Clinical trial NCT02660918
Conditions: Postoperative Pain
Sponsor: Christiana Care Health Services
Start date: 2016-04-01; Completion date: 2017-03-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine whether paracervical injection of long acting local anesthesia decreases postoperative pain following endometrial ablation under general anesthesia.

Detailed description:
Destruction of the endometrial lining to control bothersome uterine bleeding has been implemented since 1937. Currently there are various different 'second generation' energy sources to avert such bleeding, five of which are now approved in the United States. These 5 second generation devices include: Thermachoice/Cavaterm, which use high temperature fluid within a balloon; Microsulis, which applies microwaves; Novasure, which uses bipolar energy; Hydrothermablator, which uses free fluid at high temperatures; ELITT, which uses laser thermotherapy; and HerOption, which uses cryoablation. Patient selection for endometrial ablation is crucial, as it is intended for premenopausal women with normal uterine cavities and no desire for future fertility that are affected by heavy menstrual bleeding. Since the introduction of the initial 'second generation' device in 1997 these modalities have overtaken the industry mostly due to their ease of use and shorter operative times. Regardless, a Cochrane review finds insufficient evidence to prove superiority of these newer modalities over the traditional 'gold standard' resectoscopic technique.

Endometrial ablation has been demonstrated in a variety of settings including outpatient surgical centers as well as physician's offices. Evidence suggests that microwave endometrial ablation under local anesthesia is a safe and acceptable practice. Very often, when endometrial ablation is performed as an outpatient procedure, patients are pre-medicated and then receive a paracervical injection of local anesthesia to control pain intraoperatively. When endometrial ablations are performed as an outpatient procedure through a surgical center, a variety of anesthesia techniques are employed depending on the infrastructure and human and institutional resources available. These techniques may vary from conscious sedation to general anesthesia, all of which have been proven to be acceptable methods.

In this center endometrial ablations are performed as an outpatient procedure under general anesthesia with a variety of induction techniques and intraoperative pain management practices. According to physician preference, patients may receive an additional paracervical injection of local anesthetic before the procedure, immediately after, or not at all. To date, there are no studies evaluating the efficacy of local anesthetic in addition to general anesthesia for patients receiving endometrial ablation to guide physician practice. The purpose of this study is to evaluate the efficacy of local anesthetic, in addition to general anesthesia, in our large, community-based patient population, in meaningfully decreasing postoperative pain.

Arms: arm 1: Women undergoing endometrial ablation that meet the eligibility criterial will receive a standardized paracervical injection of Bupivacaine 20 mL 0.25% at the completion of the procedure. arm 2: Women undergoing endometrial ablation that meet the eligibility criterial will receive an equal volume standardized paracervical injection of Normal Saline at the completion of the procedure.
Interventions: intervention 1: Bupivacaine intervention 2: Normal Saline
Intervention descriptions: intervention 1: Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure intervention 2: Equal volume injection of normal saline with the same paracervical technique

Protocol documents:
Prot_SAP_000.pdf: 
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Page 1 of 7 
Title: Decreasing Postoperative Pain Following Endometrial Ablation:  A Randomized 
1 
Controlled Trial 
2 
 
3 
Principal Investigator: Jordan Klebanoff, MD 
4 
 
5 
Sub-Investigator: Nima Patel, MD 
6 
 
7 
Epidemiologist/Analyst: Nancy Sloan, DrPH 
8 
 
9 
Purpose: To determine whether paracervical injection of long acting local anesthesia 
10 
decreases postoperative pain following endometrial ablation under general anesthesia. 
11 
 
12 
Background:   
13 
Destruction of the endometrial lining to control bothersome uterine bleeding 
14 
has been implemented since 1937 (ACOG Committee on Practice Bulletins, 2007).  
15 
Currently there are various different ‘second generation’ energy sources to avert such 
16 
bleeding, five of which are now approved in the United States (ACOG Committee on 
17 
Practice Bulletins, 2007).  These 5 second generation devices include:  
18 
Thermachoice/Cavaterm, which use high temperature fluid within a balloon; Microsulis, 
19 
which applies microwaves; Novasure, which uses bipolar energy; Hydrothermablator, 
20 
which uses free fluid at high temperatures; ELITT, which uses laser thermotherapy; and 
21 
HerOption, which uses cryoablation.   Patient selection for endometrial ablation is 
22 
crucial, as it is intended for premenopausal women with normal uterine cavities and no 
23 
desire for future fertility that are affected by heavy menstrual bleeding.  Since the 
24 
introduction of the initial ‘second generation’ device in 1997 these modalities have 
25 
overtaken the industry mostly due to their ease of use and shorter operative times.  
26 
Regardless, a Cochrane review finds insufficient evidence to prove superiority of these 
27 
newer modalities over the traditional ‘gold standard’ resectoscopic technique (Anne 
28 
Lethaby, 2013). 
29 
 
30 
Endometrial ablation has been demonstrated in a variety of settings including 
31 
outpatient surgical centers as well as physician’s offices.  Evidence suggests that 
32 
microwave endometrial ablation under local anesthesia is a safe and acceptable practice 
33 
(Wallage S, 2003).  Very often, when endometrial ablation is performed as an outpatient 
34 
procedure, patients are pre-medicated and then receive a paracervical injection of local 
35 
anesthesia to control pain intraoperatively (Mark H. Glasser, 2009).  When endometrial 
36 
ablations are performed as an outpatient procedure through a surgical center, a variety 
37 
of anesthesia techniques are employed depending on the infrastructure and human and 
38 
institutional resources available.  These techniques may vary from conscious sedation to 
39 
general anesthesia, all of which have been proven to be acceptable methods. 
40 
 
41 
In this center endometrial ablations are performed as an outpatient procedure 
42 
under general anesthesia with a variety of induction techniques and intraoperative pain 
43 
management practices.  According to physician preference, patients may receive an 
44 


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Page 2 of 7 
additional paracervical injection of local anesthetic before the procedure, immediately 
45 
after, or not at all.  To date, there are no studies evaluating the efficacy of local 
46 
anesthetic in addition to general anesthesia for patients receiving endometrial ablation 
47 
to guide physician practice. The purpose of this study is to evaluate the efficacy of local 
48 
anesthetic, in addition to general anesthesia, in our large, community-based patient 
49 
population, in meaningfully decreasing postoperative pain. 
50 
 
51 
 
52 
Methods:  
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This study will be a single center prospective single blind randomized controlled 
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trial of premenopausal women undergoing endometrial ablation.   This study will take 
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place in the Christiana Hospital outpatient surgical center.  Patients will include English 
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speaking premenopausal women aged 30 – 55 scheduled to undergo outpatient 
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endometrial ablation in the surgical center.  These patients will be recruited either in 
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physician’s offices, by telephone based on surgical scheduling, or on the day of their 
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procedure.  All consents will be signed in person.   
60 
 
61 
   Study Design: 
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Frequently, providers will give their patients additional analgesia in the form of a 
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local anesthetic injected as a paracervical block, either before or after the completion of 
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the procedure with the hope of reducing postoperative pain.  This practice is not 
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standardized, as its efficacy has never been evaluated in the setting of endometrial 
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ablation under general anesthesia.   
67 
 
68 
The purpose of this study is to assess the efficacy of this additional local 
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anesthesia upon completion of endometrial ablation under general anesthesia.  
70 
Patients, once consented, will be randomized in blocks of 6 to either the treatment 
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group or control groups.  Those randomized to the treatment group will receive a 
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paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure 
73 
(Howard W. Jones III, 2008).  Patients randomized to the control group will receive an 
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equal volume injection of normal saline with the same paracervical technique.  
75 
Paracervical injection will be standardized to include a total dose of 20 mL divided into 
76 
four 5 mL injections at the 2, 4, 8, and 10 o’clock positions on the cervix (Howard W. 
77 
Jones III, 2008).  Paracervical block will be given at the completion of the endometrial 
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ablation. 
79 
 
80 
Only the patients and PACU staff will be blinded to the injected solution.  Once 
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general anesthesia has been induced the circulating nurse will open the study patient’s 
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unique randomization sequence and the appropriate study solution will be drawn in the 
83 
operating room.  The endometrial ablation procedure will be performed by the surgeon 
84 
in accordance with that surgeon’s specific preference for technique and device.  Upon 
85 
completion of the procedure, and before general anesthesia is reversed, the 
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paracervical injection of the patient’s unique study solution will be administered as 
87 
described above.  The operating room team including the surgeon, anesthesiologist, and 
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ancillary staff will be aware of the injected solution’s contents.  The post anesthesia care 
89 
unit (PACU) staff responsible for assessing immediate and delayed postoperative pain 
90 
will not be aware of the contents of the injected solution, except when necessary for 
91 
any unexpected complication, in which case the pharmacist maintaining the 
92 
randomization coding will break the code for that particular patient.  All patients will 
93 
receive IV Toradol with completion of the procedure and have a standardized rescue 
94 
analgesia protocol in place in the postoperative care unit setting in accordance with the 
95 
current practice described above.  Per the nursing protocols postoperative pain will be 
96 
assessed using 10 point Visual Analog Scale (VAS) and if patient’s pain is above or equal 
97 
to a 5, on the 10 point scale, they may receive additional analgesia in the form of 
98 
intravenous (IV) medication or by mouth tablets (PO).  Pain scores, as well as rescue 
99 
analgesic administered, is routinely recorded by the nursing staff and converted to a 
100 
patient’s electronic health record.   
101 
 
102 
Due to the infrastructure set up, at CCHS outpatient endometrial ablations are 
103 
performed under general anesthesia with the patients asleep for the entire procedure.  
104 
Per the standard surgical center protocol postoperative patients will be assessed 
105 
regularly for postoperative pain.  If the patients express pain equal to or beyond a 
106 
predetermined threshold of 5, on a visual analog pain scale from 0 through 10, they may 
107 
receive rescue analgesia.  Patients are taken directly from the operating room to the 
108 
PACU where their pain is assessed on arrival by trained nursing staff.  Patients are kept 
109 
in Phase 1 of recovery for a minimum of 30 minutes, and a minimum of 30 minutes in 
110 
Phase 2 before discharge following general anesthesia.  At a minimum a postoperative 
111 
patient’s pain is assessed every 10 minutes in Phase 1, and every 15 minutes in Phase 2.  
112 
Patients are candidates for rescue analgesic medications, generally in the form of 
113 
Dilaudid or Fentanyl, if their pain score is greater than 5 out of 10.  In Phase 1 pain 
114 
medication is generally given in IV form whereas in Phase 2 pain medication is usually 
115 
given PO. 
116 
 
117 
Figure 1: Visual Analog Scale 
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Upon discharge all patients will be given two additional 10 point VAS forms and 
121 
will be instructed to complete these two pain assessments at 4 hours and 8 hours after 
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their surgery.  These pain scales will be labeled before discharge with the patient's study 
123 
identification code, date, the times they are to be completed, and instructions to retain 
124 
the forms until they have spoken with the study staff on the following day.  Each patient 
125 
will be discharged with an additional prescription for twelve tablets of Tylenol #3.  Each 
126 
patient will then be contacted on the day following their surgery by a study investigator 
127 
to record the patient’s home pain scores as recalled by the patient by use of the two 
128 
pain scales completed at 4 hours and 8 hours postop.  Each patient will also be asked to 
129 
disclose how many of the twelve Tylenol #3 tablets they have remaining.   
130 
 
131 
Primary Outcome:  
132 
We propose to test a 40% decrease in the mean 10 point VAS postoperative pain score 
133 
at 1 hour after the operation.  This percent decrease is based on a separate IRB 
134 
approved retrospective chart review of the most recent patients who underwent an 
135 
endometrial ablation at the Christiana Hospital surgical center. This retrospective chart 
136 
review found that of the last twenty patients who underwent an endometrial ablation, 
137 
without any additional local anesthesia in the form of a paracervical block, the mean 
138 
postoperative pain score at 1 hour was 2.85± 2.21.  The 40% hypothesized reduction in 
139 
pain is equivalent to approximately 1 full point on the VAS scale and felt to be a clinically 
140 
meaningful decrease at the lower end of the VAS scale that could influence policy and 
141 
practice. The average standard deviation between the mean 1 hour postoperative pain 
142 
scores between the reviewed charts of the 20 patients receiving a paracervical block 
143 
and the 20 that do not was 1.78, approximately equal to 75% of the average mean pain 
144 
scores for the 40 patients who did and did not receive a paracervical block.  Using a two 
145 
tailed test, a Type I error of 5% and statistical power of 80%, and an average standard 
146 
deviation equal to 75% of the average VAS scores in both groups, the study requires a 
147 
sample of 36 patients per study group.  Assuming a 15% attrition rate this study requires 
148 
42 patients per study arm (84 total participants).  Enrollment in this study will occur for 
149 
10 months, or until the number of participants needed per study group is met, 
150 
whichever occurs first.    This allows at least 2 months for data analysis and report 
151 
composition.  Enrollment will be monitored by the Principal Investigator (Klebanoff) 
152 
monthly, to gauge when enrollment should stop.  To ensure ongoing enrollment of 
153 
similar numbers of participants in each study group, randomization in blocks of 2 will be 
154 
used, so that for each 2 patients enrolled, 1 will be assigned to each study group. 
155 
 
156 
Secondary outcomes: The study will also conduct descriptive analyses of the study 
157 
group differences in postoperative pain scores at 4 and 8 hours following surgery, 
158 
amount of rescue analgesia required postoperatively, but before discharge, time to 
159 
discharge, postoperative nausea/vomiting requiring medication, blood loss, and amount 
160 
of narcotic remaining at postoperative day one.  
161 
 
162 
Data Points: 
163 
Covariates 
164 
- age 
165 
- race/ethnicity 
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- Insurance type 
167 
Mediating variables 
168 
- BMI (height/weight) 
169 
- Indication for surgery 
170 
- surgeon (anonymous code) 
171 
- type of ablation 
172 
- cervical dilation 
173 
- type and number of previous surgeries 
174 
- intra-operative complication incidence 
175 
Outcomes 
176 
- 1 hour postop VAS pain score (primary outcome) 
177 
- 4 and 8 hours postop VAS pain score (secondary outcomes) 
178 
- blood loss 
179 
- time to discharge 
180 
- type and amount of postop opioid given 
181 
-postop anti-emetics given 
182 
- postop complication incidence 
183 
 
 
184 
 
185 
Inclusion criteria: English speaking premenopasual women, aged 30 – 55, undergoing 
186 
outpatient endometrial ablation at the CCHS SurgiCenter for menorrhagia, abnormal 
187 
uterine bleeding, or thickened endometrium. 
188 
 
189 
Exclusion criteria:  
190 
- 
Known malignancy   
191 
- 
Weight < 50 Kg 
192 
- 
Amide allergy     
193 
- 
History chronic pain 
194 
- 
Cardiac arrhythmia   
195 
- 
Dilaudid/codeine allergy 
196 
- 
History of opioid use    
197 
- 
Inability to take PO Opioids 
198 
- 
Uterine anomaly    
199 
- 
Previous ablation   
200 
- 
Concomitant laparoscopic surgery 
201 
- 
Primary language other than English 
202 
 
203 
Data analysis: Continuous variables will be assessed using Student's t-tests and 
204 
categorical variables will be assessed using the chi-square tests with Fisher's exact 
205 
significance levels should there be fewer than 5 observations in any cell.  Non-
206 
parametric tests may be used to compare median values of continuous variables. Linear 
207 
and logistic regressions will be conducted on continuous and categorical outcomes, to 
208 
adjust for any unexpected differences in covariates and to describe mediation of effect. 
209 
All data will be maintained on a CCHS server accessible only to those members of the 
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research team.  All information will be coded based on the patients unique study 
211 
number. 
212 
 
213 
Works Cited 
214 
ACOG Committee on Practice Bulletins. (2007, May). www.acog.org. Retrieved 09 21, 
215 
2015, from http://www.acog.org/Resources-And-Publications/Practice-
216 
Bulletins/Committee-on-Practice-Bulletins-Gynecology/Endometrial-Ablation 
217 
Anne Lethaby, J. P. (2013). Endometrial resection and ablation techniques for heavy 
218 
menstrual bleeding . Retrieved September 2015, from The Cochrane Library: 
219 
http://www.thecochranelibrary.com 
220 
Cohen, J. (1977). Statistical power analysis for the behavioral sciences. New York: 
221 
Academic press. 
222 
Howard W. Jones III, J. A. (2008). Te Linde's Opertive Gynecology Eleventh Edition (Vol. 
223 
11). Philadelphia, PA: Wolters Kluwer. 
224 
Mark H. Glasser, M. P.-Y. (2009, June). Office Endometrial Ablation with Local 
225 
Anesthesia Using the HydroThermAblator System: Comparison of Outcomes in 
226 
Patients with Submucous Myomas with Those with Normal Cavities in 246 Cases 
227 
Performed Over 51⁄2 Years . The Journal of Minimally Invasive Gynecology, 700-
228 
707. 
229 
Wallage S, C. K. (2003, September). A Randomised Trial Comparing Local Versus General 
230 
Anaesthesia for Microwave Endometrial Ablation. The British Journal of 
231 
Obstetrics and Gynaecology, 799-807. 
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Sample Postoperative Home Pain Scores 
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Patient Sticker 
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Study identification code # 
257 
 
258 
 
259 
Your surgery was completed at: Time and Date 
260 
 
261 
 
262 
Please rate your pain at:  Time and Date 
263 
 
264 
 
265 
 
266 
 
267 
 
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Please rate your pain at:  Time and Date 
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Please retain this form until you have spoken with a member for the study team on the 
274 
day following your surgery. 
275 

ICF_001.pdf: 
 
Page 1 of 6 
Patient Initials _______ 
 
 
Date _______ 
 
 
INFORMED CONSENT 
 
TITLE OF STUDY: 
Decreasing Postoperative Pain Following Endometrial Ablation: A 
Randomized Controlled Trial 
 
PRINCIPAL INVESTIGATOR:  Jordan Klebanoff, MD 
 
CONTACT PHONE NUMBER:  Study Pager (302) 573-7413 
 
PI OFFICE ADDRESS:  
Christiana Care Hospital 
 
 
 
 
Department of OB/GYN Research, Suite 1906 
 
 
 
 
4755 Ogletown-Stanton Road 
 
 
 
 
Newark, DE 19718  
 
INTRODUCTION  
You have been asked to take part in a clinical research study. For you to be able to decide to be part of 
this study or not, you should understand enough about its risks and benefits to make an informed 
decision. This process is known as informed consent. This consent form describes the purpose, 
procedures, possible benefits and risks of the study.  
 
Your study doctor will discuss the clinical research study with you. Clinical research studies include 
only people who choose to take part. Please take your time to make your decision. Discuss it with your 
family and friends and health care team. Please read this document carefully and if you have any 
questions, you can ask your study doctor for further explanation.  
 
You are being asked to take part in this study because you are undergoing a medical procedure to 
destroy the lining of the uterus because of bothersome bleeding, called an endometrial ablation. 
 
The person responsible for this study at Christiana Care is Jordan Klebanoff, MD. 
 
WHY IS THIS STUDY BEING DONE? 
The purpose of this study is to assess whether or not women undergoing endometrial ablation may 
benefit from additional anesthesia at the completion of their procedure.  The goal of the study is to 
reduce post-operative pain by using additional pain medication.  This information is important to know 
because currently this additional anesthesia is sometimes given, exposing patients to potential risks 
without any proven benefit. 
 
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY? 
We expect to enroll 84 people in this trial. 
 
CHRISTIANA CARE HEALTH SYSTEM 
INSTITUTIONAL REVIEW BOARD 
CCC#          35179 
IRB APPROVAL 
12-05-2016        
        THROUGH 
12-04-2017 


 
Page 2 of 6 
Patient Initials _______ 
 
 
Date _______ 
WHAT IS INVOLVED IN THE STUDY? 
If you qualify and agree to be in the study you will be asked to sign this consent form.  On the day of your 
scheduled procedure you will be “randomized” into one of two study groups. Randomization means you 
are put into a group by chance. It is like flipping a coin. Which group you are put in is done by a 
computer. Neither you nor the researcher will choose what group you will be in. You will have an 
equal chance of being placed in either group: 
 
 Group 1 will receive an injection of local anesthesia around the cervix after the 
procedure is finished 
 Group 2 will receive an injection of normal saline solution around the cervix after the 
procedure is finished 
 
You and your study doctor will not know which group you will be in. This is done to ensure the accuracy of 
the study results. Your pain will be measured according to the standard CCHS outpatient procedures.  If you 
need additional pain medications, they will be provided to you.   
 
Before leaving the surgical center you will be given two pieces of paper with a pain scale from 1-10 to rate 
your pain.  We ask that you fill out these pain scales at home two times, the first 4 hours after your surgery 
and the second 8 hours after your surgery.  The day following your surgery a study investigator will call you 
to obtain the scores you have recorded on the two pain scales.  You will also be asked to state the number of 
pain tablets that you have remaining at this time. 
 
Your involvement after discharge will include answering an additional phone call to fill out the two 
pain scales and to state the number of pain tablets you have. 
 
HOW LONG WILL I BE IN THE STUDY?  
You will be in the study from the time you sign this consent form until 1 day after the procedure. 
 
CAN I STOP BEING IN THE STUDY? 
You can stop being in the study at any time.  The researcher also maintains the right to remove you 
from participation in the study at any time to protect your health and safety.  Please tell the study 
doctor if you are thinking about stopping or if you decide to stop. If you decide to withdraw from the 
study, we will also ask you to complete an “Acknowledgement of Withdrawal Form”. 
 
WHAT ARE THE RISKS OF THE STUDY? 
While on the study, you are at risk for some side effects. You should discuss these with the researcher 
and/or your regular doctor. There also may be other side effects that we cannot predict. Side effects 
may be mild or very serious. Other drugs or treatments may be given to make side effects less serious 
and uncomfortable. Many side effects go away shortly after the intervention/drugs are stopped, but in 
some cases side effects can be serious or long-lasting or permanent. If side effects become severe, 
hospitalization may be necessary for treatment.  
 
We do not anticipate any foreseeable risk to you as a participant of this study other than what your 
doctor discussed with you regarding risks when you signed your informed consent for this procedure.  
There are inherent risks of any surgical procedure some of which are unpredictable.  There are risks 
associated with both general anesthesia as well as local anesthesia.   


 
Page 3 of 6 
Patient Initials _______ 
 
 
Date _______ 
Some of the rare side effects of the local anesthetic that will be used in this study include: irregular 
heartbeats, cardiac arrest, liver damage, and death.  Generally, these rare side effects are only 
encountered with injection of the anesthesia into a blood vessel which is not the intent for this study.   
 
There is a risk of loss of confidentiality. We minimize this by assigning you a study ID number that is 
placed on all of the study forms so that your information is not readily available. 
 
In the unlikely event that you experience any type of symptoms, side effects, or injuries due to your 
participation in the study, please let Dr. Klebanoff or the research staff know as soon as possible at 
302-573-7413. 
 
ARE THERE BENEFITS TO TAKING PART IN THE STUDY? 
If you agree to take part in this study, it is possible that you may not benefit. The study doctors hope 
the information learned from this study will benefit other patients undergoing endometrial ablation in 
the future.  
 
WHAT OTHER CHOICES ARE THERE IF I DO NOT TAKE PART IN THIS STUDY? 
You do not have to take part in this research study in order to receive treatment. Your participation is 
voluntary. You may refuse to take part, or stop participating at any time without penalty, or 
jeopardizing your continued medical care at Christiana Care, or lose benefits you would otherwise be 
entitled to.  
 
WHAT ABOUT CONFIDENTIALITY? 
We need to collect information about you to conduct this study. Your personal health information is 
health information about you that could be used to identify you. This information may include 
demographics (such as your age, sex, height, weight), information about your health now and in the 
past, any surgeries that you may have had, and other facts about you collected for the purposes of this 
research study. The information that will be collected will be the minimum needed to meet the goals of 
this research study and will be used only for the study described in this consent. If you decide not to 
allow this use of your information, you may not take part or continue to take part in the research study, 
since the researcher needs this information to meet the study goals.  
 
We try to keep your personal health information private and confidential. However, we cannot 
guarantee absolute confidentiality. Your personal information may be disclosed if required by law and 
it may be disclosed to others as described in this section. Individuals and organizations that may look 
at and/or copy your research records to conduct this research, assure quality of the data and analyze the 
data include:  
 
 Members of the research team at Christiana Care;  
 Medical staff who are directly or indirectly involved in your care related to this research;  
 People who oversee or evaluate research and care activities at Christiana Care, including the 
Christiana Care Institutional Review Board, a committee that reviews research projects to help 
ensure that the rights of research participants are protected; and  
 People from agencies and organizations that perform independent accreditation and oversight 
of research, such as the Department of Health and Human Services, Office for Human Research 
Protections.  
 


 
Page 4 of 6 
Patient Initials _______ 
 
 
Date _______ 
By signing this document, you are authorizing Christiana Care to use and release your health 
information for this research. Some of these groups listed above may not be required to protect your 
information. If permitted by law, they may be allowed to share it with others without your permission.  
 
It is also possible that important information will be shared with your primary caregiver or other health 
care professionals as needed for your safety. If information from this study is presented or published at 
scientific meetings or journals, your name and other personal health information will not be used.  
 
You have the right to see any medical information about yourself. However, during the research study 
you will not have access to all of the health information that is created or collected during the study. 
You do not have the right to review and/or copy records kept by associated with the study.  
 
If you agree to participate in the study, you still have the right to withdraw at a later time. In addition, 
at the time you withdraw you have the right to refuse to allow future information about you to be 
collected and used for the research study. If you decide to withdraw from the study, you will be asked 
to tell a member of the research staff and sign a written notice (called an Acknowledgement of 
Withdrawal form) that you no longer allow the use of information for research purposes. If you 
withdraw from the study, your information that has already been collected may still be used and 
disclosed as described in this form for the research study but no new information about you will be 
collected.  
 
It may be necessary to contact you at a future date regarding new information about the treatment you 
have received. For this reason, we ask that you notify the institution where you received treatment on 
this study of any changes in address. If you move, please provide your new address to the principal 
investigator or study staff. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this Web site at any time. 
 
WHAT ARE THE COSTS? 
Taking part in this study may lead to added costs to you or your insurance company. You or your 
insurance company will be charged for continuing medical care and/or hospitalization. Please ask 
about any expected added costs or insurance problems.  
 
Routine medical care for your condition (care you would have received whether or not you were in this 
study) will be charged to you or your insurance company. 
 
In the case of injury or illness resulting from this study, emergency medical treatment is available but 
will be provided at the usual charge. No funds will be offered to compensate you in the event of injury. 
However, by signing this document, you are not giving up any right you have to pursue legal remedies 
for injury resulting from participation in this study.  
 
WILL I GET PAID FOR BEING IN THIS STUDY? 
You will receive no payment for taking part in this study.  
 
 
 


 
Page 5 of 6 
Patient Initials _______ 
 
 
Date _______ 
WHAT ARE MY RIGHTS AS A PARTICIPANT? 
Taking part in this study is voluntary. You may choose not to take part or may leave the study at any 
time. Leaving the study will not result in any penalty or loss of benefits to which you are entitled. If 
you decide not to take part in the study, you will continue to receive the usual medical care appropriate 
for your condition. However, if you are thinking about stopping, we encourage you to talk to the 
researcher and your regular doctor first. They will tell you how to stop safely.  
 
We will tell you about new information that may affect your health, welfare, or willingness to stay in 
this study.  
 
WHO DO I CALL IF I HAVE QUESTIONS OR PROBLEMS? 
For questions about the study or a research-related injury, contact the researcher Dr. Jordan Klebanoff 
at (302) 573-7413. 
 
For questions about your rights as a research participant, contact the Christiana Care Institutional 
Review Board at (302) 623-4983.  
 
You will be given a copy of this form. 
 
SIGNATURE 
You have read the information provided above. You voluntarily agree to take part in this study.  
 
 
 
_________________________________________   
_________________ 
Signature of Research Subject 
 
 
 
 
Date 
 
 
_________________________________________ 
Printed Name of Research Subject 
 
 
_________________________________________  
_________________ 
Signature of Person Obtaining Consent 
 
 
 
Date 
 
 
_________________________________________ 
Printed Name of Person Obtaining Consent 
 
 
 
 
 
 
 
 
 
 
CHRISTIANA CARE HEALTH SYSTEM 
INSTITUTIONAL REVIEW BOARD 
CCC#          35179 
IRB APPROVAL 
12-05-2016        
        THROUGH 
12-04-2017 


 
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Patient Initials _______ 
 
 
Date _______ 
 
 
 
Christiana Care Institutional Review Board 
 
RESEARCH PARTICIPANT BILL OF RIGHTS 
 
As a participant in a research study or as someone who is asked to give consent on behalf of another 
person for such participation, you have certain rights and responsibilities. It is important that you fully 
understand the nature and purpose of the research and that your consent be offered willingly and with 
complete understanding. To aid in your understanding, you have the following specific rights: 
 
1. 
To be informed of the nature and purpose of the research in which you are participating. 
2. 
To be given an explanation of all procedures to be followed and of any drug or device to be used. 
3. 
To be given a description of any risks or discomforts which can reasonably be expected to occur. 
4. 
To be given an explanation of any benefits which may be expected by the subject as a result of 
this research. 
5. 
To be informed of any appropriate alternative procedures, drugs, or devices that may be 
advantageous and of their relative risks and discomforts. 
6. 
To be informed of any medical treatment which will be made available to the subject if 
complications should arise from this research. 
7. 
To be given an opportunity and encouraged to ask any questions concerning the study or the 
procedures involved in this research. 
8. 
To be made aware that consent to take part in the research may be withdrawn and that 
participation may be discontinued at any time without affecting continuity or quality of your 
medical care. 
9. 
To be given a copy of the signed and dated written consent form.  
10. 
To not be subjected to any element of force, fraud, deceit, duress, coercion, or any influence in 
reaching your decision to consent or to not consent to take part in the research. 
11. 
Your signature on the Informed Consent does not waive any of your legal rights. 
 
If you have any further questions or concerns about your rights as a research participant, please contact 
the Christiana Care Institutional Review Board at (302) 623-4983.