Prospective Blinded Study Looking at PO/IV Analgesia Alone Versus PO/IV Analgesia With Superior Hypogastric Nerve Block for Uterine Artery Embolization Pain Management
Phase: PHASE2
Conditions: Leiomyoma
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Clinical study proposal                                                                                    Dec 2nd, 2014 
 
____________________________________________________________Page 0 of 35 
 
 
 
 
 
 
 
Response to the ethics review: 
 
 
In accordance with the discussion at the ethics review, the protocol has 
been revised to include statements defining that the consent will be 
obtained by an interventional radiologist who will not be performing 
the procedure.  As well an age criteria has been added.  Finally, as 
suggested, in order to blind the patient further, a curtain will be draws 
between the eyes of the patient and the operating field where the nerve 
block or sham procedure will be done.  This version (version 3)  has 
now been uploaded to the system.  The only difference between this 
protocol and Version 2 are the modification of these specific elements 
that were brought up by the ethics committee.  Also clarification 
regarding the principal investigators and collaborators is done. 
 
The modified consent form will also be uploaded to the system 
(version 2) as requested by the ethics committee.   
 
Thank you very much for your suggestions.  I trust these modifications 
will statisfy fully the requests of the ethics committee. 
 
Sincerely, 
 
 
 
 
Louis-martin Boucher 
 
 
 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 1 of 35 
Prospective blinded study looking at PO/IV analgesia alone 
versus PO/IV analgesia with superior hypogastric nerve block 
for uterine artery embolization pain management 
Principal Investigator 
Louis-Martin Boucher, MD, PhD 
Assistant Professor of Interventional Radiology 
MGH, Montreal, QC / Tel: (514) 934-8003 
E-mail: lmboucher@yahoo.com 
 
Collaborators 
David Valenti, MD,CM, FRCP(C) 
Assistant Professor of Vascular and Interventional Radiology 
Head of Interventional Radiology division 
RVH, Montreal, QC / Tel: (514) 843-1545 
E-mail: david.valenti@muhc.mcgill.ca 
 
Tatiana Cabrera, MD 
Assistant Professor of Interventional Radiology 
RVH, Montreal, QC, S4.14 / Tel: (514)-934-4454/ 44454 
E-mail: tacaal@hotmail.com 
 
Carlos Torres, MD, FRCP(C) 
Assistant Professor of Interventional Radiology 
MGH, Montreal, QC / Tel: (514) 934-1934x44454 
E-mail: citorresp@yahoo.com 
 
Karl Muchantef, MD 
Assistant Professor of Interventional Radiology 
MCH, Montreal, QC / Tel: (514) 934-1934x44454 
E-mail: karlmuchantef@gmail.com 
 
Benoit Gallix, MD, PhD 
Professor of Vascular and Interventional Radiology 
Head of  Dept. Of Diagnostic Imaging 
MUHC, RVH, Montreal, QC / Tel:  (514) 934-1934 ext. 34377 
E-mail: Benoit.Gallix@muhc.mcgill.ca  

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 2 of 35 
 
 
Principal Investigators: 
Collaborators: 
Louis-Martin Boucher, MD -Montreal General Hospital 
 
David Valenti, M.D. - Royal Victoria Hospital 
Tatiana Cabrera, M.D. –Royal Victoria Hospital 
Carlos Torres, M.D. –Montreal General Hospital 
Karl Muchantef, M.D. – Montreal Children Hospital 
Benoit Gallix, M.D. –Royal Victoria Hospital 
Date of Original Protocol: 
Oct 10th, 2014 
Protocol Version: 
Ver3 
Revision History: 
Revision 
Description 
Date 
Ver1 
Initial version 
Oct 10th, 2014 
Ver2 
Revision following scientific review 
   Revisions include  
1) Explanation of UFE procedure 
2) Statistical analysis modifications 
Nov 29th, 2014 
Ver3 
Revision following ethic committee review 
   Revisions include 
1) Clarification on obtaining the consent 
which will be done by someone who is 
not performing the procedure itself and 
that separate consents will be obtained 
for the UFE and for the research protocol 
2) Age will be added to the inclulsion 
criteria 
3) The patient’s view will be blocked 
during the procedure so that they do not 
see whether the nerve block or the sham 
procedure is performed. 
Dec 2nd, 2014 
 
 
 
 
Confidentiality Statement 
This document may be disclosed to appropriate Institutional Review Boards/Independent Ethics Committees or duly 
authorized representatives of Regulatory authorities, but otherwise should remain confidential. 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 3 of 35 
Protocol Signature Page 
 
Protocol Title 
Prospective blinded study looking at PO/IV analgesia 
versus PO/IV analgesia with superior hypogastric nerve 
block for uterine artery embolization pain management 
 
Protocol No. 
1 
Protocol Version 
Ver3 
Protocol date 
Dec 2nd, 2014 
 
 
 
 
 
 
 
Dec 2nd, 2014  
Investigator Signature 
 Date 
Louis-Martin Boucher 
MUHC-RVH 
Montreal (QC) 
Name 
          Institution 
City, Province 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 4 of 35 
Abbreviations used: 
CRF 
Case Report Form 
UAE 
Uterine artery embolization 
IRMD 
Interventional Radiology Medical Doctor 
IV 
Intravenous 
PO 
Oral Administration 
REB 
Research Ethics Board 
SAE 
Serious Adverse Event 
SHGNB 
Superior Hypogastric Nerve Block 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 5 of 35 
PROTOCOL SYNOPSIS 
Title 
Prospective blinded study looking at PO/IV analgesia alone versus 
PO/IV analgesia with superior hypogastric nerve block for uterine 
artery embolization pain management 
Protocol No. 
1,  Ver 3 
Principal 
Investigators 
& Study Sites 
Louis-Martin Boucher, MD -Montreal General Hospital 
David Valenti, M.D. - Royal Victoria Hospital 
Tatiana Cabrera, M.D. –Royal Victoria Hospital 
Carlos Torres, M.D. –Montreal General Hospital 
Karl Muchantef, M.D. – Montreal Children Hospital 
Benoit Gallix, M.D. –Royal Victoria Hospital 
Study 
Objectives 
1. The primary objective is to assess whether the use of a superior 
hypogastric nerve block performed during uterine artery embolization 
procedures helps provide better pain management than oral/IV 
medications alone by assessing patient directed pain scoring and 
differences in use of oral/IV analgesics 
2.  As secondary objectives the group with the sham procedure and 
those with the superior hypogastric nerve block will be compared for 
rate of adverse events, differences in pain/complication related hospital 
admission/re-admission rates, differences in pain control as related to 
the bulk volume of fibroids, differences in pain control as related to 
fibroid disease versus adenomyosis, successful outcome of embolization 
procedure, successful relief of patient symptoms from the fibroids at 
time of follow-up   
Study Design 
& Procedure 
This is a prospective double-blinded randomized comparative trial. 
Experienced interventional radiologists at the MUHC will carry out all 
intervention.  
 
• 50 consecutive subjects meeting the eligibility criteria, scheduled 
for uterine artery embolization for symptomatic uterine fibroids 
and/or adenomyosis.  
• Consent will be obtained from all patients by a interventional 
radiologist who will not be involved in the procedure itself. 
• All procedures will be performed by a qualified interventional 
radiology medical doctor (IRMD).  
• Patients who accept to participate and fit the criteria will be 
randomized to either receive a superior hypogastric nerve block 
(SHGNB) during the procedure or simply injection of xylocaine in 
the skin at the periumbilical subcutaneous tissues (sham procedure). 
• The hypogastric nerve block or sham procedure will be performed 
by an independent interventional radiologist while the primary 
operators (radiologists and support staff) of the uterine artery 
embolization are removed from the room.  Once the block or sham 
procedure is completed, the primary operators returns to the room to 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 6 of 35 
complete the uterine artery embolization. 
• The patients view of the procedure will be blocked during this time 
to ensure they are not aware of whether they have had a nerve block 
or simply a sham procedure 
• The patient will be offered IV analgesia using midazolam and 
fentanyl during the procedure at set regular intervals 
• Similar analgesics as well as per oral analgesics will be provided as 
per set orders during the recovery period in the post-procedural 
recovery room 
• The patient will be discharged home with standard prescriptions for 
home analgesics which include routine medication and medication 
to be used for breakthrough pain.  
• At home, the patient will be filling out an online or paper survey to 
monitor use of medication and assessment of pain on a visual 
analogue pain scale.  To preserve anonymity of patients deciding to 
fill out the online survey, the patient will be assigned a anonymous 
number to be used to log into the survey system prior to leaving the 
hospital  
• Data will be gathered, stored, and analyzed. 
• Follow-up of the patient will occur as per routine 4-6 months post 
embolization to assess the clinical success of the procedure. 
 
Subject data collection on the day of the procedure will include 
demographics, relevant medical history, vital signs, use of IV 
analgesics, use of oral analgesics, use of SHGNB or sham procedure. 
Subject data collection while at home will include visual analogue pain 
scale and self-recording of medication intake.  
Study 
Rationale 
Uterine fibroids have a significant negative impact on the quality of life 
of many women who are in their reproductive years.  Problems 
associated with uterine fibroids include excessive blood loss during 
menstruation (menorrhagia) with often irregular menstrual periods 
(menometrorrhagia), in some cases leading to marked anemia and need 
for blood transfusions, excessive pain especially during menstruation 
(dysmenorrhea), and symptoms of bulk causing compression on the 
bladder and increased urinary frequency often with waking up at night 
to urinate (nocturia) or even incontinence, or compression of the rectum 
causing constipation.  As well many women suffer from painful 
intercourse (dyspareunia), which can have negative impact on self-
image and marital status. These symptoms can be very debilitating, and 
are often career limiting. 
 
Until relatively recently, most of these women had to opt for 
hysterectomy to help control these symptoms.  However in the late 
1990s, several publications demonstrated the feasibility of uterine artery 
embolization to control these symptoms.  By blocking the blood flow to 
the fibroids, the fibroids became necrotic and the symptoms resolved.  
Since then the technique has become widely accepted as a less invasive 
alternative to surgery with excellent clinical results. 
 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 7 of 35 
The biggest complication of the embolization is that of pain, which is 
almost universal.  The embolized fibroids lead to significant discomfort 
gradually decreasing over a period of 7-10 days, with most of the 
discomfort being present in the first 24 hours.  Because of this, many 
centers still routinely admit their patients overnight with patient 
controlled analgesia or with epidural analgesia catheters in place.  
However, because of constraints caused by admission availability, many 
centers are exploring better regimens of analgesia that would allow 
patients to go home on the same day as the procedure.  Here, at the 
MUHC we have an analgesia protocol that allows approximately 90% 
of our patients to be discharged home on the same day, often with 
significant but tolerable discomfort.  However there is much room for 
further pain control improvement to increase the rate of discharge, to 
improve pain control amongst discharged patients, and to reduce the 
rates of return visits to the emergency department and re-admissions 
due to uncontrolled pain while at home. 
 
The superior hypogastric nerve plexus is a primary plexus relaying pain 
information from pelvic structures, including the uterus.  A block of this 
neural plexus is a well-established technique used in cases of chronic 
pelvic pain such as that caused by pelvic-based cancers. In 2004, a 
group from Ottawa published a report using this type of nerve block to 
control the pain associated with UAE.  They placed a very small-gauged 
needle via a periumbilical anterior approach down to the nerve plexus 
anterior to the lumbosacral vertebral body and injected a long acting 
anesthetic agent called bupivacaine in the plexus.  They reported a 
significant improvement in pain control will all their patients being able 
to be discharged and only a very small proportion needing to return to 
the hospital because of uncontrolled pain.  They have had no significant 
complications attributed to the nerve block procedure itself.  However 
their study was not a formal comparitive study. 
 
Here at the MUHC, we have used this technique in several patients with 
promising initial results, but the procedure remains semi-invasive and 
we believe needs validation especially since pain is such a subjective 
symptom.  This lack of formal validation is probably why the technique 
is slow to be adopted by other groups.  We believe this study will allow 
a final conclusion regarding the use of this technique in the treatment of 
uterine fibroids embolization. 
 
The goal of the study is to compare the pain sensations patients have 
and need for analgesics post uterine artery embolization for fibroids by 
generating a double blinded situation in which neither the patient or 
primary operator of the embolization are aware of whether the block has 
been performed or not. 
Planned 
Sample Size 
Based on published data, the average pain felt by ladies post uterine 
artery embolization is 7/10 with a standard deviation of approximately 
2.5.  The published study of SHGNB for UAE demonstrated a decrease 
in pain from 7 to 2-5 depending on the analgesics regimen used.  We 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 8 of 35 
opted for the conservative drop in pain scale from 7 to 5 with a standard 
deviation of 2.5.  This gives an effect size of 0.8. With type I error 
(alpha) set at 0.05 and type II error (beta) set at 0.2 (power of 80%), the 
sample size calculations yields a needed sample size of 42.  We expect 
up to a 20% drop out rate due to loss to follow-up, giving a total sample 
size needed of 50, leaving 25 patients per group.   
 
 
Since the pain drop can be more significant that the conservative value 
we have opted to use, we suggest an interim analysis that would be 
expected to give us statistical significance if the pain scale was 
improved by 50% from 7-3.5 (4 being the number usually used by the 
recovery room to decide to release patients).  Based on similar 
calculations, to show this level of improvement (taking in account a 
similar drop out rate), one would need a total of 20 patients and 
therefore we plan on doing an interim analysis at 20 patients having 
completed the study to see if there is any need to continue the study or 
not. 
 
Inclusion 
Criteria 
1. Women with symptomatic fibroids or adenomyosis that have 
requested and been approved for uterine artery embolization 
2. Age of patients ranging between 35 and 60 years old 
3. Ability to comply with the requirements of the study procedures 
Exclusion 
Criteria 
1. 
Patients in whom the vascular anatomy prevents access to the 
superior hypogastric nerve plexus safely 
2. 
Patients who have known allergy to the anesthetic agent 
3. 
Patients with signs of skin infection at the entry site of the 
needle used to place the nerve block 
4. 
Patients with signs of infection such as fever 
5. 
Patients with history of inflammatory bowel disease of with 
signs of colitis 
6. 
Patients with uncorrectable abnormal coagulation status (INR 
>1.5 and plt < 50000 without use of anticoagulation agents) 
7. 
Patients with preexisting conditions, which, in the opinion of the 
investigator, interfere with the conduct of the study. 
8. 
Patients who are uncooperative, cannot follow instructions, or 
who is unlikely to comply with follow-up appointments or fill-
out the post-procedural pain questionnaires. 
9. 
Patients with mental state that may preclude completion of 
the study procedure or be unable to provide informed consent 
Schedule of 
Study Visits 
No change from routine schedule presently used: 
1) MRI pre-UAE 
2) Consultation pre-UAE (consent will be obtained at this time) 
3) UAE procedure (not usually the same day as the consultation) 
4) MRI 4-6 months post-UAE 
5) Consultation post-UAE after post-UAE MRI completed 
Efficacy 
Outcome 
§ Primary:   
o Reduction in pain as measured by patient self 
administration of visual analogue scale 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 9 of 35 
o Reduction in use of oral analgesics at home and 
IV/oral analgesics while in hospital 
§ Secondary:  Comparison of sham versus SHGNB group to 
look for 
o Differences in adverse events 
o Differences in pain/complication related 
admissions 
o Differences in pain in relation to total volume of 
fibroids 
o Differences in pain in relation to fibroids versus 
adenomyosis 
o Differences in successful outcome of the 
embolization both by imaging and clinically 
o Use of the online questionnaire vs the paper 
questionnaire 
Safety  
§ Possible adverse events the SHGNB would include: 
§ 
Infection 
§ 
Bowel injury 
§ 
Vascular injury/Bleeding 
§ 
Pain or nerve injury 
§ 
Allergic reaction to the anesthetic agent 
§ 
Intravascular injection of the anesthetic agent which can lead 
to cardiac arrhythmias or seizures 
§ 
Hospitalization or emergent surgery 
 
The rate of significant complications is estimated to be less than 
0.5%.    
 
In the sham group, the only significant risks would be infection and 
allergic reaction to the anesthetic agent.   
 
§ Expected possible adverse events of the uterine artery 
embolization, independent of SHGNB or not 
§ Pain 
§ Vascular injury/Bleeding 
§ Embolization material migrating to non-targeted organs 
§ Premature ovarian failure 
§ Uterine infection leading to possible hysterectomy 
§ Pulmonary Embolus 
§ Leaving a uterine sarcoma unresected 
Other than pain, which is almost universal and premature ovarian 
failure that can occur in 2-10% of patients, the other risks are in the 
order of 1-2% or less.  Other than pain, it is expected that these 
complications will be independent of whether a SHGNB is 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 10 of 35 
performed or not.  
 
Subjects with procedure related adverse events will be followed up until 
the resolution of the event. 
 
A medical monitor will analyze all serious adverse events (“SAE”) in 
order to confirm that they are unrelated to the research protocol. 
Statistical 
Methods 
Descriptive statistics will be provided for the efficacy outcome results 
and will be presented in terms of percentage, frequency, means and 
95% confidence interval. Differences between both groups will be 
compared using Chi-square test for categorical variables and, after 
verifying a normal distribution to the data, a Student’s t- test for the 
continuous variables.  Regression analysis will be performed to 
compare time dependent events.  

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 11 of 35 
 
1.0 Background 
1.1. Uterine Fibroids 
 
 
Uterine fibroids are a monoclonal tumor of smooth muscle origin.  Their cause is 
unknown but is known to be hormone responsive, being diagnosed only after menarche 
and decreasing after menopause [1]. 
Uterine fibroids are the most common pelvic tumors in women being present in 
>80% of black women and approaching 70% in white women in their late 40s.  Of these, 
50% of black women and 35% of white women have clinical symptoms caused by the 
fibroids [1].  In 2008-2009, the estimated rate of hysterectomies in Canada was 
338/100000 women > 20 years old, with an estimated $192 million dollars in associated 
hospitalization costs (Canadian Institute for Health Information).  Of these, abnormal 
menstrual bleeding and fibroids remain the most common reason for hysterectomies.   
The most common clinical symptoms associated with fibroids are increased bleeding 
during menstruation, increased pelvic pain especially during menstruation or sexual 
intercourse, and pressure effects on surrounding structures causing increased urinary 
frequency and constipation. These symptoms can be very debilitating. 
Fibroids are almost exclusively benign in nature.  However they can be difficult to 
differentiate from malignant sarcomas.  Fortunately such sarcomas are rare, being 
estimated at 0.2% or less in surgical series [2].   
 
1.2. Uterine artery embolization 
 
In view of the low risk of malignancy and the complications and cost associated 
with hysterectomies, there has been a push towards less invasive approaches to treat 
fibroids.  In the mid-late 1990s, the first few publications were released presenting intra-
arterial embolization as a method to deplete the fibroids of their blood supply and induce 
their necrosis, to treat symptomatic fibroids [3].   The procedure consists of obtaining 
intra-arterial access as is performed routinely for angiographic studies.  A catheter is 
advanced into the uterine arteries on both sides and small plastic based particles are 
injected.  The particles are carried by the blood to the fibroids where they act as plugs as 
the vessels divide and reduce their size, becoming smaller than the particles themselves.  
By doing this, the arterial blood supply to the fibroids can be blocked.  The result is 
ischemic fibroids that then undergo necrosis.   
The procedure used for the UFE is the same as is presently used at the MUHC.  It is 
performed in the angio unit with the help of fluoroscopy.  Acces is obtained in the right 
common femoral artery followed by placement of a vascular sheath.  Through the sheath, 
a 4Fr DAV or 5Fr Cobra catheter and glidewire are used to cannulate the uterine arteries.  
If there is evidence of spasm, a microcatheter is used.  Once the catheter is advanced into 
the horizontal portion of the uterine artery, an angiographic image is obtained to confirm 
absence of non-uterine vessels distal to the catheter, such as vessels feeding the vagina 
that could be damaged by the embolization.  After confirmation that no non-targetted 
vessels are seen, PVA 500-700 particles, suspended into 15-20 ml of a mixture of 50:50 
contrast:saline, are injected slowly into the uterine artery until there is loss of 
visualization of the fibroid blushes and stagnation of contrast in the uterine artery so that 
the contrast remains present in the artery for a total of at least 5 heart beats.  After the left 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 12 of 35 
artery has been treated, the right artery is treated in the same fashion.  After the treatment, 
the catheters and sheaths are removed, pressure is applied to the groin for hemostasis, and 
the patient is transferred to the recovery room. 
The UFE procedure has been found to be safe and effective with fewer 
complications than total hysterectomy.  Approximately 80-90% of women get clinical 
improvement after uterine artery embolization and 97% would recommend the procedure 
to others [4].The most common complication which is almost universal, is that of pain 
post embolization. 
 
1.3. Pain from Uterine artery embolization 
 
When UAE was first started, the need for pain control was evident.  Although it 
was initially done with general anesthesia in the USA, it was quickly found that this was 
not necessary.  However almost everyone admitted the patient overnight with morphine 
based patient controlled analgesia (PCA).  The use of PCA pumps allowed careful 
assessment of the pain course after UAE.  The information gathered shows a maximal 
pain threshold reached at approximately 2 hours post-procedure, which lasts 3-4 hours 
and then a gradual decrease to a lower plateau over another 4-6 hours.  This period of 
decrease to a lower pain plateau is the time during which attempts at discharging the 
patients from the hospital with oral pain medication is attempted [5].  Most women 
declare no longer having embolization related pain after 7-10 days. 
Because of limited availability to hospital admission after radiological procedures 
at the MUHC, and the need to offer this less invasive treatment of uterine fibroids to 
women, the interventional radiologists at the MUHC have offered the procedure with an 
aggressive IV/Oral sedation protocol while in recovery and discharge orders 4-5 hours 
after the end of the procedure.  The patients are sent home with oral pain medication.  
However despite this aggressive protocol, approximately 5-10% of patients need 
admission, not without difficulties at times due to the chronic shortage of beds.  This is 
primarily because this time point of attempted home discharge from the recovery room is 
still in the phase where the lower more tolerable pain plateau, usually reached only 
approximately 8 hours after the procedure, has not been reached yet.  Even in those that 
are successfully sent home, they report significant discomfort upon discharge from the 
hospital and there are some that return to the emergency department for pain 
management.   
In addition there is very little published data regarding pain management once the 
patients have been discharged home.  In an attempt to evaluate this, we have established 
an online survey that patients can voluntarily fill out to allow us to evaluate this in the 
future and to flag patients having significant pain, so as to offer a better service to these 
patients.  The patients sign in using an anonymous number assigned to them on the day of 
the UAE.  We would be using this survey in this study and as secondary goal, we will be 
assessing ease of use of this survey by the patients.  Alternatively, the patients can fill a 
paper based survey if they prefer. 
 
1.4. Superior Hypogastric Nerve Block 
 
Because of the difficulties dealing with pain post UAE, recently a group in Ottawa 
has applied a technique used previously to treat chronic pelvic pain from pelvic tumors to 
control the acute pelvic pain associated with UAE[6].  This consists in doing a nerve 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 13 of 35 
block at the superior hypogastric nerve plexus using a long acting anesthetic agent called 
bupivacaine.  The medication has a duration of action of  4-8 hours which can cover the 
first high pain plateau until the lower pain plateau is reached.  Using the hypogastric 
nerve block and an aggressive PO analgesia protocol, they have been able to obtain a 
100% discharge from the hospital with patients feeling only mild or no pain at time of 
discharge.  There was a 5% readmission rate due to pain. Their results suggest a 
significant improvement in pain control compared to same-day discharge protocols 
without a superior hypogastric nerve block.   
The hypogastric nerve block consists of advancing a tiny 21 or 22-gauge needle 
through the abdomen up to the anterior surface of the vertebral body located below the 
aortic bifurcation.  This is the location of the superior hypogastric nerve plexus.  Once 
there, the anesthetic agent is administered.  The potential most serious risks of the 
procedure would include transgression of bowel loops, leading to theoretical transport of 
bacteria out of the bowel into the abdomen and associated infection, and intravascular 
injection of the anesthetic agent, which can lead to cardiac arrhythmias and seizures.  In 
order to limit complications from intravascular injection of contrast, we have opted to use 
ropivacaine as the anesthetic agent, an agent with better safety profile if intravascular 
injection occurs and similar duration of action[7].  As well, the use of epinephrine in the 
anesthetic agent can help identify an intravascular injection by monitoring for an increase 
in heart rate.  Finally, prior to injecting the anesthetic agent, we inject a contrast agent 
that allows us to identify an intravascular injection under fluoroscopy (which is used for 
the UAE procedure).  The group from Ottawa has had no complications, beyond those 
that can be explained by the UAE procedure itself, in their published series of 139 
patients[6] as well as in the more than 400 patients they have treated so far (personal 
communication).  We have also performed approximately 30 of these procedures, without 
complications. 
Because of the success of the group in Ottawa in performing the SHGNB, we have 
just recently started to offer this procedure as well.  Initial results are also very 
encouraging with recovery nurses informing us that in general the patients seem to be 
doing much better with the nerve block in place.  However the data remains anecdotal.  
There have been no studies to date comparing simple oral/IV sedation to SHGNB + 
oral/IV sedation.  For this reason, probably, the procedure has been very slow to be 
adopted by people who perform UAEs.  We believe that, to put this issue to rest, there is 
a necessity for such a comparative trial and, especially important in the context of a 
subjective outcome such as pain, it is our belief that a randomized double-blinded control 
trial is needed to obtain conclusive data. This was the reason this study was put together. 
 
 
2. Research Question: 
 
Is there a difference in subjective pain score patients experience and in the need 
for analgesics post uterine artery embolization for fibroids if the patients undergo a 
superior hypogastric nerve block during the embolization procedure. 
 
3. Objectives: 
 
The primary objective is to assess:  
o Reduction in subjective pain as measured by patient self 
administration of visual analogue scale and reduction in use of oral 
analgesics at home and IV/oral analgesics while in hospital 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 14 of 35 
 
The secondary objectives are: 
o Differences in adverse events between groups with and without 
SHGNB 
o Differences in pain/complication related admissions between 
groups with and without SHGNB 
o Differences in pain in relation to total volume of fibroids between 
groups with and without SHGNB 
o Differences in pain in relation to fibroids vs. adenomyosis between 
groups with and without SHGNB 
o Differences in successful outcome of the embolization both by 
imaging and clinically between groups with and without SHGNB 
o Differences in admission rates 
o Differences in rates of return visits to ER for pain issues 
o Patient use and appreciation of the online pain survey 
 
4. Implications: 
 
This comparison trial will provide important new information regarding the role 
SHGNB could play in pain control in women post UAE.  The expected benefits would 
include increasing the availability of UAE in centers with the radiology resources to offer 
the procedure but without the ability to admit patients overnight and to some patients for 
whom pain has been a strong deterrent to proceed with UAE and who want to avoid 
hysterectomy.  In addition, another benefit, if proven to allow increased same day 
discharge, would be to decrease the admission rate post UAE which could have benefits 
both for the patient as well as for the hospital, in terms of admission bed management, 
nursing time and medication usage, and at a financial level. 
If the procedure is found not to have benefit, this study will give basis to avoid 
placing patients at risks of complications from an unnecessary added procedure. 
 
5. Data analysis and sample size Calculation 
 
 
§ Data gathering and analysis 
Nurses in the recovery room will be provided a specific medication 
escalation regimen to follow based on a patient-centered pain requirement protocol.  
At the time of discharge, the patient will be seen by the IRMD who will gather the 
data regarding the dose and frequency of use of analgesia while in the recovery 
room.  He will review the visual analogue pain scale chart with the patient and get 
her to rank the pain between a scale of 0 to 10 for the pain felt immediately after 
the procedure, 2 hours after the procedure has ended, and immediately prior to 
discharge. The recovery nurses will also have a routine pain scale evaluation prior 
to giving medication and these will be reviewed.  The patient will also be given a 
folder with a series of sheets of visual pain scales to fill out 3 times a day, at 
specific times while at home, for up to 10 days.  They will be provided with a 
stamped envelope to return to us once they are all filled out.  Alternatively, the 
patient will be offered an anonymous login ID that will allow them to fill out the 
forms by internet (using a Canadian based survey web site). 
The data will be gathered.  Confirmation of the data distribution will be 
done.  A normal distribution is expected, but statistical analyses will be modified 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 15 of 35 
accordingly.  We expect that the data analysis will consist of regression analysis of 
the temporal pain level distribution between the group with and without the 
SHGNB.  Continuous variable data, with normal distributions, subgroup analysis of 
the secondary objectives will be compared using a Student’s t- test. 
§ Sample size calculation  
 
Sample size calculations are based on published data showing the average pain 
felt by ladies post uterine artery embolization being of 7/10 with a standard deviation of 
approximately 2.5.  The published study of SHGNB for UAE demonstrated a decrease in 
pain from 7 to 5-2 depending on the analgesics regimen used [6].  We opted for the 
conservative drop in pain scale from 7 to 5 with a standard deviation of 2.5.  This gives 
an effect size of 0.8. With type I error (alpha) set at 0.05 and type II error (beta) set at 0.2 
(power of 80%), the sample size calculations yields a needed sample size of 42.  We 
expect up to a 20% drop out rate due to loss to follow-up, giving a total sample size 
needed of 50, leaving 25 patients per group.  [8]  
 
If the analysis of the data after recruiting 50 patients is highly suggestive of an effect but 
without statistical significance, and if the calculations suggest we could get statistical 
significance by doubling the number of participants, and there have been no significant 
adverse events from the nerve block, we would increase the number of patients to 100.   
If adverse events have occurred, the number would not be increased unless approval by 
the ethics committee. 
 
§ Interim analysis 
 
 
The previous sample size has been calculated with a conservative number, but the 
decrease in pain can be as large as from 7 down to 2 based on previous studies.  
Therefore the above estimation may necessitate more patients than are needed to prove 
clinical worthiness of the procedure.  Clinically, our group feels that we would proceed 
with the block if we could get at least a 50% decrease in pain from 7 down to 3.5 (a scale 
of 4 being the common number used for discharge of patients from the recovery room).  
If a similar sample size calculations is performed for such a drop, a total sample size of 
16 would be needed.  With a similar drop out rate it is our feeling that an interim analysis 
should be performed at a patient study completion number of 20, so as to avoid recruiting 
an excessive number of patients to prove the value of the procedure.    Therefore we 
would perform an interim analysis at 20 patients having completed the study.  If the data 
is statistically significant the study would be terminated early. 
 
6. Study Population 
 
The target population who will be included to participate in this study is all women 
referred to us for a UAE procedure. 
 
6.1. Inclusion criteria: 
1. 
Women with symptomatic fibroids or adenomyosis that have requested and been 
approved for uterine artery embolization 
2. 
Women age 35-60 y.o. 
3. 
Ability to comply with the requirements of the study procedures 
 
6.2. Exclusion criteria: 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 16 of 35 
1. 
Patients in whom the vascular anatomy prevents access to the superior 
hypogastric nerve plexus safely 
2. 
Patients who have known allergy to the anesthetic agent 
3. 
Patients with signs of skin infection at the entry site of the needle used to place the 
nerve block 
4. 
Patients with signs of infection such as fever 
5. 
Patients with history of inflammatory bowel disease of with signs of colitis 
6. 
Patients with uncorrectable abnormal coagulation status (INR >1.5 and plt < 
50000 without use of anticoagulation agents) 
7. 
Patients with preexisting conditions, which, in the opinion of the investigator, 
interfere with the conduct of the study. 
8. 
Patients who are uncooperative, cannot follow instructions, or who are unlikely to 
comply with follow-up appointments or fill-out the post-procedural pain 
questionnaires. 
9. 
Patients with a mental state that may preclude completion of the study procedure 
or is unable to provide informed consent 
 
6.3. Randomization: 
 
A block randomization will be used to assign patients to either the SHGNB or to 
the sham procedure group.  Randomization will be performed using a randomization 
program and the results placed in independent envelopes.  These envelopes will be 
opened based on order of inclusion into the study and will determine the group in which 
patients will be placed.  
 
7.1. Study Design and procedures 
 
This is a double-blinded prospective randomized clinical study. All procedures 
will be performed by experienced interventional radiologists in the two MUHC study 
centers:  Royal Victoria Hospital and Montreal General Hospital.  Other Canadian 
hospital centers have shown interest in this protocol and may be added to the study at 
later dates. 
 
 
Upon referral to the angiography department for a UAE, the radiologist will 
assess the patient to determine if she is eligible for recruitment into the study based on the 
inclusion and exclusion criteria (see Appendix I).  This will be performed at the time of a 
consultation, which occurs up to three months before the actual procedure.  If the patient 
is eligible, she will be explained the study and provided with an information sheet.  She 
will be allowed to decide immediately whether she wants to participate or will be allowed 
to think about it and left to decide on the day of the procedure.  An informed consent will 
be signed.  The visual analogue scale will be explained as well as the commitment to 
complete the data sheets and return them, or to use the web service. 
 
On the day of the procedure, a randomization envelope will be opened and the 
person will be assigned to either the sham procedure group or to the SHGNB group. 
 
For both groups the UAE procedure itself will be identical.  During the UAE procedure 
the patient will be offered IV sedation at the start to the amount of 1 mg of midazolam 
and 50 ug of fentanyl.  Further additional doses will be upon request from the patient 
only.  The patient will be informed to ask for more if she needs it.  Prior to giving another 
dose, the patient will be asked to rank their discomfort on a scale of 0-10. 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 17 of 35 
 
The UAE procedure consists of embolization of both uterine arteries.  The 
SHGNB is usually performed in between embolization of both sides.  Therefore for the 
SHGNB group, the block will be performed after the left uterine artery has been 
embolized.  Following the block, the right uterine artery will be embolized.  Similarly the 
sham procedure will also be performed at the time between both embolization. 
 
In order to preserve the blinding, the block will be performed by a qualified 
IRMD, not involved with the UAE. Therefore, after the left uterine artery has been 
embolized, the UAE operator and accompanying technologists will leave the room.  The 
patients vision will be blocked via a sheet placed in between their eyes and the operating 
field so that they cannot see what procedure will be done.  The second operator will come 
into the room and perform the sham procedure or the SHGNB based on patient 
assignment to either group and will then leave the room.  The primary operator will then 
return to complete the UAE procedure. 
 
The sham procedure will consist of depositing a small amount of contrast and 
anesthetic agent into the subcutaneous tissues of the infraumbilical region.  As this 
procedure will be much faster, the block IRMD will be asked to take some extra time in 
the process to extend the time to a similar amount of time that is needed for the SHGNB. 
 
In the case of the SHGNB, the infraumbilical region will be penetrated by the 
same size needle as the sham procedure but advanced deeper, past the subcutaneous 
tissues into the abdomen up to the spine.  Once the target is reached, contrast will be 
injected to ensure that the tip is in the appropriate location and the anesthetic agent will 
be injected (0.75%  ropivacaine).   
 
For the sake of blinding, the patient will be told that the SHGNB and sham 
procedure can cause similar symptoms depending on the patient.  Some patients feel the 
discomfort at the skin and others deeper.  It is our experience that this is the case, with 
some patients undergoing SHGNB feeling only the skin puncture.  In any case, it is also 
our expericen that the pain felt by either a sham procedure or a SHGNB is very short 
lived and extremely well tolerated by the patients.   By attributing similar symptoms to 
the sham procedure and telling the patient that some patients have no significant 
discomfort with the SHGNB other than the crossing of the skin we hope to blind the 
patient so that she does not know whether only the skin was frozen or whether they have 
had a SHGNB. 
 
Subject data collection at the time of enrollment will include demographics, relevant 
medical history and vital signs. Subjects will be followed-up as outlined in Table 1 to 
assess adverse events related to the procedures and clinical success of the procedure.  
Individual data collection will be considered complete at the time of the follow-up 
consultation 4-6 months after the UAE procedure. 
 
 
7.2.  Consent 
 
In this study we would be obtaining written informed consent from all patients. This will 
be obtained at the time of the first consultation or on the day of the procedure if the 
patient has had time to read the information package and agrees to it.  The consent will be 
signed outside of the angiography suite and the consent will be obtained by an 
interventional radiologist at the time of the consultation who will not be involved in the 
procedure itself.  The consent for the embolization will be separate than that for the 
hypogastric nerve block research project itself. 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 18 of 35 
 
 
Table 1: Schedule of Study Procedures 
Parameter 
Consult up to 
3m prior to 
procedure 
Day of the 
procedure 
Time between 
procedure and 
follow-up consult 
Follow-up 
consult 4-6 m 
after procedure 
Information package 
X 
 
 
 
Informed consent signed 
X 
or X 
 
 
History& exam 
X 
X 
 
X 
Randomization 
  
X 
 
 
UAE/block 
 
X 
 
 
Recovery with data gathering of 
time in hospital 
 
X 
 
 
Visual pain scale sheets give to 
patient 
 
X 
 
 
Results from visual pain scale 
sheets gathered from patient 
 
 
X 
or X 
 
 
7.3. Visit on day of  Consult  
The following should be done at the initial visit: 
• 
Obtain consent for the uterine fibroid embolization procedure 
• 
Review protocol specific inclusion and exclusion criteria. 
• 
Assess whether patient is able to provide consent or not.  If the patient is 
appropriate for the study, informed consent is obtained.  This consent will be 
obtained by an interventional radiologist who will not be involved in the 
procedure itself. 
• 
Obtain relevant medical history and current demographic data. 
Presence of inclusion criteria and absence of exclusion criteria will be verified on the 
designated source documents and eCRF.  
7.4  Day of the UAE procedure 
If consent had not been obtained at the day of the consult because the patient wanted to 
think about it some more, the patient could be asked at this time whether they want to 
participate in the study or not.  If this is the case, all discussion will occur outside of the 
angiography room and the patient given information sheet and will be given time to 
decide whether they would like to participate or not.   
 
If they have decided to participate, a pre-randomized envelope will be opened and will 
decide whether the patient gets the hypogastric block or the sham procedure. UAE will 
proceed as per usual.   The patient will be recovered for at least 4 hours in the recovery 
room.  Data regarding pain management while in the recovery room will be gathered on 
the provided information sheets (see appendix).  Before discharge, the patient will be 
seen by one of the interventional radiologists to complete a visual analog pain scale and 
collect the information that has been gathered.  The patient will be provided an 
anonymization number and reminded to fill out the pain forms at home via hard copy that 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 19 of 35 
she can bring back to us at the time of the follow-up or mail to us (see appendix), or that 
she can fill out anonymously by internet.   
 
Procedural information will be collected and stored in a secure area for future analysis. 
7.5. First 10 days following the procedure 
 
The patient has some pain scoring sheets to fill (3/d for the first three days and 
the 1/d until day 10 post procedure) which record the amount of pain and the amounts of 
pain medications used.  She can fill them on hard copies provided to her and bring them 
back at the time of the consult or mail them to us in a prestamped envelope.  She can also 
use a internet anonymous filing system to fill out the forms.   
 
7.6. Follow-up Consult 
 
 
 
The patient will be seen in follow-up consult 4-6 months after the procedure as 
per routine protocol.  At that time, the patient is evaluated for successful treatement and 
for possible delayed complications of the UAE.  Also a final questionnaire will be filled 
out regarding any issues that could have arrisen from the SHGNB. 
7.7 Protocol Revisions and/or Deviations 
 
With the exception of emergency situations, no changes or deviations in the 
conduct of this protocol will be permitted.  
The Research Ethics Board (REB) that granted original approval for the study must be 
notified of all changes in the protocol, and must provide documented approval of any 
change or deviations that may increase risk to the subject, and/or that may adversely 
affect the rights of the subject or validity of the investigation. 
In the event of an emergency, the investigator will institute any medical procedures 
deemed appropriate. However, all such procedures must be promptly recorded and 
reported to the REB. 
7.8. Data Collection: 
Patient data will be reviewed by the research investigator on a routine basis to 
ensure any adverse events and information gathered were correctly recorded. The 
following datasheets will be used through-out the study: 
 
1. Screening Form (appendix 1) will be completed by the enrolling radiologist and 
will include demographic data and inclusion and exclusion criteria. 
 
2. Data sheet at time of UAE (appendix 2) will be completed by the treating 
interventional radiologist.  
 
3. Data sheet at time of discharge from recovery room (appendix 3) will be 
completed by the treating interventional radiologist.  
 
4. Data sheets during the following 10 days post procedure (appendix 4) will be 
completed by the patient 
 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 20 of 35 
5. Data sheet at time of follow-up consult (appendix 5) will be completed by the 
interventional radiologist and the patient 
 
6. Data sheet regarding symptoms and changes in quality of life caused by the 
fibroids UFS-QoL questionnaire (appendix 6) will be completed by the patient 
at the time of the first and last consultation. 
 
 
No unique patient identifying information will appear on the screening form that will be 
coded only by a study identification number.  A key linking the patient name and study 
identification number will be maintained in a separate database.  All datasheets will be 
kept in a locked, dedicated research office.  All computer records will be maintained in a 
password-protected, limited access folder.  Paper records will be maintained in a locked, 
dedicated research office.  All patients’ charts will be kept in secure storage for 25 years, 
as required by legislation.  All privacy regulations will be respected.  Only the research 
coordinator, principal investigator, and the safety committee will have access to the 
patient data. 
 
Data integrity will be maintained throughout the study.  Logic rules within the database 
will be used to maximize integrity, and random data validation checks will be performed 
routinely.  The research investigator will review studies and patients’ data on a monthly 
basis to ensure that patient follow-up is proceeding as expected. All cases where the 
research investigator finds a discrepancy in imaging interpretation or outcome assessment 
will be reviewed by the Adjudication Committee, consisting of the principal 
investigators.  An independent radiologist from the MUHC will be asked to determine the 
outcome of a dispute amongst the Adjudication Committee. 
 
8. Data Analysis: 
Data will be collected and tabulated using the commercially available 
JMP10/SAS statistical analysis software (SAS Institute Inc., Cary, NC, USA). 
Descriptive statistics will be provided for the efficacy outcome results and will be 
presented in terms of percentage, frequency, means and 95% confidence interval of the 
means. Differences between both groups will be compared using the Chi-square test for 
categorical variables and Student’s t- test for the continuous variables. ANOVA test and 
multivariate logistic-regression analysis will be used to compare interplay of more than 
two variables. Two-tailed p-values of less than 0.05 will be set for statistical significance. 
9. Ethical considerations: 
        
Research Ethics approval from the MUHC Research Ethics Board office will be 
obtained prior to the commencement of the study or related research procedures. All 
patients will be informed about the data that will be gathered for the study.  All patients 
will have the ability to refuse participating in the study as soon as they are able to 
evaluate it and give their approval or not.  Patients will always be given options to ask 
questions at any time and questions will be answered in a non-intimidating way so as to 
try to avoid influencing the patient’s decision.  At any time, the patient can decide to 
remove himself from the study.  If this is the case, he will receive the standard of care.   
 
No unique patient identifying data will appear on the sheets that will be coded 
only by study identification number. A key linking the patient name and study 
identification number will be maintained in a separate database. All datasheets will be 
kept in a locked, dedicated research office. All computer records will be maintained in a 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 21 of 35 
password-protected, limited access folder. Paper records will be maintained in a locked, 
dedicated research office. All privacy regulations will be respected. All patients’ charts 
will be kept in secure storage for 10 years. Only the research coordinator, principal 
investigators, and the safety committee will have access to the patient data. The data will 
be reviewed by the investigators on a regular basis to ensure that patient follow-up is 
proceeding as expected and to verify imaging interpretation.  
 
10. Personnel: 
1. Research coordinator  
2. Safety committee (principal investigator/collaborators, radiologist not involved in 
study, research coordinator). 
3. Adjudication committee (principal investigator and collaborators). 
 
11. Funding: 
This study is currently a self-funded prospective randomized trial.  There is no 
formal or in-kind industry support.  Patients will not be remunerated for their 
participation in the study. 
 
12. References: 
 
1. 
BaIRMD, D.D., et al., High cumulative incidence of uterine leiomyoma in black 
and white women: ultrasound evidence. Am J Obstet Gynecol, 2003. 188(1): p. 
100-7. 
2. 
Parker, W.H., Y.S. Fu, and J.S. Berek, Uterine sarcoma in patients operated on 
for presumed leiomyoma and rapidly growing leiomyoma. Obstet Gynecol, 1994. 
83(3): p. 414-8. 
3. 
Ravina, J.H., et al., Arterial embolisation to treat uterine myomata. Lancet, 1995. 
346(8976): p. 671-2. 
4. 
Walker, W.J. and J.P. Pelage, Uterine artery embolisation for symptomatic 
fibroids: clinical results in 400 women with imaging follow up. BJOG, 2002. 
109(11): p. 1262-72. 
5. 
Worthington-Kirsch, R.L. and N.E. Koller, Time course of pain after uterine 
artery embolization for fibroid disease. Medscape Womens Health, 2002. 7(2): p. 
4. 
6. 
Rasuli, P., et al., Superior hypogastric nerve block for pain control in outpatient 
uterine artery embolization. J Vasc Interv Radiol, 2004. 15(12): p. 1423-9. 
7. 
Akerman, B., I.B. Hellberg, and C. Trossvik, Primary evaluation of the local 
anaesthetic properties of the amino amide agent ropivacaine (LEA 103). Acta 
Anaesthesiol Scand, 1988. 32(7): p. 571-8. 
8. 
Faul, F., et al., G*Power 3: a flexible statistical power analysis program for the 
social, behavioral, and biomedical sciences. Behav Res Methods, 2007. 39(2): p. 
175-91. 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 22 of 35 
Appendix I 
Screening information and selection of cases 
Last name: ----------------------------------------- First name: -------------------------------- 
Date: ------------------------------------------------------------------------------------------------ 
Date of Birth: ------------------------------------------------------- (YY/ MM / DD)   
Email address:   _________________________________@_______________._______ 
RVH/MGH # ------------------------------------                       
 
Assigned ID code: __ __ __-__ __ __-__ __ __ (MGH/RVH – Initials – # on envelope) 
 
(Fill ID code out later at time of SHGNB) 
 
 
 
INCLUSION CRITERIA 
 
YES 
No 
Referral for UAE 
 
Exclude 
Ability to comply with the requirements of the study procedures.  
 
Exclude 
Subject expected to be able to give consent at time of UAE? 
 
Exclude 
 
EXCLUSION CRITERIA 
 
Patient with abnormal anatomy on MRI in which the aortic/IVC 
bifurcations are not normally seated and cannot be used to assess the 
position of the SHGN plexus? 
Exclude 
 
Allergy to local anesthetic agent? 
Exclude 
 
Skin abnormality in the periumbilical region that preclude placement 
of a needle through this area? 
Exclude 
 
Untreated infection at time of UAE? 
Exclude 
 
History of IBD or Colitis? 
Exclude 
 
Abnormal anticoagulation status? 
Exclude 
 
Pre-existing conditions, which, in the opinion of the investigator, 
interfere with the conduct of the study? 
Exclude 
 
Uncooperative patient or cannot follow instructions, or who is unlikely 
to return to get the filter removal due to poor compliance to follow-up 
medical appointments? 
Exclude 
 
Mental state that can preclude completion of the study? 
Exclude 
 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 23 of 35 
Pre UAE MRI review: 
 
# of fibroids    (1/2/3/>3):    ________________ 
 
Size of three largest fibroid – (save image on PACS with fibroids labeled) 
 
 
 1)      ______x______x______  (cm)     % necrosis:   ________ 
 
 
2)      ______x______x______  (cm)     % necrosis:   ________ 
 
 
3)      ______x______x______  (cm)     % necrosis:   ________ 
 
% necrosis overall:   ___________ 
 
Adenomyosis:           No                   Yes:        Focal                Diffuse 
 
Ovarian anastamosis:            No 
 
 
Ovarian anastamosis:            No 
 
 
  
 
Left 
 
 
  
 
Right 
 
 
 
 
Primary symptom from fibroids: 
 
 
 
Menorrhagia       
 
Bloating 
 
Increased urinary frequency 
 
Constipation  
 
Dyspaneuria  
 
Other:______________________________ 
 
 
Attach Patient’s UFS-QOL questionnaire 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 24 of 35 
 
 
 
Appendix II   - At time of UAE 
Identification code: __ __ __-__ __ __-__ __ __    
Date of UAE: ________________________ (YY/ MM / DD)   
RVH/MGH # ______________________       Age: ____________________________ 
Do not open envelope until ready to do block (i.e. when switch doctors) 
Consent signed:                  Yes                              No (do not proceed) 
 
UAE PROCEDURAL DETAILS  (to be filled by UAE IR without knowledge of 
Randomization group): 
 
Pain scale at start of procedure  (0-10):     ___________  (time:  __:___) 
 
Embolization material and size used:   ________________________ 
 
Arteries embolized: 
 
 
Rt UA          # vial of PVA:______________ 
 
 
Lt UA  
# vial of PVA:______________ 
 
 
Rt OA  
# vial of PVA:______________ 
 
 
Lt OA  
# vial of PVA:______________ 
 
     Other:__________________                  # vial of PVA:______________ 
 
Total fluoroscopy time of entire procedure:   _____________ 
 
Ovarian artery anastamosis seen? 
 
 
No 
 
 
Left 
 
 
Right 
Complications during UAE:  
 
Pain (scale 1-10:    ________) 
 
Arterial spasm  - artery:  ________________ 
 
Extravasation  - artery: _______________ 
 
Groin hematoma 
    Other:  _______________________________________________________________ 
 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 25 of 35 
 
Status of UAE:        Successful completion of embo            
 
 
 
       
Suboptimal embo    
 
 
 
 
       
which arteries suboptimal:  __________________ 
 
 
 
       
Unable to complete Embo  
 
Pain scale at time of completion of procedure  (0-10):    _________ (time:  __:___) 
Medications used during procedure  (Dose and time): 
 
Antibiotics (Name/Dose/Time):    ________________/___________/____:____ 
 
Fentanyl (Dose/Time):   ______   ug            ______:______     
 
 
 
 
     ______   ug            ______:______    
 
 
 
 
     ______   ug            ______:______     
 
 
 
 
     ______   ug            ______:______     
 
 
 
 
     ______   ug            ______:______     
Midazolam (Dose/Time):     _________mg            ______:______    
 
 
 
 
_________mg            ______:______      
 
 
 
 
 _________mg            ______:______      
 
 
 
 
 _________mg            ______:______      
 
 
 
 
 _________mg            ______:______      
 
Other  (Name/Dose/Time):  ________________/___________/____:____ 
 
 
 
 
 
________________/___________/____:____ 
 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 26 of 35 
THIS PAGE SHOULD NOT BE SEEN BY IR/TECHS 
DOING UAE.  Do not tell patient if SHGNB or not!! 
Identification code: __ __ __-__ __ __-__ __ __    
Date of UAE: ________________________ (YY/ MM / DD)   
RVH/MGH # ______________________       Age: ____________________________ 
 
OPEN ENVELOPPE NOW! 
SHGNB PROCEDURAL DETAILS: 
     
 
 
Randomization:                        SHGNB                     or                 SHAM  
 
 
Local anesthetic agent used:  
 
 
 
 
 
 
 
0.25% bupivacaine  
 
 
 
 
 
 
 
0.25% bupivacaine with epi 
 
 
 
 
 
 
 
0.5% bupivacaine 
 
 
 
 
 
 
 
0.5% bupivacaine with epi 
 
 
 
 
 
 
 
0.75%  ropivacaine 
 
 
 
 
 
 
 
0.75% ropivacaine with epi 
 
 
 
 
 
 
 
2% Xylocaine with epi 
 
 
 
 
 
 
 
2% Xylocaine 
 
 
 
 
 
Location of needle tip for injections:    
Upper ½ of L4  
 
 
 
 
 
 
 
 
Bottom ½ of L4  
 
 
 
 
 
 
 
 
Top ½ of L5 
 
 
 
 
 
 
 
 
Bottom ½ of L5 
 
 
 
 
 
 
 
 
Top ½ of S1 
 
 
 
 
 
 
 
 
Bottom ½ of S1 
 
 
 
 
 
 
 
Other:_________________ 
 
 
How many attempts to get to correct position:______________ 
 
 
Fluoro time at beginning of SHGNB:  ________________ 
 
 
Fluoro time at end of SHGNB:  _________________ 
 
 
Total time dedicated to SHGNB  (not fluoro related):___________min 
 
 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 27 of 35 
 
 
How many sites of injections:        1             or                 2     or           >2 
 
 
 
Immediate complications from SHGNB/SHAM procedure: 
 
 
 
 
Pain  -     where:   __________________________ 
 
 
 
 
Bleeding 
 
 
 
 
Rigors/Fever 
 
 
 
    Other:  ____________________________________________ 
IR UAE:  _____________   IR SHGNB:_____________  
Technologist:_____________ 
 
 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 28 of 35 
Appendix III   -    At discharge from recovery room 
Identification code: _____________________   
Date of UAE: ________________________ (YY/ MM / DD)   
RVH/MGH # ______________________       Age: ____________________________ 
 
Pain scale at time of arrival to recovery (0-10):    _________ (time:  __:___) 
IV Medications used during recovery  (Dose/ time/pain scale at time of giving it): 
 
Fentanyl (Dose/Time):   ______   ug            ______:______    ___/10 
 
 
 
 
     ______   ug            ______:______   ___/10 
 
 
 
 
     ______   ug            ______:______    ___/10 
 
 
 
 
     ______   ug            ______:______    ___/10 
 
 
 
 
     ______   ug            ______:______    ___/10 
Midazolam (Dose/Time):     _________mg            ______:______    ___/10  
 
 
 
 
_________mg            ______:______     ___/10 
 
 
 
 
_________mg            ______:______     ___/10 
 
 
 
 
_________mg            ______:______     ___/10 
 
 
 
 
_________mg            ______:______     ___/10 
 
Other  (Name/Dose/Time):  ________________     _______     ___:___  ___/10 
 
 
 
 
 
________________     _______     ___:___  ___/10 
 
 
 
 
 
________________     _______     ___:___  ___/10 
Oral Medications used during recovery (Dose/time/pain scale at time of giving it): 
 
Empracet:     _____________/_____:_____/ _____/10 
 
Tramacet:     _____________/_____:_____/ _____/10 
 
Oxycodone:     _____________/_____:_____/ _____/10 
 
Hydromorphone:     _____________/_____:_____/ _____/10 
 
Naprosyn:     _____________/_____:_____/ _____/10 
 
Other: :     _____________/_____:_____/ _____/10 
                               _____________/_____:_____/ _____/10 
 
Pain scale at departure from recovery (0-10):    _________ (time:  __:___) 
Admission to hospital 
 
No 
 
 
 
Yes  -  Why:_____________________ 
Complications while in recovery:    _________________________________________ 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 29 of 35 
Patient D/C with antibiotics         No          
 
 
 
 
        Yes (Name/Dosage/Frequency x # Days) 
 
 
 
 
 
________________/______/______x_____d 
Patient D/C meds: (Name/Dosage/Frequency x # Days) 
 
Empracet /______/______x_____d 
 
Tramacet /______/______x_____d 
 
Oxycodone /______/______x_____d 
 
Hydromorphone /______/______x_____d 
 
Naprosyn /______/______x_____d 
 
Other:       ______________________ /______/______x_____d 
 
 
      ______________________ /______/______x_____d 
 
 
      ______________________ /______/______x_____d 
 
 
Inform patient how to fill out pain scales at home and how to do it by internet.  Give 
out the sheets but encourage using internet if possible and patient at ease with this. 
If willing to use internet: 
 
Get patient email address:    _______________________@_______________._______ 
 
Patient anonymous login name:   _______________ 
(first letter of hospital/tree numbers in assigned ID code (Ex if first patient enrolled 
and at the RVH – anonymous ID # is   R001)) 
  
Give out their login name for the anonymous internet access and write down on 
hard copy pain scale sheets that go with patient.  Give out hard copy sheets even if 
patient wants to use internet. 
Send email immediately to patient to link to internet forms. 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 30 of 35 
Appendix IV   -    Sheets to be filled out by patient 
 
We encourage you to fill out these sheets via the internet if possible 
using the following anonymous login name and password to sign in.  
Otherwise you can use these hard copies and mail them back to us 
in the prestamped envelope or bring them back to your follow-up 
visit in 4-6 months. 
 
You will receive an email giving you a link to the internet forms 
Your anonymous login name for the internet is:     ___________ 
Your Password is:    ____________ 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 31 of 35 
Example of pain scale sheet the person has to fill (hard copy but same 
questions via internet): 
This page should be filled out the fourth day after the procedure 
prior to going to bed at night. 
 
1) Rate the level of pain you experienced since the last data entry 
 
 
 
 
 
 
 
 
 
 
 
       0                                                            5                                                           10   
(no pain)                                                                                                      (worst pain ever) 
 
2) Medications used today since since the last data entry:  
 
a) Colace                 
cNo   
cYes  
b) Naprosyn      
cNo   
cYes  
c)  Empracet   
cNo   
cYes  - how many tablets?  _____________ 
d)  Tramacet  
cNo  
cYes  - how many tablets?  _____________ 
 
3) Since the last data entry, have you taken any other medications because of 
this procedure (e.g. non prescribed pain killers)?  
 
cNo  
 
cYes - please write them in the space below  
 
 
 
    Medication name and dose ______________________________________  
 
4)  Last night, did you wake up during the night because of pain? 
 
cNo   
 
cYes – how many times  __________ 
 
5) How many bowel movements did you have in the last 24 hours?   _____________ 
 
6) Did you have any vaginal bleeding/discharge in the last 24 hours? 
 
No 
 
 
Yes   - What color:   Bloody   
 
 
 
 
 
 
Green 
 
 
 
 
 
 
Beige 
 
 
 
 
 
 
Other:   _____________________ 
7) Comments ?  
 
Do you have any comments that you would like to tell us about? 
_____________________________________________________________ 
_____________________________________________________________  
 
8)  Date and time of filling this page 
 
Date :      _______/__________/________  (day/month/year)  
 
Time:  ________________ 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 32 of 35 
 
 
 
 
Appendix V  -    At follow-up consult 
 
Post UAE MRI review: 
 
# of fibroids    (1/2/3/>3):    ________________ 
 
Size of three largest fibroid labeled on pre UAE consult 
 
 
 1)      ______x______x______  (cm)     % necrosis:   ________ 
 
 
2)      ______x______x______  (cm)     % necrosis:   ________ 
 
 
3)      ______x______x______  (cm)     % necrosis:   ________ 
 
% necrosis overall:   ___________ 
 
Adenomyosis           No                    Yes:        Focal                Diffuse 
 
 
  
 
    
 % necrosis of adenomyosis:    ________ 
 
Ovarian anastamosis:            No 
 
 
  
 
Left 
 
 
  
 
Right 
 
 
Complications since the UAE: 
 
 
Persistent Pain   -   Where:____________________________ 
 
Arrested periods    - Since when:__________________________ 
 
Vaginal bleeding outside of periods    
 
Symptoms of peri-menopause (hot flushes, nights sweats, etc)  
 
 
 
 
Since when:  ________________________ 
 
Endometritis -  treated when:  __________________________ 
 
Other infection – where:_______________   treated when:______________ 
 
Need for surgery   -     
When:__________________________ 
 
 
 
 
 
Why:___________________________ 
 
Continued symptoms as they were before the UAE (no clinical improvement) 
 
Other:_________________________________________________________ 
 
 
 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 33 of 35 
 
Clinical outcome of UAE: 
 
 
Complete resolution of symptoms 
 
 
>80% improvement in symptoms 
 
 
50-80% improvement in symptoms 
 
 
20-50% improvement in symptoms 
 
 
<20% improvement in symptoms 
 
Is patient happy with the outcome (scale 0-10):   __________ 
 
Attach Patient’s UFS-QOL questionnaire 

Clinical study proposal                                                                             Dec 2nd, 2014, v3 
 
_________________________________________________________Page 34 of 35 
Appendix VI  -    UFS-QoL questionnaire 
 
See:  Spies et al.  2002.  The UFS-QOL, a new disease-specific symptom and 
health-related quality of life questionnaire for leiomyomata.  Obstet Gynecol.  
99(2):290-300.