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Narcotic-Free Percutaneous Nephrolithotomy

Primary Purpose

Nephrolithiasis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
5mg Oxycodone, Q6 PRN
10mg Ketorolac, Q6 PRN
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithiasis

Eligibility Criteria

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

Inclusion Criteria: Undergoing scheduled unilateral standard (24Fr), PCNL with at least 2cm stone burden, with expected single access Exclusion Criteria: Pregnant women History of chronic opioid abuse Allergy, hypersensitivity, or other contraindication to NSAID usage such as eGFR < 60 mL/min Peptic ulcer disease or history of gastric bypass Concurrent use of antiplatelet or anticoagulation therapy (including aspirin) Thrombocytopenia Suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis, and those at high risk of bleeding. Concomitant medications: Other NSAIDs Antiplatelet or anticoagulation medications Probenecid Pentoxifylline Allergy, hypersensitivity, or other contraindication to opioids: Current opioid prescription/usage for any reason, including active treatment with suboxone or methadone Respiratory depression Patients with acute or severe bronchial asthma or hypercarbia Patients who have or is suspected of having paralytic ileus as PCNL done under general anesthesia Patients with hepatic Impairment Concomitant medications: Monoamine Oxidase Inhibitors (MAOIs) Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics Diagnosis of chronic pain disorder Reduced sensation of abdomen or pelvis (e.g. patients with spinal cord injury) Pre-existing stent or nephrostomy tube Urinary tract anomalies such as urinary diversion, horseshoe kidney, solitary kidney, urinary stricture disease, ureteropelvic junction obstruction, pelvic kidney, stone in calyceal diverticulum) Pulmonary disease Liver disease Seizure disorders Subjects taking nephrotoxic medications Subjects taking medications that can increase sedation risk (benzodiazepines or other sedative hypnotics)

Sites / Locations

  • Mount Sinai WestRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Opioid group

NSAID

Arm Description

Patients will be prescribed 5mg Oxycodone, Q6 PRN postoperatively.

Patients will be prescribed 10mg Ketorolac, Q6 PRN postoperatively.

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS) pain scores
Visual Analog Scale (VAS) to measure pain: The minimum score of '0' indicates "no pain" and the maximum score of '10' indicates "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line. Visual analog scale (VAS) pain scores will be recorded
Visual Analog Scale (VAS) pain scores
Visual Analog Scale (VAS) to measure pain: The minimum score of '0' indicates "no pain" and the maximum score of '10' indicates "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line. Visual analog scale (VAS) pain scores will be recorded

Secondary Outcome Measures

Pill count
A pill count will be conducted of each prescribed postoperative medication.
Number of pain related calls to the office
Pain related calls to the office will be recorded.
Number of pain related ED visits
Pain related calls to the office and Emergency Department (ED) visits will be recorded.
Patient-related outcome survey (PROMIS) scores
Patients will be given a survey containing questions from Patient-related outcome survey (PROMIS) instruments. A series of person-centered measures that evaluate and monitor physical, mental, and social health in adults and children. 10-item patient-reported questionnaire. standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.

Full Information

First Posted
June 20, 2023
Last Updated
June 20, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT05924165
Brief Title
Narcotic-Free Percutaneous Nephrolithotomy
Official Title
Narcotic-Free Percutaneous Nephrolithotomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized control trial comparing oral ketorolac and opioid medication for the use of post-operative analgesia.
Detailed Description
This is a randomized control trial comparing oral ketorolac (10mg, Q6 PRN) and oxycodone (5mg, Q6 PRN) medication for the use of post-operative analgesia after kidney stone removal surgery called percutaneous nephrolithotomy (PCNL). Primary endpoints are visual analog pain scores (VAS) for days 1-5 and day 10 post operatively. Secondary endpoints are pill counts, patient-related outcome survey (PROMIS) scores, emergency room visits, and patient telephone calls. 90 subjects will be enrolled, with 45 in each group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Operating surgeon will be blinded to treatment arm intraoperatively (will not be blinded postoperatively)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Opioid group
Arm Type
Active Comparator
Arm Description
Patients will be prescribed 5mg Oxycodone, Q6 PRN postoperatively.
Arm Title
NSAID
Arm Type
Active Comparator
Arm Description
Patients will be prescribed 10mg Ketorolac, Q6 PRN postoperatively.
Intervention Type
Drug
Intervention Name(s)
5mg Oxycodone, Q6 PRN
Intervention Description
Oxycodone is an opioid that is used to relieve moderate to severe pain.
Intervention Type
Drug
Intervention Name(s)
10mg Ketorolac, Q6 PRN
Intervention Description
Ketorolac is an NSAID used to relieve moderately severe pain.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) pain scores
Description
Visual Analog Scale (VAS) to measure pain: The minimum score of '0' indicates "no pain" and the maximum score of '10' indicates "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line. Visual analog scale (VAS) pain scores will be recorded
Time Frame
post-op up to day 5
Title
Visual Analog Scale (VAS) pain scores
Description
Visual Analog Scale (VAS) to measure pain: The minimum score of '0' indicates "no pain" and the maximum score of '10' indicates "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line. Visual analog scale (VAS) pain scores will be recorded
Time Frame
post-op at day 10
Secondary Outcome Measure Information:
Title
Pill count
Description
A pill count will be conducted of each prescribed postoperative medication.
Time Frame
post-op at day 10
Title
Number of pain related calls to the office
Description
Pain related calls to the office will be recorded.
Time Frame
post-op up to day 10
Title
Number of pain related ED visits
Description
Pain related calls to the office and Emergency Department (ED) visits will be recorded.
Time Frame
post-op up to day 10
Title
Patient-related outcome survey (PROMIS) scores
Description
Patients will be given a survey containing questions from Patient-related outcome survey (PROMIS) instruments. A series of person-centered measures that evaluate and monitor physical, mental, and social health in adults and children. 10-item patient-reported questionnaire. standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Time Frame
post-op at day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Undergoing scheduled unilateral standard (24Fr), PCNL with at least 2cm stone burden, with expected single access Exclusion Criteria: Pregnant women History of chronic opioid abuse Allergy, hypersensitivity, or other contraindication to NSAID usage such as eGFR < 60 mL/min Peptic ulcer disease or history of gastric bypass Concurrent use of antiplatelet or anticoagulation therapy (including aspirin) Thrombocytopenia Suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis, and those at high risk of bleeding. Concomitant medications: Other NSAIDs Antiplatelet or anticoagulation medications Probenecid Pentoxifylline Allergy, hypersensitivity, or other contraindication to opioids: Current opioid prescription/usage for any reason, including active treatment with suboxone or methadone Respiratory depression Patients with acute or severe bronchial asthma or hypercarbia Patients who have or is suspected of having paralytic ileus as PCNL done under general anesthesia Patients with hepatic Impairment Concomitant medications: Monoamine Oxidase Inhibitors (MAOIs) Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics Diagnosis of chronic pain disorder Reduced sensation of abdomen or pelvis (e.g. patients with spinal cord injury) Pre-existing stent or nephrostomy tube Urinary tract anomalies such as urinary diversion, horseshoe kidney, solitary kidney, urinary stricture disease, ureteropelvic junction obstruction, pelvic kidney, stone in calyceal diverticulum) Pulmonary disease Liver disease Seizure disorders Subjects taking nephrotoxic medications Subjects taking medications that can increase sedation risk (benzodiazepines or other sedative hypnotics)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mantu Gupta, MD
Phone
2122411272
Email
mantu.gupta@mountsinai.org
First Name & Middle Initial & Last Name or Official Title & Degree
Blair Gallante
Email
blair.gallante@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mantu Gupta, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai West
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mantu Gupta, MD
Phone
212-241-1272
Email
mantu.gupta@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Mantu Gupta

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only aggregate data will be shared

Learn more about this trial

Narcotic-Free Percutaneous Nephrolithotomy

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