Clinical trial NCT03856788
Conditions: Laparoscopic Sleeve Gastrectomy Subcostal Transversus Abdominis Plane Block
Keywords: Randomized control trial Subcostal transversus abdominis plane block Laparoscopic sleeve gastrectomy Regional anesthesia Opioid consumption Bariatrics
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2018-12-10; Completion date: 2021-03-25
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study team will be assessing if the unilateral subcostal transversus abdominis plane (TAP) block can decrease pain and improve outcomes following laparoscopic sleeve gastrectomy surgeries.

Detailed description:
This study will be a double-blinded randomized control trial. Patients will be randomized into one of two groups. Patients in Group 1 will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL 0.25% bupivacaine on the ipsilateral side as the extraction site. Patients in Group 2 will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL sterile normal saline on the ipsilateral side as the extraction site. Investigators will be blinded to the randomization of these patients. Following performance of these blocks, patients will receive standard care for the surgery as well as during the postoperative recovery period. Data will be obtained from the EPIC electronic medical record, and from the anesthesia computer record. Patients will be asked postoperatively to assess items such as their nausea and pain scores. Patients will also be contacted by phone within 1-2 days of discharge to obtain analgesic satisfaction scores. This data will be collected on the Redcap server.

Arms: arm 1: Patients will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with normal saline on the ipsilateral side as the extraction site. arm 2: Patients will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with bupivacaine on the ipsilateral side as the extraction site.
Interventions: intervention 1: Saline intervention 2: Bupivacaine
Intervention descriptions: intervention 1: 40 mL sterile normal saline intervention 2: 40 mL 0.25% bupivacaine

Protocol documents:
ICF_002.pdf: 
Effect of Unilateral Ultrasound-Guided Subcostal Transversus Abdominis Plane Block
in Patients Undergoing Laparoscopic Sleeve Gastrectomy
PI: Christina Jeng, MD
NCT03856788
Document Date: Oct 9, 2019


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 11 
Form Version Date: 06/14/2019 
Study ID #: IRB-18-00965 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
 
 
Title: Effect of Unilateral Ultrasound-Guided Subcostal Transversus Abdominis Plane Block in 
Patients Undergoing Laparoscopic Sleeve Gastrectomy 
Name: Christina Jeng, MD 
Physical Address: 1468 Madison Avenue, 8th Floor, New York, NY 10021 
Mailing Address: 1 Gustave L Levy Place Box 1010, New York, NY 10029 
Phone: 212-241-7475 
A research study is when scientists try to answer a question about something that we don’t know enough 
about. Participating may not help you or others. 
People volunteer to be in a research study. The decision about whether or not to take part is totally  up 
to you. You can also agree to take part now and later change your mind. Whatever you decide is okay. 
It will not affect your ability to get medical care within the Mount Sinai Health System. 
Someone will explain this research study to you. Feel free to ask all the questions you want before you 
decide. Any new information that develops during this research study that might make you change your 
mind about participating will be given to you promptly. 
Basic information about this study will appear on the website http://www.ClinicalTrials.gov. There are a 
few reasons for this: the National Institutes of Health (NIH) encourages all researchers to post their 
research; some medical journals only accept articles if the research was posted on the website; and, 
for research studies the U.S. Food and Drug Administration (FDA) calls "applicable clinical trials” 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. 
The purpose of this study is to determine the most effective combination of anesthesia techniques and 
strategies can best reduce pain after a laparoscopic sleeve gastrectomy surgery. 
General anesthesia is routinely provided to patients undergoing laparoscopic sleeve gastrectomy 
surgery. General anesthesia is provided by inhaled anesthetic gas through a breathing device. Pain 
relief during the surgery and after the surgery is generally managed with intravenous narcotic pain 
medications, which are given through your IV. 
TITLE OF RESEARCH STUDY: 
PRINCIPAL INVESTIGATOR (HEAD RESEARCHER) NAME AND CONTACT INFORMATION: 
WHAT IS A RESEARCH STUDY? 
PURPOSE OF THIS RESEARCH STUDY: 
Icahn School of Medicine at Mount Sinai
Protocol: IRB-18-00965
Approved: 10/09/2019
Expires: 10/07/2020


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 11 
Form Version Date: 06/14/2019 
Study ID #: IRB-18-00965 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
 
 
 
 
 
Recently nerve blocks have been proposed as a way to potentially provide better pain control and 
recovery following surgery. This is used in addition to the general anesthesia that you would get for 
surgery. For the nerve block, the anesthesiologist will inject numbing medication (local anesthetic 
medication) around nerves in a specific portion of the body in order to numb the area for surgery. 
Sometimes the numbing medication can last for a duration after surgery as well, and hence, provide 
pain control following the surgery. Nerve blocks may help to decrease the amount of IV pain 
medications that you may need during or following surgery; this may lead to decreased nausea and 
vomiting and improved patient satisfaction. Patients may even require shorter hospital stay. 
 
For laparoscopic sleeve gastrectomy surgeries (the surgery you are about to have), we are proposing 
to do a nerve block called the “subcostal transversus abdominis plane (TAP) block”. We will use an 
ultrasound machine to identify the area and nerves of your abdomen that we want to block. We will 
then insert a needle under guidance from our ultrasound machine, and target the specific area. We 
will inject numbing medication in that area. This injection will take place after you have gone to sleep 
with general anesthesia. Nerve blocks have been shown to reduce pain for different types of 
abdominal surgeries. We believe that this specific nerve block, the subcostal TAP block, will help with 
pain control for your laparoscopic sleeve gastrectomy surgery. Our research study will test this 
hypothesis. 
You may qualify to take part in this research study because you are an adult scheduled to undergo a 
laparoscopic sleeve gastrectomy surgery. You are not eligible to participate in this study if you have a 
history of liver or kidney problems. 
Funds for conducting this research are provided by Mount Sinai. 
Your participation in this research study is expected to last 1 to 5 days which includes your hospital 
stay and a follow up phone call. Your participation will end after a final follow-up phone call is 
performed 1-3 days after your discharge from the hospital. 
 
The number of people expected to take part in this research study is 140. 
 
 
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 subcostal TAP block with numbing  medication (local 
anesthetic: bupivacaine). The second group will receive the subcostal TAP block with saline (salt water). 
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 
LENGTH OF TIME AND NUMBER OF PEOPLE EXPECTED TO PARTICIPATE 
DESCRIPTION OF WHAT’S INVOLVED: 
Icahn School of Medicine at Mount Sinai
Protocol: IRB-18-00965
Approved: 10/09/2019
Expires: 10/07/2020


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 3 of 11 
Form Version Date: 06/14/2019 
Study ID #: IRB-18-00965 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
 
 
 
 
assigned. You will have a one in two chance of being in either group. The anesthesia you receive and 
the procedures that you may undergo as part of the study are all commonly performed for your surgery 
and other surgeries similar to it. 
General anesthesia with or without a nerve block is commonly done for the surgery you are getting 
(laparoscopic sleeve gastrectomy). 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 any of them are superior to the others 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 saline instead of local anesthetic 
medication for your nerve block. This is to standardize the experiment and improve the integrity of the 
study. 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 laparoscopic sleeve gastrectomy surgery. You will get an 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 throat, which will be used to help you breathe during your surgery. Once the 
breathing tube is in place, the anesthesiologist will perform the subcostal TAP block with either local 
anesthetic or saline 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 abdomen; a 
needle will be inserted under direct ultrasound vision, and either the local anesthetic or saline will be 
injected in that area. The nerve block will take approximately 5 minutes to complete. Both study groups 
will stay asleep with inhaled anesthetic gas. Medications such as pain medication 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 and pain control. The phone conversation will take place 
about 1-3 days after you go home, and will last approximately 5 minutes. 
Icahn School of Medicine at Mount Sinai
Protocol: IRB-18-00965
Approved: 10/09/2019
Expires: 10/07/2020


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 4 of 11 
Form Version Date: 06/14/2019 
Study ID #: IRB-18-00965 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
 
 
 
 
Summary: 
 
 
All patients will undergo random 
assignment by computer generator 
 
 
 
 
 
 
 
 
 
Group 1 
Patients will receive general anesthesia 
+ nerve block (subcostal TAP block) with 
numbing medication (bupivacaine) 
Group 2 
Patients will receive general anesthesia 
+ nerve block (subcostal TAP block) with 
sterile saline (solution without 
medication) 
 
 
 
 
If you decide to take part in this research study you will be responsible for the following things: 
Periodically answering questions regarding your recovery after surgery, including your pain level, and 
presence of nausea or vomiting. These interviews will take place periodically during your hospital stay 
and through a phone interview 1-3 days after being discharged from the hospital. 
 
 
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. 
 
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 reduced pain after surgery, reduced amounts of 
opioid pain medication needed for pain control, and fewer side effects such as nausea, vomiting, 
constipation, and sedation. 
YOUR RESPONSIBILITIES IF YOU TAKE PART IN THIS RESEARCH: 
POSSIBLE BENEFITS: 
COSTS OR PAYMENTS THAT MAY RESULT FROM PARTICIPATION: 
Icahn School of Medicine at Mount Sinai
Protocol: IRB-18-00965
Approved: 10/09/2019
Expires: 10/07/2020


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 5 of 11 
Form Version Date: 06/14/2019 
Study ID #: IRB-18-00965 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
 
 
 
 
 
 
A nerve block is often performed for the surgery you will have, even if a patient is not part of the study. 
Although rare, there are reported risks associated with nerve blocks such as the subcostal TAP block. 
Possible risks with nerve blocks and this study include: 
• 
Allergies to numbing medication 
• 
Nerve injury 
This can occur if the needle goes into any nerves or if numbing medication is injected into a 
nerve. The numbing medication should be injected around the nerve. The nerves in the 
abdominal wall (where we are targeting) are small, so the chances of hitting the nerves are 
extremely small. 
• 
Bowel damage 
It is rare but possible that the needle may enter the space where the bowel lies, which can 
potentially cause injury, infection, or bleeding. However, we use an ultrasound machine which 
can help us guide our needle to try to avoid this complication. 
• 
Local anesthetic systemic toxicity 
An extremely rare side effect called “local anesthetic systemic toxicity” can occur when too 
much numbing medication builds up in the body, or is injected into unintended areas. 
Symptoms can range from mild to severe effects, such as lightheadedness, ringing noises in 
the ear, low blood pressure or heart rate, seizures, coma and death in extremely rare 
instances. Local anesthetic systemic toxicity is extremely rare, especially for nerve blocks in 
the abdomen. Use of an ultrasound machine also helps to minimize injection into unintended 
areas of the body. 
• 
Loss of private information 
There is a risk of loss of private information; this risk always exists, but there are procedures in 
place to minimize this risk. 
• 
Possibility of not getting improved pain relief 
If you are randomized to the group receiving the nerve block with saline instead of medication, 
you may not have improved pain relief. You will not know which group you are in, but you will 
have access to additional pain medications postoperatively if you require them. 
 
 
You may decide not to take part in this research study without any penalty. The choice is totally up to 
you. 
REASONABLY FORESEEABLE RISKS AND DISCOMFORTS: 
OTHER POSSIBLE OPTIONS TO CONSIDER: 
Icahn School of Medicine at Mount Sinai
Protocol: IRB-18-00965
Approved: 10/09/2019
Expires: 10/07/2020


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 6 of 11 
Form Version Date: 06/14/2019 
Study ID #: IRB-18-00965 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
 
 
 
 
If you choose to not be involved in this research study, you may still be offered a nerve block as part 
of your anesthesia management. 
If you are injured or made sick from taking part in this research study, medical care will be provided. 
Generally, this care will be billed to you or your insurance in the ordinary manner and you will be 
responsible for all treatment costs not covered by your insurance, including deductibles, co-payments 
and coinsurance. This does not prevent you from seeking payment for injury related to malpractice or 
negligence. Contact the investigator for more information. 
 
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. 
You may also 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 the 
information that was already collected if that information is necessary to complete the research study. 
Your health information may still be used or shared after you withdraw your authorization if you have 
an adverse event (a bad effect) from participating in the research study. 
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. If specimens or data have been 
stored as part of the research study, they too can be destroyed without your consent. [ 
 
If you have any questions, concerns, or complaints at any time about this research, or you think the 
research has hurt you, please contact the office of the research team and/or the Principal Investigator 
at phone number: 212-241-7473. 
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. 
IN CASE OF INJURY DURING THIS RESEARCH STUDY: 
ENDING PARTICIPATION IN THE RESEARCH STUDY: 
CONTACT PERSON(S): 
Icahn School of Medicine at Mount Sinai
Protocol: IRB-18-00965
Approved: 10/09/2019
Expires: 10/07/2020


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 7 of 11 
Form Version Date: 06/14/2019 
Study ID #: IRB-18-00965 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
 
 
 
 
• 
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. 
 
 
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. 
 
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 from EPIC and 
Compurecords, which are where the medical records are stored. 
During the study the researchers will gather information by: 
− Taking a medical history (includes current and past medications or therapies, illnesses, 
conditions or symptoms, family medical history, allergies, etc.) 
− Doing a physical examination that generally also includes blood pressure reading, heart rate, 
breathing rate and temperature 
− Completing the tests, procedures, questionnaires and interviews explained in the description 
section of this consent. 
− Reviewing medical chart records 
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 
MAINTAINING CONFIDENTIALITY – HIPAA AUTHORIZATION: 
DISCLOSURE OF FINANCIAL INTERESTS: 
Icahn School of Medicine at Mount Sinai
Protocol: IRB-18-00965
Approved: 10/09/2019
Expires: 10/07/2020


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 8 of 11 
Form Version Date: 06/14/2019 
Study ID #: IRB-18-00965 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
 
 
 
 
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 Principal Investigator may also use and share the results of these tests and procedures to treat you 
in collaboration with others in the Mount Sinai Health System. 
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.) 
- 
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  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. 
Icahn School of Medicine at Mount Sinai
Protocol: IRB-18-00965
Approved: 10/09/2019
Expires: 10/07/2020


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 11 
Form Version Date: 06/14/2019 
Study ID #: IRB-18-00965 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
 
 
 
 
Will you be able to access your records? 
During your participation in this study, you will have access to your medical record and any study 
information that is part of that record. The 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 
Icahn School of Medicine at Mount Sinai
Protocol: IRB-18-00965
Approved: 10/09/2019
Expires: 10/07/2020


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 10 of 11 
Form Version Date: 06/14/2019 
Study ID #: IRB-18-00965 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
 
 
 
 
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. 
Icahn School of Medicine at Mount Sinai
Protocol: IRB-18-00965
Approved: 10/09/2019
Expires: 10/07/2020


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 11 of 11 
Form Version Date: 06/14/2019 
Study ID #: IRB-18-00965 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev6.22.16 
 
 
 
 
Signature Block for Capable Adult 
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 
Date 
 
 
Printed name of subject 
Time 
[required if used for FDA 
documentation purposes] 
 
 
Person Explaining Study and Obtaining Consent 
 
 
Signature of person obtaining consent 
Date 
 
 
Printed name of person obtaining consent 
Time 
 
Witness Section: For use when a witness is required to observe the consent process,, 
document below (for example, subject is illiterate or visually impaired, or this 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 to consent process 
Date 
 
 
Printed name of person witnessing consent process 
Time 
Icahn School of Medicine at Mount Sinai
Protocol: IRB-18-00965
Approved: 10/09/2019
Expires: 10/07/2020

Prot_000.pdf: 
Effect of Unilateral Ultrasound-Guided Subcostal Transversus Abdominis Plane Block 
in Patients Undergoing Laparoscopic Sleeve Gastrectomy
PI: Christina Jeng, MD
NCT03856788
Document Date: Sept 9, 2019


Title: Effect of Unilateral Ultrasound-Guided Subcostal Transversus Abdominis Plane Block in
Patients Undergoing Laparoscopic Sleeve Gastrectomy
Researchers: Ying (Amy) Ye, Jordan Wicker, Garrett Burnett, Chang Park, Mike Anderson,
Christina Jeng
Hypothesis: Laparoscopic sleeve gastrectomy patients who receive unilateral
ultrasound-guided subcostal transversus abdominis plane (TAP) block will have decreased
opioid consumption
Objectives
Primary Objective:
Compare amount of intravenous (IV) opioid consumption within 24-hour period amongst
laparoscopic sleeve gastrectomy patients who receive the unilateral ultrasound-guided
subcostal TAP block with bupivacaine to those who receive the block with only sterile saline.
Secondary Objectives:
a.
Amount of intraoperative IV opioid consumption
b.
Amount of post-operative IV opioid consumption
c.
Severity of pain at rest using an 11-point numeric pain score Likert scale at 1, 6, 12 and
24-hour marks postoperatively
d.
Time to breakthrough pain after surgery
e.
Area of pain after surgery
f.
Presence of postoperative nausea (yes/no) at 1, 6, 12 and 24-hour marks
postoperatively
g.
Time to ambulation after surgery
h.
Analgesia satisfaction score at end of hospital stay
i.
Hospital length of stay
Background
Over the last decade, there has been an increasing number of people undergoing bariatric
surgeries, including laparoscopic sleeve gastrectomy. While these surgeries are performed
laparoscopically, many patients still have considerable amounts of pain. The Enhanced
Recovery After Surgery (ERAS) Society recommends a multimodal analgesic strategy for
managing pain for laparoscopic sleeve gastrectomy patients so as to improve patient comfort,
and minimize opioid consumption, thereby also reducing the complications associated with
narcotic use, such as nausea, respiratory depression, and reduced bowel motility. However,
there is currently no consensus as to the best pain management strategy for these patients. 1
Several different approaches to effective analgesic management for bariatric patients have been
proposed. Studies comparing patient-controlled epidural to standard IV patient-controlled (PCA)
opioid analgesia have been promising 2,3. However, epidural placement in morbidly obese


individuals may be technically challenging. Furthermore, complications from epidural analgesia
including hypotension, dural puncture, and spinal infection or injury can be catastrophic, limiting
routine placement in patients undergoing bariatric surgery.  Rectus sheath blocks have shown
potential to reduce postoperative pain in patients undergoing upper abdominal surgeries, but no
studies have evaluated its specific effects in laparoscopic bariatric surgery 4. Local anesthetic
infiltration into trocar sites have also been suggested, but so far has not been shown to reduce
postoperative pain 5.
Recently, transversus abdominis plane (TAP) blocks has garnered attention due to the relative
ease of placement and low risk for complications. 6 The goal of the TAP block is to deposit local
anesthesia in the plane between the internal oblique and transversus abdominis muscles so as
to anesthetize the anterior rami of the T7-L1 7,8. Studies have found that the classic TAP block,
in which the needle enters at the lumbar triangle of Petit, provided analgesia only up to T10,
making this block more suitable for lower abdominal surgeries 9,10, and less ideal for
laparoscopic sleeve gastrectomy. Recent studies are now focusing on modified TAP blocks as a
means to provide adequate perioperative analgesia for these patients 11,12. Ibrahim et al.
compared the effects of bilateral oblique subcostal TAP blocks, local anesthetic infiltration alone
at port sites, and no block or infiltration; compared to the other two groups, patients receiving
bilateral oblique subcostal TAP blocks had significantly lower pain scores postoperatively for
patients undergoing laparoscopic sleeve gastrectomy surgeries 12. Despite these positive
results, oblique subcostal TAP blocks are harder to perform than the standard subcostal TAP
block, requiring a longer ultrasound needle and larger volumes of local anesthetic 13. Ari et al.
also did not find any difference in pain scores between patients receiving bilateral subcostal TAP
blocks to those receiving both bilateral subcostal and posterior TAP blocks 11.
Adequate perioperative analgesia is immensely important for bariatric patients, yet there is still
no current consensus on optimal pain control. Regional anesthesia techniques are showing
promising results. We propose that a unilateral subcostal TAP block, which is easy to perform
with minimal risks to patients, may help in minimizing pain and nausea for patients undergoing
laparoscopic sleeve gastrectomy.
Eligibility Criteria
Inclusion Criteria:
●
Adults 18-80 years old
●
Candidate for general anesthesia
●
Undergoing laparoscopic sleeve gastrectomy
●
Patients of participating surgeons
Exclusion Criteria:
●
Prior bariatric surgery of any kind


●
Previous abdominoplasty
●
Allergy or intolerance to one of the study medications
●
ASA > 4
●
Chronic opioid use (taking opioids for longer than 3 months or daily oral morphine
equivalent of >5mg/day for one month)
●
History of alcohol/drug abuse
●
History of hepatic or renal insufficiency
●
Patient refusal
●
Patients who do not speak English
Other Aspects that Could Increase Subjects’ Vulnerability
Patients undergoing surgical procedures often have anxiety with surgery. Anesthesiologists will
treat this perioperatively with medications and reassurance.
Safeguards to Protect Subjects’ Rights and Welfare
Perioperative anxiety will be treated by reassurance and medications as per standard of care.
Regardless of participation in the study, patients will undergo their scheduled surgery. Patients
will be provided contact information on the consent form in case of any rising concerns or
suggestions. Researches will ensure that protected health information be kept safe and
confidential.
Duration of Participation
Individual participation in this study will conclude following discharge from the hospital after
laparoscopic gastrectomy surgery. Duration of participation will depend on the length of
hospitalization. Typical duration of stay for this type of surgery is usually 1--3 days.
Procedures for Subjects to Request Withdrawal
Patients may withdraw from the study at any point in the investigation. Patients will be provided
with contact information and must withdraw in writing. Should this decision be made prior to the
procedure, the patient will undergo the surgery as per current standard of care; they will not be
included in the experimental protocol. If they choose to withdraw following surgery,
post-operative data collection will stop. Regardless of decision to withdraw from the study,
subjects will receive current standard of care. Collected PHI will be destroyed at the time of
withdrawal.
Procedures for Investigators to Withdraw Subjects
The patient will be informed if they need to be withdrawn from the study. Should this decision be
made prior to the procedure, the patient will undergo the surgery as per current standard of
care; they will not be included in the experimental protocol. If this is decided following surgery,
post-operative data collection will stop. Regardless, subjects will receive current standard of
care. Collected PHI will be destroyed at the time of withdrawal.
How Participants will be Identified


Patients scheduled for laparoscopic gastrectomy procedure with Dr. Scott Nguyen and Dr.
Edwards Chin will be identified at at their preoperative surgical visit. The surgery team will
discuss the study and provide written information/consent for the patient to review.
Approximately 1 week prior to the surgery, a member of the research team will call the patient to
discuss the study further and address any additional questions or concerns. They will also
discuss the study in detail, confirm understanding, and review the consent form with the patient.
If the patient agrees to the procedure, they will sign the consent on the day of surgery in the
GP2 preoperative waiting area or in the GP3 holding area.
How Research will be Introduced to Participants
At the pre-operative surgical visit, eligible patients will be introduced to the research by the
surgical team. Approximately 1 week prior to the surgery, a member of the research team will
call the patient to discuss the study further and address any additional questions or concerns.
They will also discuss the study in detail, confirm understanding, and review the consent form
with the patient.
How Participants will be Screened
At the pre-operative surgical clinic visit, patients will be screened for eligibility based on stated
inclusion and exclusion criteria. The patient will be screened again during the follow-up phone
call made by a member of the research team approximately one week before the scheduled
surgery.
Risk to Subjects
Complications for TAP blocks and its variants, including the subcostal TAP block, are rare.
Incorrect needle advancement through the peritoneum may result in injuries to organs such as
to the stomach or bowel perforation. Other complications include hematoma, infection and local
anesthetic toxicity.
Description of Procedures Taken to Lessen the Probability or Magnitude of Risks
To minimize risk, ultrasound guidance will be used for all subcostal TAP blocks. Slow injection of
local anesthetic with intermittent aspiration will help reduce the risk of inadvertent vascular
injection of local anesthetic. Patients will be monitored in accordance to the standards of the
American Society of Anesthesiologists during the entirety of the surgery. Following the surgery,
they will be monitored in the post-anesthesia care unit.
Provisions for Research Related Harm/Injury
Patients will be provided with a phone number to call for any concerns related to surgery,
anesthesia or the study. Should any complication requiring medical attention arise, patients will
be instructed to return to the hospital. Subjects injured as a result of the this study will be
treated, with the costs billed to them and/or their insurance company. Patients will not be
compensated for research related injury.
Expected Direct Benefit to Subjects


Patients who receive a subcostal TAP block may experience less postoperative pain. This may
possibly lead to lower opioid consumption, and thereby, result in fewer side effects related to
opioid consumption.
Benefit to Society
Subcostal TAP blocks may be incorporated into an Enhanced Recovery after Surgery protocol
for laparoscopic gastrectomies should this study show decreased opioid consumption and
improved outcomes with this truncal nerve block.
Provisions to Protect the Privacy Interests of Subjects
De-identified data will be stored on secure, password-protected servers maintained by the
Mount Sinai Information Technology department. Access to the data will only be available to
Mount Sinai IT administrators and the study investigators. A one-way hash ID will be generated
for each record once the de-identified data set is released for analysis. Only the study
investigators with access to the full data set will be able to match the hash ID to the original
record. All investigators must have completed the HIPAA training pertaining to PHI
confidentiality.
Economic Impact on Subjects
There is no additional cost to subjects for participating in this study. There is no compensation
for participants.
Description of Study Design
Patients who are eligible for this subject will be invited to participate. Written informed consent
will be obtained from eligible volunteers for this study.
This study will be a double-blinded randomized control trial. Patients will be randomized into one
of two groups. Patients in Group 1 will undergo general anesthesia with a post-induction,
post-intubation, pre-procedural subcostal TAP block with 40 mL 0.25% bupivacaine on the
ipsilateral side as the extraction site. Patients in Group 2 will undergo general anesthesia with a
post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL sterile normal
saline on the ipsilateral side as the extraction site. Investigators will be blinded to the
randomization of these patients. Following performance of these blocks, patients will receive
standard care for the surgery as well as during the postoperative recovery period. Data will be
obtained from the EPIC electronic medical record, and from the anesthesia computer record.
Patients will be asked postoperatively to assess items such as their nausea and pain scores.
Patients will also be contacted by phone within 1-2 days of discharge to obtain analgesic
satisfaction scores. This data will be collected on the Redcap server.
Description of Procedures being Performed
Group allocation and instructions on preparing the injectate solution for the subcostal TAP block
will be included in a sealed envelope. On the day of the surgery, the group allocation will be


revealed to an anesthesiologist not involved with the research study. The anesthesiologist will
prepare the solution to be used for the subcostal TAP block.
Standard ASA monitors will be applied to all patients. A preoperative intravenous line will be
placed. Patients will undergo standard induction with IV propofol, fentanyl and rocuronium. All
study patients will receive 1.5mcg/kg of IV fentanyl on induction. Following induction, a
subcostal TAP block will be performed on the ipsilateral site as the extraction site. Patients will
be positioned in the supine position. A linear ultrasound probe will be parallel to the lower
margin of the rib cage. The rectus abdominis muscle, posterior rectus sheath, and transversus
abdominis muscle are identified on the ultrasound. A block needle will be advanced using an
in-plane approach from medial to lateral, targeting the fascial plane between the posterior rectus
sheath and the transversus abdominis muscle. For group 1 patients, 40mL of 0.25%
bupivacaine will be deposited in this fascial plane. For group 2 patients, 40mL of normal sterile
saline will be used instead.
General anesthesia will be maintained with inhalational anesthetic gas. Boluses of fentanyl will
be given to all patients for pain control as needed, regardless of which group they are assigned
to. Patients will also receive muscle relaxants for surgical relaxation as needed. Standard
intravenous antiemetics, 8mg ondansetron and 10mg dexamethasone, will be given at the end
of the surgery prior to extubation, unless otherwise contraindicated. Surgeons will use local
anesthetic to subcutaneously infiltrate the other port sites. Following extubation, patients will
recover in the post-anesthesia care unit (PACU) and then to the general hospital floor. Patients
will be given scheduled intravenous acetaminophen 1000 mg and ketorolac (30 mg), as well as
PRN intravenous opioids, i.e. fentanyl, hydromorphone.
Description of the Source Records that Will be Used to Collect Data about Subjects
Data will be collected from computerized medical record charts including EPIC and
Compurecords. Investigators will also ask subjects questions about items such as their pain,
nausea, and satisfaction with analgesia care.
Description of Data that Will be Collected Including Long-Term Follow-Up
Data collected includes age, gender, BMI, ASA status, duration of surgery, total opioid use in
PACU, total opioid consumption in 24 hours, severity of pain at rest on a Likert scale (0-10) and
presence of postoperative nausea (yes/no) at 1 hour, 6 hours, 12 hours and 24 hours
postoperatively, time to breakthrough pain after surgery, area of pain after surgery, time to
ambulation after surgery, analgesia satisfaction score at time of discharge, and hospital length
of stay.
Where and When Consent will be Obtained
Verbal consent will be obtained via telephone approximately 1-2 weeks prior to the surgery.
Written consent will be obtained on the day of the surgery.
Waiting Period for Obtaining Consent


Patients will receive a written consent form to review at the time that their surgery is scheduled.
Approximately 1-2 weeks prior to surgery, the patient will be contacted by an investigator to
discuss the study in detail, answer all questions and confirm understanding. Subjects will
provide verbal consent for the study via this telephone call. On the day of surgery, they will sign
a written consent form.
Description of Health Information that will be Viewed, Recorded or Generated
The following data will be collected:
1.
Amount of intraoperative IV opioid consumption
2.
Amount of post-operative IV opioid consumption
3.
Severity of pain at rest using an 11-point numeric pain score Likert scale at 1, 6, 12 and
24-hour marks postoperatively
4.
Time to breakthrough pain after surgery
5.
Area of pain after surgery
6.
Presence of postoperative nausea (yes/no) at 1, 6, 12 and 24-hour marks
postoperatively
7.
Time to ambulation after surgery
8.
Analgesia satisfaction score at time of discharge
9.
Hospital length of stay
How PHI will be Protected from Improper Use or Disclosure
Only study investigators will have access to patient data. All research team members must have
completed the institutional HIPAA certification. Extracted data will be stored on the Mount Sinai
Redcap data server, which is stored in accordance to Mount Sinai research policies. A one-way
hash ID will be generated for each record in order to de-identify the subjects. Only study
investigators with access to the full data set will be able to match the hash ID to the original
source. De-identified data will be given to a statistician employed by the Mount Sinai
Department of Anesthesiology for analysis.
When and How PHI will be Destroyed
Following publication of this study, PHI will be destroyed. Digital encrypted files on the Mount
Sinai network will be deleted permanently.
Description of PHI that will be Shared
Age, sex, BMI, ASA status will be shared. All other subject demographics such as name, MRN
or date of birth will not be shared.
Justification for Sharing PHI
De-identified data will be given to a statistician employed by Mount Sinai Department of
Anesthesiology for data analysis.
With Whom Directly PHI will be Shared


De-identified data will be given to a statistician employed by Mount Sinai Department of
Anesthesiology for data analysis.
Location where Data will be Stored
Extracted data will be stored on the Mount Sinai Redcap data server, which is stored in
accordance to Mount Sinai research policies.
Duration Data will be Stored
Data will be stored for the duration of the study until publication. Following publication, the data
will be deleted permanently from the Mount Sinai network.
Steps that will be Taken to Secure the Data during Storage Use and Transmission
Encrypted and secured flash drives and Mount Sinai emails will be used for data transmission.
All study data will be stored electronically in accordance to Mount Sinai Hospital policies.
Data analysis plan including any statistical procedures
Data analysis will be completed by a biostatistician employed by the Department of
Anesthesiology.


Summary of Study Design
●
Inclusion Criteria:
○
Adults 18-80 years old
○
Body mass index >27 and <45 kg/m^2
○
Candidate for general anesthesia
○
Undergoing laparoscopic sleeve gastrectomy
○
Patients of participating surgeons
●
Exclusion Criteria:
○
Prior bariatric surgery of any kind
○
Previous abdominoplasty
○
Allergy or intolerance to one of the study medications
○
ASA > 4
○
Chronic opioid use (taking opioids for longer than 3 months or daily oral morphine
equivalent of >5mg/day for one month)
○
History of alcohol/drug abuse
○
History of hepatic or renal insufficiency
○
Patient refusal
○
Patients who do not speak English
●
Eligible patients identified during surgery clinic → Phone call 1-2 weeks prior to surgery
to discuss study, assess participation, and obtain verbal consent → Written consent
obtained on day of surgery
●
Group allocation information revealed to separate anesthesiologist on the day of surgery
●
Intraoperative Management
○
Induction: propofol, rocuronium, lidocaine, 1.5mcg/kg fentanyl
○
Ipsilateral subcostal TAP block performed
○
Maintenance: sevoflurane, rocuronium as needed, fentanyl as needed
○
Prior to extubation: 8mg ondansetron and 10mg dexamethasone unless
otherwise contraindicated
○
Surgeon will infiltrate other port sites with local anesthetic subcutaneously
●
Following extubation, patients will receive opioids along with scheduled IV
acetaminophen and ketorolac unless otherwise contraindicated
●
Investigator or nurse will assess:
○
Pain at rest using 11-point numeric pain score Likert scale at 1, 6, 12 and 24-hour
marks postoperatively
○
Presence of postoperative nausea (yes/no) at 1, 6, 12 and 24-hour marks
postoperatively
○
Area of most pain after surgery (assessed on postoperative day 1)


○
Analgesia satisfaction score at time of discharge (assessed via telephone call
within 1-2 days of discharge)
●
Data from EPIC
○
Amount of post-operative IV opioid consumption
○
Time to breakthrough pain (time from surgery end to first requirement of IV
opioid)
○
Time to ambulation after surgery
○
Hospital length of stay
●
Data from Compurecord
○
Amount of intraoperative IV opioid consumption


References
1. Thorell, A. et al. Guidelines for Perioperative Care in Bariatric Surgery: Enhanced Recovery
After Surgery (ERAS) Society Recommendations. World J. Surg. 40, 2065–2083 (2016).
2. Ruiz-Tovar, J. et al. Postoperative pain after laparoscopic sleeve gastrectomy: comparison of
three analgesic schemes (isolated intravenous analgesia, epidural analgesia associated with
intravenous analgesia and port-sites infiltration with bupivacaine associated with intravenous
analgesia). Surg. Endosc. 31, 231–236 (2017).
3. Cho, J. S. et al. Comparison of the effects of patient-controlled epidural and intravenous
analgesia on postoperative bowel function after laparoscopic gastrectomy: a prospective
randomized study. Surg. Endosc. 31, 4688–4696 (2017).
4. Abdelsalam, K. & Mohamdin, O. Ultrasound-guided rectus sheath and transversus abdominis
plane blocks for perioperative analgesia in upper abdominal surgery: A randomized controlled
study. Saudi J. Anaesth. 10, 25–28 (2016).
5. Moncada, R. et al. Does Preincisional Infiltration with Bupivacaine Reduce Postoperative
Pain in Laparoscopic Bariatric Surgery? Obes. Surg. 26, 282–288 (2016).
6. Tsai, H.-C. et al. Transversus Abdominis Plane Block: An Updated Review of Anatomy and
Techniques. BioMed Research International (2017). doi:10.1155/2017/8284363
7. Hadzic, A. Hadzic’s Textbook of Regional Anesthesia and Acute Pain Management, Second
Edition. (McGraw-Hill Education / Medical, 2017).
8. McDonnell, J. G. et al. The analgesic efficacy of transversus abdominis plane block after
abdominal surgery: a prospective randomized controlled trial. Anesth. Analg. 104, 193–197
(2007).
9. Shibata, Y., Sato, Y., Fujiwara, Y. & Komatsu, T. Transversus Abdominis Plane Block. Anesth.
Analg. 105, 883 (2007).
10. Lee, T. H. W., Barrington, M. J., Tran, T. M. N., Wong, D. & Hebbard, P. D. Comparison of
extent of sensory block following posterior and subcostal approaches to ultrasound-guided
transversus abdominis plane block. Anaesth. Intensive Care 38, 452–460 (2010).
11. Arı, D. E. et al. Ultrasound-guided subcostal-posterior transversus abdominis plane block for
pain control following laparoscopic sleeve gastrectomy. Saudi Med. J. 38, 1224–1229 (2017).
12. Ibrahim, M. & Shamaa, H. E. Efficacy of ultrasound-guided oblique subcostal transversus
abdominis plane block after laparoscopic sleeve gastrectomy: A double blind, randomized,
placebo controlled study. Egypt. J. Anaesth. 30, 285–292 (2014).
13. Tsai, H.-C. et al. Transversus Abdominis Plane Block: An Updated Review of Anatomy and
Techniques. BioMed Res. Int. 2017, (2017).



SAP_001.pdf: 
Effect of Unilateral Ultrasound-Guided Subcostal Transversus Abdominis Plane Block in 
Patients Undergoing Laparoscopic Sleeve Gastrectomy 
PI: Christina Jeng, MD 
NCT03856788 
Document Date: Aug 24, 2022 
 
 
Statistical Analysis Plan 
 
Baseline descriptive statistics will be performed for demographic variables, intraoperative data, and for 
potential confounders. All variables will be checked for normality via Kolmogorov–Smirnov test or 
Shapiro–Wilk test as well as histogram visual inspection. Normal variables will be reported as mean, 
standard deviation, non normal variables will be reported as median [IQR]. Proportions will be reported 
as n(%) and analyzed via Chi Square test. Normal continuous variables will be analyzed via t test, or 
paired t-test depending on the variable. Non-non normal variables will be tested via Mann-Whitney U 
test. Area-under the curve analyses will be evaluated through ROC analysis or other tests as indicated. 
Where applicable, linear or logistic regression will be utilized to assess for associations of variables for 
both univariate and multivariate analysis.