NephrolithiasisNCT04597619
Evaluation of a Nonopioid Recovery Pathway Following Surgery for Kidney Stones
A study testing Novel Nonopioid Pathway in people with Nephrolithiasis, run by The Miriam Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- Novel Nonopioid Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 11 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary percutaneous nephrolithotomy at a single academic hospital site.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nephrolithiasis
- Being tested
- Novel Nonopioid Pathway
- Keywords
- Kidney Calculi, Surgery, Nephrolithotomy, Percutaneous
- Medical subject headings
- Nephrolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Nonopioid PathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Implementation Cohort | No intervention | Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway |
| Implementation Cohort | Experimental | Cohort undergoing PCNL with implementation of the novel nonopioid pathway Receives: Other: Novel Nonopioid Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol Feasibility
Number of enrolled patients / patients approached
Measured: 1 year or until subject accrual is complete
Adherence to the Protocol
Dropout of enrolled patients
Measured: 30 days after procedure
Adverse Events
Adverse events (AEs) while inpatient and following discharge
Measured: Day of procedure to 30 days after procedure
Opioid Free Discharge
Whether subject is discharged with prescription for opioids or not
Measured: Within 24 hours of discharge from hospital
Secondary outcomes (7)
Postoperative Inpatient Opioid Utilization
Postoperative inpatient intravenous opioid utilization (morphine milliEquivalents / kg / day)
Measured: 24-48 hours
Discharge Opioid Prescriptions
Opioid prescriptions written at time of discharge (morphine milliEquivalents / kg / day)
Measured: At time of discharge, average of postoperative day 1
Nonopioid Discharge Medications
Nonopioid medications given for pain
Measured: At time of discharge, average of postoperative day 1
Length of Stay (Hours)
Length of inpatient stay (hours)
Measured: 24-48 hours
Clinic Calls
Quantitative number of telephone calls to clinic for pain / discomfort within 30 days via documentation in electronic medical record
Measured: 30 days
Refill Requests
Quantitative number of requests for refills of opioid prescriptions within 30 days via documentation in EMR
Measured: 30 days
Emergency Department Visits
Quantitative number of subject presentations to emergency department for pain within 30 days via documentation in EMR
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Dec 2020
- Primary completion11 May 2022
- Study completion11 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Pragmatic Pilot Study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), Rhode Island Hospital, Brown Physicians, Inc.
- Responsible party
- Principal investigator, David Sobel, M.D., The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597619
- Sponsor's protocol ID
- 1574642
- Other IDs
- P20GM125507
- Status last verified
- Aug 2023
- First submitted
- 9 Oct 2020
- Last updated
- 25 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sobel D, Caffery P, James E, Ortiz R, Peat A, Tucci C, Pareek G. A prospective study to determine the safety and feasibility of opioid-free discharge after percutaneous nephrolithotomy. Transl Androl Urol. 2025 May 30;14(5):1379-1390. doi: 10.21037/tau-2024-692. Epub 2025 May 27.
PubMed 40529026
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Nonopioid Recovery Pathway After Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT04597619
- Acronym / sponsor ID
- 1574642
- Conditions
- Nephrolithiasis
- Keywords
- Kidney Calculi, Surgery, Nephrolithotomy, Percutaneous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), Rhode Island Hospital, Brown Physicians, Inc.
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 Jun 2022 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Posted 25 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Pre-Implementation Cohort | No intervention | –Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway |
| Implementation Cohort | Experimental | Other: Novel Nonopioid PathwayCohort undergoing PCNL with implementation of the novel nonopioid pathway |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing primary percutaneous nephrolithotomy at a single academic hospital site.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel Nonopioid PathwayThe 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. | Other | Implementation Cohort |
Primary outcome
Protocol Feasibility
Time frame: 1 year or until subject accrual is complete
Number of enrolled patients / patients approached
Adherence to the Protocol
Time frame: 30 days after procedure
Dropout of enrolled patients
Adverse Events
Time frame: Day of procedure to 30 days after procedure
Adverse events (AEs) while inpatient and following discharge
Opioid Free Discharge
Time frame: Within 24 hours of discharge from hospital
Whether subject is discharged with prescription for opioids or not
7 secondary outcomes
Postoperative Inpatient Opioid Utilization
Time frame: 24-48 hours
Discharge Opioid Prescriptions
Time frame: At time of discharge, average of postoperative day 1
Nonopioid Discharge Medications
Time frame: At time of discharge, average of postoperative day 1
Length of Stay (Hours)
Time frame: 24-48 hours
Clinic Calls
Time frame: 30 days
Refill Requests
Time frame: 30 days
Emergency Department Visits
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40529026Sobel D, Caffery P, James E, Ortiz R, Peat A, Tucci C, Pareek G. A prospective study to determine the safety and feasibility of opioid-free discharge after percutaneous nephrolithotomy. Transl Androl Urol. 2025 May 30;14(5):1379-1390. doi: 10.21037/tau-2024-692. Epub 2025 May 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Nonopioid Pathway in people with Nephrolithiasis, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protocol Feasibility (time frame: 1 year or until subject accrual is complete). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04597619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.