Clinical trial: NCT03063255
Section: Alternatives
Subsections: 12.What Other Choices Do You Have If You Do Not Want To Be In This Study?

A nerve block or muscle relaxants will be administered in an attempt to minimize obturator spasm whether you choose to participate in the study or not.
Clinical trial: NCT03063255
Section: Confidentiality
Subsections: 17. How Will Your Privacy And The Confidentiality Of Your Research Records Be Protected?

Information collected about you will be stored in locked filing cabinets or in computers with security passwords. Only certain people have the legal right to review these research records, and they will protect the secrecy (confidentiality) of these records as much as the law allows. These people include the researchers for this study, certain University of Florida officials, the hospital or clinic (if any) involved in this research, and the 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). Certain federal agencies such as the Office for Human Research Protections (OHRP), the VA Office of Research Oversight (ORO), or the VA Office of the Inspector General (OIG), that oversee human subject research may also have the legal right to review your records. Otherwise your research records will not be released without your permission unless required by law or a court order. Researchers will take appropriate steps to protect any information they collect about you. However there is a slight risk that information about you could be revealed inappropriately or accidentally. Depending on the nature of the information such a release could upset or embarrass you, or possibly even affect your insurability or employability. If the results of this research are published or presented at scientific meetings, your identity will not be disclosed.  
Department of Veterans Affairs  
  
**Date**
Title of Study:
Comparison of obturator nerve blockade and neuromuscular blockade for the prevention of adductor spasm in patients undergoing transurethral resection of bladder tumors Principal Investigator: José R. Soberón, Jr., MD **VAMC:**
North Florida/South Georgia Veterans Health System
Clinical trial: NCT03063255
Section: Duration of Study Involvement
Subsections: 9. How Many People Are Expected To Take Part In This Research Study? 70.

IRB Project \#: 201601962 Page 5 of 11 IRB Version: 04/25/2015 **VA Form 10-1086** PI Version: 10/13/2018  
  
Department of Veterans Affairs Title of Study:
Comparison of obturator nerve blockade and neuromuscular blockade for the prevention of adductor spasm in patients undergoing transurethral resection of bladder tumors Principal Investigator: José R. Soberón, Jr., MD **VAMC:**
North Florida/South Georgia Veterans Health System
Clinical trial: NCT03063255
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 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?|11A. What Are The Potential Benefits To You For Taking Part In This Research Study ?|11B. How Could Others Possibly Benefit From This Study?|11C. How Could The Researchers Benefit From This 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?|15. Will You Be Paid For Taking Part In This Study? No. 16. What If You Are Injured Because Of The Study?

Both the nerve block and muscle relaxing medications are commonly performed and acceptable techniques to prevent obturator spasm. These (nerve block or muscle relaxants) will be administered while you are under general anesthesia, so no additional discomfort should be expected. Risks of the nerve block may include nerve damage, intravascular injection of local anesthetic, cardiac arrest, seizure, bleeding/hematoma, infection, ineffective or failed block, pain at the injection site, or numbness or tingling (paresthesia). To date, no complications have been reported or associated with the obturator nerve block.  
Risks of muscle relaxing medications may include weakness, fatigue, and difficulty breathing, which may require keeping the breathing tube in place after surgery. Other risks may include pulmonary aspiration (acid from the stomach comes up into the lungs) and longer time spent in the recovery room.  
Adhesive electrodes (stickers) will be placed on your leg during surgery to measure leg muscle movement while you are asleep. Very rarely, skin irritation may occur at the site of placement. This generally goes away in 2-3 days (or less). Researchers will take appropriate steps to protect any information they collect about you. However there is a slight risk that information about you could be revealed inappropriately or accidentally. Depending on the nature of the information such a release could upset or embarrass you, or possibly even affect your insurability or employability. Other possible risks to you may include: Because we are asking you to stand up and walk before and after your procedure, there is a possibility of falling. Every possible precaution, including a fall prevention belt and close supervision, will be taken to minimize risk of falling. The device that measures your strength by having you push against it with your leg is not associated with discomfort. This study may include risks that are unknown at this time. Participation in more than one research study or project may further increase the risks to you. If you are already enrolled in another research study, please inform one of the IRB Project \#: 201601962 Page 6 of 11 IRB Version: 04/25/2015 **VA Form 10-1086** PI Version: 10/13/2018 Department of Veterans Affairs Title of Study:
Comparison of obturator nerve blockade and neuromuscular blockade for the prevention of adductor spasm in patients undergoing transurethral resection of bladder tumors Principal Investigator: José R. Soberón, Jr., MD **VAMC:**
North Florida/South Georgia Veterans Health System research team members listed in question 3 of this consent form or the person reviewing this consent with you before enrolling in this or any other research study or project. Throughout the study, the researchers will notify you of any new information that may become available and might affect your decision to remain in this study. This includes, but is not limited to, information that may affect your safety, well-being or medical care. If you wish to discuss the risks or discomforts described above or any discomforts you may experience, please ask questions now or call one of the research team members listed in question 3 of this form.

Because the obturator reflex may interfere with tumor resection, performance of an obturator block or use of neuromuscular relaxing agents may block the reflex and allow for safer operating conditions and improved cancer removal. Leg strength and fall risk assessments will be performed for all patients to determine suitability for discharge. At the present time, there are no data regarding fall risk in patients with obturator blocks. Evaluating leg strength and ability to walk may help determine if it is safe for you to be discharged from the hospital if you receive an obturator block.

This study will help future anesthesia providers decide which technique (nerve block or muscle relaxants) is better for preventing obturator spasm. The success rate and safety of one approach versus the other is not known. The results of this study may be used to guide clinical decisions for future patients undergoing TURBT or to conduct larger prospective studies.

In general, presenting research results helps the career of a scientist. Therefore, the Principal Investigator listed in question 3 may benefit if the results of this study are presented at scientific meetings or in scientific journals.  
Department of Veterans Affairs
**Date**
Title of Study:
Comparison of obturator nerve blockade and neuromuscular blockade for the prevention of adductor spasm in patients undergoing transurethral resection of bladder tumors Principal Investigator: José R. Soberón, Jr., MD **VAMC:**
North Florida/South Georgia Veterans Health System

There will be no costs to you for any procedure, treatment or testing done as part of this research study. However, medical care and services provided by the VA that are not being done only for this study (e.g., normal hospital and prescription expenses which are not part of the research study) will be charged to you or your insurance. These costs may not be charged if you are a veteran and you are being treated at the North Florida/South Georgia Veterans Health System (NF/SG VHS), however some Veterans are required to pay co-payments for medical care and services provided by the VA. These co-payment requirements will continue to apply to VA-provided medical care and services that are not part of this study."

If you experience an injury or illness as a result of your participation in this VA approved research study, all medical treatment considered necessary by your physician (emergency as well as medical treatment beyond emergency) will be provided by the VA. There will be no cost to you, unless you fail to follow the directions of the study procedures. Care will be provided at a VA medical facility unless the VA medical facility is not capable of providing the care. If this occurs, you will be treated by a private facility or physician and the VA will pay the private facility or physician for the reasonable cost of your care. In some cases the VA may approve private care for a non-veteran. If you do not follow study procedures, you may be treated by the VA on the basis of your veteran's eligibility. If you are not a veteran and have not followed study procedures the VA can only provide limited care at your expense. No additional money has been set aside for pain, suffering or any money losses you may suffer during your treatment. You have not waived any legal rights by signing this form.  
Department of Veterans Affairs
**Date**
Title of Study:
Comparison of obturator nerve blockade and neuromuscular blockade for the prevention of adductor spasm in patients undergoing transurethral resection of bladder tumors Principal Investigator: José R. Soberón, Jr., MD **VAMC:**
North Florida/South Georgia Veterans Health System In the event of a research-related injury, have questions about any discomforts that you experience while participating in this study or if you experience an adverse reaction, please immediately contact the Principal Investigator listed in question 3 of this form during the day and 786-247-2749 after business hours. If you seek emergency hospitalization in a private hospital because you are unable to come to the VA, have a family or friend contact your study doctor so that the VA can coordinate care with the private hospital.
Clinical trial: NCT03063255
Section: Procedures
Subsections: 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)?|7. What Will Be Done Only Because You Are In This Research Study?

Normal clinical care is medical or other treatment or services that you would receive even if you did not participate in this research study. You will receive general anesthesia for your procedure as well as a obturator nerve or muscle relaxing medications regardless of whether or not you choose to participate in the study.

If you agree to be in this study, we will ask you to do the following things: You will be asked to stand from a chair, walk 10 feet, and return to the seated position. A device measuring muscle strength will be used to record the strength in your legs. The device measures your strength by having you push against it with your leg. It is not associated with discomfort. Your surgery will be performed as per normal standard of care. If you agree to participate in this study you will be randomized to 1 of 2 groups. Once consent is obtained, enrollees will be randomly allocated by computer-generated randomization to one of the study groups. Randomization is like a flip of a coin that IRB Project \#: 201601962 Page 4 of 11 IRB Version: 04/25/2015 **VA Form 10-1086** PI Version: 10/13/2018 Department of Veterans Affairs Title of Study:
Comparison of obturator nerve blockade and neuromuscular blockade for the prevention of adductor spasm in patients undergoing transurethral resection of bladder tumors  
Principal Investigator: José R. Soberón, Jr., MD **VAMC:**  
North Florida/South Georgia  
Veterans Health System  
will determine to which group you will be assigned. Both techniques are currently in use at this facility. The nerve block or muscle relaxing medications will be administered while you are under anesthesia. You will then have your surgery. You will receive the nerve block or muscle relaxing medications even if you do not agree to be in this study. Three stickers will be placed on your thigh and they will be connected to a machine that measures muscle activity to determine leg movement during your procedure. Medications given during surgery and in the recovery room will be recorded. One hour after arrival to the recovery room or when you are ready for discharge, we will ask you to repeat the same evaluation as before (walking and measuring your leg strength). You will be called 24-48 hours after surgery to see if there were any complications with your procedure. The Principal Investigator listed in question 3 of this form and the research team conducting the research procedures described above will monitor how you do during the research. If you have any questions about the research procedures now or at any time during the study, please contact one of the research team members listed in question 3 of this form. Once this research study is completed, any information that could identify you might be removed from any identifiable private information or identifiable biospecimens collected and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from you or your legally authorized representative. If you have any questions now or at any time during this Research Study, please contact one of the Research Team members listed in question 3 of this form.
Clinical trial: NCT03063255
Section: Purpose of Research
Subsections: 5. Why Is This Research Study Being Done?

Agreeing to become involved in any research is always voluntary. By signing this form, you are not waiving any of your legal rights. If you decide not to participate in this IRB Project \#: 201601962 Page 2 of 11 IRB Version: 04/25/2015 **VA Form 10-1086** PI Version: 10/13/2018 Department of Veterans Affairs
**Date**
Title of Study:
Comparison of obturator nerve blockade and neuromuscular blockade for the prevention of adductor spasm in patients undergoing transurethral resection of bladder tumors Principal Investigator: José R. Soberón, Jr., MD **VAMC:**
North Florida/South Georgia Veterans Health System research, you will not be penalized in any way and you will not lose any benefits to which you are entitled. If you have questions about your rights as a research subject, please call the University of Florida Institutional Review Board (IRB) office at (352) 2739600 or the North Florida/South Georgia Veteran's Health System Research Service Office at (352) 548-6069.  
a) In general, what is the purpose of the research, how long will you be involved?  
The purpose of this research study is to compare two techniques to prevent the obturator reflex in patient undergoing transurethral resection of a bladder tumor (TURBT). You will be involved until you receive the follow-up phone call 24-48 hours after surgery.  
b) What is involved with your participation, and what are the procedures to be followed in the research?
The obturator nerve runs next to the bladder and surgery on the bladder sometimes makes the nerve move the leg while you are under anesthesia. This is called the obturator reflex. An obturator nerve block is performed to block the nerve from making the leg move. General anesthesia with muscle relaxants have also been used to prevent leg movement but the two techniques have never been directly compared. A nerve block involves injecting numbing medications around a nerve to decrease leg movement during surgery. An ultrasound machine is used to help see the nerve before injecting the numbing medicine. When an ultrasound machine is used during a block it is called an ultrasound-guided block. You are being asked to be in this research study because you are scheduled to have a TURBT.  
c) What are the likely risks or discomforts to you?
Because the nerve block is performed after you are under general anesthesia, there is no additional discomfort from the study interventions.  
d) What are the likely benefits to you or to others from the research?  
Potential benefits include prevention of the obturator reflex. The information obtained from this study may help providers decide on the best approach to prevent the obturator reflex in future surgeries.  
Department of Veterans Affairs
**Date**
Title of Study:
Comparison of obturator nerve blockade and neuromuscular blockade for the prevention of adductor spasm in patients undergoing transurethral resection of bladder tumors Principal Investigator: José R. Soberón, Jr., MD **VAMC:**
North Florida/South Georgia Veterans Health System e) What are the appropriate alternative procedures or courses of treatment, if any, that might be helpful to you? You will likely receive general anesthesia, muscle relaxant medications, and/or an obturator nerve block for your surgery regardless of your decision to participate in the research study.  
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. Additional and more detailed information is provided within the remainder of this Informed Consent form, please read before deciding if you wish to participate in this study.
Clinical trial: NCT03063255
Section: Withdrawal from Study
Subsections: 13A. Can You Withdraw From This Study?|13B.If You Withdraw, Can Information About You Still Be Used And/Or Collected?|13C. Can The Principal Investigator Withdraw You 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.

If you withdraw from this study, your research information will no longer be collected. However, information that has already been collected will continue to be used to the extent that the researchers have used it in this research study.

You may be withdrawn from the study without your consent for the following reasons:
- the study doctor thinks it necessary for your health or safety; - you have not followed study instructions;
- the sponsor has stopped the study; or
- administrative reasons require your withdrawal.  
Department of Veterans Affairs
**Date**
Title of Study:
Comparison of obturator nerve blockade and neuromuscular blockade for the prevention of adductor spasm in patients undergoing transurethral resection of bladder tumors Principal Investigator: José R. Soberón, Jr., MD **VAMC:**
North Florida/South Georgia Veterans Health System