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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM125507 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
| Rhode Island Hospital | OTHER |
| Brown Physicians, Inc. | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel Nonopioid Pathway | Other | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40529026 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-Implementation Cohort | Cohort undergoing percutaneous nephrolithotomy (PCNL) prior to implementation of the novel nonopioid pathway |
| FG001 | Implementation Cohort | Cohort undergoing percutaneous nephrolithotomy (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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-Implementation Cohort | Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Protocol Feasibility | Number of enrolled patients / patients approached | Posted | Count of Participants | Participants | 1 year or until subject accrual is complete |
|
Day of subject's surgery to thirty (30) days following stent removal.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-Implementation Cohort | Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway |
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Small pragmatic pre- and post- study without randomization designed to evaluate feasibility and safety only. Enrollment/accrual hampered by COVID-19 pandemic where healthcare rationing and other emergency response protocols limited screened patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Sobel, MD | Maine Medical Center | 207-773-1728 | david.sobel@mainehealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 7, 2022 | Aug 4, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Pragmatic Pilot Study
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|
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Previous nephrolithiasis requiring surgery | Count of Participants | Participants |
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|
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| Primary | Adherence to the Protocol | Dropout of enrolled patients | Posted | Count of Participants | Participants | 30 days after procedure |
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|
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| Primary | Adverse Events | Adverse events (AEs) while inpatient and following discharge | Posted | Count of Participants | Participants | Day of procedure to 30 days after procedure |
|
|
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| Primary | Opioid Free Discharge | Whether subject is discharged with prescription for opioids or not | Posted | Count of Participants | Participants | Within 24 hours of discharge from hospital |
|
|
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| Secondary | Postoperative Inpatient Opioid Utilization | Postoperative inpatient intravenous opioid utilization (morphine milliEquivalents / kg / day) | Posted | Median | Inter-Quartile Range | morphine mEq / kg / day | 24-48 hours |
|
|
|
| Secondary | Discharge Opioid Prescriptions | Opioid prescriptions written at time of discharge (morphine milliEquivalents / kg / day) | Posted | Median | Inter-Quartile Range | morphine mEq / kg / day | At time of discharge, average of postoperative day 1 |
|
|
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| Secondary | Nonopioid Discharge Medications | Nonopioid medications given for pain | Not Posted | At time of discharge, average of postoperative day 1 | Participants |
| Secondary | Length of Stay (Hours) | Length of inpatient stay (hours) | Posted | Median | Inter-Quartile Range | day(s) | 24-48 hours |
|
|
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| Secondary | Clinic Calls | Quantitative number of telephone calls to clinic for pain / discomfort within 30 days via documentation in electronic medical record | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Refill Requests | Quantitative number of requests for refills of opioid prescriptions within 30 days via documentation in EMR | Posted | Count of Participants | Participants | 30 days |
|
|
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| Secondary | Emergency Department Visits | Quantitative number of subject presentations to emergency department for pain within 30 days via documentation in EMR | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D014545 | Urinary Calculi |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |