Evaluation of a Nonopioid Recovery Pathway Following Surgery for Kidney Stones

NCT04597619 | Completed Results DMC

• 2 other identifiers: 1574642P20GM125507
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrolithiasis

Keywords

Kidney Calculi; Surgery; Nephrolithotomy, Percutaneous

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Postoperative Inpatient Opioid Utilization

  24-48 hours

• Discharge Opioid Prescriptions

  At time of discharge, average of postoperative day 1

• Nonopioid Discharge Medications

  At time of discharge, average of postoperative day 1

• Length of Stay (Hours)

  24-48 hours

• Clinic Calls

  30 days

Study Arms (2)

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

Other: Novel Nonopioid Pathway

Interventions

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.

Implementation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary percutaneous nephrolithotomy at a single academic hospital site.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

• 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.

  PMID: 40529026 DERIVED

MeSH Terms

Conditions

Nephrolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: David Sobel, MD
• Organization: Maine Medical Center

david.sobel@mainehealth.org

207-773-1728

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology

Model Details: Pragmatic Pilot Study

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 22, 2020
• Study Start: December 1, 2020
• Primary Completion: May 11, 2022
• Study Completion: June 11, 2022
• Last Updated: September 25, 2023
• Results First Posted: September 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)