Enhanced Recovery After Spine Surgery: A Prospective Randomized Controlled Trial to Assess Quality of Recovery and the Biochemical Stress Response to Lumbar Fusion
Phase: NA
Conditions: Enhanced Recovery After Surgery, Spine Surgery
Sponsor: Hospital for Special Surgery, New York

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Enhanced Recovery After Spine Surgery: A Prospective 
Randomized Controlled Trial to Assess Quality of 
Recovery and the Biochemical Stress Response to 
Lumbar Fusion 
 
 
FUNDER: Research & Education Fund, Department of 
Anesthesiology, Critical Care & Pain 
Management 
PROTOCOL NO.: 2016-617 
VERSION & DATE: 5/4/2020 
 
 
 
 
 
 
 
 
 
 

 
  
 
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This document contains the confidential information of the Hospital for Special Surgery.  It is provided to you and your company’s personnel for 
review.  Your acceptance of this document constitutes an agreement that you will not disclose the information contained herein to others without 
the prior written consent of the Hospital for Special Surgery.  No other use or reproduction is authorized by Hospital for Special Surgery, nor does 
the Hospital for Special Surgery assume any responsibility for unauthorized use of this protocol 
PROTOCOL SYNOPSIS 
Protocol Title: 
Enhanced Recovery After Spine Surgery: A Prospective 
Randomized Controlled Trial to Assess Quality of Recovery and 
the Biochemical Stress Response to Lumbar Fusion 
Protocol Number: 
2016-617 
Protocol Date: 
5/4/2020 
Sponsor: 
N/A 
Principal 
Investigator: 
Ellen M Soffin, MD PhD 
Products: 
NA 
Objective: 
Our primary aim was to investigate the effect of the pathway on 
patient quality of recovery compared with usual care in a 
randomized controlled trial at an orthopedic specialty hospital. 
Study Design: 
Randomized Controlled Trial 
Enrollment: 
56 
Subject Criteria: 
1. Any patient presenting for 1 or 2 level posterior lumbar 
fusion with instrumentation. 
2. Ages 21 and older. 
Study Duration: 
December 2016 – October 2018 
Data Collection: 
 
Name 
 
MRN ID 
 
Age 
 
Race 
 
Ethnicity 
 
Gender 
 
Height 
 
Weight 
 
BMI 
 
ASA 
 
QoR40 Survey Scores 
 
Details of nutritional, anesthetic, and PT management 
 
Collection of Plasma 

 
  
 
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 
PT assessment for patient discharge 
 
Surgical assessment of patient discharge 
 
Postoperative complications 
Outcome 
Parameters: 
 
The primary outcome is patient score on the Quality of 
Recovery 40 (QoR40) inventory, measured at POD3. 
1. Length of stay and time from surgery to meeting discharge 
and physical therapy goals (measured in days after 
surgery). 
2. Pain control: opioid consumption and NRS rating scales of 
pain (measured in morphine equivalents, and 
numerically, respectively, daily). 
3. Time to post-operative oral intake (measured in days after 
surgery; or hours, if on POD 0).  
4. Post-operative nausea, vomiting and ileus (measured daily 
after surgery). 
5. Levels of plasma markers of surgical stress (IL-6, cortisol, 
CRP and insulin resistance; post-operative days 0 [ie, 
PACU], 1 and 3).  
6. Other post-operative complications: presence of 
delirium/confusion, infection, DVT/PE (will be assessed 
for the entire hospital admission, but measured at 
discharge.  
7. QoR40 administered daily during the admission (starting at 
POD 0; ie, prior to PACU discharge) until POD 3, once 
on the day of discharge, and on PODs 14 and 56. 

 
  
 
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Statistical Analysis: 
1. Proposed analysis (e.g., student’s t-test, ANOVA, chi-square, 
regression, etc.): two-sample t-test 
2. Alpha level: 0.05 
3. Beta or power level: 80% 
4. Primary outcome variable estimate (mean +/- s.d. for 
continuous outcome, frequency/percentage for categorical 
variable): mean +/- SD QoR40 on POD 3 in control group = 
183.0 ± 14.1 (Bekker 2013) 
5. Number of groups being compared (use 1 for paired analysis 
within the same subjects):2 
6. Effect size or change expected between groups: 12 point 
difference in QoR40 score between groups (Myles et al., 2012 
found a 12 point 
difference in mean QoR40 score between patients with and 
without severe postoperative nausea and vomiting) 
7. Resulting number per group: 25 
8. Total sample size required: 50 + ~10% to account for attrition 
= 56 
 
 Adding 4 more patients to achieve 80% power which is 
a total sample size of 60 
 
The primary outcome (QoR40 on POD3) will be compared 
between the ERAS and conventional perioperative management 
groups using a two sample t-test or Wilcoxon rank-sum test, 
depending upon the distribution of the data. As a secondary 
analysis, linear regression will be used to compare the primary 
outcome between groups while adjusting for number of spine 
levels fused. Secondary outcomes measured once per patient 
will be analyzed by t-test or Wilcoxon rank-sum test (continuous 
data) and χ2 or Fisher’s exact test (categorical data). 
Outcomes measured multiple times per patient (e.g., plasma 
levels of IL-6, cortisol, CRP and the glucose:insulin) will be 
analyzed using regression based on a generalized estimating 
equation approach. 
Balance on demographics and baseline characteristics will be 
assessed by calculating standardized differences (difference in 
means or proportions divided by the pooled standard deviation) 
between groups. An absolute value of 0.2 or greater will be 
interpreted as more imbalance than would be expected by 
chance (Austin 2009). 
All analyses will be performed on an intention-to-treat basis. 
 
 
 

 
  
 
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1.0 INTRODUCTION 
The concept of ERAS was first introduced by Henrik Kehlet in the 1990s (Kehlet, 1997).  The 
goal of ERAS pathways is to promote faster recovery by maintaining pre-operative organ 
function and reducing the profound stress response that follows surgery.  Early studies in 
colorectal surgery patients established that “organ dysfunction”, (expressed as pain, nausea, 
vomiting, ileus, fatigue and cognitive dysfunction), together with prolonged immobilization, and 
logistical issues all contribute to slow post-operative recovery.  Kehlet hypothesized that it 
was unlikely any single surgical technique, anesthetic intervention or medication could 
significantly impact organ dysfunction individually.  However, a better recovery could be 
achieved with a multimodal approach directed towards modulating the surgical stress 
response.  This led to the introduction of ERAS for colorectal surgery in which a number of 
pre-, intra- and postoperative interventions are delivered together in order to produce 
improvements in overall clinical outcomes and healthcare resource utilization.  A recent study 
published in JAMA highlights the clinical and economic gains that can be achieved with an 
ERAS-for-colorectal surgery pathway: compared to historic controls, after introducing the 
ERAS pathway, hospital stay was reduced by 3 days, without an increase in readmission rates; 
opiate consumption was reduced by 50%; and a cost saving of almost $7000 per surgery was 
achieved (Geltzeiler et al., 2014). Given the quality improvements found in colorectal patients, 
ERAS pathways have been quickly implemented in a range of surgical specialties, including 
total joint arthroplasty (hip and knee; Aasvang et al., 2015), gynecologic oncology (Nelson et 
al., 2014), urology (Melnyk et al., 2011), vascular (Podore & Throop, 1999) and thoracic 
surgery (Tovar et al. 1998).   
 
There is a strong theoretical case for the introduction of ERAS principles to major spine 
surgery.  The demand for spine surgery is increasing, and there are wide variations in length 
of stay, complication rates, post-operative pain and functional recovery.  In particular, spinal 
procedures are associated with especially high levels of pain.  Indeed, in a recent prospective 
study of pain intensity across 179 different surgical procedures, lumbar fusion and complex 
spinal reconstruction were ranked 3 of the 6 most painful (Gerbershagen et al., 2013).  Similar 
to colorectal procedures, ileus is a frequent complication limiting recovery and increasing 
length of stay after spinal fusion (Motasem et al., 2014).  Additionally, rates of lumbar fusion 
are increasing rapidly, particularly for spinal stenosis and degenerative spondylolisthesis.  The 
US Spinal Surgery Market Outlook to 2017 indicates that advanced technologies and an aging 
population will lead to further increased demand for these procedures (Ken Research, 2013).  
At the same time, evidence derived from Medicare patients suggests that aggregated hospital 
charges are increasing while the overall procedure cost is falling, suggesting greater surgical 
complexity and/or longer length of stay (Deyo et al., 2010).  
 
Thus, there are clinical and economic imperatives to develop strategies to improve outcomes 
after spine surgery.  To date, ERAS principles have not yet been applied to spine surgery.  
Given the success of ERAS in so many surgical disciplines, here we ask whether an ERAS 
pathway can also improve quality of recovery and reduce complications after multi-level 
lumbar fusion.    

 
  
 
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A major assumption underlying the efficacy of ERAS pathways is modulation of the systemic 
inflammatory response (SIR) to surgery (Kehlet, 1997).  The stress of surgery leads to well-
characterized metabolic, endocrine and immune responses, which together promote 
physiological stability and healing (Marik & Flemmer, 2012).  The major responses to 
surgical injury include the release of proinflammatory cytokines (most importantly, IL-6) and 
acute phase proteins (C-reactive protein), elevated cortisol, and the development of insulin 
resistance (Desborough, 2000). CRP and IL-6 have the strongest association with the 
magnitude of the surgical injury (Watt et al., 2015a).   A recent meta-analysis of the effect of 
ERAS on markers of SIR after colorectal surgery concluded that overall, objective evidence 
is limited, with the exception that a laparoscopic approach is associated with reduction in IL-
6 and CRP (Watt et al., 2015).  There is limited data regarding inflammatory markers after 
spine surgery: percutaneous lumbar discectomy is associated with lower levels of 
inflammatory cytokines compared to open discectomy (Pan et al., 2014), and glucocorticoids 
modulate levels of most cytokines after osteotomy (Reikeras et al., 2009).  Bekker et al 
(2013) described reduced IL-10 and cortisol after dexmedetomidine infusion in patients 
undergoing lumbar fusion, but to date, the relationship between perioperative interventions 
and effects on SIR remains an underexplored area of research.   
 
Aasvang, E.K., Luna, I.E., Kehlet, H. (2015). Challenges in post-discharge function and 
recovery: the case of fast-track hip and knee arthroplasty. Br J Anaesth 115(6):861-6. 
Bekker, A., Haile, M., Kline, R. et al. (2013). The effect of intraoperative infusion of 
dexmedetomidine on quality of recovery after major spinal surgery. J Neurosurg Anesthesiol. 
25(1):16-24. 
Desborough, J.P. (2000). The stress response to trauma and surgery. Br J Anaesth 85:109-
17. 
Deyo, R.A., Mirza, S., Brook, I.M. et al. (2010). Trends, major complications, and charges 
associated with surgery for lumbar spinal stenosis in older adults. JAMA 303:1259-1265. 
Geltzeiler, C.B., Rotramel, A., Wilson, C. et al. (2014). Prospective study of colorectal enhance 
recovery after surgery in a community hospital. JAMA Surg. 149(9):955-61. 
Gerbershagen, H.J., Aduckathil, S., van Wijck, A.J. et al. (2013). Pain intensity on the first day 
after surgery: A prospective cohort study comparing 179 surgical procedures. Anesthesiology 
118(4):934-44.  
Kehlet, H. (1997). Multimodal approach to control postoperative pathophysiology and 
rehabilitation. Br. J Anaesth 78(5):606-17.  
Ken Research (2013). The US Spinal Surgery Market Outlook to 2017; Ageing population and 
technological 
advances 
to 
intensify 
the 
competition. 
Available 
at  
www.marketresearch.com/product/sample-7535890.pdf  
Marik, P.E. & Flemmer, M. (2012). The immune response to surgery and trauma: implications 
for treatment. J Trauma Acute Care Surg 73:801-8. 
Melnyk, M., Casey, R.G., Black, P. & Koupparis, A.J. (2011). Enhanced recovery after surgery 
(ERAS) protocols: Time to change practice? Can Urol Assoc J. 5(5):342-348.  
Motasem, A.M., Du, J.Y., Aichmair, A., Huang, R.C. et al. (2014). Multivariate analysis on risk 
factors for postoperative ileus after lateral lumbar interbody fusion. Spine 39(8):688-694.  

 
  
 
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Nelson, G., Kalogera, E. & Dowdy, S.C. (2014). Enhanced recovery pathways in gynecologic 
oncology. Gynecol Oncol. 135(3):586-94. 
Podore, P.C. & Throop, E.B. (1999). Infrarenal aortic surgery with a 3-day hospital stay: A 
report on success with a clinical pathway. J Vasc Surg. 29:787-92.  
Pan, L., Zhang, P. & Yin, Q. (2014). Comparison of tissue damages caused by endoscopic 
lumbar discectomy and traditional lumbar discectomy: a randomized controlled trial. Int J Surg 
12(5):534-7. 
Reikeras, O., Helle, A., Krohn, C.D. & Brox, J.I. (2009). Effects of high-dose corticosteroids 
on post-traumatic inflammatory mediators. Inflamm Res 58(12):891-7. 
Tovar, E.A., Roethe, R.A., Weissig, M.D. et al. (1998). One-day admission for lung lobectomy: 
an incidental result of a clinical pathway. Ann Thorac Surg. 65:803-6.  
Watt, D.G., Horgan, P.G. & McMillan, D.C. (2015a). Routine clinical markers of the 
magnitude of the systemic inflammatory response after elective operation: a systematic 
review. Surgery 157:362-80. 
2.0 PRODUCT DESCRIPTION 
N/A 
3.0 OBJECTIVE OF CLINICAL STUDY 
The specific aims are to determine if placing patients on the ERAS for spine pathway will: 
1. Improve the quality of recovery after spine surgery. 
2. Accelerate recovery. 
3. Be associated with fewer post-operative complications. 
Attenuate the stress response to surgery. 
4.0 STUDY HYPOTHESES 
Hypothesis 1:  ERAS pathway patients will experience greater quality of recovery after 
multilevel spine fusion. 
Hypothesis 2:  ERAS patients will demonstrate accelerated recovery after surgery, as 
evidenced by faster time to discharge readiness. 
Hypothesis 3:  Use of the ERAS pathway will be associated with fewer post-operative 
complications.  
Hypothesis 4:  The pathway will modulate the surgical stress response. 
5.0 STUDY DESIGN 
 
5.1 
Study Duration 
12/2016-10/2018 
5.2 
Endpoints 
 

 
  
 
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5.2.1 
Primary Endpoint 
 
The primary outcome is patient score on the Quality of Recovery 40 (QoR40) 
inventory, measured at POD3. 
5.2.2 
Secondary Endpoints 
 Length of stay and time from surgery to meeting discharge and physical therapy goals 
(measured in days after surgery). 
 Pain control: opioid consumption and NRS rating scales of pain (measured in 
morphine equivalents, and numerically, respectively, daily). 
 Time to post-operative oral intake (measured in days after surgery; or hours, if on POD 
0).  
 Post-operative nausea, vomiting and ileus (measured daily after surgery). 
 Levels of plasma markers of surgical stress (IL-6, cortisol, CRP and insulin resistance; 
post-operative days 0 [ie, PACU], 1 and 3).  
 Other post-operative complications: presence of delirium/confusion, infection, DVT/PE 
(will be assessed for the entire hospital admission, but measured at discharge.  
 QoR40 administered daily during the admission (starting at POD 0; ie, prior to PACU 
discharge) until POD 3, once on the day of discharge, and on PODs 14 and 56. 
 
5.3 
Study Sites 
Hospital for Special Surgery – Main Campus 
6.0 STUDY POPULATION 
6.1 
Number of Subjects 
 
56 
6.2 
Inclusion Criteria 
Subjects of either gender will be included if they: 
 
Any patient presenting for 1 or 2 level posterior lumbar fusion with instrumentation. 
 
Ages 21 and older. 
 
6.3 
Exclusion Criteria 
Subjects will be excluded from the study if they: 
 
Cognitive impairment (baseline dementia, cognitive dysfunction or inability to consent 
to participate). 
 
Kidney disease: GFR <60 mL/min/1.73 m2 for 3 months or more, irrespective of 
cause (Levey et al., 2012). 
 
Liver disease: transaminitis, cirrhosis, hepatitis, hypoalbuminemia, coagulopathy. 
 
Pre-existing bowel disease (inflammatory bowel disease, colectomy/ 
colostomy/diverticular disease). 
 
Allergy/intolerance/contraindication to any medication or component included in the 
ERAS pathway protocol. 

 
  
 
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 
Diabetes mellitus (types I and II). 
 
Planned minimally invasive surgical technique including use of the Coflex device. 
 
Patients whose primary or preferred language is not English. 
 
Patients planned to be discharged to rehab facility post-operatively. 
 
Planned procedures involving revisions of instrumented posterior lumbar fusions, 
xtreme lateral interbody fusions, and/or removals. 
6.4 
Randomization 
The randomization schedule will be created using SAS software by a member of the 
Healthcare Research Institute not otherwise involved in the trial. The randomization 
schedule will be stratified by number of spine levels fused (50 1-level fusions vs. 10 2-level 
fusions to account for the relative frequency of each procedure) and contain permuted 
blocks within each stratum. Randomization will be performed after the patient has signed 
informed consent to be in the study but prior to interventions and observations. 
7.0 PROCEDURES 
7.1 
Surgical Procedure 
 
1 or 2 level posterior lumbar fusion 
7.1.1 
Investigational Product Application 
N/A 
 
7.2 
Data Collection 
 
Data will be collected by an investigator or research assistant. Sources of data include 
medical records and patient physical assessments conducted by study personnel. Data will 
be recorded and managed using REDCap electronic data capture tools hosted at the 
Clinical and Translational Science Center (CTSC) at Weill Cornell Medical College. 
REDCap (Research Electronic Data Capture) is a secure, web-based application designed 
to support data capture for research studies, providing: 1) an intuitive interface for validated 
data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated 
export procedures for seamless data downloads to common statistical packages; and 4) 
procedures for importing data from external sources. Connection to REDCap occurs via the 
hospital’s encrypted cable and wireless networks, and data will be entered through a 
password-protected computer terminal or iPad.   

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7.3 
Schedule of Assessments 
 
Study Visit # 
Randomization 
Surgery 
Administration of IV 
Study Medication 
Administration of 
Topical Study 
Medication 
Blood Draw 
(from existing 
catheter) 
Collection of 
Drained Blood from 
Wound 
#1  
OR, Before 
TQ onset 
X 
SOC 
X 
 
X 
 
#2  
OR, Before 
final TQ 
release 
 
 
 
X 
X 
X (Surgeon collects 
pooled blood 
around wound) 
#3 PACU, 1 
hour after 
TQ release  
 
 
X 
 
X 
 
#4 PACU, 4 
hours after 
TQ release 
 
 
 
 
X 
X  
(Taken from 
surgical drain) 
 
X= Research Procedures 
SOC= Standard of care (care you would receive if you were not participating in this study) 
OR = Operating Room; PACU = Post-Anesthesia Care Unit; TQ = Tourniquet; IV = Intravenous 

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8.0 STATISTICAL ANALYSIS 
1. Proposed analysis (e.g., student’s t-test, ANOVA, chi-square, regression, etc.): two-
sample t-test 
2. Alpha level: 0.05 
3. Beta or power level: 80% 
4. Primary outcome variable estimate (mean +/- s.d. for continuous outcome, 
frequency/percentage for categorical variable): mean +/- SD QoR40 on POD 3 in control 
group = 183.0 ± 14.1 (Bekker 2013) 
5. Number of groups being compared (use 1 for paired analysis within the same subjects):2 
6. Effect size or change expected between groups: 12 point difference in QoR40 score 
between groups (Myles et al., 2012 found a 12 point 
difference in mean QoR40 score between patients with and without severe postoperative 
nausea and vomiting) 
7. Resulting number per group: 25 
8. Total sample size required: 50 + ~10% to account for attrition = 56 
 
 Adding 4 more patients to achieve 80% power which is a total sample size of 60 
 
The primary outcome (QoR40 on POD3) will be compared between the ERAS and 
conventional perioperative management groups using a two sample t-test or Wilcoxon rank-
sum test, depending upon the distribution of the data. As a secondary analysis, linear 
regression will be used to compare the primary outcome between groups while adjusting for 
number of spine levels fused. Secondary outcomes measured once per patient will be 
analyzed by t-test or Wilcoxon rank-sum test (continuous data) and χ2 or Fisher’s exact test 
(categorical data). 
Outcomes measured multiple times per patient (e.g., plasma levels of IL-6, cortisol, CRP 
and the glucose:insulin) will be analyzed using regression based on a generalized 
estimating equation approach. 
Balance on demographics and baseline characteristics will be assessed by calculating 
standardized differences (difference in means or proportions divided by the pooled standard 
deviation) between groups. An absolute value of 0.2 or greater will be interpreted as more 
imbalance than would be expected by chance (Austin 2009). 
All analyses will be performed on an intention-to-treat basis. 
9.0 ADVERSE EVENT ASSESSMENT 
All Adverse Events (AEs) will be reported in the final study report. Definitions for Adverse 
Event (AE) used in this study are listed below and are based on FDA and international 
guidelines: 
 
9.1 
Adverse Event (AE) 
All of the components included in the proposed ERAS pathway have evidence of benefit, no 
evidence of harm, and are used routinely in the care of patients undergoing lumbar fusion at 
HSS. The objective of this study is to ensure that those assigned to the ERAS pathway will 
receive these standard of care components. Patients who are assigned in the no-treatment 
(usual care) group will be receiving conventional perioperative management and will thus be 
considered standard of care, as well. Prior to enrollment at their pre-operative surgical clinic 
appointment, patients will be thoroughly screened to determine eligibility by a study 

 
  
 
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investigator. However, if after enrollment, the clinical judgment of the healthcare provider(s) 
deems the patient to be unfit to continue the study procedures specific to his/her ERAS group 
assignment, he/she will thereafter proceed through the conventional perioperative pathway. 
The risks of collecting plasma for this study are similar to the risks of a routine blood draw, 
including - mild pain, bruising, and very rarely infection at the place of needle insertion. 
However, the likelihood of these risks occurring is rare, as an arterial line catheter is routinely 
placed in patients undergoing this class of spine surgery in order to continuously monitor the 
patient's hemodynamics perioperatively. The study team expects to draw samples using the 
pre-existing catheter. Patients can decline to participate in further blood draws at any point 
after enrollment should discomfort become a concern. 
Participation in this research involves the potential risk of a break of confidentiality to stored 
health information. HSS tries to minimize those risks by (i) removing some direct identifiers 
from stored information (i.e., names, social security numbers, medical record numbers); (ii) 
securing, in a separate location, and limiting access to information that would be identifiable; 
and (iii) limiting access to information stored to HSS investigators. 
The likelihood of a breach of confidentiality is minimal. 
9.2 
Serious Adverse Events (SAE) 
N/A 
9.3 
Subsequent Surgical Interventions Definitions 
N/A 
9.4 
Adverse Event Reporting 
All adverse events will be reported to the DSMB and IRB within five working days of the 
event. 
10.0 INVESTIGATOR RESPONSIBILITIES, RECORD AND REPORTS 
 
10.1 Subject Consent and Information 
Written/signed consent will be collected from participants in the holding area before surgery. 
 
10.2 Subject Data Protection 
o HSS tries to minimize those risks by (i) removing some direct identifiers from information 
stored [(i.e., names, social security numbers, medical record numbers)]; (ii) securing, in a 
separate location, and limiting access to information linking codes (i.e., linkage codes) 
assigned to the registry information with direct participant identifiers; and (iii) limiting 
access to information stored to HSS investigators.  
o Access to the REDCap program is password-protected, and access to a specific study's 
information within the program is limited to the research assistant and other IRB-approved 
study personnel who have been given permission to view and/or enter study data. 
REDCap program access is authorized by the CTSC; particular study access is granted by 
the research assistant. For data exports, fields marked as protected health information 
(PHI) in REDCap will be de-identified, if feasible. 

 
  
 
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o All transmission of data will occur via encrypted networks in password-protected files. Any 
paper-based data sheets utilized for the study will have personal identifiers removed 
whenever possible and will be stored in the department's locked office. Each subject will 
be assigned a unique study number for identification, and that number will not be derived 
from or related to information about the individual. Presentations and publications that 
result from this study will not contain any individual identifiers (at most the unique study 
numbers may be referred to). Thus our research presents a minimal risk of harm to 
subjects' privacy. 
 
 

 
  
 
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