Does Single Injection Adductor Canal Block Improve Postoperative Analgesia in Patients Receiving Periarticular Local Anesthesia Injections for Total Knee Arthroplasty?
Phase: NA
Conditions: Pain Management
Sponsor: University of California, Irvine

#3567 - Does Single Injection Adductor Canal Block Improve
Postoperative Analgesia in Patients Receiving Periarticular
Local Anesthesia Injections for Total Knee Arthroplasty?
Protocol Information
Approval Comment
The IRB Approval Letter can be downloaded in the Attachments section of the protocol.
Protocol Renewal Form
Renewal Information
Review Type
Expedited
Status
Approved
Approval Date
Jul 19, 2024
Continuing Review
Date
--
Expiration Date
Jul 18, 2025
Initial Approval Date
Aug 25, 2023
Initial Review Type
Full Board
Feedback
PROTOCOLS
NCT02276495  

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Review the Study Team section and specify below if there
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Confirm the accuracy of the information on the
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Indicate the number of new subjects enrolled since last
IRB review:
0
Indicate the total number of subjects (including the
number in the previous question) enrolled since initial UCI
IRB approval:
88
Did the total number of subjects enrolled to date exceeds
the total number approved by the IRB?
No

Indicate the total number of subjects enrolled per group
since initial IRB approval:
Man (total):
35
Woman (total):
52
Nonbinary (total):
0
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Adults (total):
88
Minor (total):
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No

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Recruitment is complete and data analysis is waiting. The original PI on the
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the delay in analysis. We have a summer research volunteer who is working
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No
Risk and Safety Assessments

Relevant Recent Literature
During the past year has there been anything in relevant
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Protocol Amendment Form
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Specify the type of submission:
RENEWAL: This is a renewal that does not require changes to the approved
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Project Details
Project Title (100 words max):
Does Single Injection Adductor Canal Block Improve Postoperative
Analgesia in Patients Receiving Periarticular Local Anesthesia Injections
for Total Knee Arthroplasty?
Lead Researcher/Investigator:
Joseph Brian Rinehart

Lead Unit (i.e., Department, Organized Lead Unit, Center or
Institute):
Kuali Research (KR) follows the KFS Organizational Unit Hierarchy.
• Select the lead unit with 3 asterisks (***)
• UCSB hSCRO Researchers: Select ***UC Santa Barbara (UCSB)***
ATTENTION! For new submissions, Department Chair (DC) or Organized Lead Unit Director
(OLUD) sign-off in KRP is required before final committee approval will be granted. For more
information, visit the listserv.
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Institutional Review Board (IRB) Review
Lead Researcher's primary school/department/program is:
Biomedical (Health Sciences)
Select the level of review for this protocol:
Greater than Minimal Risk (Full Committee)
Is this expanded access, humanitarian use device, or right to
try?
Not applicable
***IR-7450 - ANESTHESIOLOGY & PERIOPERATIVE CARE (Lead Unit)***

Specify who initiated/authored the project:
Investigator
Is this study an extension of a UCI IRB approved study (e.g.,
resubmission of ongoing exempt research; open label
extension) or is it otherwise related to a UCI IRB approved
study?
Yes
If yes, provide the protocol number for the UCI IRB approved
protocol (enter multiple protocol numbers if appropriate):
IRB20141217 aka HS#2014-1217
Supplemental Documents
Does this study include a Sponsor's Master Protocol (MP) or
detailed project proposal?
No
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Select the funding source(s) (check all that apply):
Department or campus funds (includes department support, unrestricted
funds, start-up funds, personal funds, campus program awards, etc.)
Clinical Trials

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subjects, and that meets any one of the following:
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their approved indications, route of administration, population, or dose
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inspection by, the FDA as part of an application for a research or marketing permit
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sequence of numbers only):
02276495
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The proposed research qualifies as greater than minimal risk, investigator-initiated
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Potentially Hazardous Materials

Specify if any of the following hazardous materials are
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Not Applicable
Study Team
• Lead Researcher (LR): The LR must meet LR Eligibility requirements or have a Faculty
Sponsor (FS) listed who is eligible.
• Co-Researcher (CR): CRs are key personnel for conducting the research study. These
individuals work closely with the LR to design, conduct, and/or report on the research.
• Research Personnel (RP): Review the RP Heat Map to determine whether they should
be listed below.
• Administrative Contact (AC): Add ACs in the Permissions tab. Do NOT list below.
• Non-UCI researchers: Address non-UCI researchers in the Single IRB Reliance (sIRB)
section. Do NOT list below.
Researcher:
Email:
jrinehar@uci.edu
Joseph Brian Rinehart

Financial Interest:
hSCRO RESEARCHERS:
IMPORTANT! Please mark "No" for this question. COI does NOT apply to hSCRO research.
IRB RESEARCHERS:
To promote the objectivity of the research, all researchers are required to disclose their
related disclosable financial interests, per the IRB COI Policy. If you have any questions
about the COI process in general, contact the COI team.
Each member of the study team for this protocol must be asked the following question to
comply:
“Do you, your spouse/registered domestic partner, and dependent children have any
disclosable financial interests* (i) that would reasonably appear to be affected by this
research study; or (ii) in entities whose financial interests would reasonably appear to be
affected by this research study?"
No
Training:
hSCRO RESEARCHERS:
IMPORTANT! Please ignore the training column. It is only relevant for IRB researchers.
hSCRO researchers are NOT required to take CITI training courses.
IRB RESEARCHERS:
IMPORTANT! Incomplete or expired CITI training will delay IRB approval. For more
information, visit HRP Training and Education.
All study team members must complete the following Collaborative Institutional Training
Initiative (CITI) trainings:
• Human Subjects Research Protections and
• Good Clinical Practice, as applicable
Joseph Rinehart has no training courses on le.

Degree:
MD
Position/Title:
Vice Chair of Research
Affiliation:
UCI Faculty
Researcher Role:
Lead Researcher
Permissions:
Full Access
Duties:
Oversight of Research
Access/Analyze Identiable Information
Research Procedures (specify below)
Specify which research procedures:
Data analysis and manuscript writing
Specify relevant training and experience for the referenced
duties/responsibilities:
Dr. Rinehart is a board-certied UCI Health anesthesiologist. He serves as
the Vice Chair of Research for the department of Anesthesiology and
chairs IRB E committee. He has extensive clinical research experience
including funded research and countless publications.
***IR-7450 - ANESTHESIOLOGY & PERIOPERATIVE CARE (Lead Unit)***

Researcher:
Email:
pmensah@uci.edu
Financial Interest:
hSCRO RESEARCHERS:
IMPORTANT! Please mark "No" for this question. COI does NOT apply to hSCRO research.
IRB RESEARCHERS:
To promote the objectivity of the research, all researchers are required to disclose their
related disclosable financial interests, per the IRB COI Policy. If you have any questions
about the COI process in general, contact the COI team.
Each member of the study team for this protocol must be asked the following question to
comply:
“Do you, your spouse/registered domestic partner, and dependent children have any
disclosable financial interests* (i) that would reasonably appear to be affected by this
research study; or (ii) in entities whose financial interests would reasonably appear to be
affected by this research study?"
No
Paulette M Mensah

Training:
hSCRO RESEARCHERS:
IMPORTANT! Please ignore the training column. It is only relevant for IRB researchers.
hSCRO researchers are NOT required to take CITI training courses.
IRB RESEARCHERS:
IMPORTANT! Incomplete or expired CITI training will delay IRB approval. For more
information, visit HRP Training and Education.
All study team members must complete the following Collaborative Institutional Training
Initiative (CITI) trainings:
• Human Subjects Research Protections and
• Good Clinical Practice, as applicable
Paulette Mensah has no training courses on le.
Degree:
BA
Position/Title:
Clinical Research Supervisor
Affiliation:
UCI Staff
Researcher Role:
Co-Researcher
Permissions:
Full Access
***IR-7450 - ANESTHESIOLOGY & PERIOPERATIVE CARE (Lead Unit)***

Duties:
Access/Analyze Identiable Information
Research Procedures (specify below)
Specify which research procedures:
Data Analysis, manuscript writing, and research related coordination.
Specify relevant training and experience for the referenced
duties/responsibilities:
Ms. Mensah has led the clinical OR and pain team research activities
within the department for the last 6 year an has 11 years of research
experience. She manages the department's research volunteer program
and all IRB-approved, funded, and unfunded research activities. She will
be assisting the lead PI with day-to-day research operations.
Researcher:
Email:
mma3@uci.edu
Michael Ma

Financial Interest:
hSCRO RESEARCHERS:
IMPORTANT! Please mark "No" for this question. COI does NOT apply to hSCRO research.
IRB RESEARCHERS:
To promote the objectivity of the research, all researchers are required to disclose their
related disclosable financial interests, per the IRB COI Policy. If you have any questions
about the COI process in general, contact the COI team.
Each member of the study team for this protocol must be asked the following question to
comply:
“Do you, your spouse/registered domestic partner, and dependent children have any
disclosable financial interests* (i) that would reasonably appear to be affected by this
research study; or (ii) in entities whose financial interests would reasonably appear to be
affected by this research study?"
No
Training:
hSCRO RESEARCHERS:
IMPORTANT! Please ignore the training column. It is only relevant for IRB researchers.
hSCRO researchers are NOT required to take CITI training courses.
IRB RESEARCHERS:
IMPORTANT! Incomplete or expired CITI training will delay IRB approval. For more
information, visit HRP Training and Education.
All study team members must complete the following Collaborative Institutional Training
Initiative (CITI) trainings:
• Human Subjects Research Protections and
• Good Clinical Practice, as applicable
Michael Ma has no training courses on le.

Degree:
BS
Position/Title:
Anesthesia Research Volunteer
Affiliation:
UCI Other
Specify other UCI affiliation:
Former department staff returning as non-UCI medical student
Researcher Role:
Co-Researcher
Permissions:
Full Access
Duties:
Access/Analyze Identiable Information
Research Procedures (specify below)
Specify which research procedures:
Data analysis and manuscript writing
***IR-7450 - ANESTHESIOLOGY & PERIOPERATIVE CARE (Lead Unit)***

Specify relevant training and experience for the referenced
duties/responsibilities:
Mr. Ma is a former primary CRC on this project and member of the
anesthesia research team for over 5 years. He will be returning to assist
the completion of this study as a non-UCI medical student research
volunteer .He comes with extensive knowledge of the study activities and
original data collection activities. This expertise will be critical to
nalizing data analysis, writing the manuscript, and closing out the study.
Are RP tracked outside the approved protocol, in accordance
with the RP Heat Map?
Yes, RP are tracked on a Study Team Log or other comparable log
sIRB Screener
At UCI, a single IRB (sIRB) will be required for the following types of non-exempt cooperative
(multisite) research carried out within the United States:
1. New studies approved on or after January 20, 2020 supported by an agency that has
signed on to the Common Rule. For a full list of HHS Departments and Agencies that
follow the Common Rule, please click here.
2. Research supported by NIH. Click here for the official notice from NIH: NOT-
OD-16-094. There are some exceptions. For more about the NIH exceptions and
additional information on the single IRB requirement for NIH supported research (in
effect since January 25, 2018) click here.
Are UCI researchers engaged in human subjects research
activities (e.g., interact with subjects; have access to
identifiable information) at a non-UCI location?
No

Are non-UCI researchers engaged in human subjects research
activities (e.g., interact with subjects; have access to
identifiable information)?
No
Non-Technical Summary

Provide a non-technical summary of the project that can be
understood by non-scientists (250 words max):
REOPENING HS#2014-1217 TO FINALIZE DATA ANALYSIS AND
COMPLETE MANUSCRIPT WRITING. Original non-technical summary
below: Total knee arthroplasty (TKA), also known as total knee
replacement, has been associated with a signicant pain burden in the
postoperative period. Methods to manage pain associated with this
operation have in the past included injecting pain medication into the
epidural space of the spinal cord, around a peripheral nerve, around the
space surrounding the joint, or a combination of pain management
techniques. In recent years, the femoral nerve block (injection of pain
medication around the peripheral nerve, specically the femoral nerve) has
been proposed as an effective way to manage pain while sparing many of
the undesirable side effects of narcotic pain medications. Traditional
techniques of the femoral nerve block involve the injection of pain
medication around the peripheral nerve at the level of the groin area. A
nerve block at this point in the path of the femoral nerve affects all of the
musculature of the front part of the thigh as well as the nerves responsible
for sensation to the majority of the knee joint. The femoral nerve block
performed at the level of the groin provides an excellent level of pain relief
at the knee joint, but is also associated with weakness of the quadriceps
muscle. The resultant quadriceps weakness can both slow the physical
therapy process and be a risk factor for post-operative falls. Participation in
physical therapy is a critical component of the rehabilitation process and is
started as soon as tolerated by the patient. The ideal pain management
technique would provide the same degree of pain relief as the femoral
nerve block while preserving the strength in the front part of the thigh
muscles. One suggested technique to achieve both of these goals is the
injection of a large volume dilute local pain medication mixture around the
joint during surgery. This has been used as a substitute to provide pain
relief around the joint while maintaining strength in the quadriceps muscle
and the ability to participate in physical therapy. This technique however,
does not last long since the medication disperses away from the joint
space. A variation of the femoral nerve block in the lower thigh, within a
space called the adductor canal, has been demonstrated to provide

equivalent amounts of pain relief as a proximal femoral nerve block along
with preservation of motor function to the quadriceps muscle. What is not
as well-established is whether the combination of injecting pain medication
directly around the joint space in the knee along with a single injection of
pain medication in the adductor canal in the lower thigh can improve pain
scores and extend the duration of pain relief provided compared to only an
injection around the joint space.
Background & Purpose of Research

Describe the purpose, specific aims or objectives and specify
the hypotheses or research questions to be studied:
Subject Population(s)
Targeted subject populations/data sources (check that apply):
Adults
Subjects who are unable to communicate in English
The purpose of the proposed research is to determine the effect of a single injection adductor
canal block (ACB) on pain scores within 24 hours post total knee arthroplasty (TKA). This study
will compare three groups of patients: those who receive the ACB and local periarticular
infiltration, those who receive placebo ACB and local periarticular injection, and those who
receive the ACB and placebo periarticular injection.
The present study is a three-arm randomized clinical trial of:
• A.   Local periarticular infiltration (injection of dilute local anesthetic) + Placebo ACB (nerve
block performed with normal saline)
• B.   Local periarticular infiltration (injection of dilute local anesthetic) + ACB (nerve block
procedure performed with local anesthetic)
• C.   ACB (nerve block performed with local anesthetic)
The primary objective being to compare the efficacy of all groups (A), (B) and (C) with each other
with respect to 24 hr. post operative pain. The arm (A) was included to address the efficacy of
local infiltration only in comparison with groups (B) and (C). Comparison of group (B) vs. (C) is
also of primary interest of the study.
The current “standard of care” has not been established for Total Knee Arthroplasty. Nationwide
there are large variations in postoperative pain management methods for total knee arthroplasty
including lumbar epidural, intrathecal opioids, femoral nerve block with and without sciatic nerve
block, local infiltration, local wound catheters, and adductor canal blocks. All three arms are well
within acceptable standard practice for postoperative pain management for this population1.
The objective will be to answer the following research questions:
• Does the addition of an adductor canal block to a periarticular injection improve
postoperative pain scores in TKA patients at specific time intervals?
• Does the addition of an adductor canal block to periarticular injection decrease opioid use in
TKA patients?
• Is there a difference in maximum pain scores and/or opioid consumption between those
receiving adductor canal blocks only versus those receiving local infiltration analgesia.

Eligibility Criteria
1. Specify the Inclusion/Exclusion Criteria.
2. Provide a breakdown per subject cohort, as applicable
(e.g., adults vs parents vs children).
3. IMPORTANT! If utilizing UCI Health Enterprise Data &
Analytics services, include specific timeframes for
each eligibility factor, as applicable.
a. Example:
• Birth sex: female
• Age: >= 18 years old as of 2020-01-01
• The result of the most recent SARS-CoV-2 test (of any type), performed
between 2020-01-01 and 2020-12-31, was positive
• With any sub-classification of type 2 diabetes (E11*) diagnosed at any date
prior to 2020-01-01
• Did NOT have an ED visit between 2020-01-01 and 2020-12-31
Is eligibility based on age, gender, pregnancy/childbearing
potential, social/ethnic group, or language spoken (e.g.,
English Speakers only)?
Yes
Category/Group Eligibility
Adults Receiving Total Knee Arthroplasty (TKA)
Inclusion Criteria
• Males and Females age 18+ years old having total knee arthroplasty(TKA) at UCI Medical
Center
• American Society of Anesthesiologists physical status I to III
Exclusion Criteria
• Allergy to local anesthetics
• Pregnancy
• Nursing Mothers
• Children<18 years of age
• Opioid tolerant patients (defined as greater than 30mg Morphine equivalent consumed
daily)
• BMI greater than 40

1. Identify each special population that is excluded from
the study.
2. Provide the rationale for excluding each population.
Example: Eligibility Group: Age 70+, Rationale: Disease that affects the elderly
Pre-Screening without Consent
Under the revised Common Rule, an IRB may approve a proposal for the investigator to
obtain information or biospecimens to screen, recruit, or determine eligibility of prospective
subjects for a research study without informed consent. In other words, the revised Common
Rule removes the pre-2018 Common Rule requirement for an IRB to approve a waiver of
informed consent for these types of activities. This change harmonizes with FDA. 
[Refer to 45 CFR 46.116(g) of the revised Common Rule.]
Will the study team obtain information or biospecimens to
screen, recruit, or determine eligibility of prospective
subjects?
Yes
Pre-Screening Activities (check all that apply):
Study team will obtain patient information directly from medical records
Medical Records
Age
• Patients who are younger than 18 years of age are physiologically different compared
to the general population and hence, their data will create unnecessary skew when we
perform statistical tests.
Pregnancy/Childbearing Potential
• This research does not directly benefit the pregnant woman and/or fetus, and
biomedical knowledge can be obtained using subjects whoare not pregnant.
Therefore, per federal regulations, pregnant womenwill be excluded from the present
study.

Specify Medical Record Source (check all that apply):
Study team will access their own UCI patients’ records and abstract
data directly from those records
Data Points
Provide a complete list of ALL data points, variables, and/
or information that will be collected/recorded (i.e. data
abstraction form) for pre-screening/recruitment purposes:
Attached
If the list of variables will be attached as a separate document [i.e. case report form
(CRF; eCRF)], enter "See Attached" above and check the confirmation box below. 
The list of variables is attached as a separate document
IMPORTANT! Under a partial waiver of HIPAA authorization, only the minimum
necessary information should be accessed for pre-screening/recruitment activities (i.e.,
determining eligibility and contacting the subject). The information should not be
further accessed, used, or disclosed above and beyond pre-screening/recruitment
activities until a signed consent form (and signed HIPAA authorization, as applicable) is
obtained. 
Explain why pre-screening/recruitment activities could not
be done without access to the information listed above:
The medical records will be screened by the research team to identify
the potential candidate(s) for inclusion/exclusion criteria. Inclusion/
exclusion include data points such as BMI that can only be accessed
through the study. If these activities are not completed, study activities
could not happen.
Recruitment Methods

IMPORTANT!
• Recruitment materials must adhere to UCI Recruitment Guidelines.
• Various templates are available here: IRB Forms → Recruitment Templates.
• Please submit all applicable recruitment materials or a Recruitment Material Master
Template (Exempt/Expedited only).
• For more information, visit this HRP Webpage.
Indicate all methods that will be used to recruit subjects for this
study:
Recruitment Method:
Other recruitment methods
Specify 'Other' recruitment methods:
Study team members will approach their own patients, students,
employees for participation in the study. UCI study team members will
screen UCIMC medical records to determine subject eligibility and
approach patients directly about study participation
Recruitment Method:
Clinicaltrials.gov
REQUIRED! The ClinicalTrials.gov statement must be in all applicable consent documents.
HIPAA Authorization
Does this study involve the creation, access, use, or
disclosure of medical records; or does the study involve
observations of clinical interactions [i.e., Protected Health
Information (PHI)]?
Yes

Identify the Health Insurance Portability and Accountability
Act (HIPAA) Authorization process (check all that apply):
Partial waiver of HIPAA authorization requested for screening/recruitment
purposes only. Signed authorization obtained prior to further access to PHI.
Signed HIPAA authorization obtained
Waiver of HIPAA Authorization
The Health Insurance Portability and Accountability Act (HIPAA) and the California
Confidentiality of Medical Information Act (CMIA) address medical confidentiality and
access to medical information for research studies that use, create, or disclose health care
related data and records, termed “personal health information.”
• HIPAA Authorization Waivers: The HIPAA Privacy Standard [45 CFR 164.512(h)(i)(2)(ii)]
requires that certain criteria be met in order to grant a waiver of individual
authorization for research uses of Personal (Protected) Health Information.
For more information, visit: Protected Health Information.
Partial Waiver of HIPAA
A Partial Waiver of HIPAA Authorization is Requested.
Does the use or disclosure of personal health information
involve more than minimal risk?
No
Would the granting of the waiver adversely affect privacy
rights and welfare of the individuals whose records will be
used or disclosed?
No

Explain (justify) the above answer:
TIP! Consider the following:
• Are there are other federal, state, or local laws that provide rights to potential subjects
to require informed consent
• How will the study team prevent adverse affects to subjects' privacy rights and ensure
their welfare
All research personnel are aware of and been trained in UCI/HIPAA policies
and practices. Info collected during this time will only be used for pre-
screening and a subject will sign a HIPAA Authorization prior to further use
of their PHI.
Could the research practicably* be conducted without a
waiver of HIPAA authorization?
IMPORTANT! *Practicably means capable of being done; it should not be determined by
considerations of convenience, cost, or speed.
No
Explain why research could not be done if authorization was
required:
TIP! Consider the following:
• Demonstrate that it is impracticable to perform the research, and not just impracticable
to obtain consent.
• Would scientific validity be compromised through bias, have an impact on study power,
etc. if consent was required
• Would there be ethical concerns or increased risk/harm to subjects if consent were
required
• Are there pragmatic limitations that make it impossible for the study team to consent
subjects such as insufficient time, an inability to identify subjects, an inability for staff
to consent the number of subjects needed, etc
The study team will need access to medical records to properly identify
and pre-screen subjects for the trial.

Could the research practicably* be conducted without access
to, use or disclosure of the personal identifiers listed in the
PHI question?
IMPORTANT! *Practicably means capable of being done; it should not be determined by
considerations of convenience, cost, or speed.
No
Explain why research could not be done without access to,
use or disclosure of PHI:
The study team will access PHI for screening and tracking purposes.
Are the privacy risks reasonable relative to the anticipated
benefits of the research?
Yes
Describe the risk/benefit analysis performed to explain the
answer above:
The study team is aware of and trained in UCI/HIPAA policies and
practices. All PHI collected prior to obtain consent will only be used for the
purpose of pre-screening subjects.
Describe the plan to destroy the personal identifiers at the
earliest opportunity, or provide a health or research
justification for retaining the identifiers:
PHI will be destroyed per UCI/FDA trial policies and practices.

Describe the plan to protect the personal identifiers from
improper use and disclosure (i.e., describe data security
methods):
Only study team members will be allowed access to the collected PHI. All
information will be kept on secure UCI encrypted networks or in locked
cabinets within the Anesthesia Research oce.
Provide assurance that the PHI will not be reused or disclosed
to any other person or entity, except as required by law, for
authorized oversight of the research study, or for
other research for which the use or disclosure of PHI would be
permitted.
As the Lead Researcher, I assure all of the above
Informed Consent Process
Identify the methods of Informed Consent or assent process
as applicable for each participant population (check all that
apply):
No informed consent (no direct contact)
Non-English Speakers
What type of consent process will be used for Non-English
Speaking Participants?
The English version of the consent materials will be translated for non-
English speaking participants or their LAR once IRB approval is granted.
An interpreter will be involved in the consenting process.

Indicate how non-English speaking subjects or their LAR
will be consented in their language and who will be
responsible for interpreting and facilitating the informed
consent discussion for the non-English speaking subjects:
The study team has 24-hour access to a translation service with
sucient medical expertise to discuss the research in this study
Waiver or Alteration of Consent
Select the option for the Waiver or Alteration of the Consent:
OPTION A (*Most Common*): General Waiver or Alteration of the Consent
45 CFR 46.116(f)
Does the research involve more than Minimal Risk? [45
CFR 46.116(f)(3)(i)]
No
Could the research practicably* be carried out without the
waiver or alteration? [45 CFR 46.116(f)(3)(ii)]
No
Explain why research could not be done if consent was
required:
Alternatively, if appropriate, type "Same as HIPAA waiver".
Original data was obtained with approved consent documents. Study
team only intends to analyze this data. It would be extremely dicult to
obtain reconsents for the nearly 90 subjects enrolled.

If the research involves using identifiable private
information or identifiable biospecimens, could the
research practicably be carried out without using such
information or biospecimens in an identifiable format? [45
CFR 46.116(f)(3)(iii)]
No
Explain why the research could not be done without using
information or biospecimens in an identifiable format:
Original data was obtained with approved consent documents. Study
team only intends to analyze this data
Will the waiver or alteration adversely affect the rights and
welfare of the subjects? [45 CFR 46.116(f)(3)(iv)]
TIP! Consider the following:
• Are there are other federal, state, or local laws that provide rights to potential
subjects to require informed consent
• How will the study team prevent adverse affects to subjects' privacy rights and
ensure their welfare
No
Provide the rationale on why the waiver or alteration will
NOT adversely affect the rights and welfare of the
subjects:
Alternatively, if appropriate, type "Same as HIPAA waiver".
Original data was obtained with approved consent documents. Study
team only intends to analyze this data
Whenever appropriate, will the subjects be provided with
additional pertinent information after participation?
N/A: No additional information will be provided to subjects

Sample Size
IMPORTANT! Researchers access will be limited to the sample size numbers provided below.
Should researchers need access beyond these numbers, an amendment must be approved
by the IRB.
TIP! UCI has multiple tools that allow researchers to perform cohort identification analyses
for their research with de-identified patient data from the UCI Health Enterprise Data
Warehouse.
• Cohort Discovery Tool (CDT) - Powered by i2b2
• TriNetX - Email ori@uci.edu to request an account
• Slicer Dicer for EPIC
For more information, please contact Health Enterprise Data & Analytics.
Provide sample size numbers in the table below:
Pre-Screen Number:
• Estimate/anticipate the number of individual-level information needed to screen, recruit,
or determine eligibility of prospective subjects. This number should reflect an estimate
based on the anticipated rate of screen failure and/or rate of enrollment. 
• IMPORTANT! Do not access any identifiable information/record prior to securing IRB
approval. 
Maximum Number:
• Estimate/anticipate the number of individuals to be consented. Include withdrawals and
screen failures.
• For research with no subject consent (i.e. medical record review), estimate/anticipate the
number of individual-level information and/or biospecimens to be accessed/analyzed.
Expected / Target Number:
• Specify the target number of individuals needed to complete the study.
• For research with no subject contact (i.e. medical record review), specify the minimum
necessary number of individual-level records and/or biospecimens needed to address the
research question.

Category/Group:
Adults Receiving Total Knee Arthroplasty (TKA)
Age Range:
18 and over
Pre-Screen Number:
125
Maximum Number:
90
Expected / Target Number:
63
Pre-screen Number Determination:
Explain how the pre-screen number was determined (e.g.,
cohort discovery, anticipated rate of enrollment):
Anticipated rate of enrollment

Sample Size Determination:
1. Explain how the target sample size was determined (e.g.,
power analysis; precision estimation).
a. Power analysis should (at least) match the primary
outcome/endpoint.
2. Provide justification of the effect size for the primary
outcome based on preliminary data, current knowledge/
literature and/or cost consideration.
a. If appropriate, provide justification for any significant
difference between the max and expected numbers
listed above.
3. If appropriate, provide sample size justification for
secondary outcomes.
Power analysis/Sample size determination: A power analysis was
performed using a 2-sided 2-sample t-test with a signicance level of 0.017
to encounter for 3 pairwise comparisons to be performed for the primary
outcome. From our clinical data, we observed an average max pain score
value of 6.1 +/- 1.9 for arm (a), and we expect the max pain score will be
4.1 for arm (c) and 2.1 for arm (b). We calculated that 21 patients in each
group (total of 63) will provide the study an 82% power to detect a
difference of 2 in average max pain score between the treatment groups,
and a 96% power to detect a difference of 2.5.
Will this study take place only at UCI (i.e., does NOT involve
other non-UCI sites)?
Yes
Project Locations

Check all sites where UCI investigator(s) will conduct
research activities (e.g., recruitment, informed consent, and
research procedures including accessing identifiable, private
information about participants):
UCI Health Facilities or Sites (e.g. hospital, clinics, etc.)
Indicate where the research will be performed (check all the
apply):
United States
Study Design & Statistics
Include an explanation of the study design (e.g., randomized
placebo-controlled, cross-over, cross-sectional, longitudinal,
etc.) and, if appropriate, describe stratification/
randomization/blinding scheme:
Is this a study for which a statistical analysis plan is
appropriate (e.g. quantitative study design)?
Yes
The present study is a three-arm randomized clinical trial of:
A.   Local periarticular infiltration (injection of dilute local anesthetic) + Placebo ACB (nerve block
performed with normal saline)
B.   Local periarticular infiltration (injection of dilute local anesthetic) + ACB (nerve block
procedure performed with local anesthetic)
C.   ACB (nerve block performed with local anesthetic)
On the day of surgery (with informed consent), the patient will be randomized via sealed
envelope into (A), (B), or (C).
(A) ACB control (20 ml saline injection) + Local infiltration (anesthetic as required by standard of
care),
(B) ACB study (20ml 0.5% Ropivacaine) + Local infiltration
(C) ACB study (20 ml 0.5% Ropivacaine).    

Describe the statistical methods for the stated specific aims
and hypotheses. The analysis plans should match the stated
study specific aims and hypotheses:
Provide precise definitions of the study endpoints and criteria
for evaluation; if the primary outcomes are derived from
several measurements (i.e., composite variables) or if
endpoints are based composite variables, then describe
precisely how the composite variables are derived:
Describe the statistical method(s) that will be used to analyze
the primary outcome(s) or endpoints:
The comparison of group means among the 3 treatment groups with regards to maximum
average pain score within 24 hours postoperative (primary outcome).
The research hypothesis is that the average maximum pain scores within 24 hours postoperative
will be significantly lower in both ACB treatment groups comparing to the ACB controls.
Predictors
Variable(s) of interest:
Primary outcome: Average maximum pain scores within 24 hours postoperative.
Secondary Outcomes:
1. 24 Hour post-surgical opioid use
2. PACU opioid use
3. Average daily opioid use during hospitalization
4. Length of stay
5. Average NRS pain score
6. Physical therapy achievements
 
Covariates/Cofounders
The most common confounders in the study of postoperative pain management include:
1. preexisting pain
2. preoperative anxiety level
3. age
Statistical Analysis: The primary analysis will be a 2-sample t-test comparing the difference in
average max pain score within 24 hours between each pair (3 pairs) of the 3 treatment groups.
The significance level is set at 0.017 for each test. Secondary analysis will utilize analysis of
covariance (ANCOVA) to evaluate the treatment difference while adjusting for the effect of
covariates. 

If appropriate describe secondary or post hoc analyses of
primary outcome(s) or other exploratory analysis and if
necessary, provide a breakdown of the methods used per
outcome or endpoint:
Safety Monitoring Plan
UCI IRB requires that all clinical investigations involving greater than minimal risk to
subjects develop a data and safety monitoring plan to assure the safety and welfare of the
research subject/patient.
This is aligned with with NIH requirements and with federal regulations that require that IRBs
assure that the research plan makes adequate provision for monitoring the data collected to
ensure the safety of subjects/patients.
For clinical protocols involving a test article, it is common to have an independent Data
Safety Monitoring Board (DSMB).
Please read the applicable HRP webpage for further guidance.
Does this protocol require a Safety Monitoring Plan?
Yes
For secondary outcomes, ANCOVA will be applied and post hoc pairwise comparisons will be
performed if a significant group difference was observed and multiple comparison adjustment
will be performed. If the data is found to be violated with parametric assumption, appropriate
non-parametric method will be applied.  

• Feel free to cut and paste into this section from the following sources, as applicable:
• For NIH-sponsored clinical trials, the Data Safety Monitoring Plan (DSMP)
should be part of the grant application.
• For industry sponsor-initiated clinical trials, a FDA-approved DSMP should be
part of the Master Protocol or the Data Safety Monitoring Committee/Board
Charter.
• For protocols conducted at the Institute for Clinical and Translational Science
(ICTS) or Cancer Center (PRMC), the DSMP information approved by one of
these committees should be inserted into this section
• REQUIRED! Submit the following documents, as applicable in the Attachments section:
• Signed DSMB recommendation forms from independent DSMB.
• The finalized DSMB charter must be submitted before enrollment begins.
Provide details of those individuals who will be responsible
for the safety oversight of your protocol, including the
relevant experience/expertise of each individual (for UCI
investigator initiated studies conducted only at UCI, provide
the names and titles as well):
Indicate how frequently accumulated protocol data will be
reviewed and evaluated for participant safety, protocol
conduct and progress, and, when appropriate, efficacy:
The board will be comprised of the Department of Anesthesiology and Perioperative Care
Research Council. The council is composed of researchers, educators, and administration that
oversee all aspects of research of the department. One of the duties of the council is to ensure
the safety of all research being conducted with the department. The Members are the following:
Dr.Scott Engwall, Chair of the Department of Anesthesiology & Perioperative Care; Dr. Cameron
Ricks, Associate Clinical Professor and Director of the Medical Education Simulation Center; Dr.
Kei Togashi, Associate Clinical Professor; and Dr. Sean Ostlund, Assistant Professor and Director
of the Ostlund Research Lab.
The committee meets in-person or via Zoom on a quarterly basis. They also communicate on a
regular basis with research updates.

Describe the events that would trigger an unscheduled review.
Also include stopping guidelines and un-blinding rules if
applicable:
List who will be locally monitoring and collecting information
on adverse events and/or unanticipated problems (e.g., UCI
Lead Researcher, Research Coordinator, etc.).
Include the name, title and experience of the individual(s) and
further describe each individual’s role in the oversight of
subject/patient participating in the protocol.
Describe the plan for annual reporting of the participants’
safety, and the protocol's conduct, progress, and efficacy,
when appropriate:
Project Procedures
Events such as protocol deviations, adverse events and major changes to the approved study
protocol would trigger an unscheduled review.
Aside from the lead researcher, Paulette Mensah, who is a senior CRC and the Clinical Research
Supervisor, will be locally monitoring and collecting information on adverse events and/or
unanticipated problems.
The PI will submit a CPA to the IRB for annual reporting of study progress, participants' safety
and enrollment status.

Research Procedures (check all that apply):
Clinical Investigation involving an Investigational Drug or Biological Product
(including the on or off label use of an FDA approved drug)
Secondary use of Identiable Private Information (i.e., Medical/Student
Records)
Clinical Phase of Study
Indicate the phase(s) of the study, if applicable:
Phase IV

Provide a detailed chronological description of the
procedures:
Specify the total duration of a subject’s participation in the
study and clearly outline the duration of participation for each
study visit and sub-study, as applicable:
REOPENING HS#2014-1217 TO FINALIZE DATA ANALYSIS AND COMPLETE MANUSCRIPT
WRITING. Original study procedures below:
Subjects will be recruited at the time of their preoperative clearance visit. Eligible patients are
those that present for TKA and meet inclusion criteria. Subjects will be consented during their
preoperative visit within the Center for Perioperative Care. If they have not made a decision by the
end of the visit they will be approached on the day of surgery as well. On the day of surgery the
patient will be randomized via sealed envelope into either the:
 
1. ACB control (20 ml saline injection) + Local infiltration (anesthetic as required by standard of
care),
2. ACB study (20ml 0.5% Ropivacaine) + Local infiltration
3. ACB study (20 ml 0.5% Ropivacaine). 
 
The following individuals are blinded to the treatment types:
1.    Anesthesiologist performing the nerve block
2.    Postoperative nurse
 
A member of the acute pain service will perform the nerve block in the preoperative holding
area. The perioperative joint surgical home pathway will not be altered and the patient will
proceed to the operating room as per pathway protocol. A postoperative nurse will assess pain
scores. The subjects will attend standard of care physical therapy sessions where their physical
therapists will record the subjects’ physical therapy achievements onto their medical record,
which will then be accessed by authorized research personnel for data collection. 
1 day (day of surgery) : Verification or obtain informed consent, randomization, obtain block

List all data collection tools (e.g., measures, questionnaires,
observational tool) below; include citations for standardized/
validated measure(s):
Are all data collection tools standardized or validated?
Yes
UCI Health Clinical Services
Will this study require clinical items/ services from UC
Irvine Health?
No
Use of Identiable Information
Source of Information
Indicate the types/sources of identifiable private
information (check all that apply):
UCI Health Medical Records
Medical Records
IMPORTANT! Access to UCI health data is facilitated through data stewards
identified by the Health Data Governance Committee (HDGC).
Attached

Specify how UCI-Health medical records will be
obtained:
Study team will obtain information directly from UCI Health
medical records
Data Points
Specify the date-range of the data used for the
project (e.g. January 2002 to January 2020):
Initial eAPP approval (September 2014) through expiration date
of last approved IRB (July 2021).

Provide a complete list of ALL data points, variables,
and/or information that will be collected (i.e. data
abstraction form):
Randomization: A. ACB control (20 ml saline injection) + Local
inltration (anesthetic as required by standard of care), B. ACB
study (20ml 0.5% Ropivacaine) + Local inltration C. ACB study
(20 ml 0.5% Ropivacaine). The following individuals are blinded
to the treatment types: 1. Anesthesiologist performing the nerve
block 2. Postoperative nurse A member of the acute pain
service will perform the nerve block in the preoperative holding
area. The perioperative joint surgical home pathway will not be
altered and the patient will proceed to the operating room as
per pathway protocol. A postoperative nurse will assess pain
scores. The subjects will attend standard of care physical
therapy sessions where their physical therapists will record the
subjects’ physical therapy achievements onto their medical
record, which will then be accessed by authorized research
personnel for data collection. Variable(s) of interest: 1. Primary
outcome: Average maximum pain score within 24 hours
postoperative. 2. Secondary Outcomes: a. 24 Hour post-surgical
opioid use b. PACU opioid use c. Average daily opioid use
during hospitalization d. Length of stay e. Average NRS pain
score f. Physical therapy achievements Covariates/Cofounders
The most common confounders in the study of postoperative
pain management include: 1. preexisting pain 2. preoperative
anxiety level 3. age
If the list of variables will be attached as a separate
document [i.e. case report form (CRF; eCRF)], enter
"See Attached" above and check the confirmation
box below. 
The list of variables is attached

Investigational Drug or Biologic
• Upload the Investigator Brochure (IB) or Package Insert in the Attachments section to
identify the agent(s) to be used in this clinical investigation. Be sure the uploaded
items contain the following:
• Product Description
• Clinical Pharmacology
• Dosage and Guidelines for Administration (Optional)
• Dosage and administration in this investigation (if different from approved)
• Toxicity and Known Side Effects
• Precautions and Contraindications
• IMPORTANT! Documentation of a FDA Investigational New Drug (IND) Application for
the use of an investigational agent (drug/biologic) must be provided to the IRB for
review and before IRB approval may be granted.
• Please read the HRPP webpage for information about the use of drugs in clinical
investigations.
Generic Name:
Ketorolac
Trade Name/Biologic:
Toradol
Product Manufacturer:
Allergan
Does the product meet the FDA definition of a drug?
Yes
Identify the regulatory status of the product to be used in
this study:
The product is approved by the FDA and will be used according to the
FDA label

You may reference the section title and page number(s) of the Investigator Brochure or
Package Insert rather than pasting or transcribing the relevant information in the following
agent information questions.
REQUIRED! Submit the Investigator Brochure or Package Insert in the Attachments
section.
Specify the product description:
Ketorolac (Toradol) is a non-steroidal anti-inammatory drug used as an
analgesic for short-term management of moderate to severe pain.
Specify the clinical pharmacology:
Ketorolac tromethamine is a nonsteroidal anti-inammatory drug (NSAID)
that exhibits analgesic activity in animal models. The mechanism of
action of ketorolac, like that of other NSAIDs, is not completely
understood but may be related to prostaglandin synthetase inhibition.
The biological activity of ketorolac tromethamine is associated with the
S-form. Ketorolac tromethamine possesses no sedative or anxiolytic
properties. Ketorolac tromethamine is a racemic mixture of [-]S- and [+]R-
enantiomeric forms, with the S-form having analgesic activity.
Specify the indications for use:
Ketorolac is used for short-term management (up to 5 days) of
moderately severe acute pain that otherwise would require narcotics. It
most often is used after surgery.

Specify the dosage and guidelines for administration
(Optional):
Treatment should be started with ketorolac injection. Tablets are used
only if treatment is continued after patients begin to eat and drink. The
total duration of therapy should not exceed 5 days because of the
potential for gastrointestinal bleeding and other side effects. The
recommended adult intravenous single dose is 15 to 60 mg. Multiple
intravenous doses of 15 or 30 mg every 6 hours, not to exceed 60 or 120
mg a day, also may be used. Following intravenous therapy, the
recommended dose is one or two tablets initially followed by 1 tablet
every 4-6 hours, not to exceed 40 mg daily. The smaller dose is used for
patients with poor kidney function or those older than 65 years.
Specify the dosage and administration in this investigation
(if different from approved):
N/A
Specify the toxicity and known side effects:
Common side effects from ketorolac include rash, ringing in the ears,
headaches, dizziness, drowsiness, abdominal pain, nausea, diarrhea,
constipation, heartburn, and uid retention. NSAIDs reduce the ability of
blood to clot and therefore increase bleeding after an injury. Ketorolac
may cause ulcers and bleeding in the stomach and intestines, particularly
with use for more than ve days.

Specify the precautions and contraindications:
Do not take if allergic to aspirin or other nonsteroidal anti-inammatory
drugs-NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any
other allergies. tell your doctor or pharmacist your medical history,
especially of: asthma (including a history of worsening breathing after
taking aspirin or other NSAIDs), bleeding or clotting problems, blood
disorders (such as anemia), heart disease (such as previous heart
attack), high blood pressure, liver disease, growths in the nose (nasal
polyps), throat/stomach/intestinal problems (such as bleeding,
heartburn, ulcers), stroke, swelling of the ankles/feet/hands. This
medication may infrequently make you more sensitive to the sun. Avoid
prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen
and wear protective clothing when outdoors. Older adults may be more
sensitive to the effects of the drug, especially bleeding in the stomach/
intestines or kidney problems. Using high doses for a long time may
increase this risk. Before using this medication, women of childbearing
age should talk with their doctor(s) about the benets and risks (such as
miscarriage). Tell your doctor if you are pregnant or if you plan to become
pregnant.
Describe how the investigational agent will be prepared,
controlled and who will be responsible for management of
the agent:
UCI Health IDS Pharmacy
IMPORTANT! All investigational product (IP) utilized at UCI Health must be under the
control of UCI Health Investigational Drug Services (IDS) Pharmacy. This includes storage,
control, and distribution of IP.
Generic Name:
Ropivacaine
Trade Name/Biologic:
Naropin

Product Manufacturer:
AstraZeneca
Does the product meet the FDA definition of a drug?
Yes
Identify the regulatory status of the product to be used in
this study:
The product is approved by the FDA and will be used according to the
FDA label
You may reference the section title and page number(s) of the Investigator Brochure or
Package Insert rather than pasting or transcribing the relevant information in the following
agent information questions.
REQUIRED! Submit the Investigator Brochure or Package Insert in the Attachments
section.
Specify the product description:
Naropin (ropivacaine) is used as a long-acting local anesthetic for
surgical anesthesia and acute pain management.
Specify the clinical pharmacology:
: Ropivacaine is a member of the amino amide class of local anesthetics
and is supplied as the pure S-(-)-enantiomer. Local anesthetics block the
generation and the conduction of nerve impulses, presumably by
increasing the threshold for electrical excitation in the nerve, by slowing
the propagation of the nerve impulse, and by reducing the rate of rise of
the action potential. In general, the progression of anesthesia is related to
the diameter, myelination, and conduction velocity of affected nerve
bers. Clinically, the order of loss of nerve function is as follows: (1) pain,
(2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle
tone.

Specify the indications for use:
surgical anesthesia, epidural block for surgery, major nerve block, local
inltration, acute pain management, and epidural continuous infusion or
intermittent bolus (postoperative or labor).
Specify the dosage and guidelines for administration
(Optional):
20 ml 0.5% Ropivacaine
Specify the dosage and administration in this investigation
(if different from approved):
N/A
Specify the toxicity and known side effects:
Dizziness, nausea, or vomiting may occur.
Specify the precautions and contraindications:
: Naropin is contraindicated in patients with a known hypersensitivity to
ropivacaine or to any local anesthetic agent of the amide type.
Describe how the investigational agent will be prepared,
controlled and who will be responsible for management of
the agent:
UCI Health IDS Pharmacy
IMPORTANT! All investigational product (IP) utilized at UCI Health must be under the
control of UCI Health Investigational Drug Services (IDS) Pharmacy. This includes storage,
control, and distribution of IP.
Return of Results

Will Individual results be shared with subjects?
No
Will overall study results will be shared with subjects?
The overall study results will be listed on Clinicaltrials.gov
Risk Assessment

Risks and Discomforts
1. Describe and assess any reasonably foreseeable risks and
discomforts associated with each procedure for each subject
population — physical, psychological, social, legal or other.
2. If this study will involve the collection of identifiable private
information, even temporarily, for which the disclosure of the
data outside of the research could reasonably place the
subjects at risk, include the risk of a potential breach of
confidentiality.
A bullet point list is recommended.
EXPEDITED/FULL COMMITTEE ONLY: Include an assessment of their expected frequency
(e.g., common – 65%, less common – 40%, unlikely – 5%, rare - <1%) and the seriousness
(mild, moderate, severe).
RISK ASSESMENT
a) The main intervention of this study is a peripheral nerve block. The most common
complication of nerve blocks are:
 
1. Vascular injury or hematoma: Inadvertent puncture of adjacent vascular structures can lead
to perineural hematoma and is more likely to occur in patients who are anticoagulated. The
majority of vascular punctures resolve with direct pressure to the block injection site.
2.  Infection. Infection risk for single shot peripheral nerve block is negligible.
3. Nerve injury. Neurologic injuries after single shot peripheral nerve blocks are uncommon
with rates reported on the order of 1 in 10,000 blocks to 0.9 in 1000 blocks.
4. Allergic reaction to local anesthetic. Uncertain incidence.
5. Intravascular injection. Inadvertent intravascular injection of local anesthetic may lead to
local anesthetic toxicity depending upon the volume injected or injection into an adjacent
vessel.
 
b) There is a chance of breach of confidentiality. There will be a unique code assigned to each
participating patient and only necessary information for pain assessment will be obtained. Only
the lead investigator and approved UCIMC study team members will have access to identifiable
information for organization purposes only. All data will be de-identified before any statistical
tests and/or publications.
 
The potential benefits of receiving the nerve block are improved pain control and ambulation
during the first 24 hours following surgery.

Discuss what steps have been taken and/or will be taken to
prevent and minimize any risks/potential discomforts to
subjects:
Condentiality Certicates
Specify whether a confidentiality certificate been issued
for the study:
No
Potential Benets
Is there the prospect of a direct benefit anticipated for
subjects?
Yes
The steps taken to prevent and minimize any risks/potential discomforts to eligible subjects in all
experimental groups include routine monitoring applied before, during, and after the
administration of the nerve block. Ultrasound guidance will be utilized for the adductor canal
block, aiding in the avoidance of critical structures such as blood vessels. The nerve block
technique will be standardized and limited to the three listed co-researching anesthesiologists
with expertise in performing the nerve block. All participating patients in each of the
experimental groups of the present study will be randomized to receive at least one intervention
to reduce pain in the postoperative period. All patients will be either given sedation or be under
anesthesia when the interventions are performed as this is the standard of care protocol when
performing a peripheral nerve block. Throughout the study, a periodic review of the data will be
performed to assess whether or not there any large changes in postoperative pain scores and to
evaluate if a protocol revision is required.
 
Screening records will be destroyed for patients that are not enrolled and subject identifiable
data will be protected for the subjects enrolled in the study.

Describe the potential benefits subjects may expect to
receive from participation in this study:
The potential benets of receiving the nerve block are improved pain
control and ambulation during the rst 24 hours following surgery.
Specify the expected potential societal/scientific
benefit(s) of this study:
Potential societal/scientic benets from the present study would
include improved pain control and ambulation during the rst 24 hours
following surgery for total knee arthroplasty (TKA) patients.
Alternatives to Participation
Describe the alternatives to participation in the study
available to prospective subjects. Include routine (standard of
care) options as well as other experimental options, as
applicable (check all that apply):
No alternatives exist. The only alternative to study participation is not to
participate in the study
Participant Compensation

Compensation is when participants are paid for their time & efforts in research.
• Compensation should be offered on a prorated basis when the research involves
multiple sessions.
• For additional information about researcher's/department's responsibilities and current
Accounting procedures, see UCI Policy Sec. 701-03.
For more information see: Compensation Info.
Are participants compensated?
No
Participant Costs
Will subjects or their insurers be charged for study
procedures?
No
Reimbursement
Will subjects be reimbursed for out-of-pocket expenses?
No
Condentiality of Research Data
CA Information Protection Act

Are University of California / UC Irvine records (e.g.,
medical, student, employment, etc.) disclosed to the
research team?
CA Civil Code §1798 – California Information Protection Act (CIPA)
§1798.3 (c) The term disclose means to disclose, release, transfer, disseminate, or
otherwise communicate all or any part of any record orally, in writing, or by electronic or
any other means to any person or entity.
No
Participant Identiers
Will any subject/patient identifiers be collected or retained
for data analysis, recruitment, consenting and/or
compensation?
Yes
Indicate the subject/patient identifiers that will be
collected or retained for data analysis, recruitment,
consenting and/or compensation (check all that apply):
All elements of dates that are directly related to an individual: birth
date, admission date, discharge date, death date, and all ages over 89
Medical record numbers
Names
Coding Identifiers

Will a code be used to link subject/patient identifiers
with the information and/or biospecimens?
A code will be used. Subject/Patient identiers will be kept
separately from the information and/or biospecimens. The code
key will be destroyed at the earliest opportunity, consistent with the
conduct of this research
Presentation/Publication
Specify whether subject/patient identifiers will be
disclosed in presentations and/or publications:
Subject/Patient identiers will not be disclosed
Identifier Retention
Specify how long all subject/patient identifiers will be
retained. This includes identifiers stored in paper
format, stored electronically as well as video
recordings, audio recordings, photographs, etc.:
Destroyed after publication/presentation or end of protocol
Info/Biospecimen Storage

Indicate how information and/or biospecimens (including
signed consent forms) will be stored (check all that apply):
Information will be maintained electronically. Information will be
password protected and maintained in an encrypted format
Information will be maintained in hard copy. Information will be stored
in a locked area that is not accessible to non-study team members
Information will be maintained on an UCI enterprise cloud platform
Encrypted Format
Specify where the information will be maintained
electronically:
Maintained on UCI encrypted servers
Hard Copy
Specify where the information will be maintained in
hard copy:
Physical consents and/or hardcopy documents with identi
ableinformation are locked in cabinets within the research o ces
whichrequire badge access to enter.
Enterprise Cloud Platform
For enterprise cloud storage, select the location that
adheres to the UCI Protection Level required for the
research information:
Google Drive
Microsoft OneDrive

Info/Biospecimen Transport
Will subject identifiers be transported or maintained on
portable devices (e.g., laptop, smartphone, external hard
drive, etc.)?
IMPORTANT! Only the “minimum data necessary” should be stored on portable devices
or transported as doing so makes it susceptible to loss or theft.
• If there is a necessity to use a portable device, the research files must be
encrypted, and subject identifiers transferred to a secure system as soon as
possible.
• If transporting data/biospecimens the method of transport must be secure.
No
Info/Biospecimen Retention
Indicate how long research information/biospecimens will
be retained:
In accordance with UCOP policy, information/biospecimens will be
retained for 10 years after the end of the calendar year in which the
research is completed, unless otherwise specied in the award
agreement
Info/Biospecimen Sharing
The research team, authorized UCI personnel, the study sponsor (as applicable) and
regulatory entities such as the Food and Drug Administration (FDA) and the Office of
Human Research Protections (OHRP), may have access to participants' study records to
protect their safety and welfare.   
Sharing Within Scope of Project

Will research materials (information/ biospecimens) be
shared with collaborators (i.e., researchers not covered
under the UCI project), for purposes within the scope of
the current project?
No
Sharing Outside Scope of Project
Will information and/or biospecimens be shared, used
again, or stored for undefined future research purposes
beyond the scope of the current protocol?
No
Attachments
For UCI IRB templates, visit IRB Forms.
ATTENTION! If requisite documentation is not attached, the submission will be returned as
incomplete.
Maximum file size is 30MB
Attachment Type
Other
EXPIRATION NOTICE FOR HS# 2014-1217.PDF

File Comments
Expiration of original IRB (pre KRP transition)
File Name
Status (HRP Use Only)
Agenda (HRP Use Only)
Attachment Type
Other
File Comments
Data Abstraction Sheet
File Name
Status (HRP Use Only)
Agenda (HRP Use Only)
Attachment Type
Case Report Form (CRF, eCRF)
File Comments
CRF
File Name
Status (HRP Use Only)
DATA ABSTRACTION.DOCX
TIMELINE V3.DOCX

Agenda (HRP Use Only)
Attachment Type
Consent Form
File Comments
Previously approved ICF - this is a reopening for data analysis (not
needed)
File Name
Status (HRP Use Only)
Agenda (HRP Use Only)
Attachment Type
HIPAA Research Authorization Form
File Comments
Previously approved HIPAA - this is a reopening for data analysis (not
needed)
File Name
Status (HRP Use Only)
Agenda (HRP Use Only)
2014-1217_CONSENT_06-22-18.PDF
2014-1217_HIPAA_AUTHORIZATION_UCI (1).DOCX
UCI-HIPAA-AUTHORIZATION_NEW.DOCX

Attachment Type
HIPAA Research Authorization Form
File Comments
Updated HIPAA - this is a reopening for data analysis (not needed)
File Name
Status (HRP Use Only)
Agenda (HRP Use Only)
Attachment Type
Recruitment Material
File Comments
Placeholder
File Name
Status (HRP Use Only)
Agenda (HRP Use Only)
Attachment Type
UCI IRB Approval Letter
File Comments
File Name
RECRUITMENT.DOCX
3567 RENEWAL APPROVAL LETTER 07-19-24.PDF

Status (HRP Use Only)
Approved
Agenda (HRP Use Only)
Lead Researcher Certication

Investigator's Assurance
As Lead Researcher, I have ultimate responsibility for the performance of this study, the
protection of the rights and welfare of the human subjects, and strict adherence by all co-
investigators and research personnel to all Institutional Review Board (IRB) requirements,
federal regulations, and state statutes for research involving human subjects.
I hereby assure the following:
1. The information provided in this application is accurate to the best of my knowledge.
2. The information provided in this application has been discussed and shared with my
Department Chair. Any requests for changes based on this discussion are included in
this application upon submission or will be initiated by the research team either during
the IRB review process or via an amendment.
3. All named individuals on this project have read and understand the procedures outlined
in the protocol and their role on the study.
4. All named individuals on this project have completed the required Educational research
tutorials and have been made aware of the "Common Rule" (45 CFR Part 46), applicable
Food and Drug Administration (FDA) regulations (21 CFR Parts 50, 56, 312 and 812),
have read the Belmont Report, and UCI's Federalwide Assurance (FWA) that are
available on the Human Research Protections Program (HRP) website.
5. All experiments and procedures involving human subjects will be performed under my
supervision or that of another qualified professional listed on this protocol.
6. Any responses submitted on my behalf by named individuals on this project I have
prospectively agreed to.
7. I understand that, if the study described in this IRB application is supported by a federal
award or used as a basis for a proposal for funding, it is my responsibility to ensure that
the description of human subjects activities in the proposal/award is identical in
principle to that contained in this application. I will submit modifications and/or
changes to the IRB as necessary to assure the proposal/award and application are
identical in principle.
I and all co-investigators and research personnel agree to comply with all applicable
requirements for the protection of human subjects in research including, but not limited to,
the following:
1. Obtaining the legally effective informed consent of all human subjects or their legally
authorized representatives (unless waived) and using only the currently approved,
stamped consent form (if applicable).
2. Per federal regulations, once a human research study has received IRB approval, any
subsequent changes to the study must be reviewed and approved by the IRB prior to
implementation except when necessary to avoid an immediate, apparent hazard to a
subject. See Reporting of Unanticipated Problems.
3. Reporting any unanticipated problems involving risk to subjects or others, including
protocol violations per UCI IRB policy. In addition, HIPAA privacy violations must be
PROMPTLY disclosed to the UCI Privacy Officer. There are time requirements for

reporting these breaches of confidentiality, which, if not met, may result in monetary
damages to the researcher and the institution.
4. Responding appropriately to subjects' complaints or requests for information about the
study; and reporting to the IRB any subject complaints that are not resolvable by the
study team.
5. Promptly providing the IRB with any information requested relative to the project.
6. Assuring the appropriate administration and control of investigational test articles (i.e.,
investigational drugs, biologics or devices) by a qualified investigator or other
appropriate individual or entity (e.g., UCI Health pharmacy), and assuring use and
maintenance of an Investigational Drug/Biologic Accountability Log or Device
Accountability Log.
7. Registering applicable clinical trials with clinicaltrials.gov. For more information about
this topic, visit the ClinicalTrials.gov web page or the HRP webpage. The consequences
of not meeting the registration and reporting requirements include monetary damages
to the researcher and the institution.
8. Obtaining continuing review prior to study expiration (I understand if I fail to apply for
continuing review, approval for the study will automatically expire, and all human
research activities must cease until IRB approval is obtained).
9. Promptly and completely complying with an IRB decision to suspend or terminate its
approval for some or all research activities.
10
. Submitting to a routine review of human subject research records. The Compliance &
Privacy Office at UCI Health performs ongoing routine reviews of open biomedical
research protocols, in an effort to ensure in part that human subject research activities
are conducted in accordance with regulations, laws and institutional policies regarding
the protection of human subjects. In addition, the HRP unit of the Office of Research
has developed the Education Quality and Improvement Program (EQUIP). Through
EQUIP, HRP staff conduct periodic quality improvement monitoring and educational
outreach.
11
. For clinical trials initially approved by the IRB on or after January 21, 2019, posting one
(1) IRB-approved clinical trial consent form at a publicly available federal website. The
consent form must be posted after recruitment closes, and no later than 60 days after
the last study visit. For additional guidance, refer to the OHRP FAQs on Informed
Consent.
12
. Filing a final report with UCI HRP at the conclusion of this project.
As the Lead Researcher, I assure all of the above

Investigators' Disclosure of Financial Interest
In order to inform research subjects of circumstances that may affect their decision to
participate in this study, all researchers are required to disclose their financial interests with
outside institutions.  
            
The Lead Researcher of the protocol must ask the following question of all study team
members:     
“Do you, your spouse/registered domestic partner, and dependent children together have any
disclosable financial interests (i) that would reasonably appear to be affected by the
research; or (ii) in entities whose financial interests would reasonably appear to be affected
by the research?"  
A member of the study team who answers in the affirmative will be contacted by the Conflict
of Interest Oversight Committee (COIOC) to obtain additional information regarding their
specific financial interest(s). 
IMPORTANT! If there has been a change in the financial disclosures of the LR or the study
team, please also request a 'Change in Financial Interests'.
As Lead Researcher, I certify that the disclosures for all study team
members are accurate
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Contact the Office of Research
For KRP technical questions or issues:
• Visit the KRP User Guide
• Contact Electronic Research Administration (ERA)
For IRB questions and regulatory or institutional guidance:
• Visit Human Research Protections (HRP)  
• Contact the HRP staff

Administrative Details Form
Project Status
Committee:
IRB A
Project Status:
Approved
Date of Action/Determination:
07-19-2024
Amendment Status:
Date of Amendment Action/Determination:
ERA Transcription Date:
Not applicable for new studies submitted after September 07, 2021
Pre-2018 Common Rule:
Not applicable for studies initially approved after January 21, 2019 
Date of Transition:
Not applicable for studies initially approved after January 21, 2019