Clinical trial NCT05417113
Conditions: Lumbar Radiculopathy
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2022-08-31; Completion date: 2024-02-27
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to determine whether or not the addition of liposomal bupivacaine in an ESP block will have long term benefits for patients undergoing lumbar spinal fusion surgery. Given previous studies found long term benefits from liposomal bupivacaine, the hypothesis is that patients will have decreased opioid usage and improved pain scores when compared to a standard ESP block with plain 0.25% bupivacaine.

Detailed description:
This will be a double blind prospective randomized control trial comparing liposomal bupivacaine with plain bupivacaine in their effectiveness in ESP blocks in lumbar spinal fusion surgery. Patients scheduled for a lumbar spinal fusion procedure will be identified at the time of the scheduled surgery. The endpoints of this study include:

The primary objective is to compare the amount of postoperative intravenous opioid consumption among two study groups for the first 72 hours: Patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and ESP block with liposomal bupivacaine + 0.25% bupivacaine and patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and ESP block with 0.25% bupivacaine

The secondary objectives include:

Compare the severity of pain at rest at specific timepoints postoperatively. Compare general quality of recovery via QoR-15 at 48 hours, 72 hours and then at routine follow up visits occurring 2 weeks, 6 weeks, and 12 weeks postoperatively.

Measure rate of postoperative nausea/vomiting in PACU. Measure time to ambulation. Compare analgesia satisfaction score at time of discharge. Measure hospital length of stay.

Arms: arm 1: bupivacaine 0.25% in ESP blocks arm 2: liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks
Interventions: intervention 1: Liposomal bupivacaine intervention 2: Bupivacaine
Intervention descriptions: intervention 1: liposomal bupivacaine intervention 2: bupivacaine 0.25% in ESP blocks

Protocol documents:
ICF_001.pdf: 
Evaluation of the Addition of Liposomal Bupivacaine to the Erector Spinae Plane 
(ESP) Block to Multilevel Lumbar Spinal Fusion Surgery
NCT05417113
Christina Jeng, MD
Document Date: May 12, 2022


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Icahn School of Medicine at Mount Sinai 
Page 1 of 10
STUDY ID#:  STUDY-22-00168
Form Version Date: 01/17/2022
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Rev 1.19.21
____________________________
STUDY INFORMATION:
Study Title: The Effect of Adding Liposomal Bupivacaine to Bilateral Ultrasound-Guided Erector 
Spinae Plane (ESP) Block to Multilevel Lumbar Spinal Fusion Surgery 
Principal Investigator (Head Researcher): Christina Jeng, MD
Physical Address: 1450 Madison Avenue, Department of Anesthesiology, New York, NY 10029.
Mailing Address: One Gustave L. Levy Place, Department of Anesthesiology, Box 1010, New 
York, NY 10029.
Phone: (212) 241-7473
____________________________
SUMMARY OF THIS RESEARCH STUDY:
In medicine there are many unanswered questions. A research study is when scientists try to answer a 
question about something that we don’t know enough about.  Participation in a research study may or 
may not directly help you or others. Participation is entirely voluntary. It is completely up to you whether 
or not you take part. You can also change your mind at any time and it will not affect your ability to get 
medical care within the Mount Sinai Health System.  
PURPOSE OF THIS RESEARCH STUDY
The purpose of this research study is to determine if an injection near nerves in the back with a long-
acting numbing medicine (local anesthetic) is more effective than a standard local anesthetic called 
bupivacaine currently used for nerve blocks in lumbar spine surgery. During lumbar spinal fusion 
surgeries, your anesthesiologist can perform an injection in the back called an erector spinae plane 
(ESP) block. This injection helps with postoperative pain in addition to standard pain medication 
(opioid medications such as morphine) during and after your procedure.  We will perform the block 
after you are asleep and under general anesthesia. We will use an ultrasound machine to identify the 
area in your back that we want to block. We will then insert a needle and inject numbing medication in 
the target area. This medication will usually help with pain for 8-10 hours and can reduce the overall 
amount of intravenous (injection in to vein) and oral pain medications (opioids) that you might need. 
Liposomal bupivacaine is a special form of bupivacaine developed relatively recently to last 
24-72 hours. This medication has been approved by the FDA and used in a variety of injections safely 
and effectively. It is our goal to see if using this medication, instead of plain bupivacaine can be 
helpful in the setting of lumbar spinal fusion surgery as well. While regular bupivacaine works well to 
help alleviate pain after surgery for up to 24 hours, we want to see if we can extend that time even 
more by using liposomal bupivacaine. By giving some patients regular bupivacaine and some patients 
liposomal bupivacaine we will be able to directly compare if one medication is better.  
Effective Date: 5/12/2022
End Date:5/2/2023


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Icahn School of Medicine at Mount Sinai 
Page 2 of 10
STUDY ID#:  STUDY-22-00168
Form Version Date: 01/17/2022
---------------------------------------------------------FOR IRB USE ONLY--------------------------------------------------------------
Rev 1.19.21
If you choose to participate, you will be asked to:

Receive an erector spinae plane block while under general anesthesia with either bupivacaine 
or liposomal bupivacaine.  

Answer a post operative questionnaire on pain, functional status (walking, movement, 
performing basic tasks like going to the bathroom), and use of pain medications on post 
operative days 1,2, and 3 as well as 2, 6 and 12 weeks post operatively via telephone.

Receive a standardized treatment plan with regards to anesthesia and post operative pain. 
Should pain control not be adequate, this treatment plan can and will be altered to ensure 
adequate patient comfort and satisfaction.

There will be no additional cost for these medications or injections.

There will be no compensation to participate in this study.

Your information will be confidentially stored within the Mount Sinai Health system. 
The main risks to you if you choose to participate are bleeding, infection, damage to the surrounding 
tissue including but not limited to nerve and muscle damage. It is possible that this injection may cause 
an allergic reaction, a temporary drop in blood pressure, a temporary irregular heart rhythm or seizures. 
There is a risk that the injection may not be effective for pain control. 
You may also benefit from participation in this research if the injection is effective as you will need less 
anesthesia, pain medication, and could possibly recover faster and go home sooner. Instead of 
participating in this research, you can choose to decline participation in the study but would not be 
denied an injection in the back for post operative pain control if you desire.    
If you are interested in learning more about this study, please continue to read below.
____________________________
PARTICIPATION IN THIS RESEARCH STUDY:
This research study will be fully explained to you by a member of the study team. Feel free to ask all 
the questions you want before you make a decision about whether or not to participate.  Any new 
information that develops during this research study that might make you change your mind about 
participating will be given to you promptly.
You may qualify to take part in this research study because you are a relatively healthy adult individual 
undergoing lumbar spinal fusion surgery and you are not currently taking significant amounts of chronic 
pain medication.  
Funds for the liposomal bupivacaine that may be used in this research study are provided by Pacira, 
the manufacturer of liposomal bupivacaine. The funding for conducting the research is otherwise 
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 Web site will not include information that can identify you. At most, the Web site will include 
a summary of the results. You can search this Web site at any time.
Effective Date: 5/12/2022
End Date:5/2/2023


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Icahn School of Medicine at Mount Sinai 
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STUDY ID#:  STUDY-22-00168
Form Version Date: 01/17/2022
---------------------------------------------------------FOR IRB USE ONLY--------------------------------------------------------------
Rev 1.19.21
____________________________
LENGTH OF TIME AND NUMBER OF PEOPLE EXPECTED TO PARTICIPATE:
Your participation in this research study is expected to last 12 weeks until the last post-operative 
questionnaire has been completed.  
The number of people expected to take part in this research study at Mount Sinai Hospital is 84 people. 
____________________________
DESCRIPTION OF WHAT’S INVOLVED:
If you agree to participate in this research study, the following information describes what may be 
involved.

There are two study groups to which you may be assigned. Both groups will receive general 
anesthesia to fall asleep. The first group will receive the ESP block with the numbing medication 
bupivacaine. The second group will receive the ESP block with the longer acting numbing 
medication liposomal bupivacaine. The study treatment you get will be chose by a random 
computer generator. The chance of being in either group is like flipping a coin. Your study group 
assignment will be randomly chosen before your surgery. Neither you nor your study doctor will 
know what group you are in, however, this information could be obtained in an emergency. 

General anesthesia with or without a nerve block is commonly done for the surgery you are 
getting (lumbar spinal fusion). Both approaches are widely used at our hospital. Even if you were 
not part of the study, the anesthesia you would receive would be identical or very similar to one 
of these two approaches. While none of these approaches are investigational, we are 
conducting this study to see if the use of a longer acting numbing agent is superior to the current 
use of plain bupivacaine in controlling pain. 

If you were randomly assigned to be in group 1, you will receive a numbing medication called 
bupivacaine. The amount of local anesthetic medication will not exceed the accepted amount 
that should be given to patients. 

If you were randomly assigned to be in group 2, you will receive a numbing medicine called 
liposomal bupivacaine for your nerve block. You will not know which group you are randomized 
into. 

Your study involvement will begin on the day of your surgery. The beginning of surgery will 
proceed as it would for any lumbar spinal fusion surgery. You will get an intravenous line (IV) 
placed by your anesthesiologist either in the surgery waiting area or in the operating room. You 
will get medication through the IV to go to sleep. Once you are completely asleep, the 
anesthesiologist will place a breathing tube in your windpipe, which will be used to help you 
breathe during your surgery. Once the breathing tube is in place and you are positioned on your 
stomach for the surgery, the anesthesiologist will perform the ESP block with either plain 
Effective Date: 5/12/2022
End Date:5/2/2023


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Icahn School of Medicine at Mount Sinai 
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STUDY ID#:  STUDY-22-00168
Form Version Date: 01/17/2022
---------------------------------------------------------FOR IRB USE ONLY--------------------------------------------------------------
Rev 1.19.21
bupivacaine or liposomal bupivacaine depending on which study group you are in. For both 
groups, the anesthesiologist will use an ultrasound to look for the location where the nerves are 
located within your back; a needle will be inserted under direct ultrasound vision, and the local 
anesthetic will be injected in that area. The nerve block will take approximately 5 minutes to 
complete. Both study groups will stay asleep with an intravenous anesthetic medication called 
propofol. Medications such as pain medication and muscle relaxants will be given as needed to 
both groups. After the surgery, you will be taken to a surgery recovery area before you will go 
to your own hospital room. You will have pain medication and anti-nausea medication available, 
and the nurse will administer these medications if you need them. You will be periodically asked 
questions regarding your pain and nausea/vomiting during the rest of your hospital stay. A 
member of the study team will also call you after you go home from the hospital to ask you about 
your pain level and satisfaction with your anesthesia experience, functional status (ability to sit, 
stand, go to the bathroom, bath etc... with or without assistance), and your total use of opioid 
bsed medication. The phone conversation will take place on postoperative days 1,2, and 3 as 
well as during week 2, 6 and 12 and will last approximately 5 minutes.

Because this project involves the use of medications or a medical device, it is necessary that 
we make a note of your participation in the electronic medical record. That way anyone treating 
you will be aware of your participation and may be able to avoid any unfortunate outcomes that 
could arise if your research participation were unknown.
____________________________
USE OF YOUR DATA AND/OR SPECIMENS:
The private information collected as part of this research will never be used or shared for future 
research, even if the identifiable information is removed.  
____________________________
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:

Periodically answering the post-operative questionnaires honestly either via telephone or in 
person (whatever is more convenient for you and depending on your location). 
____________________________
COSTS OR PAYMENTS THAT MAY RESULT FROM PARTICIPATION:
You will not be paid for participating in this research study. Being in this research study will not lead to 
extra costs to you. You will not be reimbursed for your travel or time that may be required for study 
visits. 
Effective Date: 5/12/2022
End Date:5/2/2023


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Icahn School of Medicine at Mount Sinai 
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STUDY ID#:  STUDY-22-00168
Form Version Date: 01/17/2022
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Rev 1.19.21
____________________________
POSSIBLE BENEFITS:
It is important to know that you may not get any benefit from taking part in this research.  Others may 
not benefit either.  However, possible benefits may be improved functional outcomes after surgery such 
as being able to sit, stand, or walk sooner, decreased incidence of nausea or vomiting, decreased 
constipation, less pain medication required after surgery, decreased chance of the development of 
chronic pain, and you may be able to go home sooner because of a faster recovery. 
____________________________
REASONABLY FORESEEABLE RISKS AND DISCOMFORTS:
As stated above, the possible risks are bleeding, infection, damage to the surrounding tissue including 
but not limited to nerve and muscle damage. It is possible that this injection may cause an allergic 
reaction, a temporary drop in blood pressure, a temporary irregular heart rhythm or seizures. There is 
a risk that the injection may not be effective for pain control. 
In addition to the risks mentioned above, the following represent additional risks incurred by participating 
in this research study. 
Risk of loss of private information; this risk always exists, but there are procedures in place to 
minimize the risk.  
OTHER POSSIBLE OPTIONS TO CONSIDER:
You may decide not to take part in this research study without any penalty.  The choice is totally up to 
you. 
Instead of being in this research study, your choices may include: Proceeding with the surgery as 
planned and still having the choice to receive the erector spinae plane block injection if you desire it, 
but simply not be entered in the study. 
____________________________
IN CASE OF INJURY DURING THIS RESEARCH STUDY:
If you believe that you have suffered an injury related to this research as a participant in this study, you 
should contact the Principal Investigator. 
This does not prevent you from seeking payment for injury related to malpractice or negligence. 
Contact the investigator for more information.
____________________________
ENDING PARTICIPATION IN THE RESEARCH STUDY:
Effective Date: 5/12/2022
End Date:5/2/2023


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Icahn School of Medicine at Mount Sinai 
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STUDY ID#:  STUDY-22-00168
Form Version Date: 01/17/2022
---------------------------------------------------------FOR IRB USE ONLY--------------------------------------------------------------
Rev 1.19.21
You may stop taking part in this research study at any time without any penalty. This will not affect your 
ability to receive medical care at any of the Mount Sinai Health System hospitals or to receive any 
benefits to which you are otherwise entitled.
If you decide to stop being in the research study, please contact the Principal Investigator or the 
research staff. We will simply stop contacting you and requesting you to answer our questionnaire.    
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 removed from future use. If any data have already been shared without your 
identity, it won’t be possible to retrieve them because no one will know who you are. Data that have 
already been used will not be affected by your decision. Any data that are still linked to your identity by 
a code the researcher has will be withdrawn so that no future sharing of your data will take place.
Withdrawal without your consent: The study doctor, the sponsor or the institution 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 study team have not been followed, the 
investigator believes it is in your best interest, or for any other reason. 
____________________________
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 Principal 
Investigator at 212-241-7473. If you experience an emergency during your participation in this research, 
please call 911 or go to the emergency room. 
This research has been reviewed and approved by an Institutional Review Board. You may reach a 
representative of the Program for Protection of Human Subjects at the Icahn School of Medicine at 
Mount Sinai at telephone number (212) 824-8200 during standard work hours 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 subject.

You want to get information or provide input about this research.
____________________________
DISCLOSURE OF FINANCIAL INTERESTS:
Sometimes, physicians/researchers receive payments for consulting or similar work performed for 
industry.  Effective September 2014 Mount Sinai reviews only payments to an individual totaling more 
than $5,000 a year per entity when determining potential conflicts of interest.  If you have questions 
regarding industry relationships, we encourage you to talk your physician/researcher or visit our website 
at http://icahn.mssm.edu/ where Mount Sinai publicly discloses the industry relationships of our faculty. 
Effective Date: 5/12/2022
End Date:5/2/2023


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Icahn School of Medicine at Mount Sinai 
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STUDY ID#:  STUDY-22-00168
Form Version Date: 01/17/2022
---------------------------------------------------------FOR IRB USE ONLY--------------------------------------------------------------
Rev 1.19.21
The company sponsoring this research study (Pacira) manufactures the drug/device being tested and 
so has a financial interest that could be affected by the outcome of this research study.
____________________________
MAINTAINING CONFIDENTIALITY – HIPAA AUTHORIZATION:
As you take part in this research project it will be necessary for the research team and others to use 
and share some of your private protected health information. Consistent with the federal Health 
Insurance Portability and Accountability Act (HIPAA), we are asking your permission to receive, use 
and share that information. 
What protected health information is collected and used in this study, and might also be disclosed 
(shared) with others?  
As part of this research project, the research team at the hospital(s) involved in the research will collect 
your name, date of birth, telephone number, date of surgery, date of discharge, and medical record 
number. The researchers will also get information from your medical record including your electronic 
anesthesia record and electronic medical record that documents your care during your recovery at 
Mount Sinai Hospital. They will also get information from your first postoperative visit with your surgeon. 
During the study, the researchers will gather information by completing the chart review and interviewing 
you during your hospital stay or doctor’s appointment for any information that may not be included in 
your medical record, such as pain scores. 
Why is your protected health information being used? 
Your personal contact information is important to be able to contact you during the study. Your health 
information and the results of any tests and procedures being collected as part of this research study 
will be used for the purpose of this study as explained earlier in this consent form. The results of this 
study could be published or presented at scientific meetings, lectures, or other events, but would not 
include any information that would let others know who you are, unless you give separate permission 
to do so.
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 School’s Program for the Protection of Human Subjects 
is responsible for overseeing research on human subjects, 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 protected health information? 
As part of the study, the Principal Investigator, study team and others in the Mount Sinai workforce may 
disclose your protected health information, 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 Principal 
Investigator.) 
Effective Date: 5/12/2022
End Date:5/2/2023


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Icahn School of Medicine at Mount Sinai 
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STUDY ID#:  STUDY-22-00168
Form Version Date: 01/17/2022
---------------------------------------------------------FOR IRB USE ONLY--------------------------------------------------------------
Rev 1.19.21
- The United States Department of Health and Human Services and the Office of Human Research 
Protection. 
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 
identifier is required by law. Some records and information disclosed may be identified with a unique 
code number. The Principal Investigator 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 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 auditors, the IRB, the Office of 
Human Subjects Protection (OHRP) of the Department of Health and Human Services 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. We may publish the results of this research. However, we will keep your name and other 
identifying information confidential. 
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 
identifier is required by law. Some records and information disclosed may be identified with a unique 
code number. The Principal Investigator 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 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, the 
Office of Human Subjects Protection (OHRP) of the Department of Health and Human Services 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. We may publish the results of this research. However, we will keep your name and other 
identifying information confidential.
For how long will Mount Sinai be able to use or disclose your protected health information? 
Your authorization for use of your protected health information for this specific study does not expire
Will you be able to access your records? 
During your participation in this study, you will not be able to access your medical records. This will be 
done to prevent the knowledge of study results from affecting the reliability of the study. Your information 
will be available should an emergency arise that would require your treating physician to know this 
information to best treat you. You will have access to your medical record and any study information 
Effective Date: 5/12/2022
End Date:5/2/2023


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Icahn School of Medicine at Mount Sinai 
Page 9 of 10
STUDY ID#:  STUDY-22-00168
Form Version Date: 01/17/2022
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Rev 1.19.21
that is part of that record when the study is over or earlier, if possible. The investigator is not required 
to release to you research information that is not part of your medical record.
Do you need to give us permission to obtain, use or share your health information? 
NO! If you decide not to let us obtain, use or share your health information 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? 
You may withdraw your permission for the use and disclosure of any of your protected information for 
research, but you must do so in writing to the Principal Investigator at the address on the first page. 
Even if you withdraw your permission, the Principal Investigator for the research study may still use 
your protected information that was already collected if that information is necessary to complete the 
study. Your health information may still be used or shared after you withdraw your authorization if you 
should have an adverse event (a bad effect) from being in the study. If you withdraw your permission 
to use your protected health information for research that means you will also be withdrawn from the 
research study, but standard medical care and any other benefits to which you are entitled will not be 
affected. You can also tell us you want to withdraw from the research study at any time without canceling 
the Authorization to use your data. 
If you have not already received it, you will also be given The Hospital’s Notice of Privacy Practices that 
contains more information about how The Hospital uses and discloses your protected health 
information. 
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, even if your information will no longer be protected by federal regulations, where 
possible, Mount Sinai has entered into agreements with those who will receive your information to 
continue to protect your confidentiality. 
If as part of this research project your medical records are being reviewed, or a medical history is being 
taken, it is possible that HIV-related information may be revealed to the researchers. If that is the case, 
the following information concerns you. If this research does not involve any review of medical records 
or questions about your medical history or conditions, then the following section may be ignored. 
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.
Effective Date: 5/12/2022
End Date:5/2/2023


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CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Icahn School of Medicine at Mount Sinai 
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STUDY ID#:  STUDY-22-00168
Form Version Date: 01/17/2022
---------------------------------------------------------FOR IRB USE ONLY--------------------------------------------------------------
Rev 1.19.21
ADULT PARTICIPANT:
Your signature below documents your permission to take part in this research and to the use and 
disclosure of your protected health information. A signed and dated copy will be given to you.
_________________________
_________________________
__________
__________
Signature of subject
Printed Name of Subject
Date
Time
PERSON EXPLAINING STUDY AND OBTAINING CONSENT:
_________________________
_________________________
__________
__________
Signature of consent delegate
Printed Name of consent delegate
Date
Time
WITNESS SECTION:
When a witness is required to observe the consent process, it should be documented below (for 
example, when subject is illiterate, visually impaired, or this document accompanies a short form 
consent).
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 subject, and that consent 
was freely given by the subject.
_________________________
_________________________
__________
__________
Signature of Witness
Printed Name of Witness
Date
Time
Effective Date: 5/12/2022
End Date:5/2/2023

Prot_000.pdf: 
Evaluation of the Addition of Liposomal Bupivacaine to the Erector Spinae Plane 
(ESP) Block to Multilevel Lumbar Spinal Fusion Surgery
NCT05417113
Christina Jeng, MD
Document Date: May 12, 2022


Protocol Name:
Erector Spinae Block for Spine Surgery
Principal Investigator: 
Christina Jeng, 
Primary Contact 
Name/Contact Info:
Lily Eaker
212-241-1678
Date Revised:
11/15/2021
Study Number:
Study 20-01312
1
Revised 5/13/2021 (amendment 02)
HRP-503 Application (Protocol Supplement)
●
This application can only be used in conjunction with a protocol. If this project does not 
have a protocol from the sponsor or is already included in a grant application then a 
comprehensive protocol should be developed. A comprehensive template and online wizard 
is located at: NIH Wizard.
●
Note that, depending on the nature of your research, certain questions, directions, or entire sections below 
may not be applicable, or may have been fully covered in the protocol. Provide information if and when 
applicable. If the answer is found in the protocol please provide a page reference. If the question is not 
applicable to the study, mark the section “N/A”.  Do not delete any sections.
●
Be sure to complete any supplement questions from one or another ancillary office that you 
receive during the RUTH application process. Please make certain that the protocol, this 
503 application and responses to ancillary offices do not contradict each other and the 
information is incorporated in all documents where appropriate. Be sure to save the 
Ancillary office responses you provided within RedCap and upload them to Ruth. 
●
Throughout this application are references to checklists. These tools are used by the IRB to 
make specific regulatory findings. To allow us to do that it is the applicant’s responsibility to 
ensure that your protocol has sufficiently addressed these additional regulatory criteria for 
approval, and that the applicant identifies those protocol specific findings required by the 
checklist. how will they do that, here or a separate form? 
●
Keep an electronic copy of this version of the document. You will need to modify this copy when making 
changes.
1. Setting of the Human Research:
The research activities will take place at The Mount Sinai Hospital.
Effective Date: 5/12/2022
End Date:5/2/2023


Protocol Name:
Erector Spinae Block for Spine Surgery
Principal Investigator: 
Christina Jeng, 
Primary Contact 
Name/Contact Info:
Lily Eaker
212-241-1678
Date Revised:
11/15/2021
Study Number:
Study 20-01312
2
Revised 5/13/2021 (amendment 02)
2. Resources Available to Conduct the Human Research: (the aim here is to 
assess if the research is likely to be successful and thus justify the efforts and risks taken by the 
subjects):
Recruitment of patients will be through the practices of five orthopedic and/or neurological 
surgeons providing elective lumbar spinal fusion surgery. 12 physicians with specialized 
training in either spine surgery or regional anesthesiology with exquisite knowledge of the 
local study site, culture, and society and extensive research experience (numerous published 
studies) over the course of their careers entail the persons assisting with the trial. These 
individuals are all informed about the protocol, the investigational product(s), and their trial-
related duties and functions. The study group will conduct weekly meetings via video or in-
person conference to discuss the study protocol, investigational product(s), their trial-related 
duties and functions, and progress of the study in each stage.
3. Study Design:
a) Recruitment Methods (see PPHS policy):
Patients scheduled for a 1-2 level lumbar spinal fusion procedure will be identified at the time of the 
scheduled surgery. The study will be discussed and written consent will be provided for the patient to 
review and sign. A member of the research team will call the patient approximately 1 week prior to 
the surgery to discuss the study further and answer any questions the patient may have. This 
investigator will describe the study in detail, answer questions, confirm understanding, and review the 
consent form with the patient.  Additionally, patients will be screened for inclusion and exclusion 
criteria in the clinic at the time of the scheduled procedure prior to the phone call 1 week before 
surgery. During the follow up phone call to answer any additional questions, the patient will be 
screened again for inclusion and exclusion criteria.
b) Inclusion and Exclusion Criteria:
Inclusion criteria: Adults aged greater than or equal to 18 years old and less than or equal to 85 years 
old. Patients who are scheduled to undergo lumbar spinal fusion surgery (1-2 level) and willing and 
able to provide informed consent.
Effective Date: 5/12/2022
End Date:5/2/2023


Protocol Name:
Erector Spinae Block for Spine Surgery
Principal Investigator: 
Christina Jeng, 
Primary Contact 
Name/Contact Info:
Lily Eaker
212-241-1678
Date Revised:
11/15/2021
Study Number:
Study 20-01312
3
Revised 5/13/2021 (amendment 02)
Exclusion criteria: Patients with a history of consistent chronic opioid use for > 3 months including 
but not limited to fentanyl, morphine, oxycodone, methadone. Patients with known allergy or 
intolerance to any drug used in the study including local anesthetics, total intravenous anesthesia 
medications, and non-steroidal anti-inflammatory medications. Patients with a history of alcohol or 
drug abuse. Patients with a history of intolerance of nonsteroidal anti-inflammatory drugs. Patients 
with hepatic insufficiency. Patients with renal insufficiency. Patients with American Society of 
Anesthesiologists physical status of 4 or greater. Patients on immunosuppressive therapy. Pregnant 
patients.
c) Number of Subjects:
Total number of subjects to be accrued locally: 84
d) Study Timelines:
Duration of an individual subject’s participation in the study (including follow-up): 
Individual subject's participation will conclude 12 weeks after lumbar spinal fusion 
surgery. 
Duration anticipated to enroll all study subjects: 22 months 
Estimated date for the investigators to complete this study (complete primary analyses): 
1/1/2024.
e) Specimen Banking for Future Uses Not Part of This Project
N/A
f) Data Storage, Transmission and Confidentiality:
Effective Date: 5/12/2022
End Date:5/2/2023


Protocol Name:
Erector Spinae Block for Spine Surgery
Principal Investigator: 
Christina Jeng, 
Primary Contact 
Name/Contact Info:
Lily Eaker
212-241-1678
Date Revised:
11/15/2021
Study Number:
Study 20-01312
4
Revised 5/13/2021 (amendment 02)
Describe the data and specimens to be sent out or received. If storage will occur at Sinai 
and elsewhere (e.g. the sponsor) be sure to answer these questions for both sets of samples 
as, at the very least, governance of future uses will differ.
As applicable, describe:
●
How will data be collected?
●
How will data be transmitted? If clinical trials software or similar is being used 
provide the names as well as the security/regulatory specifications it complies with 
(e.g. FDA)
●
How will data be stored? Provide data standards where known
●
How long will data be stored?
●
What are the SOPs that govern data sharing?
●
If this project is not funded by NIH will a Certificate of Confidentiality be 
obtained? If not, why not?
●
Description of the source records that will be used to collect data about 
subjects: 
EPIC computerized medical record charting will be used to record data about 
the subjects. Additionally, investigators will ask patients questions (for 
example, nausea in PACU on 11 point Likert scale).
●
Description of data that will be collected including long-term follow-up: 
Age, Gender, BMI, ASA status, duration of surgery, total opioid use in PACU, 
total opioid consumption in 24 and 72 hours, severity of pain on Likert scale (0-
10) at 1, 6, 12, 24, and 72  hours as well as at 2 weeks, 6 weeks, and 12 weeks 
post surgery, time to breakthrough pain after surgery (first dose of pain 
medication requested after surgery is finished), incidence of vomiting in PACU, 
nausea in PACU (highest number reported on 11 point Likert scale), time to 
ambulation after surgery, time to flatus after surgery, time to first bowel 
movement after surgery, analgesia satisfaction score 3 days after discharge, 
length of stay in PACU, Quality of recovery vis QoR-15 survey at 3 days, 2 
weeks, 6 weeks, and 12 weeks postoperatively. 
Effective Date: 5/12/2022
End Date:5/2/2023


Protocol Name:
Erector Spinae Block for Spine Surgery
Principal Investigator: 
Christina Jeng, 
Primary Contact 
Name/Contact Info:
Lily Eaker
212-241-1678
Date Revised:
11/15/2021
Study Number:
Study 20-01312
5
Revised 5/13/2021 (amendment 02)
●
Description of health information that will be viewed, recorded, or generated: 
Age, Gender, BMI, ASA status, duration of surgery, total opioid use in PACU, 
total opioid consumption in 24 and 72  hours, severity of pain on Likert scale 
(0-10) at  1, 6, 12, 24, and 72 hours as well as 2 weeks, 6 weeks, and 12 weeks 
postoperatively, time to breakthrough pain after surgery (dose of pain 
medication beyond standard patient controlled analgesia regimen), vomiting in 
PACU, nausea in PACU (highest number reported on 11 point Likert scale), 
time to ambulation after surgery, time to flatus after surgery, time to first bowel 
movement after surgery, length of stay in PACU; length of stay in hospital, 
patient reported satisfaction with anesthesia, Quality of recovery vis QoR-15 
survey at 3 days, 2 weeks, 6 weeks, and 12 weeks postoperatively.
●
How PHI will be protected from improper use or disclosure: 
Only researchers involved in data collection and analysis will have access to 
patient data. All data collected by the researchers will be labeled with a one-
way hash ID. Only the study investigators will have access to the full data set 
which will allow for matching of the has ID to the original data source.  All 
researchers who will access the data have completed the institutional HIPAA 
certification. Extracted data will be de-identified before being given to the 
statistician for analysis. Any intermediary data files containing extracted PHI 
will be stored on secured hospital servers and destroyed after data analysis is 
complete. All study data at Mount Sinai stored electronically will follow 
MSMC policies. All PHI that is not stored on a limited access Mount Sinai IT 
maintained network drive will be encrypted and password protected. Statistical 
analysis will be carried out by a statistician employed by the Department of 
Anesthesiology. When the de-identified data set is released for analysis, a one-
way hash ID will be generated for each record.  Only Mount Sinai study 
investigators with access to the full data set will be able to match the hash ID to 
the original source.
●
When and how PHI will be destroyed: 
PHI will be destroyed following publication of this study. Digital encrypted 
files on the Mount Sinai network will be deleted permanently.
●
Description of PHI that will be shared: 
Effective Date: 5/12/2022
End Date:5/2/2023


Protocol Name:
Erector Spinae Block for Spine Surgery
Principal Investigator: 
Christina Jeng, 
Primary Contact 
Name/Contact Info:
Lily Eaker
212-241-1678
Date Revised:
11/15/2021
Study Number:
Study 20-01312
6
Revised 5/13/2021 (amendment 02)
Age, Sex, BMI, ASA status, surgical procedure, opioid use. All other subject 
demographics will not be shared when de-identified data is given to a 
statistician employed by the department of anesthesiology.
●
Justification for sharing PHI: 
Deidentified data will be given to a statistician employed by the department of 
anesthesiology in order to complete the study analysis.
●
With whom directly PHI will be shared: 
Deidentified data will be given to a statistician employed by the department of 
anesthesiology
●
Location where data will be stored: 
Extracted data will be de-identified before being given to the statistician for 
analysis. Any intermediary data files containing extracted PHI will be stored on 
secured hospital servers and destroyed after data analysis is complete. All study 
data at Mount Sinai stored electronically will follow MSMC policies. All PHI 
that is not stored on a limited access Mount Sinai IT maintained network drive 
will be encrypted and password protected.
●
Duration data will be stored: 
Data will be stored for the duration of the study. Encrypted data will be deleted 
permanently from the Mount Sinai network following completion of the study.
●
Steps that will be taken to secure the data during storage use and transmission: 
Extracted data will be de-identified before being given to the statistician for 
analysis. Any intermediary data files containing extracted PHI will be stored on 
secured hospital servers and destroyed after data analysis is complete. All study 
data at Mount Sinai stored electronically will follow MSMC policies. All PHI 
that is not stored on a limited access Mount Sinai IT maintained network drive 
will be encrypted and password protected.
●
Data analysis plan including any statistical procedures: 
Data analysis will be completed by a biostatistician employed by the 
department of anesthesiology.
Effective Date: 5/12/2022
End Date:5/2/2023


Protocol Name:
Erector Spinae Block for Spine Surgery
Principal Investigator: 
Christina Jeng, 
Primary Contact 
Name/Contact Info:
Lily Eaker
212-241-1678
Date Revised:
11/15/2021
Study Number:
Study 20-01312
7
Revised 5/13/2021 (amendment 02)
g) Data and Safety Monitoring Plan:
●
For projects with a Data Safety Monitoring Board/Data Safety Committee 
(DMSB/DMC):  N/A
●
If not included in the protocol, attach a description of the DMC/DSMB, including the 
number, names (if available} and area of professional expertise of the members. The 
responsibilities of the DSMB/DMC must be clear as well as their powers and their degree 
of independence. The DSMB charter must be provided to the PPHS before the study may 
begin.  Reports of the DMC/DSMB must be made available to the local PI and the MSSM 
PPHS.  The report need not contain specifics of the study or data, but there should be clear 
statement if the study can continue as is,or requires changes or termination. 
h) For other projects with greater than minimal risk a monitoring plan must be provided: 
1. List the name(s) of the individual(s) at MSSM who will be responsible for data and safety 
monitoring of this study. For each individual, indicate their role, name, title, and department 
information. The Principal Investigator may be the only monitor of a study. 
2. If the qualifications of an individual to serve as a monitor are not contained in the PPHS 
application, they must be added to the DSMP either as a narrative description or as a CV.
MSSM Principal Monitor:  Principal Investigator
Last Name: Jeng
First Name: Christina  
Academic Title: Associate Professor 
Department: Anesthesiology 
Mailing Address: 1 Gustave L Levy Place Box 1010 
 NY, NY 10029 
Phone: 212-241-6426
Fax:  
E-mail: Christina.jeng@mountsinai.org 
 
Effective Date: 5/12/2022
End Date:5/2/2023


Protocol Name:
Erector Spinae Block for Spine Surgery
Principal Investigator: 
Christina Jeng, 
Primary Contact 
Name/Contact Info:
Lily Eaker
212-241-1678
Date Revised:
11/15/2021
Study Number:
Study 20-01312
8
Revised 5/13/2021 (amendment 02)
3. Justify your choice of principal monitor in terms of the assessed risk to the research subject‘s 
health and wellbeing. In high risk studies when the principal monitor is independent of the study 
staff, indicate the individual’s credentials, relationship to the PI, and the rationale for selection. 
This protocol is a minimal risk protocol comparing two standard of care treatments. As such, no 
more than minimal monitoring is required. As an anesthesiologist who performs these 
interventions, the PI is more than capable for this task. 
4. List the specific items that will be monitored for safety (e.g., adverse events, subject compliance 
with the protocol, drop outs, etc.). 
We will monitor for adverse events as well as dropouts.  
5. Indicate the frequency at which ACCUMULATED safety and data information (items listed in 
number 3 above and interim analysis of efficacy outcomes) will be reviewed by the monitor(s) or 
the Data Monitoring Committee (DMC). Although this information must be reviewed at least 
annually, the higher the study risks, the more frequently reviews must be scheduled. 
We will review blinded data items at the halfway point of the study to look for any safety issues. 
We will not be doing formal data analysis at that timepoint.
6. Where applicable, describe rules which will guide interruption or alteration of the study design. 
N/A
7. Where applicable, indicate dose selection procedures that will be used to minimize toxicity. 
N/A
8. List any specialized grading system that will be used to evaluate adverse events (e.g., National 
Cancer Institute Common Toxicity Criteria). 
N/A
9. Describe procedures that will be used to assure data accuracy and completeness.
All members are trained in proper data entry. 
10. Should a temporary or permanent suspension of your study occur, in addition to the
PPHS, indicate to whom (NIH, FDA, sponsor, IRB) will you report the occurrence.
IRB
Effective Date: 5/12/2022
End Date:5/2/2023


Protocol Name:
Erector Spinae Block for Spine Surgery
Principal Investigator: 
Christina Jeng, 
Primary Contact 
Name/Contact Info:
Lily Eaker
212-241-1678
Date Revised:
11/15/2021
Study Number:
Study 20-01312
9
Revised 5/13/2021 (amendment 02)
i) Withdrawal of Subjects:
●
Procedures for Subjects to Request Withdrawal:
(1) Patients are able to withdraw from the study at any point in the investigation. Patients will 
be provided with contact information and must withdraw in writing.  If this decision is 
made prior to their procedure, the patient will undergo their procedure at the standard of 
care and not be included in the experimental protocol. If this decision is made following 
their procedure, the postoperative data collection will cease. The patient will receive 
standard postoperative care no matter the time of withdrawal from the study. All collected 
PHI will be destroyed at the time of withdrawal.
●
Procedures for Investigator to Withdraw Subjects:
(1) If a patient must be withdrawn from the study by the investigators, the patient will be 
informed of such as soon as this decision is made. This may be due to changes in eligibility 
or if in the opinion of the investigator, they are not appropriate candidates for an Enhanced 
Recovery After Surgery protocol.
(2) If this decision is made prior to their procedure, the patient will undergo their procedure at 
the standard of care. If this decision is made following their procedure, the postoperative 
data collection will cease. The patient will receive standard postoperative care no matter 
the time of withdrawal from the study. All collected PHI will be destroyed at the time of 
withdrawal.
4. Provisions for Research Related Harm/Injury: 
●
Subjects will be monitored during surgery and during recovery from anesthesia and 
surgery. Upon discharge, subjects will be provided with a phone number to call should 
they have any concerns related to surgery, anesthesia, or the study.  If necessary, 
subjects will be instructed to return to the hospital should any complication requiring 
medical attention occur.
●
Subjects who are injured as a result of this study will be treated and the cost will not be billed 
to them and/or their insurance carrier. Patients will not be compensated for research-related 
injury.
5. Recordings:
Effective Date: 5/12/2022
End Date:5/2/2023


Protocol Name:
Erector Spinae Block for Spine Surgery
Principal Investigator: 
Christina Jeng, 
Primary Contact 
Name/Contact Info:
Lily Eaker
212-241-1678
Date Revised:
11/15/2021
Study Number:
Study 20-01312
10
Revised 5/13/2021 (amendment 02)
N/A
6. Provisions to Protect the Privacy Interests of Subjects: 
This clinical trial does not involve active communication between the study participants. Consent 
for the procedure occurs in a private consultation/exam rooms at the attending offices at the Mount 
Sinai Hospital. Similarly, all questionnaires to be completed in a private interview with each 
patient.  All data will be maintained on a database created for this study using Microsoft Excel or 
HIPAA-compliant spreadsheet. This database will only be accessible by the research personnel 
listed in the IRB by using password protected hard drive at Mount Sinai as well as encrypted email 
(Mount Sinai emailing system). To maintain confidentiality all personal identifiable information 
will be removed from the database and labeled with a unique code. Consent forms for the study 
will be kept in a secure locked cabinet at our department. The data obtained from this study will be 
maintained indefinitely but only accessible by the investigators/coordinators on this study who are 
all HIPPA trained.
7. Economic Impact on Subjects:
There are no costs to subjects for participating in this study. The erector spinae plane block will be 
performed free of charge. There will be no additional visits or tests related to study participation 
other than the standard postoperative follow-up visit with the surgeon that would take place 
regardless of study participation.
8. Payments/Reimbursements to Subjects:
N/A
9. Consent Process:
Effective Date: 5/12/2022
End Date:5/2/2023


Protocol Name:
Erector Spinae Block for Spine Surgery
Principal Investigator: 
Christina Jeng, 
Primary Contact 
Name/Contact Info:
Lily Eaker
212-241-1678
Date Revised:
11/15/2021
Study Number:
Study 20-01312
11
Revised 5/13/2021 (amendment 02)
Participants will give verbal consent via telephone approximately 1 week prior to surgery. 
The patient will be seen preoperatively on the day of surgery to discuss the consent and 
answer any additional questions. At this time, the patient will sign written consent. 
Children and cognitively impaired individuals are not included in the study. 
Non-English speaking patients will be excluded secondary to unavailability of translated consent 
forms for all possible languages.
Where and When Consent Will Be Obtained: 
Patients will be consented at the Icahn School of Medicine at Mount Sinai, first in the spine 
surgeon’s office by Dr. Wesley Bronson on 5 E 98th St 4th Floor, New York, NY 10029, then in 
the pre-operative holding area by an anesthesiologist involved in this study, either Dr. Jeng, Dr. 
Park, Dr. Burnett, or Dr. Patel, on the 3rd floor of the Guggenheim pavilion building on 1468 
Madison Ave, New York, NY 10029. 
Waiting Period for Obtaining Consent: 
Patients will have adequate time to decide to participate in the study. Patients are free to decline 
participation or discontinue participation at any time
10.
Process to Document Consent in Writing:
The consent will be signed as described above. The patient will be given a copy of the consent 
form at signing. During the consenting process the consenter will review the consent form section 
by section with the patient. 
11.
Vulnerable Populations:
a) Unless already detailed in the protocol, please indicate which of the following populations 
are either included or excluded in this project: Indicate specifically whether you will 
include (target) or exclude each of the following populations:
Include
Exclude
Vulnerable Population Type
Effective Date: 5/12/2022
End Date:5/2/2023


Protocol Name:
Erector Spinae Block for Spine Surgery
Principal Investigator: 
Christina Jeng, 
Primary Contact 
Name/Contact Info:
Lily Eaker
212-241-1678
Date Revised:
11/15/2021
Study Number:
Study 20-01312
12
Revised 5/13/2021 (amendment 02)
x
Adults unable to consent
x
Individuals who are not yet adults (e.g. infants, children, teenagers)
x
Wards of the State (e.g. foster children)
x
Pregnant women
x
Prisoners
b) Describe other aspects of the subject population that may increase their vulnerability 
(marginalized populations, poverty, illiteracy and under-education, legal status, home/institution-
bound individuals; students participating in their professor’s research, cognitively-impaired 
minors, etc.). For those subjects at an increased risk of not understanding the aims, procedures, 
risks and benefits of this project, OR whom may be at increased vulnerability to coercion or undue 
influence, describe additional safeguards included to protect their rights and welfare.
To our knowledge there are no other aspects of the subject population that increase their 
vulnerability as spine surgery is a common surgery and our study offers two options that are 
commonly employed. Also, at any time patients can opt out of the study.
c) What steps are being taken to assure that a diverse group of research subjects are approached to 
participate in this study? What are the projected demographics of the enrolled subjects at study 
completion.
To ensure a diverse group of research subjects are approached, we are approaching all patients 
regardless of their social economic status, race etc. Any patient who fulfills the inclusion criteria 
and allows us to approach them will be offered the ability to participate
d) Review the following checklists that are available in RUTH. The research team should provide the 
“project specific findings” that are requested in the relevant checklists.  N/A
●
If the Human Research involves cognitively impaired adults, review the “CHECKLIST 
HRP-417 Criteria for Research Involving Cognitively Impaired Adults” to ensure that 
your protocol has sufficiently addressed these additional regulatory criteria for 
Effective Date: 5/12/2022
End Date:5/2/2023


Protocol Name:
Erector Spinae Block for Spine Surgery
Principal Investigator: 
Christina Jeng, 
Primary Contact 
Name/Contact Info:
Lily Eaker
212-241-1678
Date Revised:
11/15/2021
Study Number:
Study 20-01312
13
Revised 5/13/2021 (amendment 02)
approval, including protocol specific information to support the determinations.
●
If the Human Research involves persons who have not attained the legal age for consent 
to treatments or procedures involved in the research (“children”), review the 
“CHECKLIST HRP-416 Criteria for Research Involving Children” to ensure that your 
protocol has sufficiently addressed these additional regulatory criteria for approval, 
including protocol specific information to support the determinations.
●
If the Human Research involves pregnant women, review the “CHECKLIST HRP-412 
Criteria for Research Involving Pregnant Women” to ensure that your protocol has 
sufficiently addressed these additional regulatory criteria for approval, including 
protocol specific information to support the determinations.
●
If the Human Research involves non-viable neonates or neonates of uncertain viability, 
review the “CHECKLIST HRP-413 Criteria for Research Involving Non-Viable 
Neonates” “CHECKLIST HRP-414 Criteria for Research Involving Neonates of 
Uncertain Viability” to ensure that your protocol has sufficiently addressed these 
additional regulatory criteria for approval, including protocol specific information to 
support the determinations.
●
If the Human Research involves Prisoners, review the “CHECKLIST HRP-415 Research 
Involving Prisoners” to ensure that your protocol has sufficiently addressed these 
additional regulatory criteria for approval, including protocol specific information to 
support the determinations.
12.
Multi-Site Human Research:
N/A
13.
Community-Based Participatory Research
N/A
Effective Date: 5/12/2022
End Date:5/2/2023


Protocol Name:
Erector Spinae Block for Spine Surgery
Principal Investigator: 
Christina Jeng, 
Primary Contact 
Name/Contact Info:
Lily Eaker
212-241-1678
Date Revised:
11/15/2021
Study Number:
Study 20-01312
14
Revised 5/13/2021 (amendment 02)
14.
Sharing of individual and study Results with Subjects:
All results of the study will be shared with subjects if they wish to be notified through 
their preferred method of contact. 
15.
External IRB Review History
N/A
16.
Control of Drugs, Biologics, or Devices:
Liposomal bupivacaine and 0.25% bupivacaine will be stored, handled, and controlled by the 
Mount Sinai Hospital Department of Anesthesiology, Perioperative and Pain Medicine in the 
departments medication refrigerator so that it will only be used on subjects and used only by 
authorized investigators. Plaine 0.25% Bupivacaine will be obtained by anesthesiologists deemed 
to be authorized investigators from the preoperative holding area prior to use on each patient in 
Groups 1 and 2 for the ESP block.  Standard drug handling policies will be utilized for this study. 
All personnel handling medications are trained in this manner.
Effective Date: 5/12/2022
End Date:5/2/2023