Conditions: Nephrolithiasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 90
Healthy volunteers: no

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.

Arms:
arm 1: Patients will be prescribed 5mg Oxycodone, Q6 PRN postoperatively. arm 2: Patients will be prescribed 10mg Ketorolac, Q6 PRN postoperatively.

Interventions: intervention 1: 5mg Oxycodone, Q6 PRN intervention 2: 10mg Ketorolac, Q6 PRN
Intervention descriptions: intervention 1: Oxycodone is an opioid that is used to relieve moderate to severe pain. intervention 2: Ketorolac is an NSAID used to relieve moderately severe pain.

Protocol document:
Prot_SAP_001.pdf: 
Narcotic-Free Percutaneous Nephrolithotomy
NCT05924165
PI: Mantu Gupta, MD
Document Date: 4-9-2024


NARCOTIC-FREE PERCUTANEOUS 
NEPHROLITHOTOMY
Protocol Number: STUDY-23-00206
Principal Investigator: Mantu Gupta, MD
Funded by: Icahn School of Medicine at Mount Sinai
28 April 2023
Effective Date: 4/9/2024
End Date:4/8/2025


2
1
PROTOCOL SUMMARY
1.1
SYNOPSIS 
Title:
Narcotic-free Percutaneous Nephrolithotomy
Grant Number:
N/A
Study Description:
This is a randomized control trial comparing oral ketorolac and opioid 
medication for the use of post-operative analgesia.
Objectives:
Primary Objective: 
1.
To establish the non-inferiority of oral NSAIDs compared with
oral opioids for post-operative pain control after percutaneous
nephrolithotomy (PCNL)
Secondary Objectives: 
1.
To establish a standard of care pathway for post-PCNL pain
control
2.
To quantify average number of pills of pain medication required
after PCNL
Endpoints:
Primary Endpoint: 
●
Visual analog scale pain scores
Secondary Endpoints:
●
Pill counts
●
patient-related outcome survey (PROMIS) scores
●
Emergency room visits
●
Patient telephone calls
Study Population:
Adult patients 18 years and older with a planned standard percutaneous 
nephrolithotomy procedure   
Phase* or Stage:
N/A
Description of 
Sites/Facilities Enrolling 
Participants:
Written consent will be obtained at the approved clinic sites where the 
Principal Investigator sees patients (425 W. 59th Street, Suite 4F & 625 
Madison Ave, 2nd floor). Participants will undergo surgery at Mount Sinai 
West Hospital. Follow up will also occur at the aforementioned clinic sites.
Description of Study 
Intervention/Experimental 
Manipulation:
Patients undergoing PCNL will be randomized to receive either oxycodone 
or ketorolac for post-operative pain control
Study Duration*:
18-24 months
Participant Duration:
10 days
Effective Date: 4/9/2024
End Date:4/8/2025


3
Daily Visual Analog Score (VAS) via telephone call (days 1-5)
Telephone call for side effects (days 1-10)
1.2
SCHEMA 
Visit 1
<Time Point POD#0>
Visit 2
<Time Point: POD#1-10> 
Visit 3
<Time Point: POD#10>
Total N: 90
Screen potential participants by inclusion and exclusion criteria; Conduct informed 
consent process. Perform baseline assessments and medication reconciliation.
Randomize
Arm 2: Oxycodone
N = 45
Arm 1: Ketorolac
N = 45 
Day of PCNL, VAS prior to discharge from PACU
Return to office for stent removal, VAS, and PROMIS survey administration, tabulation of 
phone calls and ED visits, pill counts
Effective Date: 4/9/2024
End Date:4/8/2025


4
1.3
SCHEDULE OF ACTIVITIES
Outcome
POD#0
POD#1
POD#2
POD#3
POD#4
POD#5
POD#6
POD#7
POD#8
POD#9
POD#10
VAS Score 
(max and 
average)
X
X
X
X
X
X
X
PROMIS
X
Pill count
X
Side effect 
Telephone 
Call
x
x
x
x
x
x
x
x
x
x
x
2
INTRODUCTION
2.1
STUDY RATIONALE 
In the literature, there lacks a consensus on the utility of narcotics for post operative pain relief during 
percutaneous nephrolithotomy (PCNL). Physicians and surgeons have been entrusted with devising 
effective and strategic methods for lowering opioid prescription in light of the present national opioid 
epidemic. In place of opioid-based pharmaceuticals, urologists are increasingly recommending 
nonsteroidal anti-inflammatory drugs for postoperative analgesia due to encouraging findings, albeit 
anecdotal. We intend to conduct a prospective randomized study to demonstrate the noninferiority of 
NSAIDs (especially Ketorolac) against opioid-based medications.
Effective Date: 4/9/2024
End Date:4/8/2025


5
2.2
BACKGROUND 
Percutaneous Nephrolithotomy (PCNL) is the gold standard therapy for kidney stones larger than 2 cm, 
with a higher stone-free rate and fewer re-do procedures than ureteroscopic and shockwave procedures. 
Postoperative pain is a common concern for patients and a challenge for surgeons, since it is one of the 
most frequent reasons for hospital readmission. Pain following PCNL should be regarded as a result of the 
technique. Smaller diameter tracts and alternative postoperative renal drainage have been studied as 
potential pain-relieving strategies, but only for simple cases. Post-PCNL pain is largely controlled with 
analgesic medicines, in particular narcotics and recently non-steroidal anti-inflammatory drugs (NSAIDs) 
in order to limit opioid consumption. In urological operations, it has been demonstrated that patients are 
routinely over prescribed opioid pills.  The greatest issue with narcotics is their abuse, which may lead to 
addiction and deadly overdoses, and evidence indicates that even short-term usage of opioids for post-
operative pain can lead to long-term use. This opioid crisis is a significant concern presently with 
astounding figures. While both narcotics and NSAIDS are both commonly prescribed after PCNL, no 
standard of care has been established.
Recently, the use of NSAIDs has been promoted because prostaglandin inhibition in ureteral smooth 
muscle may be advantageous for both renal colic and postoperative pain. There is data that indicates the 
non-inferiority and safety of NSAIDs (mostly Ketorolac) compared to opioids in kidney stone (ureteroscopy 
and PCNL) post-operative therapy, indicating lower peak pain intensity and lower average pain levels in 
comparison to the narcotics control group. The average pain intensity and pain score were also evaluated 
one week following the surgery in another study that assessed pain one week later. A comparative 
examination of the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids is required to better 
establish the value of NSAIDs in post-operative PCNL care, resulting in the use of narcotics only when 
medically necessary and preventing potential addiction.
2.3
RISK/BENEFIT ASSESSMENT 
2.3.1
KNOWN POTENTIAL RISKS 
Side effects associated with Ketorolac include: 

Gastrointestinal and bleeding risks: nausea, vomiting, diarrhea, gas, peptic ulcers, gastrointestinal
bleeding, and/or perforation of the stomach or intestines

Cardiovascular risks: serious cardiovascular thrombotic events, myocardial infarction, stroke,
hypertension

Renal (kidney) risks: renal impairment (although this risk is low because eligible subjects must
have documented eGFR < 60 mL/min).

Other risks:  dizziness, drowsiness, mental/mood changes, allergic reactions
Effective Date: 4/9/2024
End Date:4/8/2025


6
Risks associated with oxycodone include constipation, nausea, vomiting, headache, pruritus (itchy skin), 
insomnia (trouble sleeping), dizziness, asthenia (weakness/tiredness), and somnolence (drowsiness).
Subjects will be counseled to call our office (24-hour line) if they experience any side effects so that they 
can discuss this with a provider. 
2.3.2
KNOWN POTENTIAL BENEFITS 
Given the duration of study and the “as needed” nature of post-operative analgesia, the prescription is 
for a limited number of days. We do not anticipate any further benefit to the study participants aside from 
adequate postoperative pain control. 
2.3.3
ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
Study participants will be exposed to commonly prescribed analgesic medication. Medication overuse will 
be minimized as no more than 3 days of ‘as needed medication” would be prescribed. 
3
OBJECTIVES AND ENDPOINTS 
OBJECTIVES
ENDPOINTS
JUSTIFICATION FOR 
ENDPOINTS
PUTATIVE 
MECHANISMS OF 
ACTION
Primary
To establish the non-
inferiority of oral NSAIDs 
compared with oral opioids 
for post-operative pain 
control after percutaneous 
nephrolithotomy (PCNL)
The primary endpoint will be 
determination of visual 
analog scale (VAS) pain 
scores on POD#0-5, and 
again on POD#10
VAS score is the 
most accurate 
representation of 
quantifiable pain 
post-operatively
N/A
Secondary
Effective Date: 4/9/2024
End Date:4/8/2025


7
OBJECTIVES
ENDPOINTS
JUSTIFICATION FOR 
ENDPOINTS
PUTATIVE 
MECHANISMS OF 
ACTION
1.
To establish a
standard of care
pathway for post-
PCNL pain control
2.
To quantify average
number of pills of
pain medication
required after PCNL
1.
Pill counts performed
on POD#10 (at time
of stent removal)
2.
Determination of
number of pain-
related office phone
calls and ED visits
Pill counts and 
pain-related office 
phone calls/ED 
visits will allow us 
to determine the 
feasibility of 
establishing a non-
opioid pathway 
after PCNL
N/A
Tertiary/Exploratory 
N/A
N/A
N/A  
N/A
4
STUDY DESIGN
4.1
OVERALL DESIGN
The proposed study will be a randomized controlled trial (RCT) designed to assess the non-inferiority of 
non-opioid pain management after PCNL.  Patients who are scheduled to undergo PCNL (see 
inclusion/exclusion criteria) will be randomized in a 1:1 ratio into one of two groups: 1) an opioid group, 
in which patients will be discharged home with 12 tablets of oxycodone (5mg, Q6 PRN) in addition to the 
standard post-procedural, stent-related medications of oxybutynin and phenazopyridine. 2) an NSAID 
group, in which patients will be discharged home with 12 tablets of ketorolac (10mg Q6 PRN) in addition 
to the standard post-procedural, stent-related medications of oxybutynin and phenazopyridine. While 
both oxycodone and ketorolac are both commonly prescribed after PCNL, no standard of care has been 
established. Block randomization will take place prior to study initiation and surgeons will be blinded to 
each patient’s allocated study group before and during surgery.  After informed consent, patients will then 
undergo PCNL as per standard of care in our practice.  A 6Fr silicone stent will also be placed at the end 
of the procedure as is the standard of care in our practice.  
Patients will be asked to provide their VAS pain score at multiple time points including POD#0 (just prior 
to discharge from hospital), and POD#1-5 (via telephone call).  At each of these time points, maximum 
and average VAS scores for the preceding 24 hours will be provided. Patients will also be asked if they are 
experiencing any side effects on POD #1-10 via telephone call. As is our routine practice, patients will have 
their stents removed on POD#10 in the office.  During this office visit, patients will again provide a VAS 
pain score, and will complete the PROMIS survey (see attachment).  Pill counts will be performed of all 
prescription medications and tabulation of pain-related office phone calls and ED visits will also be 
performed.  Thus, patients will be enrolled for a total of 10 days.
Effective Date: 4/9/2024
End Date:4/8/2025


8
Patients will be instructed to call our 24-hour phone number if they run out of medication, are 
experiencing pain, or are experiencing side effects. The surgeon will evaluate the patient’s pain intensity. 
If the patient's pain is controlled while on the allocated medication and has ran out of medication, the 
doctor will refill the same medication. However, if the patient’s pain is not being controlled adequately or 
if they are not tolerating the medication/experiencing side effects, the surgeon will prescribe the other 
medication and they will cross over to the other study group.  
4.2
SCIENTIFIC RATIONALE FOR STUDY DESIGN
In this study, the group receiving opioids (oxycodone) will be considered our control group.  This is still 
considered the standard of care in parts of the world. Our comparison group has been chosen to receive 
ketorolac for several reasons.  First, NSAIDs such as ketorolac provide analgesic and anti-inflammatory 
pathways that have both been shown to reduce renal- and stent-related colic.  Second, ketorolac (and 
NSAIDs in general) have been demonstrated to be non-inferior in terms of pain control during 
ureteroscopic laser lithotripsy, a less invasive type of surgery for kidney stones. 
Opioids have gained worldwide attention in recent years due to their potential for abuse, addiction, in 
addition to their other side effects of nausea, vomiting, constipation, and altered mental status.  In this 
regard, ketorolac has no known potential for addiction or abuse, and has a relatively favorable side effect 
profile.
4.3
JUSTIFICATION FOR INTERVENTION
Both post operative medications are commonly prescribed but a head-to-head comparison of their 
efficacy has not been studied in a prospective randomized study. Study participation requires no 
additional visits or excessive effort placed upon the study participants as standard of care intervention 
and follow will be the same regardless of study participation or not.
4.4
END-OF-STUDY DEFINITION
A participant is considered to have completed the study if he or she has completed the baseline 
assessment, provided VAS pain scores on POD#1-5 via phone call, and returned for stent removal on 
POD#10, at which time pill counts and PROMIS survey will be performed.
5
STUDY POPULATION
5.1
INCLUSION CRITERIA
In order to be eligible to participate in this study, an individual must meet the following criteria:
Effective Date: 4/9/2024
End Date:4/8/2025


9
1.
Undergoing scheduled unilateral standard (24Fr), PCNL with at least 2cm stone burden, with
expected single access
5.2
EXCLUSION CRITERIA
An individual who meets any of the following criteria will be excluded from participation in this study:
1.
Pregnant women
2.
History of chronic opioid abuse
3.
Allergy, hypersensitivity, or other contraindication to NSAID usage such as
o
eGFR < 60 mL/min
o
Peptic ulcer disease or history of gastric bypass
o
Concurrent use of antiplatelet or anticoagulation therapy (including aspirin)
o
Thrombocytopenia
o
Suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis,
incomplete hemostasis, and those at high risk of bleeding.
o
Concomitant medications:
▪
Other NSAIDs
▪
Antiplatelet or anticoagulation medications
▪
Probenecid
▪
Pentoxifylline
4.
Allergy, hypersensitivity, or other contraindication to opioids:
o
Current opioid prescription/usage for any reason, including active treatment with
suboxone or methadone
o
Respiratory depression
o
Patients with acute or severe bronchial asthma or hypercarbia
o
Patients who have or is suspected of having paralytic ileus as PCNL done under general
anesthesia
o
Patients with hepatic Impairment
o
Concomitant medications:
▪
Monoamine Oxidase Inhibitors (MAOIs)
▪
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
5.
Diagnosis of chronic pain disorder
6.
Reduced sensation of abdomen or pelvis (e.g. patients with spinal cord injury)
7.
Pre-existing stent or nephrostomy tube
8.
Urinary tract anomalies such as urinary diversion, horseshoe kidney, solitary kidney, urinary
stricture disease, ureteropelvic junction obstruction, pelvic kidney, stone in calyceal diverticulum)
9.
Pulmonary disease
10. Liver disease
11. Seizure disorders
12. Subjects taking nephrotoxic medications
13. Subjects taking medications that can increase sedation risk (benzodiazepines or other sedative
hypnotics)
Effective Date: 4/9/2024
End Date:4/8/2025


10
5.3
LIFESTYLE CONSIDERATIONS
If the subject can possibly get pregnant, they must agree to use at least two forms of contraception. All 
subjects that can get pregnant will be given a pregnancy test on the day of the procedure in the pre-
operative area. 
5.4
SCREEN FAILURES
Screen failures are defined as participants who consent to participate in this study but are not 
subsequently assigned to the study intervention or entered in the study. Individuals who do not meet the 
criteria for participation in this trial (screen failure) because of meeting one or more exclusion criteria that 
are likely to change over time may be rescreened.
Examples of screen failures specific to this trial include:
1.
Intraoperative determination of need for more than 1 access tract
2.
Significant renal pelvis perforation and/or urinary extravasation
5.5
STRATEGIES FOR RECRUITMENT AND RETENTION
Patients will be recruited from the practices of Dr. Mantu Gupta and Dr. Atallah.  Dr. Gupta and Dr. Atallah 
have one of the busiest kidney stone practices in the area providing ample patients to recruit into the 
study.  We do not anticipate any issues with retention as patient involvement will occur at two visits.  The 
first visit on the day of the surgical intervention. The second visit takes place during an obligatory 
outpatient follow up visit.  The follow up visit is considered obligatory as patients will have their ureteral 
stents removed at this visit. 
6
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S)
6.1
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION
6.1.1
STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION
Randomization will occur preoperatively. All subjects will undergo surgical interventions that abide by 
broadly accepted guidelines and standards of care, allowing for slight variations in technique as seen 
necessary by the attending surgeon Dr. Gupta and Dr. Atallah.
Subjects are assigned to receive either Oxycodone or Ketorolac postoperatively. 
Effective Date: 4/9/2024
End Date:4/8/2025


11
6.1.2
ADMINISTRATION AND/OR DOSING
Oxycodone dose: 12 tablets of 5mg, Q6 PRN
Ketorolac dose: 12 tablets of 10mg, Q6 PRN
6.2
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING
Randomization in this study will be performed prior to initiation of patient enrollment via computer-based 
algorithm.  All study staff members who are active participants in patient care (e.g. surgeons) will be 
blinded to the allocated study sequence before and during surgery.  After surgery, the surgeon will 
prescribe the allocated medications.
Subjects will not be blinded to their study group. 
6.3
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE
In order to remain active in the study, participants will receive a phone call once daily for the first 5 days 
after surgery (POD#1-5).  During this phone call, VAS pain scores will be assessed, and participants will be 
reminded to adhere to the prescribed study medications to the extent possible.
6.4
CONCOMITANT THERAPY
For this protocol, participants may use non-opioid analgesics for pain control, including over-the-counter 
medications such as acetaminophen (in both groups) and over-the-counter NSAIDs (in the opioid group), 
and prescribed medications.  Participants in the ketorolac group will be advised not to take additional 
over-the-counter NSAIDs (e.g. ibuprofen). Medication usage will be assessed at each study visit and 
documented. 
6.4.1
RESCUE THERAPY
Rescue therapy will not routinely be prescribed at study initiation.  Participants have access to a physician 
within the study group at all times via telephone call.  If pain control is inadequate with study medications, 
participants who call may be prescribed additional rescue medication. If the patient's pain is controlled 
while on the allocated medication and has ran out of medication, the doctor will refill the same 
medication. However, if the patient’s pain is not being controlled adequately or if they are not tolerating 
the medication/experiencing side effects, the surgeon will prescribe the other medication and they will 
cross over to the other study group.  
Effective Date: 4/9/2024
End Date:4/8/2025


12
7
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL
7.1
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION
Discontinuation of study medication will take place if the patient has any adverse effects or allergic 
reactions to the medication. Patients will be instructed to call the study team if any adverse effects occur. 
Additionally, a member of the study team will screen for any adverse events during the phone calls on 
POD’S 1-5.  
7.2
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY
Patients will be considered enrolled in the study once consent has been signed. Participants may discontinue or 
withdraw from the study for any reason and at any point in time through the conclusion of the study.
7.3
LOST TO FOLLOW-UP
A single follow up visit is required to complete enrollment criteria for this study. Participants who fail to show up to 
their first follow up appointment for stent removal will be automatically withdrawn from the study and previously 
collected urine samples will be discarded as above.
8
STUDY ASSESSMENTS AND PROCEDURES
8.1
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS
8.1.1
DEFINITION OF ADVERSE EVENTS
Any untoward medical occurrence, unintended sign, symptom, illness or disease temporally associated 
with the study protocol regardless of the suspected cause.
8.1.2
DEFINITION OF SERIOUS ADVERSE EVENTS
Effective Date: 4/9/2024
End Date:4/8/2025


13
An Adverse Event that is considered “serious” if it meets at minimum one of the three Seriousness 
reporting criterions below:
1. Led to death,
2. Led to a serious injury which:
a. Resulted in a life-threatening illness or injury, or
b. Resulted in a permanent impairment of a body structure or a body function, or
c. Resulted in medical or surgical intervention to prevent life-threatening illness or injury or
permanent impairment to a body structure or a body function
8.1.3
CLASSIFICATION OF AN ADVERSE EVENT
8.1.1.1 SEVERITY OF EVENT
•
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily
activities.
•
Moderate – Events result in a low level of inconvenience or concern with the therapeutic
measures. Moderate events may cause some interference with functioning.
•
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug
therapy or other treatment. Severe events are usually potentially life-threatening or
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”.]
8.1.1.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION
All AEs will be assessed for relationship to the study protocol based on the following definitions:
Not Related: There is no clear evidence that the AE has a relationship to the study protocol and can be 
attributed to an underlying or concurrent illness/clinical condition or an effect of another device, drug or 
treatment.
Related: There is a clear causal relationship of the AE to the marketed device or procedure beyond 
reasonable doubt.
8.1.2
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP
All enrolled subjects will be monitored for adverse events by review of the medical record on a monthly 
basis by Dr. Gupta.  Subjects will have routine follow up scheduled 10 days postoperatively at which time 
in-person visit will be performed and assessment of adverse events may be performed.
8.1.3
ADVERSE EVENT REPORTING 
Effective Date: 4/9/2024
End Date:4/8/2025


14
Adverse events must be reported to the IRB as soon as possible and no later than 2 working days after 
the PI first becomes aware of the event. The PI or designee must record all AE information that can be 
gathered within the reporting timeframe and enter it onto the AE eCRF.
Relevant follow-up information should be submitted to the IRB as soon as it becomes available and/or 
upon request. 
8.1.4
SERIOUS ADVERSE EVENT REPORTING 
Serious adverse events must be reported to the IRB as soon as possible and no later than 2 working 
days after the PI first becomes aware of the event. The PI or designee must record all AE information 
that can be gathered within the reporting timeframe and enter it onto the AE eCRF.
Relevant follow-up information should be submitted to the IRB as soon as it becomes available and/or 
upon request. 
8.1.5
REPORTING EVENTS TO PARTICIPANTS 
All SAE’s or AE’s will be reported to affected participants by the principal investigator directly.
9
STATISTICAL CONSIDERATIONS 
9.1
STATISTICAL HYPOTHESES
Null Hypothesis: There is no difference in post operative pain control between NSAIDS and narcotics
Alternative Hypothesis: There is a difference in post operative pain control between NSAIDS and narcotics
9.2
SAMPLE SIZE DETERMINATION
To obtain a statistical power of 80% with a 5% significance level (alpha), with a 2.5 standard deviation of 
the outcome, a sample size of 80 subjects would be required to run a non-inferiority study between the 
two arms. A noninferiority limit of 1.4 was chosen based on prior literature appropriate to this study 
population.
To account for the possibility of screen failures (intraoperative determination of need for more than 1 
access tract, renal pelvis perforation, and/or urinary extravasation), 10 patients have been added which 
equals 90 patients total enrolled. 
Effective Date: 4/9/2024
End Date:4/8/2025


15
9.3
POPULATIONS FOR ANALYSES
We will be performing an intention-to-treat analysis, and all enrolled subjects will be included for analyses. 
9.4
STATISTICAL ANALYSES
9.4.1
GENERAL APPROACH
Survey, quantitative, and qualitative variables will be presented as medians, interquartile ranges, and 
percent, respectively.  The p-value to be used for statistical significance is 0.05 (two-tailed).
9.4.2
ANALYSIS OF THE PRIMARY ENDPOINT(S)
Visual analog scale pain scores will be analyzed using t-tests to compare medians.  
9.4.3
ANALYSIS OF THE SECONDARY ENDPOINT(S)
Pill counts and patient-related outcome survey (PROMIS) scores will be analyzed using t-tests to compare 
medians. 
Emergency room visits and patient telephone calls will be analyzed as categorical outcomes using Chi-
squares. 
10
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS
10.1.1 INFORMED CONSENT PROCESS
The standard informed consent process for research outlined in SOP HRP-090 will be followed. 
Effective Date: 4/9/2024
End Date:4/8/2025


16
10.1.1.1
CONSENT PROCEDURES AND DOCUMENTATION
Subjects will be recruited from Dr. Mantu Gupta’s and Dr. William Atallah’s practice. Patients will be 
recruited during initial presentation to the office. Consent will be obtained at the initial office visit when 
decision to proceed to surgery has been made.
Potential subjects will be informed of the study at their preoperative visit (see above point) and may 
sign the consent at that time if they feel comfortable.  If subjects require time for further contemplation, 
the consent may be signed on the day of surgery in the preoperative area (prior to administration of any 
anesthesia).  This gives potential subjects at least 24 hours to consider the study and review the consent 
form.
We anticipate that no more than 5-10 minutes will generally be required to explain the consent form.  
However, longer and more extensive discussions will be available to those who request or require.  All 
potential subjects will be verbally informed that their participation is completely optional and that their 
decision of whether or not to participate does not impact their care in any manner.  Subjects will be 
asked to verbally repeat and summarize their involvement in the study.  A copy of the consent form will 
be provided to the subject directly after signing the form.
10.1.2 CONFIDENTIALITY AND PRIVACY 
 All data will be housed in Mount Sinai’s REDCap database. The data is will be deidentified and stored with 
protected passwords. The data will be reported to the sites in aggregate. The publication will also not 
mention any center by name. The results in the publication will be in aggregate form and anonymous.
Urine samples will be kept in a secure freezer in the Mount Sinai West pathology lab.  Only study staff will 
have access to these samples.
10.1.3 FUTURE USE OF STORED SPECIMENS AND DATA 
The data will be deleted 6 years after publication, per regulations. Data will not be shared with any outside 
organizations.  
10.1.3.1
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
Effective Date: 4/9/2024
End Date:4/8/2025


17
Data collection will be the responsibility of the research staff at the site under the supervision of the site 
investigator. The investigator will be responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported.
All source documents will be completed in a neat, legible manner to ensure accurate interpretation of 
data.  
Hardcopies of the study visit worksheets will be provided for use as source document worksheets for 
recording data for each participant consented/enrolled in the study.  Data recorded in the electronic case 
report form (eCRF) derived from source documents will be consistent with the data recorded on the 
source documents. 
Clinical data (including adverse events (AEs), concomitant medications, and expected adverse reactions 
data) and clinical laboratory data will be entered into the electronic data capture (EDC) system, a 21 CFR 
Part 11-compliant data capture system. The data system includes password protection and internal quality 
checks, such as automatic range checks, to identify data that appear inconsistent, incomplete, or 
inaccurate. Clinical data will be entered directly from the source documents.
The data safety will be monitored by the PI.
10.1.3.2
STUDY RECORDS RETENTION 
Study documents will be retained until at least 6 years have elapsed since the formal discontinuation of 
clinical development of the study intervention. These documents should be retained for a longer period, 
however, if required by local regulations. No records will be destroyed without the written consent of the 
principal investigator.
10.1.4 PROTOCOL DEVIATIONS 
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, 
International Council on Harmonization Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) 
requirements. The noncompliance may be either on the part of the participant, the investigator, or the 
study site staff. As a result of deviations, corrective actions will be developed by the site and implemented 
promptly. 
It will be the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within 5 working days of identification of the protocol deviation, or within 5 working days of 
the scheduled protocol-required activity. All deviations will be addressed in study source documents. 
Effective Date: 4/9/2024
End Date:4/8/2025


18
Protocol deviations will be sent to the reviewing Institutional Review Board (IRB) per their policies. The 
site investigator will be responsible for knowing and adhering to the reviewing IRB requirements.
The PI will be responsible for any vigilance and monitoring of the data.
Effective Date: 4/9/2024
End Date:4/8/2025

ICF_000.pdf: 
Narcotic-Free Percutaneous Nephrolithotomy
NCT05924165
PI: Mantu Gupta, MD
Document Date: 4-9-2024


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__________________________
STUDY INFORMATION:
Study Title: Narcotic-Free Percutaneous Nephrolithotomy 
Study site(s): Mount Sinai West
Principal Investigator (Lead Researcher): Mantu Gupta, MD
Physical Address: 425 W. 59th Street, Suite 4F. New York, NY 10019
Mailing Address: 425 W. 59th Street, Suite 4F. New York, NY 10019
Phone: 212-241-1272
____________________________
SUMMARY OF THIS RESEARCH STUDY:
This document explains a research study you might be interested in joining.  Participation in the study 
is voluntary. You can agree to join or not. Your decision will not limit your ability to receive care at Mount 
Sinai. You should only agree to take part if you understand the study and if all of your questions about 
the research study are answered. If you do join the study, the research team must share any new 
information with you that may change your mind about taking part.
The purpose of this research study is to determine if a non-steroidal anti-inflammatory drug (NSAID) 
called ketorolac (similar to ibuprofen) is an effective alternative to narcotic pain medication (oxycodone) 
following kidney stone removal surgery (percutaneous nephrolithotomy).
If you choose to take part, no additional visits are required, and there is only a minimal change from the 
normal standard of care. You will be asked to: 

Complete a brief, one question survey regarding your pain levels via telephone call for the first 
five days after surgery. 

Bring your leftover medication that was prescribed to you after surgery to your follow up 
appointment for a pill count

Complete a five-minute survey during your follow up appointment regarding your pain/discomfort 
and post operative experience 

Agree to have private information study data stored for the duration of the study. Once the study 
is complete, your data will be de-identified. 

There is no payment for taking part in the study. 
If you choose to take part, the main risks to you are potential side effects from each medication. The 
main risks associated with ketorolac include gastrointestinal upset and renal impairment (although this 
Effective Date: 4/9/2024
End Date:4/8/2025


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is very rare). The main risks associated with oxycodone include constipation and nausea/vomiting. A 
full list of potential side effects can be found in the risks section of this consent form. If you run out of 
medication, your pain is not well controlled, or if you are having side effects from your medication, 
please call our 24-hour phone number (212-241-1272) to speak to a member of our team. Our team 
will prescribe you additional medication or a different medication to help with your pain. 
You will not benefit directly from taking part in this research.
Instead of taking part in this research, you may have your kidney stone removal surgery without taking 
part in this research study. As part of standard care your physician may prescribe either ketorolac, 
oxycodone or some other pain medication for postoperative pain management.
If you are interested in learning more about this study, please continue to read below.
____________________________
STUDY PARTICIPATION: 
You may qualify to take part in this research study because you are scheduled to undergo kidney stone 
removal surgery, called percutaneous nephrolithotomy (PCNL). 
Your participation in this research study is expected to last 10-14 days. 
There are 90 people expected to take part in this research study at Mount Sinai West. 
Funds for conducting this research study are provided by Mount Sinai.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This website will not include information that can identify you. At most, the website will include a 
summary of the results. You can search this website at any time.
 
__________________________
DESCRIPTION OF WHAT IS INVOLVED:
If you agree to take part in this research study, here is what may be involved:
o
On the day of surgery, you will undergo PCNL with your study doctor according to the standard of 
care. 
o
Following surgery, you will be randomly assigned to one of two groups which will decide what 
medications are prescribed to you for postoperative pain:
1.
Ketorolac (an NSAID medication similar to ibuprofen)
2.
Oxycodone (a narcotic medication)
Effective Date: 4/9/2024
End Date:4/8/2025


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o
Both medications are routinely prescribed after PCNL and considered normal standard of care. 
o
Following surgery, a member of the research team will ask you what your pain level is on a scale of 
1-10. 
o
For the first ten days after surgery, a member of the research team will follow up with you via 
telephone call to ask you what your pain level is on a scale of 1-10 (for the first five days) and if you 
are experiencing any side effects (for all ten days).  
o
When you return to the office for your stent removal 10-14 days after surgery, you will be instructed 
to bring back all your unused medication so that we can conduct a pill count. A team member will 
call you 24 hours before your appointment for an additional reminder. 
o
At your follow up appointment, you will be asked to complete a five-minute survey about your 
postoperative pain and experience. You will also be asked to rate your pain on a scale of 1-10. 
o
After the surveys and pill count are done, your participation in the study is complete. 
Randomization
No one, not you, or anyone from your medical team or from the research team will be able to choose 
what post operative medication you are prescribed. It will be by chance, like flipping a coin. You will 
have an equal one in two chance of being given each medication. 
Pregnancy
If you can possibly get pregnant, a urine test for pregnancy will be done before you begin the study on 
the day of surgery.
You cannot be included in the study if you are or become pregnant, as the study drugs could harm 
your fetus. You also should not be in the study if you are producing milk to feed a child as the study 
drug could harm your baby.
Unless you are at least one year past menopause or have had a successful operation to make 
pregnancy impossible, you should use at least two methods of effective birth control. Unless you are 
sexually abstinent (not having genital sex) the recommended methods of birth control are:

The consistent use of approved hormonal birth control (pill, patches, or rings), 

An intrauterine device (IUD), 

Contraceptive injection (Depo-Provera), 

Double barrier methods (Diaphragm with spermicidal gel or condoms with contraceptive foam), 

Sexual abstinence (no sexual activity), 

Sterilization (a vasectomy, getting tubes tied, or a hysterectomy).
All birth control methods (other than abstinence and sterilization) are only effective if you use them 
properly, start them at least one month before you begin the research study, and continue using them 
throughout the research study and for one month after the research study ends. If you are unsure 
Effective Date: 4/9/2024
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whether the method of birth control you use is approved to use while you are in this study, you should 
ask the Lead Researcher before you begin the study. If you are less than one-year post-menopausal, 
you could still become pregnant. If you or your partner becomes pregnant, or may be pregnant, at any 
time during the study, you must tell a person from the research team immediately. The team may stop 
the study drug and refer you/your partner to an obstetrician/gynecologist for follow-up. 
Should you/your partner become pregnant, whether or not you/your partner have the baby, the people 
funding and overseeing the research may ask for information on the pregnancy, even if you are no 
longer part of the study. You/your partner will be asked for additional written consent to share this 
information if that happens.
____________________________
USE OF YOUR DATA AND/OR SAMPLES:
In addition to being used to complete this research study, your personal information (such as, name, 
address, date of birth, social security number), and study data may also be used and shared for 
additional (future) research.  Before anything is shared, all of your identifying personal information will 
be removed and it will be replaced with a code. Researchers are not planning on giving you the details 
of any of this future research nor the results. That means that a research project might be done that you 
would not consent to if provided with the details of that research project. If you do not want any future 
research to be done with your data, even with your identity removed, please do not sign this consent 
form or take part in the study.    
____________________________
YOUR RESPONSIBILITIES IF YOU TAKE PART IN THIS RESEARCH:
If you decide to take part in this research study, you will be responsible for the following things:

Follow the directions of the study doctor and study staff. 

Allow us to follow your care for 10-14 days and access your medical records

Complete the telephone survey for the first five days after surgery

Return to the office for your follow up appointment and take the five minute survey given to you.

Call our 24-hour phone number (212-241-1272) if you run out of medication, are experiencing 
severe pain, or you are experiencing side effects from your medication. 
____________________________
COSTS OR PAYMENTS THAT MAY RESULT FROM PARTICIPATION:
You will not be paid for taking part in this study. Being in this study will not cost you anything extra. 
____________________________
POSSIBLE BENEFITS:
This study is not designed to benefit you personally. However, we hope the information from this study 
will provide valuable data on the pain medications needed after kidney stone surgery.  
Effective Date: 4/9/2024
End Date:4/8/2025


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____________________________
POSSIBLE RISKS AND DISCOMFORTS:

Physical risks include side effects for each medication:
o
Risks associated with oxycodone include constipation, nausea, vomiting, 
headache, pruritus (itchy skin), insomnia (trouble sleeping), dizziness, asthenia 
(weakness/tiredness), and somnolence (drowsiness).
o
Risks associated with ketorolac include:

Gastrointestinal and bleeding risks: nausea, vomiting, diarrhea, gas, peptic 
ulcers, gastrointestinal bleeding, and/or perforation of the stomach or 
intestines

Cardiovascular risks: serious cardiovascular thrombotic events (blood clots), 
myocardial infarction (heart attack), stroke, hypertension

Renal (kidney) risks: renal impairment (this is rare because your baseline 
renal function is normal).

Other risks:  dizziness, drowsiness, mental/mood changes, allergic 
reactions (rare) 

Risk of loss of private information; this risk always exists, but there are procedures in place 
to minimize the risk.  

Group Risks - Although your name will not be given to researchers, basic information such 
as your race, ethnic group, and sex may be shared. This information helps researchers 
learn whether the factors that lead to health problems are the same in different groups of 
people. It is possible that such findings could one day help people of the same race, ethnic 
group, or sex as you. However, they could also be used to support harmful stereotypes or 
discrimination. 

Privacy Risks - Your name and other information that could directly identify you (such as an 
address, date of birth, or social security number) will never be placed into a database. 
However, because your genetic information is unique to you, there is a small chance that 
someone could trace it back to you. The risk of this happening is very small, but may grow 
in the future. Since the database contains genetic information, a break in security may also 
pose a potential risk to blood relatives as well as yourself. For example, it could be used to 
make it harder for you (or a relative) to get or keep a job or insurance. If your private 
information was misused, it is possible you would experience other harms, such as stress, 
anxiety, stigmatization, or embarrassment from revealing information about your family 
relationships, ethnic heritage, or health conditions.
____________________________
OTHER OPTIONS TO CONSIDER:
You may decide not to take part in this research study. If you decide not to take part, this will not affect 
the clinical care you receive at Mount Sinai. The choice is totally up to you.
Effective Date: 4/9/2024
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Instead of being in this research study, you can still have the kidney stone removal surgery described 
in this study. 
____________________________
IN CASE OF INJURY DURING THIS RESEARCH STUDY 
If you are injured or made sick from taking part in this research study, you will get medical care. 
Generally, it will be billed to you or your insurance.  You will be responsible for all treatment costs not 
covered by your insurance, including deductibles, copayments, and coinsurance. This does not prevent 
you from seeking payment for injury related to malpractice or negligence. You can contact the Lead 
Researcher for more information.
____________________________
ENDING PARTICIPATION IN THE RESEARCH STUDY:
You may stop taking part in this study at any time.  No matter what you choose, your care and benefits 
through Mount Sinai will not be negatively impacted.
If you decide to stop being in the study, please contact the Lead Researcher or the research staff.   
You may also withdraw your permission for the researchers to use and share any of your protected 
information for research, but you must do so in writing to the Lead Researcher at the address on the 
first page. Even if you withdraw your permission, the Lead Researcher may still use the information that 
was already collected if that information is necessary to complete the research study. Your health 
information may still be used or shared after you withdraw your authorization if you have an adverse 
event (a bad effect) from taking part in the research study.
If you decide you don’t want your data to be used for research anymore, you can contact the researcher 
and ask to have your data withdrawn or labeled so that they will not to be used in additional projects or 
shared. If your data have already been shared with researchers, those researchers will be asked to stop 
using them. However, if any data has already been shared without your identity or a linking code, it 
won’t be possible to retrieve them. Data that have already been used will not be affected by your 
decision. If your data have already been deposited in an external repository, the study team will request 
that your data be removed.
Withdrawal without your consent: The Lead Researcher, the funder or Mount Sinai may stop your 
involvement in this research study at any time without your consent. This may be because the research 
study is being stopped, the instructions of the research team have not been followed, the Lead 
Researcher believes it is in your best interest, or for any other reason. If data have been stored as part 
of the research study, they too can be destroyed without your consent.  
Effective Date: 4/9/2024
End Date:4/8/2025


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____________________________
CONTACT INFORMATION:
If you have any questions, concerns or complaints at any time about this research, or you think the 
research has harmed you, please contact the office of the research team and/or the Lead Researcher 
at phone number 212-241-1272.
____________________________
DISCLOSURE OF FINANCIAL INTERESTS:
Researchers sometimes get paid for consulting or doing work for companies that produce drugs, 
biologics or medical devices. If you have questions regarding industry relationships, you are 
encouraged to talk to the Lead Researcher or visit our website at http://icahn.mssm.edu/ where Mount 
Sinai publicly discloses the industry relationships of our faculty.   
____________________________
MAINTAINING CONFIDENTIALITY – HIPAA AUTHORIZATION:
As part of this study, some of your private and/or protected health information will be obtained, used, 
and shared with your permission. There is a Federal Health Insurance Portability and Accountability Act 
(HIPAA) that makes sure this is done correctly and safely. 
What is protected health information (PHI)? 
PHI is the combination of two things:
1.
PHI contains information that identifies you. It will be used to contact you and link you to your 
health information, like name, date of birth, medical record number, and address.  
2.
PHI also contains health information, including information about your mental and physical 
health from your visits to doctors or hospitals, or from study visits. 
Every time you visit a hospital or your doctor, PHI is created and recorded in your medical record by 
your healthcare providers. In the same way, the PHI created as part of this study will be linked to who 
you are and your medical information. 
What PHI is collected and used in this research study, and might also be shared with others? 
As part of this study, the research team at the hospital(s) involved in the research will collect your 
address, telephone number, dates directly related to you (birth, admission, discharge, follow up date), 
and medical records number. 
Effective Date: 4/9/2024
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During the study, the researchers will gather information by: 

Reviewing and/or taking your medical history (includes current and past medications or 
therapies, illnesses, conditions or symptoms, family medical history, allergies, etc.) 

Doing a physical examination that generally also includes blood pressure reading, heart rate, 
breathing rate, and temperature.

Completing the tests, procedures, questionnaires and interviews explained in the description 
section of this consent.
Why is your PHI being used?
Researchers need the information that identifies you so they can contact you during the study. They 
need your health information and the results of any tests and procedures being collected as part of this 
study to answer the questions posed in the study. The purpose of the study is discussed earlier in this 
consent form. Before researchers analyze the data, they remove any information that would let others 
know who you are or that you took part in the study. If researchers publish or present study results at 
scientific meetings, lectures, or other events, their presentations would not include any information that 
would let others know who you are, unless you give separate permission to do so.
The Lead Researcher may also use and share the results of these tests and procedures with other 
healthcare providers at Mount Sinai who are involved in your care or treatment. The research team and 
other authorized members of The Mount Sinai Health System (“Mount Sinai”) workforce may use and 
share your information to ensure that the research meets legal, institutional or accreditation 
requirements. For example:

The Mount Sinai Program for the Protection of Human Subjects is responsible for overseeing 
research on human participants and may need to see your information. 

If you receive any payments for taking part in this study, the Mount Sinai Finance Department 
may need your name, address, social security number, payment amount, and related 
information for tax reporting purposes.  

If the research team uncovers abuse, neglect, or reportable diseases, this information may be 
disclosed to appropriate authorities. 
Who, outside Mount Sinai, might receive your PHI?
As part of the study, the Lead Researcher, research team and others in the Mount Sinai workforce may 
disclose your PHI, including the results of the research study tests and procedures, to the following 
people or organizations: (It is possible that there may be changes to the list during this research study; 
you may request an up-to-date list at any time by contacting the Lead Researcher.)
-
The United States Department of Health and Human Services (DHHS) and the Office of 
Human Research Protection (OHRP) (the government organization that is responsible for 
protecting human research participants).
In all disclosures outside of Mount Sinai, you will not be identified by name, social security number, 
address, telephone number, or any other direct personal identifier unless disclosure of the direct 
Effective Date: 4/9/2024
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identifier is required by law. Some records and information disclosed may be identified with a unique 
code number. The Lead Researcher will ensure that the key to the code will be kept in a locked file, or 
will be securely stored electronically. The code will not be used to link the information back to you 
without your permission, unless the law requires it, or rarely if the Institutional Review Board (IRB) 
allows it after determining that there would be minimal risk to your privacy. It is possible that a sponsor 
or their representatives, a data coordinating office, a contract research organization, may come to 
inspect your records. Even if those records are identifiable when inspected, the information leaving the 
institution will be stripped of direct identifiers.  Additionally, when applicable, the monitors, auditors, the 
IRB, OHRP, as well as the Food and Drug Administration (FDA) will be granted direct access to your 
medical records for verification of the research procedures and data. OHRP and FDA are authorized to 
remove information with identifiers if necessary to complete their task. By signing this document you 
are authorizing this access. The results of this research may be published. However, your name and 
other identifying information will be kept confidential.
For how long will Mount Sinai be able to use or disclose your PHI? 
Your authorization for use of your PHI for this specific study does not expire.
Will you be able to access your records?
During your participation in this study, you will have access to your medical record and any study 
information that is part of that record. The research team is not required to release research information 
to you that is not part of your medical record.
Do you need to give the researchers permission to obtain, use or share your PHI?
NO! If you decide not to let the research team obtain, use or share your PHI, you should not sign this 
form, and you will not be allowed to volunteer in the research study. If you do not sign, it will not affect 
your treatment, payment, or enrollment in any health plans or affect your eligibility for benefits.
Can you change your mind?
If you decide to stop being in the study, please contact the Lead Researcher or the research staff.
The research team may ask you whether they can continue to collect information from your medical 
record. You will also have to decide if you wish to limit the continued use of the information collected 
during the study. Under US privacy laws you may also withdraw your permission for the researchers to 
use and share any of your protected information for research, but you must do so in writing to the Lead 
Researcher at the address on the first page. 
Even if you withdraw your permission, the Lead Researcher may still use the information that was 
already collected, but only to complete this research study. Your health information may still be used or 
shared after you withdraw your authorization if you have an adverse event (a bad effect) from taking 
part in the research study.
Effective Date: 4/9/2024
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It is important for you to understand that once information is disclosed to others outside Mount Sinai, 
the information may be re-disclosed and will no longer be covered by the federal privacy protection 
regulations. However, where possible, Mount Sinai has entered into agreements with those who will 
receive your information to continue to protect your confidentiality.
If researchers are reviewing your medical records or asking questions about your medical history or 
conditions, it is possible that they may learn information related to your HIV status. If that is the case, 
the following information concerns you. If researchers are not reviewing your medical records or asking 
questions about your medical history or conditions, then you may ignore the following section.
_________________________________________________________________________________
Notice Concerning HIV-Related Information 
If you are authorizing the release of HIV-related information, you should be aware that the recipient(s) is 
(are) prohibited from re-disclosing any HIV-related information without your authorization unless permitted 
to do so under federal or state law. You also have a right to request a list of people who may receive or use 
your HIV-related information without authorization. If you experience discrimination because of the release 
or disclosure of HIV-related information, you may contact the New York State Division of Human Rights at 
(888) 392-3644 or the New York City Commission on Human Rights at (212) 306-5070. These agencies are 
responsible for protecting your rights.
_____________________________________________________________________________________
____________________________
How the Institutional Review Board (IRB) can help you:
This research has been reviewed and approved by an Institutional Review Board (IRB). You may reach 
a representative of the Mount Sinai Program for Protection of Human Subjects at telephone number 
(212) 824-8200 during regular work hours (Monday-Friday, 9am-5pm, excluding holidays) for any of the 
reasons listed below. This office will direct your call to the right person within the Mount Sinai Health 
System:

Your questions, concerns, or complaints are not being answered by the research team.

You cannot reach the research team.

You are not comfortable talking to the research team.

You have questions about your rights as a research participant.

You want to get information or provide input about this research.
Effective Date: 4/9/2024
End Date:4/8/2025


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ADULT PARTICIPANT:
Your signature below documents your permission to take part in this research study and to the use and 
disclosure of your protected health information. A signed and dated copy will be given to you.
_________________________
_________________________
__________
__________
Signature of Participant
Printed Name of Participant
Date
Time
PERSON EXPLAINING STUDY AND OBTAINING CONSENT:
_________________________
_________________________
__________
__________
Signature of Consent Delegate
Printed Name of Consent Delegate
Date
Time
WITNESS SECTION:
My signature below documents that the information in the consent document and any other written 
information was accurately explained to, and apparently understood by, the participant, and that 
consent was freely given by the participant.
_________________________
_________________________
__________
__________
Signature of Witness
Printed Name of Witness
Date
Time
Effective Date: 4/9/2024
End Date:4/8/2025