Post-Operative Lumbar Surgical Pain Outcomes
with Implementation of Pre-Operative Pain
Medicine Consult
Does a preoperative pain management consult effect post-operative
lumbar surgical outcomes?
PI – Kyla Stripling, APRN, ACNP-BC
Assistant Instructor of Neurosurgery
Vanderbilt University Medical Center
Division of Neurological Surgery, Spine Division
1500 21st Avenue South, Suite 1506
Nashville, TN 37212
Co-PI- Heather Jackson, NP
Assistant Instructor of Anesthesiology
Vanderbilt University Medical Center
Division of Multispecialty Adult Anesthesiology
1301 Medical Center Drive, 4648 TVC
Nashville, TN 37232
Protocol Version #: 1
Protocol Date: 9/5/13
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Confidential
Table of Contents:
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Background
Study Objectives
Inclusion/Exclusion Criteria
Methods
Risks
Reporting of Adverse Events or Unanticipated Problems involving Risk to
Participants or Others
Statistical Considerations
Privacy/Confidentiality Issues
Follow-up and Record Retention
References
Protocol Version #: 1
Protocol Date: 9/5/13
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1.
Background
Current literature knowledge regarding pre-operative Pain Medicine consult and
reduction in post-operative pain is limited and underdeveloped. Review of the literature
illustrates a multitude of perioperative and postoperative medication management and
interventions/procedures in regards to managing pain. The majority of the research
focuses on identifying risk factors, pain outcomes, and specific diagnosis, such as
Chronic Regional Pain Syndrome (CRPS). There is minimal research illustrating how
preoperative pain management influences postoperative outcomes.
2.
Study Objectives and Hypotheses
The purpose of this study is to examine the implementation of a Nurse Practitioner driven
preoperative pain management intervention and the effect on postoperative pain control
within an acute three-month postoperative period. This study will focus on the
postoperative need for long-term opioid therapy, occurrence of Failed Back Surgery
Syndrome (FBSS) after surgery, and functionability following a pain management
consult(s) prior to surgery.
Primary Objective:
The primary aim of the study is to examine whether pre-surgical Pain Medicine consult
will improve or reduce postoperative pain within an acute 3-month period reducing the
need for long-term opioid therapy, occurrence of FBSS after surgery, and functionability
following a pain management consult(s) prior to surgery using Visual Analog Scale
(VAS), Oswestry Disability Form, Patient Satisfaction Questionnaire, and monitoring
length on opioids after surgical intervention.
Secondary Hypotheses:
Pre-operative Pain Medicine consult will reduce the occurrence of FBSS.
3.
Inclusion/Exclusion Criteria
Inclusion Criteria:
a. 1 or less spinal surgeries
b. Lumbar surgery
c. Ages 18 years old ≤ or ≥65 years old
Exclusion criteria
d. Not a corrective surgery for failed instrumentation/pseudarthrosis
e. No history of osteoporosis/osteopenia
f. No history of chronic pain
g. No history of opioid dependency or mental health history
4.
Methods
A total of 20-25 patients who meet the above inclusion and exclusion criteria will be
randomly selected over a 3-4 month period and followed through the initial three month
post-operative course followed by both the Pain Medicine NP and Neurosurgery Spine
NP.
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Protocol Date: 9/5/13
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Selection Process
 Whom: Kyla Stripling, Spine NP
 Credentials: APRN, ACNP-BC
 Location: VAV Neurosurgery Clinic
 When: Initial pre-surgical consult
Follow up
The patient will be seen by Kyla Stripling, NP (Neurosurgery-Spine) at 6 weeks and 12
weeks post-operative, and by Heather Jackson, NP (Pain Medicine) at 8 weeks and 12
weeks. If additional follow up or monitoring is warranted this will be scheduled per
patient needs.
5.
Risks
To protect the patient’s confidentiality, all data will be stored on a password protected
server in a locked area of the VUMC Department of Anesthesiology or Neursosurgery.
This data will only be accessable by the PI and KSP.Leave this in, it is templated
language and how we must handled all info per HIPPA
6.
Reporting of Adverse Events or Unanticipated Problems involving Risk to Participants or
Others
Adverse events will be monitored throughout the study. All clinically significant adverse
events will be monitored until resolution or, if the adverse event is determined to be
chronic, a cause is identified. If an adverse event remains unresolved at the conclusion of
the study, the investigator will assess whether continued follow-up of the adverse event is
warranted. In those cases where the investigator deems that there is a need for further
follow-up, the investigator will establish a plan for follow-up and communicate that
directly to the study subject.
The PI of this study will report adverse events to the IRB per IRB reporting guidelines.
7.
Statistical Considerations
Statistical Analysis Plan:
Descriptive Statistics
Primary Aim:
The primary aim of the study is to examine whether Visual Analog Scale (VAS),
Oswestry Disability Form and Patient Satisfaction Questionnaire scores will be lower at
12 week post-operative follow up visit for study population gropu verses randomized
group.
Secondary Aims:
The secondary aim is to examine if the study population gropup will have reduce length
of time on opioid medications verses randomized group.
Power Calculation:
Randomization Scheme:
A stratified, block randomization scheme with blocks of size 4 will be used to allocate patient to
the group with UTB or ISB, stratification will based on gender. A randomization table (Table 3)
Protocol Version #: 1
Protocol Date: 9/5/13
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with up to 32 patient assignments for each stratum was created by randomly permuting treatment
(UUII) within each block. The table shows the first male patient will be assigned to UTB group.
The randomization table will be provided later using excel table (e.g. as below)
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8.
Privacy/Confidentiality Issues
All reasonable efforts will be made to keep a patient’s protected health information (PHI)
private and confidential. The data that’s collected will be stored in a password protected
electronic database located in a locked area of VUMC. Only the PI and Key Study
Personnel (KSP) will have access to medical records and study data.
Patients will be assigned a unique code which will not be derived or related to individual
identifiers. The code will correspond with the subject’s row number in an Excel
Spreadsheet. For instance, patient “1” will be in row “2”. Patient “2” will be in row “3”
and so on. Identifiable links to the data will be kept separate from the data set and will be
destroyed once the study is closed. These links will include the patient’s name and
medical record number. Only Key Study Personnel (KSP) will have access to the linked
data elements and codes.
Study participant data will be collected electronically and by hand using patient medical
records. The data will be labeled in an Excel spreadsheet according to the type of data
collected. For example, column “A” is titled “Age”. A member of the research team will
enter the age of each subject in the row that corresponds with their unique code under
column “A”. Including, limited access to medical records and creation of a limited data
set. Federal privacy guidelines will be followed when using or sharing any protected
health information.
Data points will be queried and recorded in an electronic database from patient
medical records. This database will be stored on a password protected server in a
locked area of VUMC and will only be accessed by the PI and KSP. Once the
study is concluded, all patient identifiers will be destroyed.
9.
Follow-up and Record Retention
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Protocol Date: 9/5/13
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Research Records will be retained by the Perioperative Clinical Research Institute (PCRI)
for a period of six (6) years after the submission of the final report and close-out
procedures on the research project for which the Research Records were prepared.
The retention of the original Research Records shall be the responsibility of the Principal
Investigator on behalf of PCRI, but at all times shall remain the property of PCRI, unless
otherwise specified by law, regulation or agreement.
10.
References
Buvanendran, A. Chronic postsurgical pain: are we closer to understanding the puzzle?
Anesthesia & Analgesia, 2012, 115, 2.
Buvanendran A, Kroin JS, Della Valle CJ, Kari M, Moric M, Tuman KJ. Perioperative oral
pregabalin reduces chronic pain after total knee arthroplasty: a prospective, randomized,
controlled trial. Anesthesia & Analgesia. 2010, 110 (1): 199-207.
Clark H, Bonin R, Orser B, Englesakis M, Wijeysundera D, Katz, J. The prevention of chronic
postsurgical pain using gabapentin and pregabalin: a combined systematic review and metaanalysis. Anesthesia & Analgesia. 2012, 115: 428-42.
Cohen SP, Srinivasa NR. Prevention of chronic postsurgical pain: the ongoing search for the holy
grail of anesthesiology. Anesthesiology. 2013, 118 (2): 241-243.
Dahl JB, Kehlet, H. Preventive analgesia. Current Opinion in Anaesthesiology. 2011, 24 (3): 3318.
Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine 2000; 25 (22): 2940-2952
Gilron I, Moore RA, Wiffen PJ, McQyay HJ. Pharmacotherapy for the prevention of chronic pain
after surgery in adults. The Cochrane Library, 2010, issue 11.
Hance C, Woodhouse L, Kennedy D, Stratford P, Katz J. Stregies ained at preventing chronic post
surgical pain: comprehensive perioperative pain management after total joint replacement
surgery. Physiotherapy Canada. 2011, 63(3): 289-304.
Hegarty D, Shorten G. Multivariate prognostic modeling of persistent pain following lumbar
discectomy. Pain Physician. 2012, 15:421-434.
Zakkar M, Frazer S, Hunt I. Is there a role for gabapentin in preventing or treating pain following
thoracic surgery? Interactive Cardiovascular and Thoracic Surgery, 2013, July 6.
Zang J, Ho K, Wang Y. Efficacy of pregabalin in acute-postoperative pain: a meta-analysis.
British Journal of Anaesthesia. 2011, 106: 454-62.
Protocol Version #: 1
Protocol Date: 9/5/13
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