Clinical trial NCT03001843
Conditions: Laparoscopic Gastric Bypass Obesity Pain, Postoperative
Sponsor: University of Florida
Start date: 2017-02-22; Completion date: 2018-12-21
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will help to determine if investigators can minimize narcotic use in laparoscopic gastric bypass patients while maintaining adequate pain control. This will allow investigators to minimize the negative side effects of narcotics which is a goal in this population.

Detailed description:
The study will be a head to head observational study of patients who have undergone gastric bypass surgery. The methods of intraoperative anesthesiology will be Ketamine or Narcotic. Both are FDA approved methods of delivering anesthesia.

The amount of narcotics a patient receives is part of the medical record post-operatively will be followed from post-anesthesia care unit (PACU) through to discharge. The amount of narcotics needed to control the patient's pain (converted to morphine equivalent units) and pain scores (a hospital standard measure) will be collected for 48 hours for the study, or until discharge, whichever occurs sooner. The conversion to a morphine equivalent unit allows investigators to compare different narcotics the patient may receive in a more standardized way. The results will be analyzed and compared between the two groups.

Arms: arm 1: This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine. arm 2: This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.
Interventions: intervention 1: Ketamine intervention 2: Narcotics intervention 3: pain scale
Intervention descriptions: intervention 1: Anesthesia of only Ketamine intervention 2: The narcotic group will receive no ketamine but rather a more standard anesthetic intervention 3: 0-10 pain scale. 0 = no pain and 10 = worst pain

Protocol documents:
Prot_002.pdf: 
Does a ketamine Infusion decrease post-operative narcotic consumption after gastric bypass surgery?
NCT03001843
Most recent approval: 2/22/2017
UNIVERSITY OF FLORIDA ACADEMIC HEALTH CENTER 


Does a ketamine Infusion decrease post-operative narcotic consumption after gastric bypass surgery? 
 
Investigators: David Smyth CRNA PI, Joshua Sappenfield MD , and Jeffrey  
Friedman MD 
 
Abstract:  Among the negative side effects of narcotics is respiratory depression.  The risks of respiratory 
depression are exacerbated when coupled with pre-existing sleep apnea.  The obese patient population 
is predisposed to sleep apnea and are a growing population, increasingly presenting for gastric bypass 
surgery as a means to lose the excess weight.  One drug which can decrease the need for narcotics while 
still delivering good pain relief is ketamine.  It is our hypothesis that an intra operative infusion of 
ketamine will decrease the amount of post-operative narcotics required for adequate pain relief and 
thereby the patients will be exposed to fewer narcotic side effects. 
 
Background:  According to the Centers for Disease Control (CDC), approximately one third of American 
adults, about 78.6 million, are obese.  Obesity contributes greatly to healthcare costs in this country 
accounting for $147 billion in 2008, according to the most recent data available from the CDC.1 The 
health risks associated with obesity cited by the CDC include, but are not limited to coronary heart 
disease, high blood pressure, type 2 diabetes, cancers, stroke, liver and gall bladder disease, sleep 
apnea, and osteoarthritis 1.   
 
Several treatments for obesity exist with varied efficacy and long term success rates. With 
caloric reduction as the initial treatment it was found that after 6 months there is a reduction in initial 
body weight of about 8%; however beyond 4-5 years the amount of weight loss drops off to 4% .2   In 
contrast Gastric Bypass Surgery has shown “that patients lose about 2/3 to 3/4 of their excess weight 
over the first two years. Longer term studies have shown that on average patients keep off at least 1/2 
of the excess over 5 to 15 years.” 3 
 
Obesity is an epidemic in America and surgical interventions have been shown to provide 
greater and longer lasting weight loss compared to conservative measures such as caloric restriction.  
Among surgical interventions, gastric bypass has shown better maintenance of weight loss than vertical 
banded gastroplasty .4   It is therefore probable that anesthesia providers will be seeing an increasing 
number of obese patients presenting for gastric bypass in the coming years.  The tremendous healthcare 
costs related to obesity as well as the high success rate of gastric bypass “a loss of 50% of excess weight 
as long as 14 years postoperatively”4 make this an important issue for anesthesia providers. Managing 
this group of patients with their co-morbidities presents its own unique challenges and one of those 
challenges is effective post-operative pain control while maintaining adequate ventilation as this group 
is highly prone to sleep apnea even before undergoing an anesthetic and administration of narcotics. 
 
The dangers of sleep apnea in this group should not be taken lightly.  In a closed claims analysis 
from 1990 through 2009 it was found that there were 92 cases probably or definitely related to post-
operative narcotic related respiratory depression and in 77% of those cases, the patient suffered death 
or severe brain damage.    The review article found that the typical patient who would suffer an adverse 


event due to narcotic related respiratory depression was “an obese adult patient with severe OSA 
receiving opioids postoperatively without continuous electronic monitoring, oxygen supplementation or 
CPAP” and obese adult patients are the population receiving laparoscopic gastric bypass.  In the 
American Society of Anesthesiologists Practice Guidelines for the Perioperative Management of Patients 
with Obstructive Sleep Apnea, the ASA and its consultants make the statement that “the potential for 
respiratory compromise should be considered in selecting intraoperative medications”.    The ASA also 
makes the desirability of opiod reduction in this population clear by stating they “strongly agree that to 
reduce opioid requirements, nonsteroidal anti-inflammatory agents and other modalities (e.g., ice, 
transcutaneous electrical nerve stimulation) should be considered if appropriate”.    
 
 
One medication that shows promise in the management of this group is ketamine.  Ketamine is 
a dissociative anesthetic with well documented analgesic properties.     The primary aspect of interest is 
that ketamine delivers pain relief which lasts beyond its expected effective time; it was found that 
preemptive administration of ketamine and administration of an infusion throughout abdominal surgery 
resulted in a decrease narcotic requirements when compared to the group who received a bolus of 
ketamine at abdominal closure; even though both groups had similar pain scores the infusion group had 
a lower narcotic requirement for two days after surgery.7   The next property of interest ketamine 
possesses is the fact that administration of ketamine has been shown to have a narcotic sparing 
effect.7,9,10 Another property of interest for the obese population is that  ketamine  maintains functional 
residual capacity (FRC) and increases the rib cage’s contribution to tidal breathing8 making respiratory 
depression less of a concern with ketamine than with narcotic pain medication immediately after the 
surgery, which can be important in a population (obese patients) already predisposed to sleep apnea. 
 
A study performed by Fu compared pre-incisional ketamine along with an infusion to a single 
dose given post incision closure.  After the surgery, pain scales and amount of narcotic used by each 
group were compared and an infusion of ketamine was found to decrease narcotic requirements more 
than a single bolus of ketamine.7   The proposed study compares a pre-incision bolus and intra-op 
infusion of ketamine to the standard practice of narcotic bolusing in gastric bypass surgery.   Additionally 
this study will compare the total amount of narcotic used as well as average pain relief scores between 
the two groups.  Therefore, the purpose of this research project is to determine if an intraoperative 
infusion of ketamine during bariatric surgery decreases narcotic requirements in the first 48 hours post 
operation. 
 
Specific Aims:  This study will attempt to determine if it is possible to reduce the post-operative opioid 
requirements for patients undergoing laparoscopic gastric bypass surgery while still providing 
acceptable levels of pain relief by utilizing an intra-operative infusion of ketamine.  This study will 
compare two groups of patients presenting for gastric bypass surgery.  The two groups will be 
randomized to a control group who will receive a standard, narcotic based pain relief anesthetic and the 
study group which will receive an intra operative ketamine infusion.  After the surgery the patients’ 
narcotic use and pain scores will be followed for 48 hours to determine if the intra operative ketamine 
infusion is effective at decreasing post-operative narcotic requirements. 


Research Plan:  The study will be a head to head experiment with one group receiving narcotic 
medication during the surgery and the other group receiving a ketamine infusion.  Both groups will 
receive 2 mg of versed on the way from pre op holding to the operating room, which is standard 
practice.  
 
We plan to enroll at least 48 patients in this study, with 10 additional patients in case patients 
are removed from the study for any reason.  This number was arrived at by a power analysis performed 
by Terry Vasilopoulos last year and it was estimated that to see a 30% reduction in narcotic use we 
would need two groups of 24, emphasizing that this would be a pilot study.  The study by Fu utilized two 
groups of twenty participants each and fount that “cumulative morphine consumption on D1 and D2 
was reduced by approximately 40%”.7  The surgeon, Dr Friedman, performs between three and five 
laparoscopic gastric bypasses per week so this number of patients should be able to be enrolled in a 
reasonable amount of time. 
The ketamine group will receive 100 mcg of fentanyl at induction of anesthesia and then no 
further narcotics during the surgery.    During induction the patient will receive a 20 mg bolus of 
ketamine, a dose of propofol deemed appropriate by the anesthesia team to render the patient 
unconscious and a dose of neuromuscular blocking medication followed by an intraoperative infusion of 
ketamine at 5 mcg/kg/min beginning after induction, and ending at the beginning of wound closure.  
The narcotic group will receive no ketamine but rather a more standard anesthetic consisting of 
100 mcg of fentanyl, a dose of propofol deemed appropriate by the anesthesia team to render the 
patient unconscious and a dose of neuromuscular blocking medication for induction.   Intraoperatively 
only the narcotic group will be given intraoperative boluses of fentanyl and 0.3 mg of hydromorphone 
approximately 45 minutes prior to the end of surgery.   
Both groups will receive 1 gram of Ofirmev (acetaminophen) infused over 15 minutes starting 
when wound closure begins.  They will also both receive neuromuscular blockade reversal medication 
and a dose of Zofran at the end of the surgery.   These medications are routine for this surgery. 
Anesthesia providers will be allowed to provide other non-analgesic medications to the patient which is 
consistent with their usual practice. 
  The amount of narcotics a patient receives is part of the medical record.  Beginning in the PACU 
amount of narcotics needed to control the patient’s pain (converted to morphine equivalent units) and 
pain scores (a hospital standard measure) will be collected for 48 hours for the study , or until discharge, 
whichever occurs sooner.  The conversion to a morphine equivalent unit is to allow us to compare 
different narcotics the patient may receive in a more standardized way.  The results will be analyzed and 
compared between the two groups.  
 
Patients will be eligible for inclusion in this study if they are between 18 and 65 years old 
presenting for laparoscopic gastric bypass surgery at Shands Hospital.   
 
Patients would be excluded if they are below 18 or older than 65 or have hypersensitivity, 
allergy, or contraindications to fentanyl, propofol, hydromorphone or ketamine; the medications which 
could be administered in this study.  Patients with cardiovascular disease who cannot tolerate the 
sympathomimetic effects of ketmine and ASA 4 patients will be excluded from this study. 


 
Participants for this study will be recruited by Dr Friedman in his surgical clinic. If they are going 
to require gastric bypass surgery they will be informed of the study and asked to participate.   The 
patients will be randomized into the two treatment groups utilizing a computer generated block 
randomization to get groups of equal size in each treatment.  There will be 9 blocks of 6 and 1 block of 4 
in order to evenly divide the 58 patients. 
Patients PHI will be accessed by the study staff in collecting the data and clinicians in providing 
care to the patients.  The only data which will be recorded will be pain scores and narcotic usage during 
the 48 hours after surgery.   Consent for participation in the study will be scanned into the patient's 
record.  Hard copies of the data will be saved in a locked drawer in Dr. Sappenfield's lock office until 
converted into a digital format, consistent with the department's protocol.  The data will be analyzed 
with the help of the anesthesia departments statistical consultant. 
 
Possible Discomforts and Risks: The patients will be undergoing gastric bypass surgery which, by its 
nature, is painful.  They will be given FDA approved medications, consistent with their labeling, during 
the operation to minimize that pain.  Post operatively the patients will be given whatever medications 
they need to control their pain.   The largest potential side effects of ketamine is vivid dreams which 
may be unpleasant, this side effect should be blunted or avoided by the pre-operative administration of 
versed.   As ketamine is a standard anesthetic drug, in the event of a temporary state of confusion or 
agitation related to ketamine the PACU would do as they do with any patient who has this reaction to 
ketamine and dim the lights and draw the curtains, allowing the patient to remain calmer as they wake 
from anesthesia.  If the emergence is too distressing an additional dose of versed may be administered 
to blunt the reaction.   
 
Possible Benefits:  The patients could experience satisfactory pain relief while using less narcotics a goal 
recommended by the ASA.  In receiving less narcotics the patients should have a lower incidence of 
negative side effects of narcotics including respiratory depression.  The benefit to future patients will be 
if we are able to show that we can both decrease use of post-operative narcotics while maintaining 
satisfactory pain relief we can utilize this as a standard anesthetic regimen and avoid some of the 
negative and dangerous side effects of narcotics. 
 
Conflict of Interest: Neither I nor the study team have any conflicts of interest involved in this study.    
 
Bibliography: 
1. 
Cdc.gov. Adult Obesity Facts | Data | Adult | Obesity | DNPAO | CDC. 2015. Available at: 
http://www.cdc.gov/obesity/data/adult.html. Accessed June 25, 2015. 
2. 
Kopelman P. Obesity Reviews - Volume 8, Issue Supplement s1 - March 2007 - Wiley Online 
Library. Onlinelibrarywileycom. 2007. Available at: 
http://onlinelibrary.wiley.com/doi/10.1111/obr.2007.8.issue-s1/issuetoc. Accessed June 14, 2015. 


3. 
Callery C. Gastric Bypass Expectations | Gastric Bypass | Weight Loss Surgery. Thinnertimescom. 
2015. Available at: http://www.thinnertimes.com/weight-loss-surgery/gastric-bypass/gastric-bypass-
expectations.html. Accessed June 25, 2015. 
4. 
Fabricatore A, Wadden T. Treatment of Obesity: An Overview. Clinical Diabetes. 2003;21(2):67-
72. doi:10.2337/diaclin.21.2.67. 
5.           March 3, 2015    Factors Related to Postoperative Respiratory Depression. (n.d.). Retrieved June 
2, 2016, from 
http://www.patientsafetysolutions.com/docs/March_3_2015_Factors_Related_to_Postoperative_Respi
ratory_Depression.htm     
6. 
  (2014). Practice Guidelines for the Perioperative Management of Patients with Obstructive 
Sleep                    
7. 
Fu E, Miguel R, Scharf J. Preemptive Ketamine Decreases Postoperative Narcotic Requirements 
in Patients Undergoing Abdominal Surgery. Anesthesia & Analgesia. 1997;84(5):1086-1090. 
doi:10.1213/00000539-199705000-00024. 
8. 
Mankikian B, Cantineau J, Sartene R, Clergue F, Viars P. Ventilatory Pattern and Chest Wall 
Mechanics during Ketamine Anesthesia in Humans. Anesthesiology. 1986;65(5):492-499. 
doi:10.1097/00000542-198611000-00007. 
9. 
Lofsky A. Sleep Apnea and Narcotic Postoperative Pain. Apsforg. 2002. Available at: 
http://www.apsf.org/newsletters/html/2002/summer/04sleepapnea.htm. Accessed June 1, 2015. 
10. 
Schmid R, Sandler A, Katz J. Use and efficacy of low-dose ketamine in the management of acute 
postoperative pain: a review of current techniques and outcomes. Pain. 1999;82(2):111-125. 
doi:10.1016/s0304-3959(99)00044-5.            
 
 
 
   

ICF_003.pdf: 
Does a Ketamine Infusion Decrease Post Operative Narcotics
NCT03001843
Last approved: 1/3/2019


IRB Project #: 201500836
IRB Version: 10/19/2011
PI Version: 1/05/2017
Page 1 of 9
INFORMED CONSENT FORM
to Participate in Research, and
AUTHORIZATION
to Collect, Use, and Disclose Protected 
Health Information (PHI)
INTRODUCTION
Name of person seeking your consent:
Place of employment & position: 
Please read this form, which describes the study in some detail. A member of the 
research team will describe this study to you and answer all of your questions.  Your 
participation is entirely voluntary.  If you choose to participate you can change your mind 
at any time and withdraw from the study.  You will not be penalized in any way or lose any 
benefits to which you would otherwise be entitled if you choose not to participate in this 
study or to withdraw. If you have questions about your rights as a research subject, 
please call the University of Florida Institutional Review Board (IRB) office at (352) 273-
9600.   
GENERAL INFORMATION ABOUT THIS STUDY
1. Name of Participant ("Study Subject")
___________________________________________________________________ 
2.
What is the Title of this research study?
Does a Ketamine Infusion Decrease Post Operative Narcotics
Study ID:IRB201500836   Date Approved: 1/3/2018   Expiration Date: 1/3/2019


IRB Project #: 201500836
IRB Version: 10/19/2011
PI Version: 1/05/2017
Page 2 of 9
3.
Who do you call if you have questions about this research study?
Principal Investigator:  David Smyth CRNA (352) 642-5859 24 hours a day
Co-Investigatort: Josh Sappenfield, M.D., office: 352-273-6567
4.  Who is paying for this research study? 
The sponsor of this study is the University of Florida.
5. Why is this research study being done? 
      This research is being done to see if medication we administer in the operating room 
during weight loss surgery can help to decrease the amount of narcotics patients need 
after surgery while still keeping their pain adequately controlled.  You are being invited 
to participate in this study as you are scheduled to undergo a weight loss surgery.   
      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.
WHAT CAN YOU EXPECT IF YOU PARTICIPATE IN THIS STUDY?
6.  What will be done as part of your normal clinical care (even if you did not 
participate in this research study)?  
You will receive a laparoscopic gastric bypass and all of the usual medical care     
associated with that procedure.
7.  What will be done only because you are in this research study? 
The type of pain medication given during the operation will be controlled by the study 
guidelines.    You will be randomly assigned – much like the flip of a coin - to one of 
two groups; half of the participants will receive a ketamine infusion, the other half will 
be receiving narcotic pain medications (what is usually given during surgery) to 
control your pain; you will not know which medication you receive during the 
operation.  Both types of medication are in common use and FDA approved.  After 
the surgery you will be given pain medications to keep your pain levels under control.  
We will be collecting data on how you rate your pain as well as how much medication 
is required to keep you comfortable. 
If you have any questions now or at any time during the study, please contact one of 
the research team members listed in question 3 of this form.
Study ID:IRB201500836   Date Approved: 1/3/2018   Expiration Date: 1/3/2019


IRB Project #: 201500836
IRB Version: 10/19/2011
PI Version: 1/05/2017
Page 3 of 9
8.   How long will you be in this research study?  
 This study will follow you during your surgery and for 48 hours after surgery.
9.
How many people are expected to take part in this research study?  
 We will be following up to 58 participants in this study.
WHAT ARE THE RISKS AND BENEFITS OF THIS STUDY AND 
WHAT ARE YOUR OPTIONS?
10.What are the possible discomforts and risks from taking part in this research 
study?  
The major side effect from  Ketamine is an "emergence reaction" and can include a 
dreamlike state and vivid dreams, possibly some nightmares.  Some of this may be 
avoided by small dose of relaxing mediation regularly given to surgical patients before 
going of the operating room. You will receive the relaxing medication, regardless of 
the group you will be assigned to. You will be monitored for this emergence reaction 
and treated as indicated as part of your stay in the recovery unit. If you receive 
narcotic medications only you are not expected to have an emergence reaction, but 
may have a slightly greater chance of postoperative nausea and it may take longer for 
your bowels to move.
11a. What are the potential benefits to you for taking part in this research study?
You may or may not benefit from participation in this study, because we do not know 
whether one approach is better than the other.     
11b. How could others possibly benefit from this study?
If this approach can decrease the need for narcotic medications after gastric bypass 
surgery while keeping pain levels adequate, we can recommend this anesthetic 
approach for patients having gastric bypass surgery.
 11c. How could the researchers benefit from this study?
In general, presenting research results helps the career of a scientist. Therefore, the 
Principal Investigator listed in question 3 of this form may benefit if the results of this 
study are presented at scientific meetings or in scientific journals.
Study ID:IRB201500836   Date Approved: 1/3/2018   Expiration Date: 1/3/2019


IRB Project #: 201500836
IRB Version: 10/19/2011
PI Version: 1/05/2017
Page 4 of 9
12.What other choices do you have if you do not want to be in this study? 
You do not have to participate in this study.  It will not negatively affect your 
anesthesia care if you decide not to participate.  You will receive anesthesia and pain 
medications for your surgery whether you participate or not.
13a. Can you withdraw from this study?
You are free to withdraw your consent and to stop participating in this study at any 
time.  If you do withdraw your consent, you will not be penalized in any way and you 
will not lose any benefits to which you are entitled. 
If you decide to withdraw your consent to participate in this study for any reason, 
please contact one of the research team members listed in question 3 of this form.  
They will tell you how to stop your participation safely.
If you have any questions regarding your rights as a research subject, please call the 
Institutional Review Board (IRB) office at (352) 273-9600.
13b.If you withdraw, can information about you still be used and/or collected?
      If you withdraw from the study no new information will be collected for study purposes.  
You will still be asked to rate your pain and your medications will be part of your 
normal medical record as this data is normally collected whether you are involved in 
the study or not, it will just not be reviewed by the study staff. 
13c. Can the Principal Investigator withdraw you from this study? 
      You may be withdrawn from the study without your consent for the following reasons:

The study doctor considers it advisable for a clinical reason

If it is in your best interest

You no longer meet the criteria for the study
WHAT ARE THE FINANCIAL ISSUES IF YOU PARTICIPATE?
14. If you choose to take part in this research study, will it cost you anything?
Study Drugs
The cost the drugs used in this study will be billed to you or your insurance company 
in the usual manner. You will be responsible for paying any deductible, co-
insurance, or co-payments for these services, and for any non-covered or out-of-
network services.
Study Services
Study ID:IRB201500836   Date Approved: 1/3/2018   Expiration Date: 1/3/2019


IRB Project #: 201500836
IRB Version: 10/19/2011
PI Version: 1/05/2017
Page 5 of 9
The Sponsor will pay for the following study-required activities at no cost to you:
1. Review of your medical history.
2. Data collection from your medical chart.
If you receive a bill for these services, please contact David Smyth at (352) 642-
5859.
Items/Services Not Paid for by the Sponsor
All medical services you receive would have been provided to you even if you were 
not in this study. These services will be billed to you or your insurance company in 
the usual manner. You will be responsible for paying any deductible, co-insurance, 
or co-payments for these services, and for any non-covered or out-of-network 
services.
15. Will you be paid for taking part in this study?
No.
16. What if you are injured because of the study?  
Since this is a data collection study, there is a very low risk of study-related injury. 
However, if you are injured as a direct result of your participation in this study, only 
the professional services that you receive from any University of Florida Health 
Science Center healthcare provider will be provided without charge. These healthcare 
providers include physicians, physician assistants, nurse practitioners, dentists or 
psychologists. Any other expenses, including Shands hospital expenses, will be billed 
to you or your insurance provider.
You will be responsible for any deductible, co-insurance, or co-payments. Some 
insurance companies may not cover costs associated with research studies or 
research-related injuries. Please contact your insurance company for additional 
information.
The Principal Investigator will determine whether your injury is related to your 
participation in this study.
No additional compensation is routinely offered. The Principal Investigator and others 
involved in this study may be University of Florida employees. As employees of the 
University, they are protected under state law, which limits financial recovery for 
negligence.
Please contact one of the research team members listed in question 3 of this form if 
you experience an injury or have questions about any discomforts that you 
experience while participating in this study.
Study ID:IRB201500836   Date Approved: 1/3/2018   Expiration Date: 1/3/2019


IRB Project #: 201500836
IRB Version: 10/19/2011
PI Version: 1/05/2017
Page 6 of 9
17. How will your health information be collected, used and shared?
If you agree to participate in this study, the Principal Investigator will create, collect, 
and use private information about you and your health. This information is called 
protected health information or PHI. In order to do this, the Principal Investigator 
needs your authorization.  The following section describes what PHI will be collected, 
used and shared, how it will be collected, used, and shared, who will collect, use or 
share it, who will have access to it, how it will be secured, and what your rights are to 
revoke this authorization. 
Your protected health information may be collected, used, and shared with others to 
determine if you can participate in the study, and then as part of your participation in 
the study.  This information can be gathered from you or your past, current or future 
health records, from procedures such as physical examinations, x-rays, blood or urine 
tests or from other procedures or tests. This information will be created by 
participating in study procedures.  More specifically, the following information may be 
collected, used, and shared with others:

Information about your health history

Your reported pain levels and amount of medications taken to treat pain.

Your name, gender, date of birth, medical record number, dates of you pre-
operative clinic visit and surgery

Your anesthesiology records about this surgery
This information will be stored in locked filing cabinets or on computer servers with 
secure passwords, or encrypted electronic storage devices. 
Some of the information collected could be included in a "limited data set" to be used 
for other research purposes.  If so, the limited data set will only include information 
that does not directly identify you.  For example, the limited data set cannot include 
your name, address, telephone number, social security number, photographs, or 
other codes that link you to the information in the limited data set.  If limited data sets 
are created and used, agreements between the parties creating and receiving the 
limited data set are required in order to protect your identity and confidentiality and 
privacy.
18.  For what study-related purposes will your protected health information be 
collected, used, and shared with others?
Your PHI may be collected, used, and shared with others to make sure you can 
participate in the research, through your participation in the research, and to evaluate 
the results of the research study.  More specifically, your PHI may be collected, used, 
and shared with others for the following study-related purpose(s):
To determine if administration of the study medication during surgery can help 
decrease post-operative narcotic needs while providing satisfactory pain control. 
Study ID:IRB201500836   Date Approved: 1/3/2018   Expiration Date: 1/3/2019


IRB Project #: 201500836
IRB Version: 10/19/2011
PI Version: 1/05/2017
Page 7 of 9
Once this information is collected, it becomes part of the research record for this 
study.  
19.  Who will be allowed to collect, use, and share your protected health 
information?
Only certain people have the legal right to collect, use and share your research 
records, and they will protect the privacy and security of these records to the extent 
the law allows. These people include:
•
the study Principal Investigator (listed in question 3 of this form) and research staff 
associated with this project.
•
other professionals at the University of Florida or Shands Hospital that provide 
study-related treatment or procedures.
•
the University of Florida Institutional Review Board (IRB; an IRB is a group of 
people who are responsible for looking after the rights and welfare of people 
taking part in research).  
20.  Once collected or used, who may your protected health information be shared 
with?
Your PHI may be shared with:
•
The study sponsor (listed in Question 4 of this form).
•
United States governmental agencies who are responsible for overseeing 
research, such as the Food and Drug Administration, the Department of 
Health and Human Services, and the Office of Human Research Protections.
•
Government agencies who are responsible for overseeing public health 
concerns such as the Centers for Disease Control and federal, state and local 
health departments.
Otherwise, your research records will not be released without your permission unless 
required by law or a court order. It is possible that once this information is shared with 
authorized persons, it could be shared by the persons or agencies who receive it and 
it would no longer be protected by the federal medical privacy law.  
Study ID:IRB201500836   Date Approved: 1/3/2018   Expiration Date: 1/3/2019


IRB Project #: 201500836
IRB Version: 10/19/2011
PI Version: 1/05/2017
Page 8 of 9
21.  If you agree to take part in this research study, how long will your protected 
health information be used and shared with others?
      Your PHI will be used and shared with others for 6 years after the study closes. 
      You are not required to sign this consent and authorization or allow researchers to 
collect, use and share your PHI. Your refusal to sign will not affect your treatment, 
payment, enrollment, or eligibility for any benefits outside this research study. 
However, you cannot participate in this research unless you allow the collection, use 
and sharing of your protected health information by signing this consent and 
authorization.
      You have the right to review and copy your protected health information.  However, 
we can make this available only after the study is finished.
      You can revoke your authorization at any time before, during, or after your 
participation in this study.  If you revoke it, no new information will be collected about 
you.  However, information that was already collected may still be used and shared 
with others if the researchers have relied on it to complete the research.  You can 
revoke your authorization by giving a written request with your signature on it to the 
Principal Investigator.
      
Study ID:IRB201500836   Date Approved: 1/3/2018   Expiration Date: 1/3/2019


IRB Project #: 201500836
IRB Version: 10/19/2011
PI Version: 1/05/2017
Page 9 of 9
SIGNATURES
As an investigator or the investigator’s representative, I have explained to the participant 
the purpose, the procedures, the possible benefits, and the risks of this research study; 
the alternative to being in the study; and how the participant’s protected health 
information will be collected, used, and shared with others: 
Signature of Person Obtaining Consent and 
Authorization
Date
You have been informed about this study’s purpose, procedures, possible benefits, and 
risks; the alternatives to being in the study; and how your protected health information will 
be collected, used and shared with others.  You have received a copy of this Form.  You 
have been given the opportunity to ask questions before you sign, and you have been 
told that you can ask   questions at any time.  
You voluntarily agree to participate in this study. You hereby authorize the collection, use 
and sharing of your protected health information as described in sections 17-21 above.  
By signing this form, you are not waiving any of your legal rights.
Signature of Person Consenting and Authorizing
Date
 
 
Study ID:IRB201500836   Date Approved: 1/3/2018   Expiration Date: 1/3/2019