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NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
Practice Guide for Anesthetic Management of the
Parturient Undergoing External Cephalic Version (ECV)
Joseph P. McVicker
East Carolina University College of Nursing
1
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
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Approval
Practice Guide for Anesthetic Management of the Parturient Undergoing External Cephalic
Version (ECV)
This DNP Scholarly Project by Joseph P. McVicker is recommended for approval.
Signature on File________________________________________________________________
Robin Webb Corbett, PhD, FNP-C, RNC
Date
Committee Chair
Signature on File________________________________________________________________
Michelle Taylor Skipper, DNP, FNP-BC
Date
Signature on File________________________________________________________________
Steven Banks, MD, FACOG
Date
LCDR, MC, USN
Community Member
Signature on File________________________________________________________________
Michelle Skipper, DNP, FNP-BC
Date
DNP Program Director
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
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Abstract
Despite the World Health Organization’s recommendation that cesarean delivery (CD)
rates not exceed 15%, one in three women in the United States have a CD. This is a 50%
increase since the mid 1990’s. The Term Breech Trial resulted in a perceived prohibition of
elective vaginal delivery (VD) for breech presentation (BP). BP of the fetus occurs in 3-4% of
all pregnancies, accounts for 6-8% of primary CD, and 87-98% of all BPs result in CD. “…The
most important determinant of the overall cesarean rate is the primary cesarean rate” (Branch &
Silver, 2012, p.946). The American College of Obstetricians and Gynecologists (ACOG)
recommends offering external cephalic version (ECV) to all parturients that are determined to be
acceptable candidates. ECV presents a statistically safe alternative to CD for fetal BP at term
when VD is desired (Collaris & Oei, 2004). Fear of pain frequently results in refusal of ECV
and pain is a frequent reason for termination of ECV attempts. In addition to alleviating pain,
central neuraxial blockade (CNB) reduces abdominal muscle tone leading to an increased
success rate of ECV. Naval Hospital Camp Lejeune (NHCL) has no standard practice for
involving anesthesia in the pre-procedural counseling and management of ECV candidates. The
goal of this project is the development of an agency clinical practice protocol based on best
evidence to guide the care of patients undergoing ECV at NHCL. Following an extensive
literature review, an agency clinical practice protocol is developed and formally presented to
stakeholders for future implementation based on an interprofessional care model.
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
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Acknowledgments
I would like to thank my wife, Susan McVicker, for her love and support throughout this
academic journey. I am grateful for the support of my academic committee including my chair,
Dr. Robin Webb-Corbett, Dr. Tracey Bell, and my community member, Dr. Steven Banks.
Additionally, I express my gratitude to the Commanding Officer of Naval Hospital Camp
Lejeune for allowing me to conduct my scholarly project within his organization. The support of
Naval Hospital Camp Lejeune’s departments of anesthesia, obstetrics, family medicine, nursing
and professional education was without a doubt a major motivating and supportive factor in the
completion of this project. Last, but not least, I would like to thank Mrs. Kerry Sewell of the
Laupus Library for her patience and research strategy assistance.
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
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TABLE OF CONTENTS
CHAPTER
I.
II.
INTRODUCTION……………………………………………….
RESEARCH BASED EVIDENCE………………………………
Breech Presentation and Cesarean Delivery Statistical Data…….
Cesarean Delivery Concerns……………………………………..
External Cephalic Version to Avoid Cesarean Delivery………...
Anesthesia and External Cephalic Version………………………
Risks of Anesthesia in Obstetric Patients………………………..
Cost and Efficacy………………………………………………..
THEORETICAL MODEL………………………………………
METHODOLOGY………………………………………………
The Need for a Practice Protocol………………………………..
Search Strategy…………………………………………………..
Resources and Project Cost Analysis……………………………
RESULTS………………………………………………………..
DISCUSSION……………………………………………………
SUMMARY……………………………………………………...
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7
7
7
7
10
12
14
15
19
19
19
20
21
23
24
REFERENCES………………………………………………………………….
25
APPENDICES…………………………………………………………………..
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III.
IV.
V.
VI.
VII.
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
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Practice Guide for Anesthetic Management of the Parturient
Undergoing External Cephalic Version (ECV)
In the United States, the majority of women diagnosed with fetal breech presentation
(BP) at term deliver their babies by Cesarean delivery (CD). This is due to documented higher
maternal and fetal morbidity and mortality associated with vaginal breech delivery. The option
of external cephalic version (ECV) or manually turning the fetus to a cephalic or vertex
presentation is an alternative for women desiring vaginal delivery (VD). Frequently women who
were candidates for ECV have refused it due to fear of pain, and pain has been the most common
reason for terminating ECV attempts.
The purpose of this project was to establish an agency clinical practice protocol for
anesthesia consultation and management of parturients who are candidates for ECV at Naval
Hospital Camp Lejeune (NHCL). NHCL is a community hospital with a high volume, full
service obstetric practice that provides care for active duty military personnel and their families.
With approximately 2,000 deliveries including 272 CDs in 2015, NHCL is the third most
productive obstetric service in Navy Medicine. In the same year, there were 35 ECV procedures
performed at NHCL with only twelve of these procedures performed in conjunction with central
neuraxial blockade (CNB). What is not known is the number of patients eligible for ECV, the
number of patients who refuse the procedure, and whether consultation with anesthesia would
increase procedural acceptance and effect a further decease in the frequency of CD at NHCL.
The absence of a local or professional organizational clinical practice guideline (CPG) provided
an opportunity to apply an evidence-based process improvement initiative for the anesthetic
management of this patient population. The process improvement project was presented to the
department heads of anesthesia and obstetrics. Following their approval, the Director of Surgical
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
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Services was briefed and a letter of support was received from the Commanding Officer of
NHCL (see Appendix A).
Research Based Evidence
Breech Presentation and Cesarean Delivery Statistical Data
Despite the World Health Organization’s recommendation that CD rates not exceed 15%
(Wang, Tan, Kanagalingam, & Tan, 2013), one in three women in the United States have a CD
(Martin, Hamilton, Ventura, Osterman, & Mathews, 2013). This is a 50% rate increase since the
mid 1990’s (Branch & Silver, 2012). If the current trend in primary and secondary CD
continues, 56.2% of all deliveries in the U.S. by 2020 will be by CD (Solheim et al., 2011).
BP of the fetus occurs in 3-4% of all pregnancies at term (Bogner et al., 2014; Truijens,
van der Zalm, Pop, & Kuppens, 2014; Vlemmix et al., 2013). BP accounts for 6-8% of all
primary CD and 87-98% of BPs at term result in elective CD (Tan, Macario, Carvalho, Druzin,
& El-Sayed, 2010; Weiniger et al., 2010; Weiniger, 2013). Women who have had a prior CD
due to BP have a 91% CD recidivism rate resulting in as much as a 20% contribution to the
overall elective CD rate (Weiniger, 2013). Preston and Jee (2013) propose a reduction in the rate
of CD in Canada of up to 14% utilizing ECV to avoid elective, primary CD. According to
Branch & Silver, “…the most important determinant of the overall cesarean rate is the primary
cesarean rate” (2012, p. 946). Of note, the presence of a uterine scar from a previous CD does
not preclude ECV to facilitate a trial of labor and the possibility of VD (Abenhaim, Varin, &
Boucher, 2009; Burgos et al., 2014).
Cesarean Delivery Concerns
The Term Breech Trial, an international, multicenter, randomized trial conducted by
Hannah et al. (2000) revealed significant maternal and neonatal morbidity associated with
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
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elective VDs with breech presentation. Subsequently, elective VDs for breech presentation (BP)
at term fell into disfavor and CD became the preferred mode of delivery for this patient
population (Weiniger, 2013). Despite the preference for CD when BP is diagnosed at term, CD
is considered major abdominal surgery and presents significant immediate and delayed risks to
the mother (see Table 1), (Silver et al., 2006). This concern for maternal morbidity was
reaffirmed in a study evaluating adjacent organ injury, including bladder and bowel, in repetitive
CDs (Ozcan et al., 2015). There is also a subsequent increase risk for malpresentation in future
pregnancies for women who have had a prior CD (Hehir et al., 2012).
Table 1
Maternal Morbidity of Women Who Had Cesarean Deliveries Without Labor
The preference to opt for CD in order to avoid neonatal complications associated with
vaginal breech delivery was challenged and arguments were made that when strict criteria were
met, planned vaginal breech delivery was safer than CD (Goffinet et al., 2006). This assertion
for the safety of vaginal breech delivery was later discounted by a 2016 meta-analysis that
reported perinatal morbidity and mortality at two- to five- fold greater in vaginal breech
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
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deliveries when compared to CD (Berhan & Haileamlak, 2016). Fetal and perinatal risks
associated with breech presentation and delivery at term are presented in Table 2. There is short
term risk of neonatal asphyxia, scalp lacerations, respiratory morbidities, immunologic effects,
altered gastrointestinal flora, negative hematologic effects, as well as negative hemodynamic
effects due to alteration in norepinephrine production, with additional evidence to support an
association of CD with asthma, food allergy, and atopy (Gregory, Jackson, Korst, & Fridman,
2012). The aggregate maternal, fetal, and perinatal risks support cephalic vaginal delivery in
contrast to CD.
Table 2
Fetal and Perinatal Risks Associated with Breech Presentation and Delivery at
Term
Complication
Incidence
Intrapartum fetal death
Increased 16-fold
Perinatal mortality
1.30%
Intrapartum asphyxia
Increased 3.8-fold
Cord prolapse
Increased 5-20-fold, 1.3%
Birth trauma
Increased 13-fold, 1.4%
Dystocia, difficulty delivering head
4.6-8.8%
Spinal cord injury with extended head
21%
Major anomalies
6-18%
Prematurity
16-33%
Hyperextension of the head
5%
Fetal heart rate abnormalities
15.20%
From “Malpresentations and Shoulder Dystocia,” by S. M. Seeds, J.
W. Seeds, 2012. In S.G. Gabbe, J. R. Niebyl, et al, (Eds), Obstetrics:
Normal and problem pregnancies (pp. 388-414) Philadelphia:
Elsevier/Sanders. Adapted with permission.
External Cephalic Version to Avoid Cesarean Delivery
Many techniques have been attempted to induce the spontaneous repositioning of the
fetus to a cephalic presentation. Maternal knee chest positioning, relaxation techniques, spinal
vibroacoustic stimulation, warmed saline amniotic infusions, acupuncture, burning of an herb
called moxibustion near the skin, and a positioning technique called Indian Version have all been
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
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attempted strategies to facilitate cephalic version (Bolaji & Alabi-Isama, 2009). In the absence
of conflicting co-morbidities, pregnant women, with singleton pregnancies and a diagnosis of BP
at term are candidates for ECV (ACOG, 2015). Elective ECV presents a safe, viable alternative
to CD for women who present with fetal BP at term and desire to attempt VD (Bogner et al.,
2014; Lim et al., 2014; Rosman et al., 2014, Vlemmix et al., 2013). It is beyond the scope of this
project to discuss and determine patient eligibility or candidacy for ECV.
CD remains the primary delivery mode for term BP (Aaronson & Goodman, 2014).
Success rate for ECV without anesthesia varies from 20% to 60% with most reports in the 50%
range (Bogner et al., 2014; Kok, Van Der Steeg, Mol, Opmeer, & Van Der Post, 2008; Lim et
al., 2014; Weiniger, 2013). The rate of CD following successful ECV is decreased to 21% (de
Hundt, Velzel, de Groot, Mol, & Kok, 2014). Despite ACOG’s recommendation that ECV
should be offered to all acceptable candidates, only up to 70% of women undergo procedural
attempts at ECV (Rosman et al., 2014). Fear of pain is expressed 25% of the time and is the
most common reason for refusal of ECV (Ciliacus et al., 2014; Rijnders, Offerhaus, van
Dommelen, Wiegers, & Buitendijk, 2010; Truijens et al., 2014; Vlemmix et al., 2013). Pain is
cited as a frequent reason for termination of ECV attempts. This is supported by an eight fold
greater incidence of termination of ECV attempts due to pain for patients without anesthesia as
compared to women with an anesthetic (Goetzinger, Harper, Tuuli, Macones, & Colditz, 2011).
Anesthesia and External Cephalic Version
General anesthesia was initially used to facilitate ECV but has since been abandoned in
favor of CNB due to a 1% incidence of fetal mortality associated with general anesthesia (Bolaji
& Alabi-Isama, 2009). CNB is a general term that includes epidural, spinal and combined
spinal-epidural techniques. These techniques involve the placement of a needle into the vertebral
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
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canal to facilitate the injection of local anesthetics and/or opiates into the epidural space or spinal
fluid (Bolaji & Alabi-Isama, 2009). Anesthesia with CNB anesthesia remains the only technique
with grade A evidence to support its use to increase the success rate of fetal version and decrease
the incidence of CD (Bolaji & Alabi-Isama, 2009). All CNB techniques have been shown to
decrease pain and increase the success rates of ECV when anesthetic as opposed to analgesic
doses of local anesthetic are delivered (Lavoie & Guay, 2010; Sultan & Carvalho, 2011).
Furthermore, CNB reduces abdominal muscle tone and guarding contributing to the increased
success rate of successful ECV attempts (Weiniger, 2013). Spinal anesthesia was shown to be
effective in increasing the success rate of ECV in nulliparous women and increasing the VD rate
(Weiniger et al., 2007). Although patients report increased satisfaction and decreased pain
scores with intravenous and CNB analgesia, neither of these approaches consistently increases
the success rate of ECV. In contrast, CNB using anesthetic dosing of local anesthetics did
increase the success rate of ECV (Birnbach et al., 2001; Khaw et al., 2015; Sullivan et al., 2009).
The efficacy of CNB anesthesia to facilitate ECV is supported in Table 3.
Table 3
Efficacy of Central Neuraxial Block (CNB) Anesthesia, CNB Analgesia, and No Intervention for Facilitation
External Cephalic Version (ECV) Success
Study/Year
Country
Design
ECV Success
ECV Success
ECV Success
Favor ECV
Rate w/ CNB
Rate w/ CNB
Rate w/ No
w/CNB
Anesthesia
Analgesia
Intervention
Anesthesia
Khaw/2015
Hong Kong
RCT
83% (52/63)
N/A
64% (40/63)
Yes
Weiniger/ 2013
Israel/ USA LR
68% (104/153) 45% (44/97)
38% (96/255)
Yes
Goetzinger/2012 USA
SR & MA 60% (151/253) N/A
38% (96/255)
Yes
Sultan/2011*
USA
SR
69% (107/156) 45% (44/97)
38% (96/255)
Yes
Lavoie/2010
Canada
MA
64% (80/125)
44% (94/214)
35% (121/342)
Yes
Weiniger/2010
Israel
RCT
87% (27/31)
N/A
58% (19/33)
Yes
Yoshida/ 2010
Japan
RC
79% (41/52)
N/A
56% (19/34)
Yes
Bolaji/ 2009
UK
SR & MA 51% (174/339) N/A
35% (103/295)
Yes
Sullivan/2009
USA
RCT
N/A
47% (23/48)
31% (15/48)
N/A
Macarthur/2004 Canada
MA
50% (119/238) N/A
34% (82/242)
Yes
Birnbach/2001
USA
PSNR
N/A
80% (16/20)
33% (5/15)
N/A
Note. RCT-Randomized Controlled Trial, LR- Literature Review, SR-Systematic Review, MA-Meta-Analysis,
RC-Retrospective Cohort Study, PSNR-Prospective Study Not Randomized. *Data limited to include only
Randomized Controlled Studies of Neuraxial Blockade for ECV.
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Risks of Anesthesia in Obstetric Patients
CNB in the obstetric population is not without risk. Appropriate patient evaluation to
determine eligibility and risk stratification for the procedure is required. The more common
risks and complications of CNB include maternal hypotension, as frequent as 90%, which must
be taken seriously as it directly impacts placental perfusion, but this is routinely treated with
intravenous fluid and vasopressor medications (Stamer & Wulf, 2001). Post dural puncture
headache occurs in 2.5% of patients who receive spinal anesthesia and two thirds of patients who
have accidental dural puncture with larger epidural needles (Stamer & Wulf, 2001). The rate of
unintentional dural puncture is reported as high as 3.6% in facilities performing less than 300
epidurals and as low as 0.19% in facilities performing at least 1,000 epidurals annually (Stamer
& Wulf, 2001). Of those obstetrical patients receiving CNB only 0.2% require subsequent
invasive treatment with epidural blood patch for post dural puncture headache (Yamasato,
Kaneshiro, & Salcedo, 2015). Bacteremia, systemic bacterial infection, is preclusive of CNB
due to the risk of meningitis and epidural abscess with frequencies reported as high as 1:3,000 to
1:50,000. These rates are inclusive of developing and third world countries as well as
immunocompromised patients who are at higher risk for infectious complications (Moen &
Irestedt, 2008). In further discussion of morbidity, Moen and Irestedt (2008) report that western,
developed nations have significantly lower rates of infectious complications with CNB. Spinal
cord trauma is rare and an understanding of anatomical variation of spinal cord anatomy and
proper selection of injection site all but obviates this complication (Moen & Irestedt, 2008).
It is postulated that the lack of protective pain reflexes or biofeedback due to CNB may
allow for greater pressure to be applied to the abdomen and uterus during ECV and potentially
increase the risk of placental abruption or uterine rupture (Bolaji & Alabi-Isama, 2009; O’Brien
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
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& Adashi, 2014). However, when failed ECV attempts without CNB were repeated with the
addition of spinal anesthesia, success rates improved and substantially reduced force was needed
in the subsequent, successful ECV efforts with no increased incidence of maternal or fetal
morbidity (Suen et al., 2012). Success rates for ECV in the 36-37 gestational age fetuses
increased from 56% to 79% with CNB with a resulting decrease in CD rate from 50% to 33% for
this population (Yoshida et al., 2010). Repeating ECV attempts with CNB following an initial
failed attempt without CNB was advocated in an earlier prospective study (Cherayil, Feinberg,
Robinson, & Tsen, 2002). ACOG does not advocate ECV prior to 37 weeks (ACOG, 2016).
Despite the evidence that CNB improves the success rate for ECV at 37 weeks without increased
morbidity, it is common practice in the U.S., as well as at NHCL, to attempt ECV at 37 weeks
without anesthesia and if unsuccessful, reattempt ECV at 39 weeks with CNB in place so that
immediate CD may be performed if ECV is again unsuccessful (Caughey & El-Sayed, 2010). If
ECV is successful at 39 weeks, labor is induced and the epidural catheter placed for the ECV is
used for labor analgesia. When choosing to delay reattempts at ECV to 39 after a failed attempt
without anesthesia at 37 weeks, the increase in fetal size at the later date may negatively impact
the likelihood of successful ECV (Caughey & El-Sayed, 2010). Additionally, onset of
spontaneous labor or rupture of the amniotic membranes when waiting to 39 weeks may also
decrease the likelihood of success or outright preclude ECV attempts (Bolaji & Alabi-Isama,
2009). There are concerns that ECV at 37 weeks would result in a significantly high rate of
reversion to breech presentation, however, this rate is only 1-2% after 37 weeks (Collaris & Oei,
2004). The overall return to BP or reversion rate is reported to be 3-10% and includes patients
receiving ECV at 36 weeks gestation (Tan et al, 2010).
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
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Cost and Efficacy
Any procedure must be evaluated not only for clinical efficacy but also procedural cost.
The mean cost for ECV with CNB and VD is approximately $7,500 with CNB adding only $134
to the total cost. As reflected in Table 4, the cost for CD can exceed $9000 (Carvalho, Tan,
Macario, El-Sayed, & Sultan, 2013).
Table 4
Mean Costs (in 2010 US dollars) of External Cephalic Version (ECV) With and Without
Neuraxial Anesthesia (CNB), Vaginal (VD), and Cesarean Delivery (CD)
Hospital Cost
OB & Nursing Svce. &
Supplies
Anesthesia Svce. &
Supplies
Mother’s time*
Totals
ECV
$798
$174
$115
$1087
ECV w/CNB
$798
$174
VD
$3966
$1746
Elective CD
$6291
$1954
Emergent CD
$6291
$1971
$134
$218
$251
$535
$115
$1221
$345
$6275
$460
$8956
$575
$9372
Note. * Cost of mother’s time was itemized for each procedure expected duration/expected
length of stay. Adapted from “A cost analysis of neuraxial anesthesia to facilitate external
cephalic version for breech fetal presentation,” by Carvalho et al. 2013, Anesthesia and
Analgesia, 117(1), 155-159. Copyright 2013 by International Anesthesia Research Society.
The estimate for the cost CD does not include care for the neonate, which is usually
greater following CD. CNB does increase the cost of the individual ECV procedure by
approximately 12% but accounts for only 3% of the total delivery costs (Carvalho et al., 2013).
Increasing the success rates of ECV and decreasing the rate of CD is cost effective in both the
short and long term (Carvalho et al., 2013). The Carvalho et al. review includes the costs of
anesthetic complications in their calculations (2013). Reports concerning costs must take the
country of origin into account as CD rates and fixed costs including personnel vary widely
(O'Brien & Adashi, 2014). Revenue generation, insurance reimbursements, and consumable
supplies also have significant impacts on the cost analysis (Weiniger, Spencer, Weiss, Ginsberg,
& Ezra, 2014). Future or delayed costs should also be considered. It is postulated that if 17 CDs
can be avoided for every 100 ECV’s attempted, there would be a potential reduction of 10,000
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
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CDs in the U.S. annually (Yamasato et al., 2015). Table 5 represents a more aggressive
reduction of 29,508 CDs by performing ECV with CNB amounting to an annual cost savings of
$37,588,351 (Niu et al., 2016).
Table 5
Comparison of outcomes and costs for performing external cephalic version (ECV) with or
without spinal anesthesia in a cohort of 126,000 nulliparous women with breech presentation
Maternal deaths
Cesarean Deliveries
Successful ECVs
Cost (in $100,000s)
QALY (In 1000s)
ECV w/Spinal
2
68,619
81,739
1,342
3,412
ECV w/o Spinal
2
98,127
39,705
1,379
3,409
Difference
0
29,508
42,034
38
3
From “External Cephalic Version with or without spinal anesthesia: a cost-effectiveness
analysis,” by B. Niu et al. 2016, American Journal of Obstetrics and Gynecology, 214(1), S206.
Copyright 2016 by Elsevier, Inc.
Niu et al. did not identify the annual costs for CD in their report (2016). Additional
savings will be realized in the subsequent CDs that will be avoided due to prevention of the
primary CD (Yamasato et al., 2015). There is iatrogenic and incidental morbidity and mortality
associated with CD (see Tables 1&2). These complications significantly increase the cost of
healthcare. This author has not seen these additional expenses considered in any cost analysis in
his review of the literature.
When addressing cost from a societal or community health perspective, quality adjusted
life years (QALY) are a significant consideration. ECV followed by VD resulted in a favorable
calculation of $7,900/QALY (Tan et al., 2010). This is much lower than the $50,000/QALY
threshold established to determine the favorability of an intervention (Tan et al., 2010).
Theoretical Model
Consistent with the doctor of nursing practice focus on translational research, process
models present stages or steps to facilitate the translation of research into practice. The Iowa
Model Revised: Evidence-Based Practice to Promote Excellence in Health Care (The Iowa
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
16
Model) is an action model (The Iowa Model Collaborative, 2015). The model’s 2015 version
uses interdisciplinary verbiage favoring its use in health care applications. The streamlined flow
chart of the model is depicted in Figure 1.
Figure 1. The Iowa Model Revised: Evidence-Based Practice to Promote Excellence in
Health Care. Used/Reprinted with permission from the University of Iowa Hospitals and Clinics.
Copyright 2015. For permission to use or reproduce the model, please contact the University of
Iowa Hospitals and Clinics at (319)384-9098.
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
The application of the framework to this project development is presented (see Figure 2).
Figure 2. Iowa Model Outline on left. Parallel project application on right.
17
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
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The first step of the process calls for identifying triggering issues or opportunities. For
the purposes of this project the relatively recent increase in patients receiving ECV at NHCL
with inconsistencies in consultation for anesthetic intervention by obstetricians and a variety of
anesthetic management techniques comprised what the IOWA model describes a clinical trigger.
Further inquiry revealed new preliminary evidence in the literature that found the variability in
practice was inconsistent with the evidence. This led to the next step in the process map, stating
the question. Is there evidence to support the development of a practice guide or protocol for the
anesthetic management of ECV patients? Additionally, can the department of anesthesia effect a
change in practice to improve the success rate of ECV and thereby decrease the rate of CD at
NHCL? The formation of a team is the next step in the process. The core team for this project
includes the author and academic committee. However, the NHCL department chairs of
anesthesia and obstetrics as well as the director of surgical services who expressed interest and
provided support for the endeavor are considered team members.
Assembly, appraisal, and synthesis of the body of knowledge comprise the next phase in
the Iowa Model (The Iowa Model Collaborative, 2015). The literature, with rare exception,
reflects an overall consensus that the addition of CNB to ECV results in superior patient
outcomes increasing success rates of ECV and decreasing the incidence of CD without
increasing costs. In fact, there is overall savings in both the short-term and long-term prediction
models (Carvalho et al., 2013). More importantly than cost, the maternal, fetal, and perinatal
risks of CD are avoided. Following design and piloting the intervention, the Iowa Model
continues with integrating and sustaining the practice change. It is at this phase that this project
will end and leave post implementation evaluation for future study. The determination of
appropriateness of the change to practice and subsequent integration and sustainment will be the
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
19
end outcome of the post implementation evaluation. Dissemination of the results is the final step
in the process. This allows for feedback to those involved and contribution to the broader
community promoting evidence-based practice (The Iowa Model Collaborative, 2015).
Methodology
The Need for a Practice Protocol
ACOG, The American Society of Anesthesiologists, and The American Association of
Nurse Anesthetists do not have published clinical practice guidelines for anesthesia involvement
or management of parturients undergoing ECVs. Currently, NHCL does not have a standard
practice or guideline for involvement of anesthesia as part of pre-procedural counseling and
anesthetic management of ECV candidates.
Search Strategy
This project was reviewed and found to be outside the jurisdiction of the East Carolina
University, University & Medical Center Institutional Review Board, as it does not meet the
current federal descriptions of human subject research (see Appendix B). An extensive literature
review of PubMed, OVID, and the Cochrane Database of Systematic Reviews was conducted.
The search was limited to title and abstract restricting results to 2001 or later to focus on current
evidence. Seminal publications were individually searched. The search terms included fetal
version, external cephalic version, ECV, anesthesia, cesarean section, and costs. All articles
published in peer-reviewed journals were eligible for inclusion. The author evaluated the results
of this search and reviewed the title and abstract of all search results. Extraneous reports were
excluded if not germane to the current subject. After eliminating duplicates, all remaining
articles were obtained in full and evaluated. The author, based on subject matter and relationship
to the current project, determined further exclusion. Manual review of remaining journal
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
20
reference pages was completed and additional articles were evaluated for inclusion. The search
strategy flow sheet is presented (see Figure 3).
PubMed: Fetal, Version, Anesthesia
39 results 18 excluded
PubMed: Anesthesia, Cesarean Section,
Version
34 results, 30 excluded, 4 duplicates
PubMed: Cost-Benefit Analysis, Costs,
Cost Control, Health Care Costs, Hospital
Costs, AND Fetal Version
26 results, 19 excluded, 2 duplicates
Net 21 Articles
Net 0 Articles
Net 5 Articles
PubMed: Anesthesia, Spinal, Analgesia,
Anesthesia, Combined Spinal Epidural,
Neuraxial, AND Fetal Version, External
Cephalic Version
45 Results, 17 excluded, 20 Duplicates
Net 8 Articles
OVID: Version, Fetal, Anesthesia
19 results, 13 Excluded
Net 6 Articles
Cochrane Systematic Reviews :External
Cephalic Version, Breech
7 results, 5 excluded
Net 2 Articles
Manual examination of citations in
reviewed publications and other sources
12 results
Net 12 Articles
TOTAL NET ARTICLES FOR INCLUSION
55
Figure 3. Literature selection flow sheet
Resources and Project Cost Analysis
Costs of the project were limited to office supplies as well as academic institutional
tuition and fees borne by the author. Online access to East Carolina University’s library
resources and other open source sites were utilized. The author has invested approximately four
hundred hours amounting to a personnel expense, excluding input from faculty and academic
committee members, of twenty-four thousand dollars. The timeline for the project is attached
(see Appendix C).
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
21
This project is limited to the development of the agency specific clinical practice
protocol. Post implementation assessment is a matter for future analysis whether by pilot study
or prospective analysis of CD rate, cost, morbidity, as compared to previous events documented
in patient records. Future work would include short and long-term evaluation of compliance.
Results
The current practice at NHCL includes formal consultation to an anesthesia provider,
anesthesiologist or Certified Registered Nurse Anesthetist, by an obstetric provider for patients
with certain comorbid conditions prior to admission. This process remains unchanged and
criteria are listed in the amended NHCL Clinical Practice Guideline for Anesthesia Consultation
Prior to Admission is presented (see Appendix D). In the past, pre-anesthetic evaluation and
counseling for ECV was routinely conducted on the day of the procedure unless subsequent CD
was planned following an unsuccessful ECV attempt. Based on the evidence and ACOG (2016)
recommendation for utilization of CNB for ECV, Appendix D provides for anesthesia
consultation for all patients with fetal BP at 36 weeks following the diagnosis and initial
counseling by the attending obstetric provider. Anesthesia counseling is conducted in
preparation for planned ECV at 37 weeks or later. The addition of pre-procedural consultation to
anesthesia for ECV evaluation and counseling does not result in increased workload for
anesthesia providers. It changes the sequence of events since all patients admitted for labor and
delivery at NHCL are evaluated and consented for anesthetic intervention by an anesthesia
provider. Obstetric patients presenting to anesthesia for pre-procedural visits are counseled on
the risks, benefits, and potential complications of CNB as well as general anesthesia for labor
and delivery. Consistent with ACOG’s practice bulletin, the added benefits of anesthesia in
regards to alleviation of procedural pain and increased success rates of ECV with the placement
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
22
of a CNB are addressed during this counseling (ACOG, 2016). The complete process is
described in proposed Clinical Practice Protocol, Management of Patients Receiving External
Cephalic Version (see Appendix E).
A formal presentation of the clinical evidence supporting the use of CNB to facilitate the
success of ECV was presented to the anesthesia and obstetric departments’ staff. The goal of
this early involvement was to allow for active engagement of members and open discourse
concerning the paradigm change in anesthesia services from simply facilitating surgery to
actively enhancing clinical outcomes of procedures. The obstetrics department chair addressed
specific concerns and questions raised by obstetric practitioners that were outside the practice of
anesthesia and are specifically related to obstetrical practice. These concerns included
documentation of surgical history and physical and administrative process for outpatient
admission for ECV procedure for patients at 37 gestational age without planned delivery.
Additionally, the NHCL Board of Directors was briefed on the protocol as a process
improvement initiative and board members offered positive commentary regarding risk
management, fiscal soundness, women’s health, evidence-based practice, and expansion of
services.
The provision of anesthesia for ECV has not been universally practiced and ACOG
advocacy for utilization of CNB for ECV was not expressed by ACOG until 2016 (ACOG,
2016). All anesthesia providers at NHCL have clinical privileges and provide CNB on a routine
basis. The recent release of the ACOG practice bulletin promotes the benefits of CNB anesthesia
in increasing the success rates of ECV and decreasing the CD rate (ACOG, 2016). Providing
anesthesia, not only to alleviate pain, but also to augment and facilitate an increase in the success
of ECV attempts may be conceptually foreign to many anesthesia and obstetrical providers.
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
23
The goal of this project was achieved. The Naval Hospital Camp Lejeune, Department of
Anesthesia Clinical Practice Protocol, Management of Patients Receiving External Cephalic
Version has received formal approval by all required signatories and was effective August 1,
2016.
Discussion
At NHCL, data concerning the success of ECV with and without anesthesia, as well as
the rate for primary CD for BP has not been examined in the past. As a military treatment
facility, NHCL’s patient population is highly mobile; as such long-term implications, morbidity,
and patient outcomes are not always available. Despite the utilization of an inpatient electronic
medical record, providers currently cannot access the information and associated data from other
military treatment facilities in the network. Evaluation of immediate or short-term efficacy is
possible. Data mining by CPT code is one mechanism to collect data concerning ECV, VD, and
CD for NHCL. Since the evaluation would involve success or failure of ECV with and without
anesthesia, all ECV procedures meet inclusion criteria for follow up evaluation. Additionally,
NHCL’s inpatient electronic medical record includes a note template for providers to document
the success or failure of ECV procedures with a single check box. This data entry point provides
an opportunity to evaluate the individual and overall ECV success rate at NHCL. The
development of an electronic data collection tool will provide a mechanism for further evaluation
of implementation and efficacy of the clinical practice protocol. As a process improvement
initiative, local implementation is the primary goal for this protocol. However, given similarities
in the organizational structures and practice models within Navy Medicine there may be
implications for broader dissemination and adoption at other naval hospitals. This project will be
submitted for publication in the AANA Journal. Additionally, given the interprofessional subject
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
24
matter, application for publication in midwifery or women’s health journals will also be
explored. The involvement of an OB/GYN physician in this author’s advisory committee
provides an opportunity for interprofessional co-authorship and potential broader options for
publication in medical journals.
Summary
Following the conceptual framework of the Iowa Model (see Figure 2) an extensive
literature review was conducted and evidence supports utilization of CNB for ECV at term. As
well, ACOG issued a practice bulletin advocating the use of CNB for ECV (ACOG, 2016).
Using anesthesia to improve procedural outcomes, reduce healthcare costs, decrease maternal
and neonatal morbidity, and enhance the quality of life for post partum women requires a
paradigm shift for both anesthesia and obstetric providers. Use of this clinical practice protocol
provides an opportunity to improve short and long term outcomes for women’s health by
decreasing the frequency of primary and repeated CD and the associated surgical complications.
The population specific applicability for NHCL requires ongoing, longitudinal study to ensure
that the outcomes derived from the implementation of this protocol demonstrate evidence of a
best practice model for this facility and its patients.
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
25
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NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
Appendix A
33
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
Appendix B
34
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
Appendix C
Project Timeline
Semester 3 (May 18-July 31, 2015) Scholarly Practicum 1
June 15-16
DNP Intensives
June 17
Library Day with Librarian
June 23
Revision Abstract, submitted to BB
June 25
Request letter of support to NHCL
June 29
Committee chair and members finalized. Agreement Form Completed
July 2
Letter of support follow up if not returned.
July 8
Final Paper (including Committee Members) submitted
July 28
Time Log to BB (100-hrs. minimum)
Semester 4 (January 11- April 28, 2016) Scholarly Practicum 2
Jan 11
Start Lit review update (ongoing)
Feb 8-10
DNP Intensives
IRB application
IRB Approval Submission
Mar 21
First draft paper detailing the full project to BB and committee membership.
Apr 18
Final paper detailing the full project to BB and committee membership.
Apr 26
SP2 Time log to BB (150-hrs. minimum)
Apr 26
Chair Approval for progression to SPIII
Semester 5
May 16
June 13-15
July 5
July 29
Aug 1
(May 16- July 28, 2016) Scholarly Practicum 3
Start working on pre DNP Intensive deliverables
DNP Intensives
Presentation to NHCL Board of Directors
Scholarly Practicum log to BB (125-hrs. minimum)
Effective date of Protocol for NHCL
Semester 6 (Aug 22- Dec 5, 2016) Scholarly Practicum 4
Aug 18
Presentation to Medical Executive Committee NHCL
Sep 10
Dissemination Plan Submitted
Sep 12-14
DNP Intensives
Sep 28
Presentation to Nursing Executive Committee NHCL
Nov 17
Formal Poster Presentation to CON
Nov 28
Scholarly Practicum log to BB (125-hrs. minimum)
TBD
Article/Journal Submission
35
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
Appendix D
36
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37
NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION
Appendix E
38
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39
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40