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Evaluation of a Nonopioid Recovery Pathway Following Surgery for Kidney Stones

Primary Purpose

Nephrolithiasis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Novel Nonopioid Pathway
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithiasis focused on measuring Kidney Calculi, Surgery, Nephrolithotomy, Percutaneous

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 eGFR < 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.

Sites / Locations

  • Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Pre-Implementation Cohort

Implementation Cohort

Arm Description

Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway

Cohort undergoing PCNL with implementation of the novel nonopioid pathway

Outcomes

Primary Outcome Measures

Protocol Feasibility
Number of enrolled patients / patients approached
Adherence to the Protocol
Dropout of enrolled patients
Adverse Events
Adverse events (AEs) while inpatient and following discharge
Opioid Free Discharge
Whether subject is discharged with prescription for opioids or not

Secondary Outcome Measures

Postoperative Inpatient Opioid Utilization
Postoperative inpatient intravenous opioid utilization (morphine milliEquivalents / kg / day)
Discharge Opioid Prescriptions
Opioid prescriptions written at time of discharge (morphine milliEquivalents / kg / day)
Nonopioid Discharge Medications
Nonopioid medications given for pain
Length of Stay (Hours)
Length of inpatient stay (hours)
Clinic Calls
Quantitative number of telephone calls to clinic for pain / discomfort within 30 days via documentation in electronic medical record
Refill Requests
Quantitative number of requests for refills of opioid prescriptions within 30 days via documentation in EMR
Emergency Department Visits
Quantitative number of subject presentations to emergency department for pain within 30 days via documentation in EMR

Full Information

First Posted
October 9, 2020
Last Updated
August 28, 2023
Sponsor
The Miriam Hospital
Collaborators
National Institute of General Medical Sciences (NIGMS), Rhode Island Hospital, Brown Physicians, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04597619
Brief Title
Evaluation of a Nonopioid Recovery Pathway Following Surgery for Kidney Stones
Official Title
Evaluation of a Nonopioid Recovery Pathway After Percutaneous Nephrolithotomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
May 11, 2022 (Actual)
Study Completion Date
June 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
Collaborators
National Institute of General Medical Sciences (NIGMS), Rhode Island Hospital, Brown Physicians, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis
Keywords
Kidney Calculi, Surgery, Nephrolithotomy, Percutaneous

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Pragmatic Pilot Study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-Implementation Cohort
Arm Type
No Intervention
Arm Description
Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway
Arm Title
Implementation Cohort
Arm Type
Experimental
Arm Description
Cohort undergoing PCNL with implementation of the novel nonopioid pathway
Intervention Type
Other
Intervention Name(s)
Novel Nonopioid Pathway
Intervention Description
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.
Primary Outcome Measure Information:
Title
Protocol Feasibility
Description
Number of enrolled patients / patients approached
Time Frame
1 year or until subject accrual is complete
Title
Adherence to the Protocol
Description
Dropout of enrolled patients
Time Frame
30 days after procedure
Title
Adverse Events
Description
Adverse events (AEs) while inpatient and following discharge
Time Frame
Day of procedure to 30 days after procedure
Title
Opioid Free Discharge
Description
Whether subject is discharged with prescription for opioids or not
Time Frame
Within 24 hours of discharge from hospital
Secondary Outcome Measure Information:
Title
Postoperative Inpatient Opioid Utilization
Description
Postoperative inpatient intravenous opioid utilization (morphine milliEquivalents / kg / day)
Time Frame
24-48 hours
Title
Discharge Opioid Prescriptions
Description
Opioid prescriptions written at time of discharge (morphine milliEquivalents / kg / day)
Time Frame
At time of discharge, average of postoperative day 1
Title
Nonopioid Discharge Medications
Description
Nonopioid medications given for pain
Time Frame
At time of discharge, average of postoperative day 1
Title
Length of Stay (Hours)
Description
Length of inpatient stay (hours)
Time Frame
24-48 hours
Title
Clinic Calls
Description
Quantitative number of telephone calls to clinic for pain / discomfort within 30 days via documentation in electronic medical record
Time Frame
30 days
Title
Refill Requests
Description
Quantitative number of requests for refills of opioid prescriptions within 30 days via documentation in EMR
Time Frame
30 days
Title
Emergency Department Visits
Description
Quantitative number of subject presentations to emergency department for pain within 30 days via documentation in EMR
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of a Nonopioid Recovery Pathway Following Surgery for Kidney Stones

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