Randomized Control Trial to Assess the Efficacy of Preoperative Erector Spinae Blocks on Cardiac Surgery Postoperative Outcomes
Phase: PHASE2
Conditions: Pain, Postoperative, Opioid Use, Perioperative Complication, Heart Diseases
Sponsor: Rutgers, The State University of New Jersey

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INTERVENTIONAL
RESEARCH PROTOCOL TEMPLATE
(HRP-503a)
Randomized Control Trial to Assess the Efficacy of Preoperative Erector 
Spinae Blocks on Cardiac Surgery Postoperative Outcomes
Protocol # 2022001580
Primary Investigator:
Leonard Y. Lee, MD
Chair, Department of Surgery
Telephone: 732-235-8725
Email Address: leele@rwjms.rutgers.edu
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Table of Contents
Skip To Section: Hold CTRL + Click (Below) To Follow Link in Blue
1.0
Research Design
1.1
Purpose/Specific Aims
1.2
Research Significance
1.3
Research Design and Methods
1.4
Preliminary Data
1.5
Sample Size Justification
1.6
Study Variables
1.7
Drugs/Devices/Biologics
1.8
Specimen Collection
1.9
Data Collection
1.10
Timetable/Schedule of Events
2.0
Project Management
2.1
Research Staff and Qualifications
2.2
Research Staff Training
2.3
Other Resources
2.4
Research Sites
3.0
Multi-Center Research
4.0
Subject Considerations
4.1
Subject Selection and Enrollment Considerations
4.2
Obtaining Identifiable Information About Non-Subjects
4.3
Number of Subjects
4.4
Consent Procedures
4.5
Special Consent Populations
4.6
Economic Burden and/or Compensation For Subjects
4.7
Risks of Harm/Potential for Benefits to Subjects
5.0
Special Considerations
5.1
Health Insurance Portability and Accountability Act (HIPAA)
5.2
Family Educational Rights and Privacy Act (FERPA)
5.3
Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations)
5.4
General Data Protection Regulation (GDPR)
5.5
 NJ Access to Medical Research Act (Surrogate Consent) 
6.0
Data Management Plan
6.1
Data Analysis
6.2
Data Security
6.3
Data Safety And Monitoring
6.4
Reporting Results
6.5
Secondary Use of Data
7.0
Research Repositories – Specimens and/or Data
8.0
Approvals/Authorizations
9.0
Bibliography
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1.0 Research Design
1.1 Purpose/Specific Aims
The goal of this pilot study is to describe and compare Ultrasound-Guided Erector Spinae 
Plane (ESP) Blocks using Exparel® (bupivacaine liposome injectable suspension) to 
Marcaine® (bupivacaine hydrochloride) for pain management and outcomes after cardiac 
surgeries.
A.  Objectives 
To assess and compare patients treated with Exparel vs. Marcaine on; 

postoperative opioid usage, 

postoperative subjective pain scale

postoperative nonopioid analgesic usage

composite adverse outcomes, encompassing all-cause mortality and major 
morbidity (stroke, MI, respiratory failure, kidney failure)

postoperative quality of life 
B.  Hypotheses / Research Question(s)
Compared to Marcaine patients treated with Exparel will have:

less usage of opioid pain medications

noninferior rates of major adverse outcomes, including morality and major 
morbidity

lower postoperative pain scores

less usage of nonopioid analgesics

improved quality of life  
1.2 Research Significance
Postoperative pain is a major concern for patients after cardiovascular surgery (1). 
With an increasing emphasis on improving perioperative care arising from evidence-
based protocols such as Enhanced Recovery After Surgery (ERAS), reducing 
postoperative pain not only increases patient satisfaction, but also decreases 
postoperative complications and improves outcomes. Reduced postoperative pain 
also decreases rates of pneumonia and time on mechanical ventilation, in the ICU, or 
in the hospital (2). Importantly, decreasing postoperative pain can also reduce high 
dose opioid usage, the established method of managing postoperative pain, thereby 
decreasing rates of nausea/vomiting, intubation time, and mortality (3). Methods of 
reducing postoperative pain, such as neuraxial anesthesia and deep plexus blocks, 
are associated with an increased risk of epidural hematoma; an alternate solution, 
therefore, is using fascial plane blocks (4).
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Since 2018, our institution is one of very few that uses pre-operative fascial plane 
blocks for cardiac surgery patients, implementing bilateral plane blocks for the 
sternotomy approach and unilateral plane blocks for the right mini-thoracotomy 
approach. Results from these blocks have been quite favorable but not yet validated. 
A study in which subjects are randomized to not receive an ESP block preoperatively 
would raise concerns regarding equipoise.Therefore, this study is designed to better 
understand the overall effects of these blocks by comparing FDA approved 
medications, Exparel (current practice at RWJUH) and Marcaine. Marcaine (0.25% 
bupivacaine HCl) has an onset of action on the order of seconds and generally within 
one minute from the time of injection, and an effect duration of roughly seven hours.(5) 
Exparel is a commercially available extended-release formulation of liposomal 
bupivacaine, which extends the effect duration to an upward of 72 hours from the time 
of injection with similarly immediate onset of action.(6) Several studies have compared 
local injections of Marcaine (plain bupivacaine) with Exparel (liposomal bupivacaine) 
in the setting of inguinal hernia repair, knee arthroplasty, breast augmentation, and 
hemorrhoidectomy, with results favoring the use of liposomal bupivacaine based on 
improvements in subjective pain at the initial postoperative pain assessment.(6) 
Clinical trials are currently underway, investigating the effect of liposomal bupivacaine 
for local anesthesia and compared with epidural anesthesia in thoracoscopic 
surgery.(7,8) In a recent clinical trial published in JAMA, patients undergoing 
cardiothoracic or vascular surgery subjected to truncal incisions did not demonstrate 
a significant benefit with respect to pain control or adjunctive opioid usage when 
treated with liposomal bupivacaine over plain bupivacaine via local injection.(9) Still, 
a gap in the literature exists with respect to the use of liposomal bupivacaine versus 
plain bupivacaine for erector spinae plane block in the setting of sternotomy. The aim 
of this prospective study is to determine the impact of preoperative fascial plane blocks 
with Exparel compared to Marcaine on outcomes following cardiac procedures.
1.3 Research Design and Methods
A. Research Procedures
This study is a prospective, randomized, controlled trial. 
Consent will be obtained prior to any study procedures.
The subject will be randomly assigned to receive either Exparel or Marcaine during 
surgery.
Randomization will be done in blocks of 10 (5 Exparel and 5 Marcaine) within each 
surgery group (Mini thoracotomy procedures (Minis) or Open sternotomy (Open). 
One of 10 sealed envelopes (either Exparel or Marcaine) will be drawn prior to 
surgery to determine which drug the subject will receive.
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Designated study staff (not involved with patient assessments) will randomize and 
inform the anesthesiologist which medication to administer via the block. The 
subject and all other study staff will be blinded to treatment group.
The anesthesiologist will administer the block per routine care utilizing the 
designated medication.  
Surgery will be performed per standard of care.
SF-12 questionnaire will be administered/completed prior to surgery and at the 
routine follow-up clinic visit.
B. Data Points
Study ID
 
Exparel group?
 
Age
 
Gender
 
Ethnicity
 
BMI
 
Race
 
Admit Date
 
Discharge Date
 
LOS 
 
LOS ICU
 
Time of intubation
 
Time of extubation
 
Intubation time
 
Primary operating surgeon
Case booking status
Elective or Urgent(diagnosis & 
surgery occurring in same 
hospitalization)
Hospitalization costs
 
Co-morbidities: 
 
inflammatory disorders (list)
 
pre-existing arrhythmias
atrial or ventricular
Hypertension, dyslipidemia, DM
 MI, Pre-op 
pacemaker/defibrillator, CVA
Smoking History
STS and NYHA score
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Outcomes (through 30 days)
 
Pneumonia
 
Respiratory failure with ventilatory support >48h
 
Pulmonary embolism
 
DVT
 
Organ Failure
 
Post-op MI
clinical dx, cardiogenic shock
Acute renal failure requiring renal replacement 
therapy
 Dialysis CVVH
Cerebral Vascular Accident (CVA)
Infection
wound or line & UTI
Readmission  
Post op Arrhythmia
Atrial, ventricular 
New Post-op A-fib
 Post op pacemaker/defibrillator
Exacerbation of Pre-existing A-Fib
 
Discharge Status:
 
Home, Rehab or Expired
 
Pain scores thru postop d 5 
Daily Average
One time pain score at f/u visit
One score
 
 
In-hospital opioid usage (dose mg/day)
 thru postop d 5 
PCA Dilaudid (Hydromorphone)
convert all to morphine
IV Dilaudid
 
Oral Dilaudid
 
PCA Fentanyl
 
IV Fentanyl
 
Oral Fentanyl
 
Opioid start and stop dates
 
morphine, oxycodone, percocet/any combined 
meds
 
codeine, tylenol #3
 
 
 
In-hospital non-opioid usage 
thru postop d 5 
Lyrica (Pregabalin)
 
Gabapentin
 
Toradol (Ketorolac)
 
Tramadol
 
Motrin (Ibuprofin)
 
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SSRI/SNRI
 
                                                      Acetaminophen
non- Opioid start and stop dates
 
 
 
SF-12 scores (baseline and f/u)
 
C. Study Duration
Subject participation will be through postoperative clinic visit (approximately 4 
weeks after surgery).
It will take approximately 2 years to complete this study.
D. Endpoints
Upon completion of enrollment, data will be analyzed to determine feasibility of 
proceeding with a larger trial. Based on the results of our preliminary trial in a small 
cohort of patients, the investigators will expand enrollment in the study to the 
predetermined sample size expected to be sufficient to achieve statistical 
significance. In order to calculate this number of study subjects needed to detect 
a statistically significant difference between the Exparel and plain Marcaine 
groups, a lowest clinically significant difference in postoperative opioid utilization 
was referenced from existing literature. (See power calculation.)
1.4 Preliminary Data N/A
1.5 Sample Size Justification
Primary outcome is postoperative opioid use. Secondary outcome is pain scores.
Power calculations are based on this study by Song et al, which showed opioid 
consumption 72 hours after operation for the ESP block and control groups were 0.945 
± 0.605 mg/kg v 1.247 ± 0.184 mg/kg [p = 0.36]). Standard deviations are thus 0.605 
and 0.184 for the ESP and control groups, respectively.
For this pilot project the investigators anticipate consenting/enrolling up to 150 
participants with a target of obtaining data from 96 participants (to allow for screen 
failures or those lost to follow-up)
 48 Mini thoractomies (N=24 Exparel, N=24 Marcaine)
 48 Open sternotomies (N=24 Exparel, N=24 Marcaine).
Enrolling a 96-patient sample for this initial pilot study is justified in that this sample will 
be sufficient to generate preliminary data and to prove feasibility under the existing study 
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protocol. At this benchmark, the investigators anticipate that a statistically significant 
difference will not be detectible; however, by simply expanding enrollment to a larger 
cohort and including the existing patients in the later analysis, efficiency will be optimized 
while minimizing waste of valuable research resources. 
Pacira Pharmaceuticals, Inc is providing funds for this study but is not a “sponsor”, 
Pacira’s justification for increasing the number of subjects; “sample required for 
comparing in mean of opioid consumption 72 hr after treatment between 2 groups is 47 
per group after adjusting for 20% drop out rate (total sample size: 94).  
 
This is the information used for sample size calculation:
Outcome measure: opioid consumption 72 hours after treatment
Planned analysis method: 2 samples (2-sided) T test assuming unequal variance.
Alpha=0.05
Beta=0.2 (power =80%)
Effect size: 0.302 (=1.247-0.945)
Sd for tx : 0.605, Sd for control: 0.185
Expected drop out: 20% 
# of group: 2 (As a primary objective, only two groups may be considered in sample size 
calculation. Comparing between bilateral arms unilaterally as a secondary objective is 
possible by stratification in randomization scheme.)
To obtain equal numbers in each group the investigators will enroll 96 subjects.
1.6 Study Variables
A.   Independent Variables, Interventions, or Predictor Variables 
Current standard of care for patients undergoing cardiac surgery at RWJUH is to 
have field block using Exparel (FDA approved for this indication).  For this study 
subjects will be randomized to receive Exparel or Marcaine (also FDA approved 
for this indication). The independent variables are the treatments: Exparel in saline 
versus Marcaine in saline. History of chronic pain or chronic reliance on pain 
medication will be controlled for, along with other demographic and clinical 
baseline characteristics, through multivariate regression analysis. 
B.  Dependent Variables or Outcome Measures 
Primary Outcome:
Postoperative opioid consumption 
Secondary Outcomes:
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Postoperative nonopioid analgesic consumption
Postoperative pain scores
Postoperative complications and outcomes (composite of all-cause mortality and 
major morbidity)
Postoperative qualify of life with SF-12
Hospitalization costs
1.7Drugs/Devices/Biologics 
A. Schedule and Administration
The study medication (Exparel or Marcaine) will be administered per standard of 
care via Ultrasound-Guided Erector Spinae Plane (ESP) Blocks, bilaterally for 
sternotomy and unilaterally for mini-thoracotomy. The drug will be administered 
prior to cardiac surgery. The dosage will be determined by patient body weight.  
 
B. Drug/Device Accountability and Storage Method
Both Exparel and Marcaine are stocked and stored at RWJUH pharmacy located 
at 1 RWJ Place, New Brunswick, NJ 08901will be prepared, dispensed, disposed 
of and accounted for per RWJUH’s pharmacy standard practice. 
Specimen Collection N/A
1.9 Data Collection
       Primary Data Collection

Research staff (listed on eIRB) will collect information from the subject’s 
medical record (Epic) and RWJUH Decision Support Service (costs) 

Postoperative pain scores, opioids consumed, and nonopioids consumed will 
be collected prospectively as a part of routine clinical care and stored in Epic. 
Opioid doses will be converted to morphine equivalents. Pain scores, 
morphine equivalents, and the type and quantity of nonopioid medications 
consumed will be averaged in the first five postoperative days or until 
discharge (whichever is later) and again at the follow up visit. 

SF-12 questionnaires will be completed by subjects before surgery and at 
follow up. (Takes < 5 minutes to complete)     
Above data will be entered into the Redcap study database (Redcap is database 
program purchased by Rutgers for use in research. The study database is maintained 
on the secure RWJMS server, password protected and only accessible to the 
designated research staff.)
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Upon completion of study all identifiers in the database will be removed and stored by 
study specific ID only. Once this is done there will be no link between subject and 
health information.
De-identified data will be stored for 6 years in accordance with Rutgers requirements.
2.0 Project Management
2.1 Research Staff and Qualifications
All investigators listed in eIRB are CITI trained.  PI and each coordinator have > 25 
years’ experience conducting clinical trials.
2.2Research Staff Training
The PI has met with study staff while developing the study. Prior to starting, the PI 
will meet with study staff to review the protocol, procedures and each one’s 
responsibilities going forward. Study progress will be reviewed at monthly meetings.
2.3 Other Resources  N/A
2.4 Research Sites
Rutgers Robert Wood Johnson Medical School (RWJMS)
Robert Wood Johnson University Hospital (RWJUH)
3.0 Multi-Center Research
N/A
4.0 Subject Considerations
4.1 Subject Selection and Enrollment Considerations 
A. Method to Identify Potential Subjects / B. Recruitment Details
Potential subjects will be recruited from the Cardiac Surgery Clinic and/or Service (in-
patients) day(s) or weeks prior to surgery. The PI or Study Nurse will review patient’s 
chart for eligibility. Study investigator will discuss the study with the subject.  If subject is 
interested, they will proceed with the consent process.
C. Subject Screening
Inclusion Criteria

Adults (18– no upper age limit)

Scheduled for mini thoracotomy (i.e. valve repair) or open sternotomy (i.e. 
bypass graft) at RWJUH (in and out-patients). 
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Exclusion Criteria
Patients will be excluded if they; 

Are currently on pain medication or pain regimen for chronic pain

Convert to sternotomy(for thoracotomies)

Require, upon intraoperative discovery and surgeon’s decision, the need 
for an unplanned secondary procedure other than the originally scheduled 
index operation

Emergent surgery
Non-English speaking (The majority of the PI's patient population speak 
English. As a pilot study the investigators cannot afford  to enroll non-
English speaking subjects due to time, personnel and financial constraints.

Currently on mechanical circulatory support 

On vasoactive medications, 

intubated 

active infection 

patients otherwise deemed ineligible for ESP block due to safety concerns 
by the investigators.
4.2 Obtaining Identifiable Information About Non-Subjects
N/A
4.3 Number of Subjects
A. Total Number of Subjects
For this pilot project the investigators anticipate consenting/enrolling up to 150 
participants, with a target of obtaining data from 96 participants (to allow for screen 
failures and those lost to follow-up).
 48 Mini thoractomies (N=24 Exparel, N=24 Marcaine)
 48 Open sternotomies (N=24 Exparel, N=24 Marcaine)
B. Total Number of Subjects If Multicenter Study
N/A
C. Feasibility
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In the past year more the 1500 cardiac surgeries were performed at RWJUH in New 
Brunswick. The medications involved in this study are readily available and utilized 
as standard of care. 
4.4 Consent Procedures
A. Consent Process
A. Consent Process / Documenting Consent

Individual Roles for Researchers Involved in Consent
Study MDs or Nurses listed on eIRB will identify potential subjects from the: 

Location of Consent Process
1. Cardiac Surgery Clinic. He/she will discuss the study (5-10 mins.) with the 
subject and give them the written consent to read. After reading the consent, all 
questions will be answered (as much time as necessary), written consent 
obtained, and a copy given to the subject. If the subject takes the consent home 
to read the study doctor or nurse will follow up and if subject wants to participate, 
written consent will be obtained at another clinical appointment (office visit or pre-
admission testing). Protecting Privacy – Discussion and consent will take place 
in private clinic room.
2. In-patient Cardiac Surgery Service. Patients will be approached one or more 
days prior to surgery in the hospital room.  MD/RN will discuss the study with the 
subject (5-10 mins.)  and give them the written consent to read. MD/RN will 
return after allowing ample time for the patient to read the consent. Once read all 
questions will be answered (as much time as necessary) , written consent 
obtained, and a copy given to the subject. Protecting Privacy – Discussion and 
consent will take place at the patient’s bedside.
Consent and process will be documented in subject’s medical record as a note 
by the investigator obtaining consent.
Ongoing Consent  N/A
Coercion or Undue Influence Consent discussion starts with explaining that this 
study is completely voluntary, and they can say no or stop the discussion at any 
time.  
Subject Understanding After all questions have been answered and before 
signing the consent, the investigator will ask several questions about the study to 
ensure the subject understands.
Waiver or Alteration of Consent Process   N/A
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4.5 Special Consent/Populations
A. Minors-Subjects Who Are Not Yet Adults N/A
B. Wards of the State  N/A
C. Non-English-Speaking Subjects  N/A 
D. Enrolling Adults Lacking Decision-Making Capacity (Surrogate Consent) 
N/A
4.6 Economic Burden and/or Compensation for Subjects
A. Expenses 
Subjects will not incur any costs due to participation in this study. Cost of the 
medication is included in the surgery cost.
B. Compensation/Incentives N/A
C Compensation Documentation N/A
4.7 Risks of Harm/Potential for Benefits to Subjects
A. Description of Risks of Harm to Subjects
Reasonably Foreseeable Risks of Harm and Minimizing these Risks
Both medications in this study are FDA approved for this indication.  The risks of 
each drug are very similar.  Subjects undergoing cardiac surgery at RWJUH 
would normally receive Exparel.  Therefore the only risk specific to this study is if 
one medication is less effective at controlling pain then the other.  If this occurs, 
the subject’s pain and/or other side effects will be managed per routine clinical 
care.
Common side effects of Marcaine include:

nausea,

vomiting,

chills or shivering,

headache,

back pain,

dizziness,

problems with sexual function,

restlessness,

anxiety,

dizziness,

ringing in the ears,
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
blurred vision, or

tremors.
Side effects of Exparel include:

dizziness,

drowsiness,

nausea,

constipation,

vomiting,

itching,

headache,

back pain, or

swelling in hands or feet.
Loss of confidentiality - Every effort will be made to maintain patient 
confidentiality. Only study personnel will have access to the study data. 
B. Procedures which Risk Harm to Embryo, Fetus, and/or Pregnant Subjects N/A
C. Risks of Harm to Non-Subjects N/A
D. Assessment of Social Behavior Considerations N/A
E. Minimizing Risks of Harm The only risk specific to this study is if one medication is 
less effective at controlling pain then the other.  If this occurs, the subject’s pain 
and/or other side effects will be managed per routine clinical care.
F. Potential Direct Benefits to Subjects
There may be no direct benefit to subjects. Future cardiac patients may benefit from 
the knowledge gained from this study.
5.0 Special Considerations
5.1 Health Insurance Portability and Accountability Act (HIPAA) 
HIPPA language included in consent.
5.2 Family Educational Rights and Privacy Act (FERPA) N/A
5.3 Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) N/A
5.4 General Data Protection Regulation (GDPR) N/A
5.5 NJ Access to Medical Research Act (Surrogate Consent) N/A
6.0 Data Management Plan
6.1 Data Analysis
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The investigators will conduct a Mann-Whitney or t-test (the latter if the data collected is 
a normal distribution) for continuous variables, and a Fisher’s exact or chi-squared (the 
former if N<10) for categorical variables. The investigators will initially compare sample 
descriptive data to scale the range of diversity within and between the two groups. 
After describing the sample, the investigators will compare continuous dependent 
variables (length of stay in the hospital and the ICU, costs, pain scores, and postoperative 
opioid and non-opioid pain medication use) with Mann-Whitney or t-tests. The 
investigators will repeat these calculations by operation type.
Opioid use will be quantified by morphine equivalents, as variables will present in mode 
of administration and type of opioid. The measurements will be taken as a total volume 
used during the hospital stay and a total volume used during the week of the follow up 
appointment.
Pain scores will be averaged daily through post-op day 5 and again at the first follow-up 
appointment (~4 weeks after discharge).
Paired t-test will be performed on SF-12 scores.
6.2 Data Security

Research staff will enter information from the subject’s medical record and SF-12 
results into the Redcap study database 

Upon completion of study all identifiers in the database will be removed and 
stored by study specific ID only. Once this is done there will be no link between 
subject and health information.

De-identified data will be stored for 6 years in accordance with Rutgers 
requirements.
6.3 Data and Safety Monitoring N/A
6.4 Reporting Results
A. Subject Results Reporting
      Results will not be shared with individual subjects.
B. Professional Reporting
Results will be submitted for presentation and publication in the appropriate surgical 
or rehabilitation journals, conferences, and forums
6.4 Secondary Use of the Data   N/A
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C. Clinical Trials Registration, Results Reporting and Consent Posting
Once approved, this study will be registered on clinicaltrials.gov.
6.5 Secondary Use of the Data   
The PI may use this data in the future but no plans to share with other investigators.
7.0 Research Repositories – Specimens and/or Data
N/A
8.0 Approvals/Authorizations
RUG/IRC form uploaded
9.0 Bibliography
1. Toscano A, Barbero C, Capuano P, et al. Chronic postsurgical pain and quality of 
life after right minithoracotomy mitral valve operations. J Card 
Surg. 2022;37: 1585-90.
2. Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N. 
Comparison of continuous thoracic epidural analgesia with bilateral erector 
spinae plane block for perioperative pain management in cardiac surgery. Ann 
Card Anaesth. 2018; 21(3):323-7.
3. Macaire P, Ho N, Nguyen T, Nguyen B, Vu V, Quach C, Roques V, Capdevila X. 
Ultrasound-Guided continuous thoracic erector spinae plane block within an 
enhanced recovery program is associated with decreased opioid consumption 
and improved postoperative rehabilitation after open cardiac surgery – a patient-
matched, controlled before-and-after study. J Cardiothorac Vasc Anesth. 2019;33 
(6):1659-67.
4. Song K, Xu Q, Knott VH, Zhao CB, Clifford SP, Kong M, Slaughter MS, Huang Y, 
Huang J. Liposomal bupivacaine–based erector spinae block for cardiac 
surgery.J Cardiothoracic and Vascular Anesthesia. 2021;35 (5):1555-9.
5. Collins JB, Song J, Mahabir RC. Onset and duration of intradermal mixtures of 
bupivacaine and lidocaine with epinephrine. Can J Plast Surg. 2013;21(1):51–3.
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