitalWhether subject is discharged with prescription for opioids or not
Protocol Feasibility1 year or until subject accrual is completeNumber of enrolled patients / patients approached

Secondary

MeasureTime frameDescription
Clinic Calls30 daysQuantitative number of telephone calls to clinic for pain / discomfort within 30 days via documentation in electronic medical record
Postoperative Inpatient Opioid Utilization24-48 hoursPostoperative inpatient intravenous opioid utilization (morphine milliEquivalents / kg / day)
Emergency Department Visits30 daysQuantitative number of subject presentations to emergency department for pain within 30 days via documentation in EMR
Refill Requests30 daysQuantitative number of requests for refills of opioid prescriptions within 30 days via documentation in EMR
Discharge Opioid PrescriptionsAt time of discharge, average of postoperative day 1Opioid prescriptions written at time of discharge (morphine milliEquivalents / kg / day)
Nonopioid Discharge MedicationsAt time of discharge, average of postoperative day 1Nonopioid medications given for pain
Length of Stay (Hours)24-48 hoursLength of inpatient stay (hours)

Countries

United States

Participant flow

Participants by arm

ArmCount
Pre-Implementation Cohort
Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway
14
Implementation Cohort
Cohort undergoing PCNL with implementation of the novel nonopioid pathway 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.
6
Total20

Baseline characteristics

CharacteristicPre-Implementation CohortTotalImplementation Cohort
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
4 Participants6 Participants2 Participants
Age, Categorical
Between 18 and 65 years
10 Participants14 Participants4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants1 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants19 Participants6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Previous nephrolithiasis requiring surgery4 Participants5 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
12 Participants17 Participants5 Participants
Sex: Female, Male
Female
4 Participants7 Participants3 Participants
Sex: Female, Male
Male
10 Participants13 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 140 / 6
other
Total, other adverse events
0 / 140 / 6
serious
Total, serious adverse events
0 / 140 / 6

Outcome results

Primary

Adherence to the Protocol

Dropout of enrolled patients

Time frame: 30 days after procedure

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pre-Implementation CohortAdherence to the Protocol14 Participants
Implementation CohortAdherence to the Protocol6 Participants
Primary

Adverse Events

Adverse events (AEs) while inpatient and following discharge

Time frame: Day of procedure to 30 days after procedure

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pre-Implementation CohortAdverse Events0 Participants
Implementation CohortAdverse Events0 Participants
Primary

Opioid Free Discharge

Whether subject is discharged with prescription for opioids or not

Time frame: Within 24 hours of discharge from hospital

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pre-Implementation CohortOpioid Free Discharge10 Participants
Implementation CohortOpioid Free Discharge6 Participants
Primary

Protocol Feasibility

Number of enrolled patients / patients approached

Time frame: 1 year or until subject accrual is complete

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pre-Implementation CohortProtocol Feasibility14 Participants
Implementation CohortProtocol Feasibility10 Participants
Secondary

Clinic Calls

Quantitative number of telephone calls to clinic for pain / discomfort within 30 days via documentation in electronic medical record

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pre-Implementation CohortClinic Calls1 Participants
Implementation CohortClinic Calls1 Participants
Secondary

Discharge Opioid Prescriptions

Opioid prescriptions written at time of discharge (morphine milliEquivalents / kg / day)

Time frame: At time of discharge, average of postoperative day 1

ArmMeasureValue (MEDIAN)
Pre-Implementation CohortDischarge Opioid Prescriptions30.0 morphine mEq / kg / day
Implementation CohortDischarge Opioid Prescriptions0 morphine mEq / kg / day
Secondary

Emergency Department Visits

Quantitative number of subject presentations to emergency department for pain within 30 days via documentation in EMR

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pre-Implementation CohortEmergency Department Visits2 Participants
Implementation CohortEmergency Department Visits0 Participants
Secondary

Length of Stay (Hours)

Length of inpatient stay (hours)

Time frame: 24-48 hours

ArmMeasureValue (MEDIAN)
Pre-Implementation CohortLength of Stay (Hours)1 day(s)
Implementation CohortLength of Stay (Hours)1 day(s)
Secondary

Nonopioid Discharge Medications

Nonopioid medications given for pain

Time frame: At time of discharge, average of postoperative day 1

Secondary

Postoperative Inpatient Opioid Utilization

Postoperative inpatient intravenous opioid utilization (morphine milliEquivalents / kg / day)

Time frame: 24-48 hours

ArmMeasureValue (MEDIAN)
Pre-Implementation CohortPostoperative Inpatient Opioid Utilization4.0 morphine mEq / kg / day
Implementation CohortPostoperative Inpatient Opioid Utilization0 morphine mEq / kg / day
Secondary

Refill Requests

Quantitative number of requests for refills of opioid prescriptions within 30 days via documentation in EMR

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pre-Implementation CohortRefill Requests0 Participants
Implementation CohortRefill Requests0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026