Clinical trial NCT03063255
Conditions: Cancer of Bladder
Sponsor: University of Florida
Start date: 2017-04-25; Completion date: 2019-09-19
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients diagnosed with posterolateral bladder tumors will be invited to participate in the study. Subjects will be randomized to receive an ultrasound-guided obturator block or a neuromuscular blocking agent after the induction of general anesthesia in an attempt to block the obturator reflex during surgery.

Detailed description:
The purpose of this research is to compare the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents versus obturator block. Transurethral resection of bladder tumor(s) (TURBT) is a commonly performed procedure to diagnose and treat bladder cancer. The obturator nerve is located lateral to the bladder wall in the pelvis prior to innervating the adductor muscles of the thigh. Depending on the location of the tumor(s), electrocautery or surgical stimulation may result in stimulation of the obturator nerve, resulting in adduction of the leg, which is called the adductor reflex or spasm. This may occur violently and unexpectedly, and result in bladder perforation, bleeding, or cancer dissemination.

Arms: arm 1: Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block. arm 2: Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents.
Interventions: intervention 1: Obturator block intervention 2: Neuromuscular block
Intervention descriptions: intervention 1: Subjects allocated to the obturator block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to post-anaesthesia care unit (PACU) or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction. intervention 2: Subjects allocated to the neuromuscular block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to PACU or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction.

Protocol documents:
Prot_SAP_002.pdf: 
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Title: Comparison of obturator nerve blockade and neuromuscular blockade for the 
prevention of adductor spasm in patients undergoing transurethral resection of bladder 
tumors. 
NCT: NCT03063255 
Date:  October 25, 2016


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Protocol 
 
1. Project Title: 
 
Comparison of obturator nerve blockade and neuromuscular blockade for the 
prevention of adductor spasm in patients undergoing transurethral resection of bladder 
tumors. 
 
2. Investigator(s): 
 
Principal investigator:   
José R. Soberón, Jr., MD 
 
 
 
 
NF/SG Veterans Health System 
 
 
 
 
Malcom Randall VA Medical Center 
 
 
 
 
Department of Anesthesiology 
 
 
 
 
1601 Archer Road 
 
 
 
 
Gainesville, Florida 32608 
 
 
 
 
Work:  (352) 548-6000, Extension 3581 
 
 
 
 
Pager:  (352) 413-2317 
 
 
 
 
Cellular:  (786) 247-2749 
 
 
 
 
Email:  jose.soberon@va.gov 
 
Sub-Investigator(s):  
Benjamin K. Canales, MD, MPH 
 
 
 
 
UF Health Shands & Malcom Randall VA Medical Center 
 
 
 
 
Department of Urology 
 
3. Abstract: 
 
Transurethral resection of bladder tumor(s) (TURBT) is a commonly performed 
procedure to diagnose and treat bladder cancer.  The obturator nerve is located lateral 
to the bladder wall in the pelvis prior to innervating the adductor muscles of the thigh.  
The adductor muscles include the adductor longus, adductor brevis, adductor magnus, 
and the pectineus muscle.  These muscles are innervated by the obturator nerve and 
the adductor magnus muscle receives additional innervation from the tibial nerve [1].  In 
addition to hip adduction, these muscles contribute to flexion/extension as well as 
internal and external rotation of the hip [1].   
 
Depending on the location of the tumor(s), electrocautery or surgical stimulation may 
result in stimulation of the obturator nerve, resulting in adduction of the leg, which is 
called the adductor reflex or spasm.  This may occur violently and unexpectedly, and 
result in bladder perforation, bleeding, or cancer dissemination [2].   
 
Ultrasound-guided obturator nerve blockade has been advocated as a technique to 
minimize or ablate the obturator reflex [2-4] in patients receiving spinal or general 
anesthesia for TURBT.  Quadriceps weakness secondary to peripheral nerve blocks 
has been associated with an increased risk of falls in the orthopedic population [5-8].  
Although obturator nerve blockade (ONB) results in adductor weakness [9, 10], it is not 


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known if this results in an increased fall risk.  Much of the anesthesiology literature on 
ONB is focused on patients undergoing knee surgery and, to our knowledge, no 
literature exist regarding the incidence of falls in patients receiving an ONB for TURBT.   
 
To date, there are no prospective studies comparing the incidence of adductor spasm in 
patients undergoing general anesthesia with neuromuscular blocking agents versus 
obturator block.  No major complications—including falls—have been reported with 
obturator nerve blocks.  This may be a reflection of underutilization, lack of reporting, or 
simply a reflection of their use primarily in an orthopedic patient population whose 
mobility status is limited and closely observed.   
 
4. Background: 
 
Much of the available data on obturator blocks is taken from the orthopedic anesthesia 
literature on patients undergoing knee surgery.  To date, there are no complications 
(including falls) related to obturator blocks reported in the literature.  ONB is performed 
in patients undergoing TURBT to minimize or ablate the obturator reflex [2-4]. 
 
Ultrasound guided regional anesthetic techniques have a long record of safety and 
efficacy, and are commonly performed for patients undergoing surgery in both the 
outpatient and inpatient setting.   
 
Neuromuscular blocking medications are commonly used to prevent patient movement 
under general anesthesia.  Use of neuromuscular agents may result in postoperative 
weakness, which may lead to hypoxemia and airway obstruction, complaints of muscle 
weakness or fatigue, longer postanesthesia care unit stays, delays in tracheal 
extubation, increased risk of pulmonary aspiration, and atelectasis [11].  Additionally, 
adductor spasm has been reported despite the use of these medications [12, 13].   
 
Furthermore, there is a study that suggests that use of an obturator nerve block in 
patients undergoing TURBT may prolong time to cancer recurrence in patients with 
superficial bladder tumors [14].  The obturator block results in a decreased incidence of 
adductor spasm, which allows for optimal surgical conditions and improved tumor 
resection [14].  The incidence of adductor spasm during TURBTs is currently unknown.  
While one study has estimated the incidence to be 16.5% [18], three others have 
reported it to be 40-55% [13, 19, 20] in patients with posterolateral bladder tumors. 
 
Given the presence of the adverse events associated with use of neuromuscular 
blocking agents and the current lack of adverse events reported with the obturator 
block, we are interested in conducting an investigation comparing the two approaches in 
a prospective and randomized manner. 
 
5. Specific Aims: 
 


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The primary objective will be to compare the incidence of adductor spasm (also known 
as the obturator reflex) during transurethral resection of posterolateral bladder tumors 
under general anesthesia. 
 
Secondary objectives will include assessments of leg weakness and fall risks, as 
measured using a handheld dynamometer and the timed up and go (TUG) test, 
respectively.  Adverse events related to the anesthetic and surgical techniques will also 
be recorded. 
 
6. Research Plan: 
 
Veterans diagnosed with posterolateral bladder tumors will be invited to participate in 
the study.  After obtaining written informed consent, the veteran will be randomized to 
receive an ultrasound-guided obturator block or a neuromuscular blocking agent after 
the induction of general anesthesia in an attempt to block the obturator reflex during 
surgery.  Both techniques are commonly performed and accepted techniques for the 
prevention of the obturator reflex. 
 
Inclusion criteria  
1. Patients ≥ 18 years of age undergoing TURBT for unilateral or bilateral 
posterolateral bladder tumors 
2. Ability to understand and provide informed consent 
 
Exclusion criteria 
1. Patient refusal or inability to provide informed consent 
2. True allergy, not sensitivity, to any of the following substances:   
a. Local anesthetics 
b. Propofol 
c. General anesthetic agents 
3. Pregnancy 
4. Severe hepatic impairment 
5. Evidence of infection at or near the proposed needle insertion site 
6. Any sensorimotor deficit of the lower extremity, whether acute or chronic, as 
determined by the PI 
7. Inability to walk without assistance 
8. Lower extremity joint replacement surgery in the preceding six months 
 
Methods:   
Research related procedures:  Veterans (n=60) with be randomized to the obturator 
block or neuromuscular block arm upon enrollment, using randomized permutated 
blocks of six (GraphPad Software, Inc).  The TUG test and dynamometer 
measurements will be obtained preoperatively and one hour postoperatively.  Handheld 
dynamometers are commonly used to determine leg muscle strength and have been 
utilized in multiple recent nerve block studies and other clinical settings [7, 8, 15].  The 
TUG test requires the participant to stand from a seated position, walk ten feet, turn 
around, and return to a seated position.  The test is free and available to all health care 


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providers (http://www.cdc.gov/steadi/index.html).  It is a sensitive and specific tool for 
evaluating fall risk with excellent intra- and interrater reliability [16].  It is easily 
performed, does not require specialized equipment or training, and correlates well with 
other balance and gait measures [17].  Times ≥ 13.5 seconds are associated with an 
increased risk of falls [16, 17]. 
 
Once a potential study candidate provides consent to participate in the study, s/he will 
undergo a baseline TUG test and dynamometer measurements.   
 
Planned statistical analyses 
All analyses will be conducted in JMP Pro 12.0 (SAS Institute, Cary, NC). Categorical 
measures (e.g. block success) will be summarized as percentages (%). For continuous 
measures (e.g. TUG, dynamometer), normally distributed measures will be summarized 
as means and standard deviations, and non-normally distributed measures will be 
summarized as median with interquartile range. Differences in block success between 
groups will be examined with χ2 tests. Differences in dynamometer measurements and 
TUG tests will be examined through t-tests, with transformation of outcomes as 
necessary to satisfy assumptions of the statistical test. P < 0.05 will be considered 
statistically significant.  
 
Sample size justification 
The target sample size for the proposed study is n=60 (n=30 per group). Power 
calculations were performed assuming 80% power and alpha=0.05. With n=60, our 
sample can detect a minimum 28% decrease is block success in the neuromuscular 
block group compared to the obturator block group, assuming a 97% success rate in the 
obturator block group. This sample size will also be able to detect a minimum group 
mean difference of 7.4 on the TUG (SD=10.0).  
 
Obturator block group 
Standard of care:  After the induction of general anesthesia, the block will be performed 
on the side of the posterolateral bladder tumor(s).  If a patient has bilateral 
posterolateral bladder tumors, bilateral blocks will be performed.  A time out procedure 
will be performed confirming the patient’s identity, the proposed surgical procedure, and 
laterality of the tumor(s) and block procedure(s).  The patient’s inguinal region will be 
cleansed with Chlorohexidine prep solution.  A 21ga Pajunk SonoPlex needle will be 
advanced under ultrasound guidance and 20-30mL of 2% mepivacaine will be injected 
using an interfascial approach.  All nerve blocks will be performed by Dr. José Soberón, 
who has expertise in ultrasound-guided regional anesthesia.  Block time will be counted 
as the time from needle insertion until the completion of the injections.  Any 
inadequate/failed blocks will be recorded.  Unless clinically indicated, neuromuscular 
blocking agents will be avoided (with the exception of succinylcholine for tracheal 
intubation). 
 
Neuromuscular block group 
Standard of care:  After the induction of general anesthesia, rocuronium (a 
neuromuscular blocking agent) will be administered intravenously in 5-10mg increments 


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titrated to a goal of 2/4 twitches.  An obturator block will not be performed unless 
adductor spasm persists despite the administration of additional rocuronium.   
 
Research related procedure:  The incidence of block- and procedure-related adverse 
events, including the obturator reflex, will be recorded.  In addition to clinical 
observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor 
spasm using continuous electromyography.  Adhesive skin (non-needle) electrodes will 
be placed on the thigh to objectively detect and record instances of adductor spasm. 
 
Standard of care:  Unless contraindicated, all patients will be extubated and transported 
to the post anesthesia care unit (PACU).  The patients will then be discharged home or 
to a hospital room (per the surgical service).   
 
Research related procedure:  One hour after arrival to PACU or when discharge criteria 
are met (whichever comes first), repeat dynamometer measurements and TUG tests 
will be performed.  Patients will be called 24-48 hours post procedure to inquire about 
falls or evidence of nerve injury, as well as patient satisfaction.   
 
7. Possible Discomforts and Risks: 
 
In addition to the risks of general anesthesia, veterans in the obturator block group may 
experience the following:  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).  These events are rare and, to 
date, none of these complications have been reported in patients receiving an obturator 
block.   
 
Because the obturator block will be performed after the induction of general anesthesia, 
the enrolees should not experience any discomfort during the block procedure. 
 
8. Possible Benefits: 
 
Because adductor spasm may interfere with tumor resection, performance of an 
obturator block or use of neuromuscular relaxing agents may block or ameliorate the 
reflex and allow for safer operating conditions and improved cancer removal.  The 
efficacy 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. 
 
9. Conflict of Interest: 
 
None of the investigators have any relevant financial disclosures. 
 
10.  References: 
 


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1. Patricios J. Adductor muscle and tendon injury. UpToDate. 
http://www.uptodate.com/contents/adductor-muscle-and-tendon-
injury?source=machineLearning&search=adductor+injury&selectedTitle=1%7
E74&sectionRank=4&anchor=H49279219#H49279219. Updated August 18, 
2015. Accessed September 22, 2016. 
 
2. Mihara T, Itoh H, Hashimoto K, Goto T. Trans-resectoscope stimulation 
predicts the need to block adductor response during bladder tumor resection. 
Anesth Analg. 2013 Sep;117(3):740-4. doi: 
10.1213/ANE.0b013e3182a07063. 
 
3. Hızlı F, Argun G, Güney I, Güven O, Arık AI, Başay S, Günaydın H, Başar H, 
Köşüş A. Obturator nerve block transurethral surgery for bladder cancer: 
comparison of inguinal and intravesical approaches: prospective randomized 
trial. Ir J Med Sci. 
 
4. Ishiyama T, Kotoda M, Asano N, Ikemoto K, Masamune T, Matsukawa T. 
Ultrasound-guided out-of-plane obturator nerve block. Anaesthesia. 2013 
Oct;68(10):1074-5. doi: 10.1111/anae.12432. 
 
5. Wasserstein D, Farlinger C, Brull R, Mahomed N, Gandhi R. Advanced age, 
obesity and continuous femoral nerve blockade are independent risk factors 
for inpatient falls after primary total knee arthroplasty. J Arthroplasty. 2013 
Aug;28(7):1121-4. doi: 10.1016/j.arth.2012.08.018 
 
6. Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity 
continuous peripheral nerve blocks and patient falls after knee and hip 
arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 
10.1213/ANE.0b013e3181fb9507. 
 
7. Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. 
The effects of ultrasound-guided adductor canal block versus femoral nerve 
block on quadriceps strength and fall risk: a blinded, randomized trial of 
volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 
10.1097/AAP.0b013e318295df80. 
 
8. Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. 
Adductor canal block versus femoral nerve block and quadriceps strength: a 
randomized, double-blind, placebo-controlled, crossover study in healthy 
volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 
10.1097/ALN.0b013e318279fa0b 
 
9. Akkaya T, Ozturk E, Comert A, Ates Y, Gumus H, Ozturk H, Tekdemir I, 
Elhan A. Ultrasound-guided obturator nerve block: a sonoanatomic study of a 
new methodologic approach. Anesth Analg. 2009 Mar;108(3):1037-41. doi: 
10.1213/ane.0b013e3181966f03. 


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10. Helayel PE, da Conceição DB, Pavei P, Knaesel JA, de Oliveira Filho GR. 
Ultrasound-guided obturator nerve block: a preliminary report of a case 
series. Reg Anesth Pain Med. 2007 May-Jun;32(3):221-6. 
 
11. Murphy GS, Brull SJ. Residual neuromuscular block: lessons unlearned. Part 
I: definitions, incidence, and adverse physiologic effects of residual 
neuromuscular block. Anesth Analg. 2010 Jul;111(1):120-8. doi: 
10.1213/ANE.0b013e3181da832d. Epub 2010 May 4. Review. 
 
12. So PC. Two case reports of obturator nerve block for transurethral resection 
of bladder tumour. Hong Kong Med J. 2004 Feb;10(1):57-9 
 
13. Tatlisen A, Sofikerim M. Obturator nerve block and transurethral surgery for 
bladder cancer. Minerva Urol Nefrol. 2007 Jun;59(2):137-41. PubMed PMID: 
17571049. 
 
14. Tekgül ZT, Divrik RT, Turan M, Konyalioğlu E, Şimşek E, Gönüllü M. Impact 
of obturator nerve block on the short-term recurrence of superficial bladder 
tumors on the lateral wall. Urol J. 2014 Mar 3;11(1):1248-52. 
 
15. Jæger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, 
Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve 
block for analgesia after total knee arthroplasty: a randomized, double-blind 
study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 
10.1097/AAP.0000000000000015. 
 
16. Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional 
mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. 
 
17. Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls 
in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 
2000 Sep;80(9):896-903. 
 
18. Khorrami MH, Javid A, Saryazdi H, Javid M. Transvesical blockade of the 
obturator nerve to prevent adductor contraction in transurethral bladder 
surgery. J Endourol. 2010 Oct;24(10):1651-4. doi: 10.1089/end.2009.0659. 
 
19. Bolat D, Aydogdu O, Tekgul ZT, Polat S, Yonguc T, Bozkurt IH, Sen V, Okur 
O. Impact of nerve stimulator-guided obturator nerve block on the short-term 
outcomes and complications of transurethral resection of bladder tumour: A 
prospective randomized controlled study. Can Urol Assoc J. 2015 
Nov-Dec;9(11-12):E780-4. doi: 10.5489/cuaj.3149. 
 


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20. Mihara T, Itoh H, Hashimoto K, Goto T. Trans-resectoscope stimulation 
predicts the need to block adductor response during bladder tumor resection. 
Anesth Analg.2013 Sep;117(3):740-4. doi: 10.1213/ANE.0b013e3182a07063.  
 

ICF_004.pdf: 
Title: Comparison of obturator nerve blockade and neuromuscular blockade for the prevention of 
adductor spasm in patients undergoing transurethral resection of bladder tumors. 
NCT: NCT03063255 
Date: October 25, 2018 


VA RESEARCH CONSENT FORM
Subject Name:
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 
IRB Project #: 201601962
Page 1 of 11
IRB Version: 04/25/2015
VA Form 10-1086
PI Version: 10/13/2018 
Department of Veterans Affairs
INFORMED CONSENT FORM
to Participate in Research
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 also 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 VA or other 
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, 
concerns, complaints, wish to discuss problems or talk to someone independent of the 
research staff, obtain information, or offer input, please call either of the following offices: 
(1) the University of Florida Institutional Review Board (IRB) office at (352) 273-9600; or (2) 
the North Florida/South Georgia Veteran’s Health System Research Service Office at (352) 
548-6069. 
Study ID:IRB201601962   Date Approved: 10/25/2018   Expiration Date: 10/3/2019


VA RESEARCH CONSENT FORM
Subject Name:
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 
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
GENERAL INFORMATION ABOUT THIS STUDY
1. Name of Participant ("Study Subject")
___________________________________________________________________ 
For PI Use:
Participant Social Security Number: 
SSN should be written on this consent form by the research team prior to scanning into the VHA 
health record; if the subject does not have a VHA health record, this requirement is N/A.
2.
What is the Title of this research study?
Comparison of obturator nerve blockade and neuromuscular blockade for the 
prevention of adductor spasm in patients undergoing transurethral resection of 
bladder tumors
3.  Who can you call if you have questions, concerns, or complaints about this    
research study?
Principal Investigator:  
     José R. Soberón, Jr, MD
Department of Anesthesiology
NF/SG Veterans Health System
1601 Archer Road
Gainesville, Florida 32608
Pager:  (352) 413-2317
4.  Who is paying for this research study? 
The sponsor of this study is Veterans Administration
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 
Study ID:IRB201601962   Date Approved: 10/25/2018   Expiration Date: 10/3/2019


VA RESEARCH CONSENT FORM
Subject Name:
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 
IRB Project #: 201601962
Page 3 of 11
IRB Version: 04/25/2015
VA Form 10-1086
PI Version: 10/13/2018 
Department of Veterans Affairs
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) 273-
9600 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.
Study ID:IRB201601962   Date Approved: 10/25/2018   Expiration Date: 10/3/2019


VA RESEARCH CONSENT FORM
Subject Name:
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 
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
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.
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)? 
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.
7.  What will be done only because you are in this research 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 
Study ID:IRB201601962   Date Approved: 10/25/2018   Expiration Date: 10/3/2019


VA RESEARCH CONSENT FORM
Subject Name:
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 
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
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.
8. How long will you be in this research study?
Your participation will be complete after the follow-up phone call(s) or 3 days, 
whichever happens first.
9. How many people are expected to take part in this research study?
70.
Study ID:IRB201601962   Date Approved: 10/25/2018   Expiration Date: 10/3/2019


VA RESEARCH CONSENT FORM
Subject Name:
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 
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
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?
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 
Study ID:IRB201601962   Date Approved: 10/25/2018   Expiration Date: 10/3/2019


VA RESEARCH CONSENT FORM
Subject Name:
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 
IRB Project #: 201601962
Page 7 of 11
IRB Version: 04/25/2015
VA Form 10-1086
PI Version: 10/13/2018 
Department of Veterans Affairs
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. 
11a. What are the potential benefits to you for taking part in this research study ?
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.
11b. How could others possibly benefit from this study?
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.
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 may benefit if the results of this study are 
presented at scientific meetings or in scientific journals.
Study ID:IRB201601962   Date Approved: 10/25/2018   Expiration Date: 10/3/2019


VA RESEARCH CONSENT FORM
Subject Name:
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 
IRB Project #: 201601962
Page 8 of 11
IRB Version: 04/25/2015
VA Form 10-1086
PI Version: 10/13/2018 
Department of Veterans Affairs
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.
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 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.  
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 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. 
Study ID:IRB201601962   Date Approved: 10/25/2018   Expiration Date: 10/3/2019


VA RESEARCH CONSENT FORM
Subject Name:
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 
IRB Project #: 201601962
Page 9 of 11
IRB Version: 04/25/2015
VA Form 10-1086
PI Version: 10/13/2018 
Department of Veterans Affairs
WHAT ARE THE FINANCIAL ISSUES IF YOU PARTICIPATE?
14. If you choose to take part in this research study, will it cost you anything?
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.”
15. Will you be paid for taking part in this study?
No.
16. What if you are injured because of the 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.
Study ID:IRB201601962   Date Approved: 10/25/2018   Expiration Date: 10/3/2019


VA RESEARCH CONSENT FORM
Subject Name:
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 
IRB Project #: 201601962
Page 10 of 11
IRB Version: 04/25/2015
VA Form 10-1086
PI Version: 10/13/2018 
Department of Veterans Affairs
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.
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.
Study ID:IRB201601962   Date Approved: 10/25/2018   Expiration Date: 10/3/2019


VA RESEARCH CONSENT FORM
Subject Name:
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 
IRB Project #: 201601962
Page 11 of 11
IRB Version: 04/25/2015
VA Form 10-1086
PI Version: 10/13/2018 
Department of Veterans Affairs
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 alternatives to being in the study; and how privacy will be protected: 
Signature of Person Obtaining Consent 
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 privacy will be protected.  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 other questions at any time.  
You voluntarily agree to participate in this study.  By signing this form, you are not waiving 
any of your legal rights.
Signature of Person Consenting 
Date
Study ID:IRB201601962   Date Approved: 10/25/2018   Expiration Date: 10/3/2019