Complication Rates for Fluoroscopic Guided Interlaminar

Complication Rates for Fluoroscopic Guided
Interlaminar Lumbar Epidural Steroid
Injections: Certified Registered Nurse
Anesthetists and Physicians
Dr. Donald E. Beissel, DNP, CRNA, DAAPM
Southwest Interventional Pain Specialists
-Discuss the prevalence of chronic spine related pain in the USA
-Discuss financial and logistical impediments to access to chronic pain care
for rural and elderly patients
-Describe the study method of the topic at hand
-Describe the complication rates of CRNAs and Physicians when
providing fluoroscopic guided LESIs
-Describe the implications of this research on rural and elderly patients in
need of chronic pain care and the providers who are willing to provide that
-Describe the direction of future research
Why study this?
What SB 682 Meant
 No Fluoroscopy guidance for CRNAs…
 No Kyphoplasty…
 No Radio Frequency Ablation…
 No Implanted devices…
 until August 28, 2016- Sunset
 We were given 4 years to get evidence and education
programs in order.
Review of the
The Cost of Low Back Pain
 Back pain is the leading cause of disability in the world
(Crow and Willis, 2009).
 Respiratory illness is the only complaint that accounts for
more missed work time.
 Two thirds of of people will experience low back pain
(LBP) in their lives.
 LBP costs $100 billion/year in the USA (Pizzo & Clark,
There are fewer than 4,000 physician pain management providers in the USA
(Pizzo and Clark, 2012).
Multiple physician specialties and advanced practice RNs (including Certified
Registered Nurse Anesthetists) have billed Medicare for fluoroscopy guided pain
management procedures since at least 1998 (Manchikanti, 2004).
“Providing acute and chronic pain management and treatment is within the
professional scope of practice of CRNAs. CRNAs employing pain management
techniques is neither new nor unusual and has long been a part of CRNA
practice. By virtue of education and individual clinical experience, a CRNA
possesses the necessary knowledge and skills to employ therapeutic, physiological,
pharmacological, interventional, and psychological modalities in the management
and treatment of acute and chronic pain. The AANA believes that it is incumbent
upon the individual CRNA to assure his or her competency when delivering
anesthesia services, including pain management and treatment.” (AANA, 1994)
Manchikanti Study
 Manchikanti, et al. studied complication rates for 10,000
consecutive fluoroscopic guided injections near the spine
in 2012.
 Fourteen hundred and fifty of these were interlaminar
 Low complication rate.
 Basis of comparison for this study.
Published Complication
 There are no complication rate studies for CRNAs
providing fluoroscopic guided pain procedures.
 American Society of Anesthesiologists closed claims
study. One hundred and fourteen epidural steroid
injection complications-total performed unknown
(Fitzgibbon, et al.)
 McGrath, Schaefer, & Malkamaki (2011) found a
complication rate of 0.6%, but only studied 123 Lumbar
Epidural Steroid Injections (LESIs).
Access and Cost
 The Lewin Group examine four case studies of rural pain
patients in 2012.
 They compared the cost of care by a local CRNA to
traveling to a physician for injections, having surgery, and
having no care at all.
 They found that cost saving and increased quality of life
were associated with treatment by the local CRNA over
the other options.
What did this study do?
 I explored whether or not CRNAs have complication rates
similar to physicians when performing fluoroscopic guided
interlaminar LESIs.
 I studied one procedure to establish the methods to study all
fluoroscopic guided procedures in the future.
 This procedure was chosen because it is commonly performed
by both CRNAs and physicians (Manchikanti, 2004;
Manchikanti, Helm, Singh, & Hirsch, 2014).
 I also studied cost by determining distance from the CRNA
participants to the closes physician pain provide.
 I tracked participant satisfaction to determine if the providers
were satisfied with the data collection process.
Study Design and
 Participants were recruited from across the USA via
online pain management discussion boards with over
1,000 members.
 Twenty-seven expressed interest.
 Nineteen enrolled.
 Thirteen completed all phases of data collection.
 Participants were surveyed about education, experience,
and their practice situations.
Procedural Complications
 Six month collection period on an Excel spreadsheet.
 Number of procedures.
 Incidence of 20 different complications.
Participant Satisfaction
 Participants were asked to respond to: “the data was easy
to collect while performing clinical duties”, “the study was
the right length of time”, “the study has value for CRNA
pain management practice”,” it was easy to contact the
lead researcher with questions about the study” and “I am
willing to be a subject/collect data for future studies of a
similar nature.”
Participant Demographics
by the 3 practices in urban areas. Mean is 9,164 after the urban sites are removed.
**Mean distance to physician provided injections is 97.5 miles when the 3 urban participants
are removed.
Other Results
 8 providers have Master’s Degrees
 5 Providers have Doctoral Degrees (DNP, DNAP, PhD,
or EdD)
 3 Providers performed the procedures in an office, 1 was
in a pain clinic, 8 were in hospitals, and 1 provider worked
in both a hospital and a surgery center.
 There were 3 female CRNAs and 10 male CRNAs.
Complication Rates
Participant Satisfaction
What? It wasn’t perfect?
 I could not obtain the definitions that Manchikanti, et al.
(2012b) used in their study. I used standard, widely
accepted definitions of complications. Complication
rates between groups in this study may be due to
differences in definitions.
 This procedure only examines one of many fluoroscopic
guided injections performed near the spine. That study
comes next!
Direction of Future
The Future…
 A bigger study with all of the fluoroscopic guided
 Application for AANA Post-Doctoral Fellowship
 Creation and maintenance of a complications database
for CRNAs doing fluoroscopic guided procedures.
 Use of this data to define safety to guide legal and policy
discussions around procedures and patient safety.
Steps to advance access to
CRNA provided pain care
 Council on Accreditation of Nurse Anesthesia Programs
Fellowship in Chronic Pain Management at Hamline
 AANA Professional Practice Guidelines for CRNAs
Providing Chronic Pain Care
 NBCRNA Non Surgical Pain Management Specialty
 This dissertation and future complication studies.
What about…
 Three participants practice in large metropolitan areas,
skewing population and distance results. When discussing
rural access, these distance numbers should be excluded.
 Differences in rates between physicians and CRNAs are
likely due to differences in definition, but it is impossible
to know.
 Vasovagal reaction differences may be due to lack of or
provision of sedation during procedures. This variable
should be included in the next study.
Provider Diversity
 The physician group was made up of three
anesthesiologists who all practice in the same group.
 The CRNA participants had diverse levels of education,
CRNA experience, pain injection experience, injection
performance frequency, and practice setting.
 None of the complications were correlated with any of
the CRNA demographics.
 This refutes claims that CRNAs have higher complication
rates due to training and education (Manchikanti, 2012a).
What about “Paralysis and
 There were no episodes of patient paralysis or death in
either study group.
 There were 3,238 combined procedures by both groups
of providers in this study.
 This suggests that this procedure is safe when performed
by members of either profession.
Implications for
How do we apply this?
 This project addressed the ethical issue of access to and
distribution of care. The current pain management system is
primarily comprised of physician providers in populated urban
areas and non-physician providers, including CRNAs, practicing
primarily in rural areas with financially disadvantaged patients. (The
Lewin Group, 2012). Rural and disadvantaged patients have
difficulty traveling to, or paying for physician provided pain care.
Because this study found that CRNAs providing fluoroscopic
guided LESIs do not have a higher complication rates than
physicians on 18 of 20 complications, and physicians have
published low fluoroscopic guided injection complication rates
(Botwin, et al, 2000, 2003, and 2006; Manchikanti et al., 2012b), we
encourage providers to continue to offer CRNA provided
fluoroscopic guided procedures, rather than forcing patients to
choose between traveling great distances and going without care.
We also encourage legislative and regulatory action to ensure access
to these procedures for underserved patient populations.
Dr. Mary Mackenburg-Mohn, PhD, RN, PNP Friend, mentor, and invaluable advocate for this
project. She encouraged me to pursue the DNP
and to choose Brandman University. I have
known Mary since I was a brand new EMT in
1991 and my life is richer for knowing her.
Dr. Mary Mays, PhD-An invaluable resource on
design and voice of this project with fantastic
insight on how to tell the story. I speak for my
entire cohort in thanking her for her guidance.
AANA Foundation-This study was funded, in
part, by a Doctoral Fellowship from the American
Association of Nurse Anesthetists Foundation.
American Association of Nurse Anesthetists Board of Directors. (1994). AANA position statement 2.11, Pain Management. Retrieved
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