Clinical trial NCT04080739
Conditions: Pain Management
Sponsor: University of Alabama at Birmingham
Start date: 2020-01-13; Completion date: 2022-03-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this protocol is to evaluate the safety and efficacy of regional anesthesia for head and neck patients undergoing microvascular free flap reconstruction.

Detailed description:
The increasing rate of opioid related overdose mortality is well documented in the literature and approached 15 per 100,000 in 2017. Because of a growing epidemic in the US, the medical community is under scrutiny to curtail opioid prescription. However, this is weighed against surgical outcomes; importantly, postoperative pain has adverse effects on function, recovery and quality of life.

Regional anesthesia provides a non opioid based, pain control strategy. First, regional anesthesia decreases systemic adverse events including respiratory failure in abdominal surgery, decreases length of stay and improves rehabilitation in common orthopedic procedures such as total knee arthroplasty and shoulder arthroplasty. Second, the physiologic benefits of regional anesthesia are compelling including augmented micro and macrocirculation, maintenance of body temperature and decreased systemic stress response through chemical sympathectomy. Finally, regional anesthesia has been established as safe in the microvascular and anesthesia literature for pediatric, and adult patients.

Arms: arm 1: US-guided ipsilateral sciatic nerve block for fibula free flap patients utilizing ropivacaine 0.2% at 2-8 cc/hr for fibula free flap patients; US-guided infraclavicular brachial plexus nerve block for forearm free lap patients utilizing ropivacaine 0.2% at 2-8cc/hr for forearm free flap patients. arm 2: No regional anesthetic of any kind during the surgical procedure.
Interventions: intervention 1: ropivicaine 0.2%
Intervention descriptions: intervention 1: 2-8 cc/hr of 0.2% ropivicaine given as a regional block via US-guided ipsilateral sciatic nerve block for fibula free flap patients or US-guided infraclavicular brachial plexus nerve block for forearm free flap patients.

Protocol documents:
Prot_SAP_000.pdf: 
Regional Block for Postoperative Free Flap Care 
 
 
Study Protocol & Statistical Analysis Plan 
 
NCT04080739 
 
Date of Last Protocol Approval 
4/3/2023 
 
 
Anthony Morlandt, MD, Principal Investigator 
University of Alabama at Birmingham 
Birmingham, AL 35294 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Purpose:  
The purpose of this protocol is to evaluate the safety and efficacy of regional anesthesia for head and 
neck patients undergoing microvascular free flap reconstruction. 
 
Background: 
The increasing rate of opioid related overdose mortality is well documented in the literature and 
approached 15 per 100,000 in 2017 (1, 2). Because of a growing epidemic in the US, the medical 
community is under scrutiny to curtail opioid prescription. However, this is weighed against surgical 
outcomes; importantly, postoperative pain has adverse effects on function, recovery and quality of life 
(3, 4, 5).  
 
Regional anesthesia provides a non opioid based, pain control strategy. First, regional anesthesia 
decreases systemic adverse events including respiratory failure in abdominal surgery (6), decreases 
length of stay and improves rehabilitation in common orthopedic procedures such as total knee 
arthroplasty (7) and shoulder arthroplasty (8). Second, the physiologic benefits of regional anesthesia 
are compelling including augmented micro and macrocirculation, maintenance of body temperature and 
decreased systemic stress response through chemical sympathectomy (9, 10). Finally, regional 
anesthesia has been established as safe in the microvascular and anesthesia literature for pediatric (11), 
and adult patients (12, 13). 
 
Participants (Screening and Selection) 
a. How many participants are to be enrolled at UAB (if other sites relying on UAB IRB, list the 
number for each site)? 50 
b. Describe the characteristics of anticipated or planned participants (if multiple groups, 
repeat list for each group). 
Sex: All 
Race/Ethnicity: All 
Age: 18+ 
Health status: All 
c. From what population(s) will the participants be derived? Patients who have presented to 
Departments of Oral and Maxillofacial Surgery and Otolaryngology for evaluation and 
treatment of head and neck disorders requiring free flap reconstruction. 
 
Describe your ability to obtain access to the proposed population that will allow recruitment of 
the necessary number of participants: The PI and sub-Is have practices specifically designated 
for treating head and neck disorders, with potential for enrollment. These patients will be 
identified from individuals treated by the investigators in their clinics. 
 
 
d. Describe the inclusion/exclusion criteria:  
Inclusion criteria: 


• Age > 18 
• Able to consent for themselves 
• Undergoing a head and neck surgery at UAB with reconstruction using either a 
forearm free flap or a fibula free flap 
Exclusion criteria: 
• Age < 18 
• Unable to consent for themselves 
• Non-English speakers 
• Non-resectable tumor 
• Have a known opioid tolerance, or are on a home opioid regimen for a chronic 
condition. (Short-term opioid use for diagnostic procedures (i.e. biopsy) or new 
cancer diagnosis will be allowed).  
• Patients with known hepatic failure, renal failure, or sulfa allergy, as 
determined by standard of care labs drawn within 30 days of enrollment 
 
e. If participants will comprise more than one group or stratification, describe each group (e.g., 
treatment/intervention, placebo, controls, sham treatment) and provide the number of 
participants anticipated in each group. There will be two arms of the study: 
• Control Group (to have 25 participants) will no regional anesthetic pain block 
intraoperatively. Participants will post-operatively receive acetaminophen 650 
mg Q6hr, ibuprofen 400 mg Q6hr if GFR >60, oxycodone 5 mg Q6hr x 2 weeks 
for pain control. This will be our control group. 
• Treatment Group (to have 25 participants) will receive a regional anesthetic 
pain block intraoperatively (US-guided ipsilateral sciatic nerve block for fibula 
free flap patients; US-guided infraclavicular brachial plexus nerve block and 
ropivacaine 0.2% for forearm free lap patients). Participants will post-
operatively receive acetaminophen 650 mg Q6hr, ibuprofen 400 mg Q6hr if 
GFR >60, oxycodone 5 mg Q6hr x 2 weeks for pain control. This will be our 
control group 
 
Procedures: 
Potential participants will be approached during their regularly-scheduled clinic visit about participation 
in the study. Only patients who have already been deemed appropriate surgical candidates prior to 
enrollment will be approached. If they agree to participate, they will sign an informed consent form. 
During this visit, we will collect demographic information, medical history, concomitant medications, 
vital signs, height, and weight.  
Participants will be randomized to one of the two following groups: 
• 
Control Group (to have 25 participants) will no regional anesthetic pain block 
intraoperatively. Participants will post-operatively receive acetaminophen 650 mg Q6hr, 
ibuprofen 400 mg Q6hr if GFR >60, oxycodone 5 mg Q6hr x 2 weeks for pain control. 
This will be our control group. 
• 
Treatment Group (to have 25 participants) will receive a regional anesthetic pain block 
intraoperatively (US-guided ipsilateral sciatic nerve block for fibula free flap patients; 
US-guided infraclavicular brachial plexus nerve block and ropivacaine 0.2% for forearm 
free lap patients). Participants will post-operatively receive acetaminophen 650 mg 


Q6hr, ibuprofen 400 mg Q6hr if GFR >60, oxycodone 5 mg Q6hr x 2 weeks for pain 
control. This will be our control group 
 
Participants will have their scheduled functional endoscopic sinus surgery procedure. Participants 
randomized to the Treatment Group) will receive the appropriate regional anesthetic during the surgery. 
After surgery, participants will be given a pain diary to record their pain score on a scale of 1-10, and a 
place to record their use of opioids, as well as over-the-counter non-steroid anti-inflammatories such as 
acetaminophen and ibuprofen. Participants will record their scores and drug use daily for ten days post-
surgery. At their first post-operative clinic visit, the diary will be reviewed, and their opioid use will also 
be evaluated by counting the pills left on their prescription. 
 
Data points/variables to be collected during the study could include the following, to be ascertained 
from the medical record and/or patient report:  
• 
Name 
• 
Medical Record Number 
• 
Age 
• 
Gender 
• 
Medications given by anesthesia intra- and post-operatively 
• 
Post-operative pain medication used prior to and after discharge 
• 
Post-operative complications 
• 
Post-discharge/post-operative pain evaluation by patient diary 
 
Benefits: 
Benefits of this research include using a more effective and less risky pain regimen for head and neck 
surgery patients. We propose that the new pain regimen will result in better pain control and result in 
less opioid pain medication usage which would be safer for patients. 
 
Risks: 
There will be no additional clinical or surgical risks other than the normal risks for patients in this 
population undergoing this type of treatment. 
There is a risk of randomization associated with this protocol, in that the treatment for the treatment 
group may prove less effective or have more side effects than the control group.  
Though both the treatment group and the control group will receive be prescribed the exact same 
amount of opioid medication for use for post-operative surgical pain, there is a chance that the control 
group will use more of the medication than the treatment group for relief of their post-surgical pain. 
 
Statistical Analysis Plan: 
All statistical analyses will be completed using SPSS software, version 28 (SPSS Inc., Chicago, IL). For all 
tests, the statistical significance will be set at P values of <.05. 
 


References: 
 
1. Bohnert AS, Valenstein M, Bair MJ, et al. Association between opioid prescribing patterns and 
opioid overdose-related deaths. JAMA. 2011;305(13):1315-21. 
 
2. Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and Opioid-Involved Overdose Deaths - 
United States, 2013-2017. MMWR Morb Mortal Wkly Rep. 2018;67(5152):1419-1427. 
 
3. Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain 
Res. 2017;10:2287-2298. 
 
4. Wu CL, Naqibuddin M, Rowlingson AJ, Lietman SA, Jermyn RM, Fleisher LA. The effect of pain 
on health-related quality of life in the immediate postoperative period. Anesth Analg. 
2003;97(4):1078-85, table of contents. 
 
5. Peters ML, Sommer M, De rijke JM, et al. Somatic and psychologic predictors of long-term 
unfavorable outcome after surgical intervention. Ann Surg. 2007;245(3):487-94. 
 
6. Rigg JR, Jamrozik K, Myles PS, et al. Epidural anaesthesia and analgesia and outcome of major 
surgery: a randomised trial. Lancet. 2002;359(9314):1276-82. 
 
7. Macfarlane AJ, Prasad GA, Chan VW, Brull R. Does regional anesthesia improve outcome after 
total knee arthroplasty?. Clin Orthop Relat Res. 2009;467(9):2379-402. 
 
8. Warrender WJ, Syed UAM, Hammoud S, et al. Pain Management After Outpatient Shoulder 
Arthroscopy: A Systematic Review of Randomized Controlled Trials. Am J Sports Med. 
2017;45(7):1676-1686. 
 
9. Macdonald DJ. Anaesthesia for microvascular surgery. A physiological approach. Br J Anaesth. 
1985;57(9):904-12. 
 
10. Hahnenkamp K, Theilmeier G, Van aken HK, Hoenemann CW. The effects of local anesthetics 
on perioperative coagulation, inflammation, and microcirculation. Anesth Analg. 2002;94(6):1441-
7. 
 


11. Bjorklund KA, Venkatramani H, Venkateshwaran G, Boopathi V, Raja sabapathy S. Regional 
anesthesia alone for pediatric free flaps. J Plast Reconstr Aesthet Surg. 2015;68(5):705-8. 
 
12. Parikh RP, Sharma K, Guffey R, Myckatyn TM. Preoperative Paravertebral Block Improves 
Postoperative Pain Control and Reduces Hospital Length of Stay in Patients Undergoing 
Autologous Breast Reconstruction after Mastectomy for Breast Cancer. Ann Surg Oncol. 
2016;23(13):4262-4269. 
 
13. Ruan QZ, Diamond S, Zimmer S, Iorio ML. Assessing the Safety and Efficacy of Regional 
Anesthesia for Lower Extremity Microvascular Reconstruction: Enhancing Recovery. J Reconstr 
Microsurg. 2018;34(4):293-299. 
 

ICF_001.pdf: 
Page 1 of 7
Version Date: 10/14/19
CONSENT FORM TO BE PART OF A RESEARCH STUDY
Title of Research:
Regional Block for Postoperative Free Flap Care
UAB IRB Protocol #:
IRB-300003574
Principal Investigator:
Anthony Morlandt, MD
Sponsor:
UAB Department of Oral and Maxillofacial Surgery
 
General Information
You are being asked to take part in a research study. This research study is 
voluntary, meaning you do not have to take part in it. The procedures, risks, and 
benefits are fully described further in the consent form.
Purpose
The purpose of the study is to determine if receiving extra pain medication during 
your head and neck surgery effects the amount and kind of pain medication that 
is taken after surgery.
Duration & Visits
You will be in this study for up to 21 days.
Overview of Procedures
If you decide to take part in this study, you will assigned by chance to one of the 
treatment groups. This is called randomization. 

If you are picked for the Treatment Group, you will receive ropivacaine 
0.2% before, during, and after your surgery, during your hospital stay 
only.

If you are picked for the Control Group, you will not receive any local 
anesthetic during your surgery.
Both groups will have surgery (including anesthesia) in the routine manner that 
planned for you, based on your condition. Those in the Treatment Group will 
receive extra medication before and during their surgery, while those in the 
Control Group will not receive any extra medication during their surgery. Both 
groups will receive the same post-operative prescription pain medications 
(oxycodone or morphine, acetaminophen, ibuprofen), will complete a daily pain 
diary (recording pain score and medications taken), and will have a prescription 
pain medication pill count at the first post-operative clinic visit. 
Risks
You will be assigned to a group by chance, which may prove to be less effective or 
to have more side effects than the other study group or alternatives. 
The most common side effects of the medications include nausea/vomiting, 
constipation, dizziness, itching, rash, and headache.
Benefits
You may not benefit directly from taking part in this study. However, this study 
may help us better understand how to treat post-surgical pain in the future.
Alternatives
You do not have to participate in this study to receive standard of care treatment 
for your head and neck disorder. Your doctor will tell you more about other 
treatments that may be available to you. You may choose to have no treatment at 
all. One alternative may be to not to participate in this study.
UAB IRB
Approved
07-Jan-2020
until
09-Jul-2020


Page 2 of 7
Version Date: 10/14/19
Purpose of the Research Study
We are asking you to take part in a research study because you are scheduled to have surgery for your head 
and neck disorder. You will be given a prescription for opioid and non-steroid anti-inflammatory pain 
medications (NSAIDs) as part of your routine care after your surgery. The purpose of this research study is to 
determine if receiving extra pain medication (a regional pain block) before and during your surgery effects the 
amount and kind of pain medication that is taken after surgery.
There will be 50 participants enrolled at UAB.
Study Participation & Procedures
If you agree to join the study, your medical record will be reviewed to obtain information regarding your 
medical condition and diagnosis, as well as demographic information, such as your age and gender. 
You will be randomly picked (like the flip of a coin) to receive either the study intervention, or to receive the 
standard of care treatment during your surgery:

If you are picked for the Treatment Group, you will receive ropivacaine 0.2% prior to, during, and after 
your head and neck surgery, during your hospital stay.

If you are picked for the Control Group, you will not receive any local anesthetic during your head and 
neck surgery.
You will then have your surgery. This surgery will be performed in the routine manner that was planned for 
you, based on your condition.  
If you are picked for the Treatment Group, you will have a catheter placed prior to your surgery. This is 
considered routine for all patients who receive pain blocks for head and neck procedures. You will receive the 
extra medication during the procedure, and for 3-5 days following your procedure while you are in the 
hospital. The catheter will be removed before you are discharged from the hospital. 
If you are picked for the Control Group, you will not have the catheter placed, and you will not receive any 
extra medication during or after the procedure.
After your surgery, you will be prescribed pain medication in the routine manner. These are the same 
medications that you would have whether you were participating in this study or not. While you are in the 
hospital, we will collect information on your use of pain medication from your medical record. You will also be 
asked to complete a pain scale, graded on a scale of 1-10, three times a day while you are in the hospital.
For study purposes, you will be given a study diary to complete when you are discharged from the hospital. 
This will consist of the pain scale listed above, as well as a medication diary. You will be asked to record all of 
the medications you take for the pain you experience after your surgery. 
At your first post-operative clinic visit (Day 14-21), you will bring in your study diary and your medicine bottles 
so that we can count the number of pills you have left on your prescriptions. We will record these amounts for 
our research data only. 
The daily study diary will take approximately 5 minutes per day to complete. The total amount of time you will 
be in the study is up to 21 days, depending on when your first post-operative clinic visit is scheduled.


Page 3 of 7
Version Date: 10/14/19
Risks and Discomforts
All of the drugs to be used in this study are FDA-approved, commonly-used, widely available, generic 
medications. These drugs will be used at their standard dosing for their approved indications.
If you are picked for the Treatment Group, you will receive extra pain medication before or during your 
surgery.
The most common side effects of ropivacaine 0.2% (Naropin®) are:

nausea/vomiting

headache

fever

itching

confusion

tinnitus, or ringing in the ears

altered or impaired sense of taste

irregular heart rhythms
There is no additional risk to taking ropivacaine as part of this study. It does not have cross reactions or other 
known interactions that may lead to increased risks, other than those listed above.
No matter what group you are assigned to, you will receive prescriptions for oxycodone, acetaminophen 
(commonly known as Tylenol), and/or ibuprofen (commonly known as Advil or Motrin) for any post-operative 
surgical pain you may have. During your stay in the hospital after your surgery, you may be given morphine in 
an IV for your pain. 
Risks associated with oxycodone include:

constipation

nausea/vomiting

sleepiness

dizziness

itching

headache

dry mouth
Risks associated with acetaminophen include:

liver damage/failure

headache

nausea

itching
Risks associated with ibuprofen include:

nausea

heartburn

diarrhea

abdominal pain

constipation

bloating

dizziness


Page 4 of 7
Version Date: 10/14/19

headache

rash

tinnitus, or ringing in the ears
Risks associated with morphine (IV) include:

Nausea/vomiting

Constipation

Lightheadedness

Dizziness

Drowsiness

Increased sweating

Dry mouth

Pain, redness, or swelling at the injections site
There is no additional risk to taking these medications as part of this study. There aren’t any known increased 
risks for taking these medications in combination. They do not have any cross reactions with each other or 
other known interactions that may lead to increased risks, other than those listed above.
All surgical procedures will be performed in the routine manner. There will be no additional clinical or surgical 
risks, other than the normal risks for patients undergoing this type of treatment.
There is a risk of a loss of confidentiality for patients involved in research studies. All of your personal and 
medical information will be stored in a locked area. Only qualified research staff will have access to this 
information. Once your research data has been collected, all information that could link your personal identity 
to your medical information will be deleted. There will be no personally identifying information used to report 
any findings from this study.
You will be assigned to a group by chance, which may prove to be less effective or to have more side effects 
than the other study group or alternatives. There is a chance that those assigned to Control Group (who will 
not the extra pain medication prior to or during the surgery) will have an increase use of this post-operative 
pain medication.
Confidentiality and Authorization to Use and Disclose Information for Research Purposes
Federal regulations give you certain rights related to your health information. These include the right to know 
who will be able to get the information and why they may be able to get it. The study doctor must get your 
authorization (permission) to use or give out any health information that might identify you.
What protected health information may be used and/or given to others?
All medical information, including but not limited to information and/or records of any diagnosis or treatment 
of disease or condition, which may include sexually transmitted diseases (e.g., HIV, etc.) or communicable 
diseases, drug/alcohol dependency, etc.; all personal identifiers, including but not limited to your name, social 
security number, medical record number, date of birth, dates of service, etc.; any past, present, and future 
history, examinations, laboratory results, imaging studies and reports and treatments of any kind, including but 
not limited to drug/alcohol treatment, psychiatric/psychological treatment; financial/billing information, 
including but not limited to copies of your medical bills; any other information related to or collected for use in 
the research study, regardless of whether the information was collected for research or non-research (e.g., 


Page 5 of 7
Version Date: 10/14/19
treatment) purposes; records about any study drug you received or about study devices used; and consent 
forms from past studies that might be in your medical record.
Your consent form will be placed in your medical record at UAB Health System. This may include either a paper 
medical record or electronic medical record (EMR). An EMR is an electronic version of a paper medical record 
of your care within this health system. Your EMR may indicate that you are on a clinical trial and provide the 
name and contact information for the principal investigator.
If you are receiving care or have received care within this health system (outpatient or inpatient), results of 
research tests or procedures (i.e. laboratory tests, imaging studies and clinical procedures) may be placed in 
your existing medical record.
If you have never received care within this health system (outpatient or inpatient), a medical record will be 
created for you to maintain results of research tests or procedures.
Results of research tests or procedures may be placed in your medical record. All information within your 
medical record can be viewed by individuals authorized to access the record.
A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S. Law. This 
website will not include information that can identify you. At most, the website will include a summary of the 
results. You can search this website at any time.
Who may use and give out information about you?
Information about your health may be used and given to others by the study doctor and staff. They might see 
the research information during and after the study.
Who might get this information?
All Individuals/entities listed in the informed consent document(s), including but not limited to, the physicians, 
nurses and staff and others performing services related to the research (whether at UAB or elsewhere). Your 
information may also be given to the sponsor of this research. “Sponsor” includes any persons or companies 
that are working for or with the sponsor, or are owned by the sponsor, or are providing support to the sponsor 
(e.g., contract research organization).
Information about you and your health which might identify you may be given to:

the Office for Human Research Protections (OHRP)

the U.S. Food and Drug Administration (FDA)

Department of Health and Human Services (DHHS) agencies

Governmental agencies in other countries

Governmental agencies to whom certain diseases (reportable diseases) must be reported

the University of Alabama at Birmingham - the physicians, nurses and staff working on the research study 
(whether at UAB or elsewhere); other operating units of UAB, UAB Hospital, UAB Highlands Hospital, 
University of Alabama Health Services Foundation, Children’s of Alabama, Eye Foundation Hospital, and 
the Jefferson County Department of Health, as necessary for their operations; the UAB IRB and its staff

the billing offices of UAB and UAB Health Systems affiliates and/or Children’s of Alabama and its billing 
agents
Why will this information be used and/or given to others?


Page 6 of 7
Version Date: 10/14/19
Information about you and your health that might identify you may be given to others to carry out the 
research study. The sponsor will analyze and evaluate the results of the study. In addition, people from the 
sponsor and its consultants will be visiting the research site. They will follow how the study is done, and they 
will be reviewing your information for this purpose.
What if I decide not to give permission to use and give out my health information?
By signing this consent form, you are giving permission to use and give out the health information listed above 
for the purposes described above. If you refuse to give permission, you will not be able to be in this research.
May I review or copy the information obtained from me or created about me?
You have the right to review and copy your health information. However, if you decide to be in this study and 
sign this permission form, you will not be allowed to look at or copy your information until after the research is 
completed.
May I withdraw or revoke (cancel) my permission?
Yes, but this permission will not stop automatically. The use of your personal health information will continue 
until you cancel your permission.
You may withdraw or take away your permission to use and disclose your health information at any time. You 
do this by sending written notice to the study doctor. If you withdraw your permission, you will not be able to 
continue being in this study.
When you withdraw your permission, no new health information which might identify you will be gathered 
after that date. Information that has already been gathered may still be used and given to others. This would 
be done if it were necessary for the research to be reliable.
Is my health information protected after it has been given to others?
If you give permission to give your identifiable health information to a person or business, the information may 
no longer be protected. There is a risk that your information will be released to others. Including others 
outside of UAB, without your permission.
Voluntary Participation and Withdrawal
Whether or not you take part in this study is your choice. There will be no penalty if you decide not to be in it. 
If you decide not to be in the study, you will not lose any benefits you are otherwise owed.
You are free to withdraw from this study at any time. Your choice to leave the study will not affect your 
relationship with this institution. Contact the study doctor if you want to withdraw from the study.
You may be removed from the study without your consent if the sponsor ends the study, if the study doctor 
decides it is not in the best interest of your health, or if you are not following the study rules.
If you are a UAB student or employee, taking part in this research is not a part of your UAB class work or 
duties. You can refuse to enroll, or withdraw after enrolling at any time before the study is over, with no effect 
on your class standing, grades, or job at UAB. You will not be offered or receive any special consideration if you 
take part in this research.
Cost of Participation
There will be no cost to you for taking part in this study. The costs of your standard medical care will be billed 
to you and/or your insurance company in the usual manner.


Page 7 of 7
Version Date: 10/14/19
Payment for Participation
You will not be paid to participate in this study. 
Payment for Research-Related Injuries
UAB has not provided for any payment if you are harmed as a result of taking part in this study. If such harm 
occurs, treatment will be provided. However, this treatment will not be provided free of charge.
Questions
If you have any questions, concerns, or complaints about the research or a research-related injury including 
available treatments, please contact the study doctor. You may contact Dr. Morlandt at (205) 996-2799 or 
after hours by paging him at (205) 934-3411.
If you have questions about your rights as a research participant, or concerns or complaints about the 
research, you may contact the UAB Office of the IRB (OIRB) at (205) 934-3789 or toll free at 1-855-860-3789. 
Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through Friday.
Legal Rights
You are not waiving any of your legal rights by signing this consent form.
Signatures
Your signature below indicates that you have read (or been read) the information provided above, and that 
you agree to participate in this study. You will receive a copy of this signed consent form.
Signature of Participant
Date
Signature of Person Obtaining Consent
Date