Does Ultrasound-guided CSE Technique Improve Midline Placement of Epidural Needle Thereby Helping Junior Residents With Correct Placement of the Catheter Compared to the Placement Using With Anatomical Landmarks?
Phase: NA
Conditions: Pregnancy
Sponsor: Icahn School of Medicine at Mount Sinai

Protocol Title: Does Ultrasound-guided CSE Technique Improve Midline Placement 
of Epidural Needle Thereby Helping Junior Residents With Correct Placement of the 
Catheter Compared to the Placement Using With Anatomical Landmarks?  
PI: Dr. Barbara Orlando 
NCT02747238 
Document Date: Jan 25, 2017 

 
 
 
Protocol Name: 
Does Ultrasound-Guided CSE (Combined Spinal Epidural) 
Improve Midline Placement of Epidural Needle with Positive 
CSF Flow Through the Spinal Needle, Compared to Catheter 
Placement using Palpation of Anatomical Landmarks: A 
Comparative Study Done in Junior Residents Rotating for the 
First Time on the Labor and Delivery Floor  
Principal Investigator:  Barbara Orlando, MD. 
Primary Contact 
Name/Contact Info: 
Barbara Orlando, MD.  
Date Revised: 
January 25, 2017 
Study Number: 
IRB 15-0031 / HSM# 15-00583/IF# 1780780 
 
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Revised 7/21/14, Version 8 22 24014 
  
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Brief Summary of Research (250-400 words):  
Epidurals provide superior labor analgesia and anesthesia compared to other modalities.  Unfortunately, 
failure of the epidural is a frequent problem (up to 27% in some studies).  These include insufficient 
analgesia, catheter dislodgement and conversion to general anesthesia and may result from technical 
difficulties, insufficiency of local anesthetics, epidural septum or midline adhesions, and misplacement of 
the epidural catheter (half of the failures). The combined spinal epidural technique (CSE) technique is 
widely utilized by obstetric anesthesiologists. The epidural space is located with a larger bore needle, a 
smaller spinal needle is used to deliver local anesthetic then an epidural catheter is placed. With CSE, 
pain relief is rapid and profound due to the spinal injection and the epidural catheter can be used for labor 
after the spinal doses wears off or if there is a need for cesarean delivery. CSE provides 
comparable/decreased failure rates for labor analgesia and surgical anesthesia, compared to epidural.  
Positive CSF flow in the spinal needle confirms correct epidural needle placement in the epidural space 
and in the midline position.  This should minimize lateralized placement of the catheter with less 
unilateral analgesia.  

 
 
 
Protocol Name: 
Does Ultrasound-Guided CSE (Combined Spinal Epidural) 
Improve Midline Placement of Epidural Needle with Positive 
CSF Flow Through the Spinal Needle, Compared to Catheter 
Placement using Palpation of Anatomical Landmarks: A 
Comparative Study Done in Junior Residents Rotating for the 
First Time on the Labor and Delivery Floor  
Principal Investigator:  Barbara Orlando, MD. 
Primary Contact 
Name/Contact Info: 
Barbara Orlando, MD.  
Date Revised: 
January 25, 2017 
Study Number: 
IRB 15-0031 / HSM# 15-00583/IF# 1780780 
 
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The practice of CSE relies on the palpation of anatomical landmarks not always easy to feel.  For junior 
resident, it can be challenging to identify those landmarks on a patient in pain with higher average weight 
due to the pregnancy. Therefore, the epidural needle may be placed “off midline” with failure to pierce 
the dura with the spinal needle. The spinal dose will not be possible and this could result in an increased 
“failed” or suboptimal epidural analgesia.   
Ultrasound (US) has recently been utilized to facilitate placement of lumbar epidurals and spinals by 
imaging the lumbar spine in different scanning planes to identify the epidural space.  The two acoustic 
windows used are the transverse and the longitudinal paramedian plans to identify the correct interspace, 
depth and midline position. 
A previous study done by our team, comparing “blind” vs US guidance technique, did not show any 
significant difference in term of success rate or complications. However, the study was done by 4 trained 
physicians with lot of practice. We thought about doing this study with junior residents rotating for the 
first time on the floor, to see if there is any difference in their learning curve using the US versus the 
“blind” technique.   
 
1) Objectives 
 
Research Question:   
 
To determine if the junior resident learning curve is improved using the US technique. 
 
Background 
The objective of this study is to determine if US guided CSE technique will improve, in the junior 
residents’ population rotating for the first time on the labor and delivery floor, the placement of the 
epidural needle in the midline position, thereby increasing the incidence of positive CSF flow in the spinal 
needle and correct placement of the catheter.  By randomly assigning patients to one or the other 
technique for the same junior resident throughout his rotation, it will be possible to determine if 
ultrasound guided CSE technique more accurately places the epidural needle in the midline position 
compared to epidural needle placement via palpation of anatomical landmarks, and if the learning curve 
and success rate is better with the US technique compared to the anatomical landmark technique.  
 
2) Setting of the Human Research 
 
The study will take place at the Roosevelt site on the Labor and Delivery Floor. 
 
 

 
 
 
Protocol Name: 
Does Ultrasound-Guided CSE (Combined Spinal Epidural) 
Improve Midline Placement of Epidural Needle with Positive 
CSF Flow Through the Spinal Needle, Compared to Catheter 
Placement using Palpation of Anatomical Landmarks: A 
Comparative Study Done in Junior Residents Rotating for the 
First Time on the Labor and Delivery Floor  
Principal Investigator:  Barbara Orlando, MD. 
Primary Contact 
Name/Contact Info: 
Barbara Orlando, MD.  
Date Revised: 
January 25, 2017 
Study Number: 
IRB 15-0031 / HSM# 15-00583/IF# 1780780 
 
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3) Resources Available to Conduct the Human Research 
 
The Mount Sinai Roosevelt’s Labor and Delivery floor is a busy unit with an average of 7000        
deliveries per year. Enrolling 48 patients should be feasible in a year period. The idea is to have this study 
repeated every month with each new junior resident coming to rotate for the first time, for at least 6 
months to see if there is a pattern. In addition, we have a team of OB anesthesia trained attending and 
fellow who will be involved in this study and keeping track of the results. 
 
4) Study Design 
a) Recruitment Methods 
The objective of this study is to determine if US guided CSE technique will improve, in the junior 
residents’ population rotating for the first time on the labor and delivery floor, the placement of the 
epidural needle in the midline position, thereby increasing the incidence of positive CSF flow in the spinal 
needle and correct placement of the catheter.  By randomly assigning patients to one or the other 
technique for the same junior resident throughout his rotation, it will be possible to determine if 
ultrasound guided CSE technique more accurately places the epidural needle in the midline position 
compared to epidural needle placement via palpation of anatomical landmarks, and if the learning curve 
and success rate is better with the US technique compared to the anatomical landmark technique. The 
resident will be his/her own control since he will alternately do the procedure with one or the other 
technique, in a randomly assign process. A consent to participate in the study will be given to the resident 
prior to including him/her in the study. This will give them the right to "decline participation" without any 
repercussion on their training. The resident's decision about whether or not to participate in this study and 
their performance in the study will in no way affect their standing with the residency at Mt. Sinai and their 
future employment. 
 
 
Group 1: Ultrasound group 
Woman requests epidural for pain relief 
Ultrasound guided CSE placed 
Continuous epidural infusion started 
Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml 
 
Group 2: Palpation of anatomical landmarks 
Woman requests epidural for pain relief 
CSE placed using palpation of anatomical landmarks 
Continuous epidural infusion started 

 
 
 
Protocol Name: 
Does Ultrasound-Guided CSE (Combined Spinal Epidural) 
Improve Midline Placement of Epidural Needle with Positive 
CSF Flow Through the Spinal Needle, Compared to Catheter 
Placement using Palpation of Anatomical Landmarks: A 
Comparative Study Done in Junior Residents Rotating for the 
First Time on the Labor and Delivery Floor  
Principal Investigator:  Barbara Orlando, MD. 
Primary Contact 
Name/Contact Info: 
Barbara Orlando, MD.  
Date Revised: 
January 25, 2017 
Study Number: 
IRB 15-0031 / HSM# 15-00583/IF# 1780780 
 
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Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml 
 
As part of the recruitment methods, we will place recruitment flyers with study information in OB clinics, 
OB physician offices and have them posted at prenatal visits for parents planning delivery at the hospital. 
The investigator will present this study at OB department meeting such as OB Grand Rounds so the study 
can be described to the OB physicians. The OB physicians can be asked to post the flyer in their offices 
and asked if their patients can be recruited for this study. This information flyer will describe this study 
and provide a contact number for the PI or a member of the study team. This is so that patients can contact 
the study team to get more information about the study. If contacted potential subjects can receive the 
consent form in the mail to review and discuss with the investigators prior to presenting in the labor ward 
and providing consent there. This will give patients enough time to ask any questions they may have 
about the study before they sign the consent form. If the patient did not inquire about the study prior, upon 
admission to labor and delivery, further information will be provided, questions answered, and consent 
will be obtained by co-investigators. 
All potential participants will be given the option to be approached by the research team or not. If they 
agree to it, the research team will get in contact with the patient. Participants will be randomized to either 
Group 1 or Group 2 for our junior resident. After obtaining informed consent during early labor, the 
patients will have the midline identified and marked with a surgical marker either by ultrasound or 
midline palpation. Prior to be included in the study, the junior resident will be given a permission note 
with an option to "decline participation" without any repercussion on their training. The resident's 
decision about whether or not to participate in this study and their performance in the study will in no way 
affect their standing with the residency at Mt. Sinai and their future employment.  If they agree to conduct 
the study, they will be briefly trained to the use of US or to the landmark technique by one of our OB 
anesthesia attending participating in the study. Thereafter, the junior resident will attempt to perform a 
CSE. Positive or negative CSF flow in the spinal needle will be recorded.  In addition, the number of 
attempts and adjustments will be recorded.  Each group will receive the same intrathecal dose of fentanyl 
and local anesthetic and started on the same epidural infusion.  After 2 hours, participant’s dermatome and 
analgesia levels will be assessed using temperature and sensation. 
 
 
 
b) Inclusion and Exclusion Criteria 
 
Inclusion Criteria: 
 
a. Term (>37 weeks gestation) 
b. Vertex presentation 
c. Singleton gestation 

 
 
 
Protocol Name: 
Does Ultrasound-Guided CSE (Combined Spinal Epidural) 
Improve Midline Placement of Epidural Needle with Positive 
CSF Flow Through the Spinal Needle, Compared to Catheter 
Placement using Palpation of Anatomical Landmarks: A 
Comparative Study Done in Junior Residents Rotating for the 
First Time on the Labor and Delivery Floor  
Principal Investigator:  Barbara Orlando, MD. 
Primary Contact 
Name/Contact Info: 
Barbara Orlando, MD.  
Date Revised: 
January 25, 2017 
Study Number: 
IRB 15-0031 / HSM# 15-00583/IF# 1780780 
 
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d. Ability to provide informed consent 
e. Request for analgesia for labor pain 
f. Maternal age 18 years or greater     
 
Exclusion Criteria: 
 
a. Preterm (< 37 weeks gestation) 
b. Presentation other than vertex (breech, transverse) 
c. Active drug/alcohol dependence 
d. Previous spinal surgeries 
e. Known spinal deformities 
f. 9 cm and greater dilation 
 
 
c) Number of Subjects 
The study design is a prospective randomized study.  The statistics involved require 48 patients per 
resident who rotates for a month on Labor and Delivery. The anticipated duration of the study is one year. 
This will allow for a power analysis of 80%. 
 
That is 24 participants in each group 
24 in Group 1 (ultrasound group) 
24 in Group 2 (palpation using anatomical landmarks) 
 
d) Study Timelines 
Each patient included in the study will be followed for 2 hours after placement of the CSE.  
Participant’s dermatome and analgesia levels will be assessed using temperature and sensation. The need 
for replacing the CSE will be accounted for, as well as the incomplete/absent block after the spinal dose 
wears off. 
This study should be completed within a year period after it starts. 
 
 
e) Endpoints 
Primary objective:   
 
To determine if the junior resident learning curve is improved using the US technique. 
 
Secondary objective: 

 
 
 
Protocol Name: 
Does Ultrasound-Guided CSE (Combined Spinal Epidural) 
Improve Midline Placement of Epidural Needle with Positive 
CSF Flow Through the Spinal Needle, Compared to Catheter 
Placement using Palpation of Anatomical Landmarks: A 
Comparative Study Done in Junior Residents Rotating for the 
First Time on the Labor and Delivery Floor  
Principal Investigator:  Barbara Orlando, MD. 
Primary Contact 
Name/Contact Info: 
Barbara Orlando, MD.  
Date Revised: 
January 25, 2017 
Study Number: 
IRB 15-0031 / HSM# 15-00583/IF# 1780780 
 
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Revised 7/21/14, Version 8 22 24014 
 
We believe that ultrasound guided CSE technique will help junior resident rotating for the first time 
on the labor and delivery floor to place more accurately the epidural needle in the midline position as 
compared to placing the epidural needle via palpation of anatomical landmarks.  This will result in 
increased ability to deliver the spinal dose with positive CSF in the spinal needle, to have correct 
midline placement of the epidural catheter, and to obtain adequate symmetrical labor 
analgesia/anesthesia.  
 
Tertiary objective: 
 
To determine if the ultrasound guided CSE technique will decrease the number of angle adjustments 
(redirections) of the epidural needle the ultrasound guided CSE technique and the number of attempts 
to locate the epidural space and midline position 
 
f) Procedures Involved in the Human Research 
 
All potential participants will be given the option to be approached by the research team or not. If they 
agree to it, the research team will get in contact with the patient. Participants will be randomized to 
either Group 1 or Group 2 for our junior resident.  After obtaining informed consent during early 
labor, the patients will have the midline identified and marked with a surgical marker either by 
ultrasound or midline palpation by the junior resident. Once the junior resident has identified the 
insertion point by either technique, this same resident will then attempt to perform the CSE by using 
the mark made. Positive or negative CSF flow in the spinal needle will be recorded.  In addition, the 
number of attempts and adjustments will be recorded.  Each group will receive the same intrathecal 
dose of fentanyl and local anesthetic and started on the same epidural infusion.  Each patient will be 
monitored per the ASA guidelines for monitoring in neuraxial analgesia placement (blood pressure 
cuff, pulse oximeter and fetal heart monitoring). Initially, the data recorded on a sheet made for the 
study, will include: number of insertion/redirection of epidural needle in the same epidural space, 
number of epidural space attempted, obtention of CSF. After 2 hours, participant’s dermatoma and 
analgesia levels will be assessed using temperature and sensation. We will also record need to replace 
CSE, unilateral block, adequate pain relief. 
 
g) Data Management and Confidentiality 
 
Participants will be asked to sign an informed consent that is approved by the St. Luke’s-Roosevelt 
IRB and will receive a copy of the approved consent.  Original signed consents will be placed in the 
patient’s permanent medical record.  All the material obtained in the study will be used for research 

 
 
 
Protocol Name: 
Does Ultrasound-Guided CSE (Combined Spinal Epidural) 
Improve Midline Placement of Epidural Needle with Positive 
CSF Flow Through the Spinal Needle, Compared to Catheter 
Placement using Palpation of Anatomical Landmarks: A 
Comparative Study Done in Junior Residents Rotating for the 
First Time on the Labor and Delivery Floor  
Principal Investigator:  Barbara Orlando, MD. 
Primary Contact 
Name/Contact Info: 
Barbara Orlando, MD.  
Date Revised: 
January 25, 2017 
Study Number: 
IRB 15-0031 / HSM# 15-00583/IF# 1780780 
 
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purposes only.  All data will be confidential and no patient identification will be part of the permanent 
data record.  The data will be HIPPA compliant and will be stored in a locked file cabinet in the 
anesthesia office. 
  
 
h) Provisions to Monitor the Data to Ensure the Safety of Subjects 
 
There are no additional health risks to the participants in the study.  
 
i) Withdrawal of Subjects 
 
The patient’s involvement in this study is completely voluntary and all subjects will be informed that 
they can withdraw at any time without loss of benefits to which they are otherwise entitled 
 
5) Risks to Subjects 
 
All the potential risks have been discussed.  Potential benefit for the patients is a well-placed epidural 
catheter that provides symmetrical labor analgesia.  The risks are reasonable in relation to the 
anticipated benefits that are expected to result. 
There will be no exposure to radiation because of participating in this study 
 
6) Provisions for Research Related Harm/Injury 
The research does not involve more than minimal risk to subjects.  
 
7) Potential Benefits to Subjects 
 
The potential benefit is a well-placed epidural catheter in either branch of the study, which provides 
adequate symmetrical labor analgesia. The learning curve might be faster with the ultrasound 
technique. 
 
8) Economic Impact on Subjects 

 
 
 
Protocol Name: 
Does Ultrasound-Guided CSE (Combined Spinal Epidural) 
Improve Midline Placement of Epidural Needle with Positive 
CSF Flow Through the Spinal Needle, Compared to Catheter 
Placement using Palpation of Anatomical Landmarks: A 
Comparative Study Done in Junior Residents Rotating for the 
First Time on the Labor and Delivery Floor  
Principal Investigator:  Barbara Orlando, MD. 
Primary Contact 
Name/Contact Info: 
Barbara Orlando, MD.  
Date Revised: 
January 25, 2017 
Study Number: 
IRB 15-0031 / HSM# 15-00583/IF# 1780780 
 
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Revised 7/21/14, Version 8 22 24014 
Patients will not incur any additional financial expense as a consequence of being enrolled in this 
study. 
 
 
9) Payments to Subjects 
 
Patients will not be compensated for participation in this study. 
 
 
10) 
Consent Process 
 
Patients will be offered participation in the study after a standard preoperative evaluation is performed.  
The patient’s involvement in this study is completely voluntary and all subjects will be informed that they 
can withdraw at any time without loss of benefits to which they are otherwise entitled. 
 
 
11) 
Process to Document Consent in Writing 
 
A written informed consent will be obtained from the patient before the epidural placement. 
 
12) 
Vulnerable Populations 
 
Include 
Exclude 
Vulnerable Population Type 
 
N 
Adults unable to consent 
 
N 
Individuals who are not yet adults (e.g. infants, children, teenagers) 
 
N 
Wards of the State (e.g. foster children) 
Y 
 
Pregnant women 
 
N 
Prisoners 
 
US assisted not guided