- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04597619
Evaluation of a Nonopioid Recovery Pathway Following Surgery for Kidney Stones
Evaluation of a Nonopioid Recovery Pathway After Percutaneous Nephrolithotomy
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02906
- Miriam Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Protocol Feasibility
Time Frame: 1 year or until subject accrual is complete
|
Number of enrolled patients / patients approached
|
1 year or until subject accrual is complete
|
Adherence to the Protocol
Time Frame: 30 days after procedure
|
Dropout of enrolled patients
|
30 days after procedure
|
Adverse Events
Time Frame: Day of procedure to 30 days after procedure
|
Adverse events (AEs) while inpatient and following discharge
|
Day of procedure to 30 days after procedure
|
Opioid Free Discharge
Time Frame: Within 24 hours of discharge from hospital
|
Whether subject is discharged with prescription for opioids or not
|
Within 24 hours of discharge from hospital
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Inpatient Opioid Utilization
Time Frame: 24-48 hours
|
Postoperative inpatient intravenous opioid utilization (morphine milliEquivalents / kg / day)
|
24-48 hours
|
Discharge Opioid Prescriptions
Time Frame: At time of discharge, average of postoperative day 1
|
Opioid prescriptions written at time of discharge (morphine milliEquivalents / kg / day)
|
At time of discharge, average of postoperative day 1
|
Nonopioid Discharge Medications
Time Frame: At time of discharge, average of postoperative day 1
|
Nonopioid medications given for pain
|
At time of discharge, average of postoperative day 1
|
Length of Stay (Hours)
Time Frame: 24-48 hours
|
Length of inpatient stay (hours)
|
24-48 hours
|
Clinic Calls
Time Frame: 30 days
|
Quantitative number of telephone calls to clinic for pain / discomfort within 30 days via documentation in electronic medical record
|
30 days
|
Refill Requests
Time Frame: 30 days
|
Quantitative number of requests for refills of opioid prescriptions within 30 days via documentation in EMR
|
30 days
|
Emergency Department Visits
Time Frame: 30 days
|
Quantitative number of subject presentations to emergency department for pain within 30 days via documentation in EMR
|
30 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Pathological Conditions, Anatomical
- Urolithiasis
- Urinary Calculi
- Calculi
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Calculi
- Nephrolithiasis
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
Other Study ID Numbers
- 1574642
- P20GM125507 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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