Conditions: Analgesia Sternotomy
Keywords: Pecto-intercostal Fascial Block Postoperative Pain Cardiac Surgery
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 31
Healthy volunteers: no

Brief summary:
The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare postoperative analgesia provided by Pecto-intercostal Fascial Block (PIFB) when performed with local anesthetic solution with or without perineural adjuvants in patients following cardiac surgery involving sternotomy. The study team hypothesizes that the patients receiving PIFB with bupivacaine with epinephrine, clonidine, and dexamethasone will have lower dynamic pain over the first 36 hours compared to those receiving PIFB with just bupivacaine and epinephrine.

Detailed description:
This will be a randomized, triple-blinded, prospective, feasibility trial. Written informed consent will be obtained from all study participants prior to randomization. Patients scheduled to undergo cardiac surgery involving sternotomy at Atrium Health Wake Forest Baptist will be screened for eligibility. These patients will be approached for enrollment by research staff either during their preoperative assessment clinic visit prior to their surgery date, or when admitted as inpatients and scheduled for surgery. Subjects chosen to participate will be randomized into one or other arm and PIFB will be performed after skin closure and before transport from the operating room to the ICU. For patients who are randomized at enrollment but later excluded due to exclusion criteria prior to block placement, their randomization assignment will be replaced at the end of the initial recruitment.

Arms:
arm 1: Subjects in this arm receive standard of care PIFB after surgery arm 2: Subjects in this arm receive standard of care PIFB with additional medications after surgery

Interventions: intervention 1: Pecto-intercostal Fascial Block (PIFB) intervention 2: PIFB with adjuvants
Intervention descriptions: intervention 1: PIFB done with bupivacaine and epinephrine intervention 2: PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone

Protocol document:
Prot_SAP_001.pdf: 
Ver 09/11/2023 
Short Title 
PIFB with Perineural Adjuvants for Postoperative Analgesia Following Sternotomy 
 
Full Title 
Pecto-intercostal Fascial Block with Perineural Adjuvants for Postoperative Analgesia Following 
Sternotomy in Patients Undergoing Cardiac Surgery 
 
Principal Investigators 
Scott Coleman, DO, FASE 
 
Sponsor or Funding Source 
Departmental funding 
 
 
Summary/Purpose/Rationale 
 
Multimodal pharmacologic therapy is a mainstay of postoperative analgesia for patients 
undergoing cardiothoracic surgery involving sternotomy. Diligent control of postoperative pain 
for patients following cardiac surgery is essential for promoting early mobilization and improved 
respiratory mechanics, as well as decreasing the incidence of delirium, myocardial oxygen 
demand, and risk of developing chronic pain1. Emerging evidence suggests that pain after 
cardiothoracic surgery falls into four distinct trajectories, with over 50% of patients reporting 
moderate to high pain even on the 30th postoperative day2. Several regional anesthesia 
procedures have demonstrated improvement in postoperative pain after median sternotomy but 
remain underutilized3,4. 
 
While thoracic epidural catheters confer visceral and somatic analgesia and have long been 
considered the gold standard for management of postoperative pain following cardiothoracic 
surgery, there are notable concerns involving systemic heparinization following epidural 
placement increasing the risk of epidural hematoma, with potentially catastrophic neurologic 
sequelae, as well as one of the more common side effects of hypotension from sympathetic 
blockade, which can be deleterious for cardiac patients in the immediate postoperative period5,6. 
For these reasons, the field of regional anesthesia has progressed to investigating more peripheral 
targets for nerve blockade that are distant from the neuraxis and more targeted to the specific 
drivers of surgical pain. Fascial Plane Blocks (FPB) have become a common approach to 
blocking afferent sensory innervation of the chest wall for patients undergoing cardiothoracic 
surgery involving sternotomy, including Pectoral (PECS) blocks, Serratus Anterior Plane (SAP) 
blocks, and Erector Spinae Plane (ESP) blocks4,7. The Pecto-Intercostal Fascial Block (PIFB) is 
one such approach that anesthetizes the anterior cutaneous branches of the second through the 
sixth intercostal nerves, which innervate the sternum and overlying soft tissue, by injection of 
local anesthetic in the fascial plane between the pectus major and internal intercostal muscles. 
The PIFB has been demonstrated to reduce postoperative resting and dynamic pain scores, 
postoperative opioid consumption, time to extubation, duration of intensive care unit (ICU) stay, 
and incidence of postoperative nausea and vomiting (PONV) in patients following cardiac 
surgery8,9. 


Ver 09/11/2023 
Perineural adjuvants are commonly used in peripheral nerve blocks (PNB) to extend the duration 
of analgesia, but they remain relatively understudied in FPB. Specifically, the glucocorticoid 
steroid dexamethasone, alpha-2 adrenergic receptor agonists dexmedetomidine and clonidine, 
and the opioid receptor agonists nalbuphine and buprenorphine have been used to varying 
degrees of success for extending the duration of PNB10-15. Extending the analgesic duration of 
single shot PIFB is highly clinically-relevant, given that catheter-based techniques require 
deploying foreign bodies close to the surgical field of the sternum bilaterally, which create an 
additional nidus for infection and become at risk of displacement due to surgical retraction 
during the procedure. The ideal analgesic FPB for patients undergoing cardiac surgery with 
sternotomy would involve a single-shot technique with long-lasting sternal coverage to confer 
resting and dynamic analgesia of the chest wall to promote improved respiratory mechanics, 
allow for earlier extubation, facilitate earlier patient mobilization, and reduce opioid 
consumption. For this block to appropriately match the postoperative timeline, it would ideally 
last upwards of 24 hours to include the time surrounding extubation, as well as early respiratory 
physical, and occupational therapy sessions.  
 
Our group has previously demonstrated that the addition of perineural dexamethasone to long-
acting local anesthetics in PNB increases the duration of analgesia that is not replicated with IV 
dexamethasone administration, as directly assessed by sensitivity to pinprick10,16. Clonidine is 
another commonly-used perineural adjuvant known to safely extend the analgesic duration of 
regional procedures and is well-tolerated in many of our PNB and FPB12,17-19. Epinephrine has 
long been used as a perineural adjuvant that extends analgesic duration of PNB by causing 
localized vasoconstriction that limits systemic uptake of local anesthetics and has an added 
safety benefit of being a marker of intravascular injection20. While concern has been raised about 
the potential toxicity of perineural adjuvants when studied in vitro21, data from in vivo studies, as 
well as years of experience from our group have demonstrated safety and tolerability of 
perineural epinephrine, clonidine, and dexamethasone when used in the context of safe block 
performance techniques, such as appropriate patient selection with exclusion of those with pre-
existing neurologic deficits, monitoring of injection pressure, and the addition of peripheral 
nerve stimulation to ultrasound guidance for blocks with motor nerve components16,22.  
 
Objectives 
The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare 
postoperative analgesia provided by PIFB when performed with local anesthetic solution with or 
without perineural adjuvants in patients following cardiac surgery involving sternotomy. We 
hypothesize that the patients receiving PIFB with bupivacaine with epinephrine, clonidine, and 
dexamethasone will have lower dynamic pain over the first 24 hours compared to those receiving 
PIFB with just bupivacaine and epinephrine. The primary outcome will be the 24 hour area under 
the curve (AUC) pain scores, based on patient-reported dynamic NRS pain scores with incentive 
spirometer (IS) use measured at 6, 12, 18, and 24 hours after block placement in patients that are 
extubated. We set a minimally clinical important difference (MCID) to be 10% for AUC pain 
scores with IS use. Secondary outcomes will include patient-reported NRS pain scores at rest at 
6, 12, 18, and 24 hours after block placement; cumulative 24 hour opioid consumption; time to 
first postoperative opioid administration after extubation; time to extubation; duration of ICU 
admission; incentive spirometry volumes at 6, 12, 18, and 24 hours after block placement; 


Ver 09/11/2023 
nausea incidence; vomiting incidence; postoperative delirium incidence; and patient-reported 
NRS satisfaction with the analgesic regimen.  
 
Risks to Subjects 
The PIFB has been shown to be a safe block, given its superficial target plane between the 
pectoralis major and internal intercostal muscles. Although the intended location is not 
intrathoracic, but rather, superficial to it, the relative proximity to the parietal pleura makes 
pneumothorax a potential risk of the PIFB. The transversus thoracis muscle is deep to the 
intended fascial plane and constitutes a safe “backstop” in case of needle advancement farther 
than intended, before arriving at the parietal pleura. The presence of the internal mammary 
arteries and veins, which reside in the deeper plane between the internal intercostal and 
transversus thoracis muscles, are also theoretically potentially at risk of needle puncture, 
although they are easily visualized and avoided during PIFB performance. Another FPB that 
similarly targets the anterior cutaneous branches of the upper intercostal nerves, called the 
Transversus Thoracis Plane (TTP) block, entails advancing the needle to this deeper plane, 
where the internal mammary vessels lie. Given the intrathoracic location of this deeper block, 
and attendant risks of pneumothorax and internal mammary vessel injury, our institution has 
opted to avoid TTP block placement, in favor of the PIFB, as the latter is generally regarded as a 
safer block. To date, there have been no incidences at our institution or in the literature of any 
identified pneumothorax or internal mammary vessel injury occurring as a result of PIFB 
placement. 
 
The risks will be minimized by continuous, real-time, in-plane ultrasound guidance of our 
echogenic block needles only after identifying the correct anatomy, using color Doppler function 
on our ultrasound machine as appropriate to more readily identify vascular structures and avoid 
them. Blocks will be performed by anesthesiologists well versed in performance of the PIFB, or 
by trained anesthesiology residents or fellows directly supervised by them. 
 
The use of local anesthetics always bodes a potential risk of local anesthetic systemic toxicity 
(LAST) as a result of systemic uptake from intravascular injection, rapid vascular absorption, or 
overdose of local anesthetic solution. We employ a multifaceted approach to minimize the risk of 
LAST by including local concentration and dose in the context of the patient’s weight during the 
regional timeout procedure, using epinephrine as both an intravascular marker and local 
vasoconstrictor to limit systemic uptake of local staying below the recommended upper limit of 
local anesthetic dose of 3mg/kg for bupivacaine with epinephrine, and aspirating frequently, 
including before any injection of local anesthetic solution, and in between each aliquot of 5cc of 
local before proceeding with dosing. This study has an exclusion criterion such that minimum 
body weight must be above 50kg for inclusion, so that no patients in whom the prescribed local 
anesthetic dose would be higher than the recommended upper limit of bupivacaine dosing will be 
enrolled, as detailed below. 
 
 
 
 
 
 


Ver 09/11/2023 
Methods/Measurements 
 
Design 
This will be a randomized, triple-blinded, prospective, feasibility trial that will take place after 
approval from our Institutional Review Board. Investigational New Drug Exemption has been 
obtained  from the US Food and Drug Administration for use of the perineural adjuvants and is 
filed as FDA IND Exemption 165506. Written informed consent will be obtained from all study 
participants prior to randomization.  This trial has been registered  on www.clinicaltrials.gov as 
NCT05676814. 
 
Selection Criteria 
Inclusion: Adults between 18 and 90 years of age undergoing cardiac surgery involving 
sternotomy at Atrium Health Wake Forest Baptist, and who have consented to participate and 
lack any contraindications to PIFB for postoperative analgesia will be recruited for participation 
in the study.  
 
Exclusion: Patients with any contraindications to regional anesthesia, such as history of allergy 
to amide local anesthetics or any of the perineural adjuvants; existing neurologic deficit in the 
chest wall; remaining intubated at the six hour point after block placement; weight under 50kg; 
undergoing emergency surgical procedures or urgent return to the operating room; active 
endocarditis or mediastinitis; moderate to severe right ventricular function before or after 
cardiopulmonary bypass; reliance on mechanical circulatory support devices, such as intra-aortic 
balloon pump or Impella; reliance on extracorporeal membrane oxygenation; localized or 
systemic infection; chronic use of high dose opioid analgesics (defined as daily use greater than 
30 oral morphine milligram equivalents (OMME) for over one month prior to surgery); as well 
as those who are pregnant, will be excluded from participation. Intraoperative opioids will be 
limited to fentanyl, therefore patients who receive any other opioids will be excluded. 
Additionally, any administration of ketamine, methadone, and dexmedetomidine during 
intraoperative and postoperative settings will exclude the subjects from the study. Furthermore, 
postoperative administration of tramadol, NSAIDs, muscle relaxants, and Haldol will exclude the 
subjects from the study. Any patients who refuse enrollment or withdraw their consent will also 
be excluded and any of their information already collected will be destroyed. 
 
Setting 
Patients between 18 and 90 years of age, scheduled to undergo cardiac surgery involving 
sternotomy at Atrium Health Wake Forest Baptist will be screened for eligibility. These patients 
will be approached for enrollment by research staff either during their preoperative assessment 
clinic visit prior to their surgery date, or when admitted as inpatients and scheduled for surgery. 
During this visit, the study will be discussed in detail, and eligible participants will be offered the 
ability to ask any questions and sign consent forms at that time, or decide at a later time prior to 
surgery. Study staff will also review the surgical schedule and offer to call eligible participants to 
discuss the research study to determine their interest.  At that time, if interest is shown, the 
consent will be emailed to them for review prior to their hospital admission to allow adequate 
time for consideration.  Those subjects will then be seen on the morning of surgery to obtain a 
written informed consent. All patients will be provided with a signed copy of their written 
informed consent for their records.  


Ver 09/11/2023 
 
 
 
 
Study Protocol 
 
Baseline data collection 
After time of consent, enrolled patients will be informed on the appropriate use of an incentive 
spirometer (IS), asked to rate their baseline verbal pain score both at rest and with use of an 
incentive spirometer (IS) on the eleven-point numerical rating scale (NRS: 0-10, where 0 
represents no pain and 10 represents the worst imaginable pain). Maximum effort IS volumes 
will be measured in triplicate and averaged, and patient characteristics will be recorded, 
including age, gender, height, weight, BMI, ASA physical status classification score, surgeon, 
planned surgical procedure, as well as preoperative opioid use and doses. 
 
Randomization 
Subjects will be randomized on the day of surgery, specifically prior to the start of their 
procedure. Surgery will proceed as scheduled, and patients will be anesthetized and monitored 
per our usual cardiac anesthesiology practice with general anesthesia. At the end of the 
cardiopulmonary bypass circuit run, patients will be reassessed for the aforementioned exclusion 
criteria before the randomized block is placed.  Patients will be blinded to their treatment arm 
assignment, as will all research personnel who be responsible for collection of outcome data, as 
well as the surgeons performing the cardiac procedure, and the critical care staff caring for the 
patients in the postoperative period. PIFB will be performed after skin closure and before 
transport from the operating room to the CVICU. For patients who are randomized at enrollment 
but later excluded due to exclusion criteria prior to block placement, their randomization 
assignment will be replaced at the end of the initial recruitment. 
 
Interventions 
Once the surgical team is finished with skin closure, bilateral PIFB will be placed by a faculty 
anesthesiologist well-versed in the performance of ultrasound-guided regional anesthesia and 
performance of PIFB blocks, or by a trained anesthesia resident or fellow directly supervised by 
them. This will be done by obtaining a longitudinal, parasagittal view of the costal cartilage 1-
2cm lateral to the sternum at the level of the fourth or fifth rib and guiding a block needle in the 
cephalad direction in plane to the fascial plane between Pectus Major and Internal Intercostal 
muscles, with the goal of obtaining cephalad spread along the plane over multiple costal cartilage 
levels, as described previously23. PIFB will be performed bilaterally using a volume of 30cc of 
local anesthetic solution per side, with dosing in 5cc aliquots only after confirming aspiration is 
negative for blood and that a small aliquot of local solution demonstrates spread in the intended 
plane. We will repeat aspirations in between each aliquot of 5cc of local anesthetic, as is our 
standard practice, to monitor for intravascular needle position.  
 
Patients randomized to the control arm will receive bilateral PIFB with a total of 60cc of 0.25% 
bupivacaine with 2.5mcg/cc epinephrine (1:400,000 dilution), and those in the experimental arm 
will receive bilateral PIFB with a total of 60cc of 0.25% bupivacaine with 2.5mcg/cc epinephrine 
(1:400,000 dilution), 1.67mcg/cc clonidine, and 0.1mg/cc preservative-free dexamethasone. 


Ver 09/11/2023 
Patients will be monitored throughout block placement using standard ASA monitors including 
telemetry, heart rate, blood pressure, pulse oximetry, and end-tidal capnography. Following 
placement of bilateral PIFB, patients will be transported still intubated to the ICU with propofol 
infusion for sedation, as per institutional protocol for routine postoperative care. 
 
As is our current practice, patients will be managed with ICU nursing-administered titrated 
boluses of IV fentanyl for analgesia before extubation based upon signs of nociception, including 
hypertension, tachypnea, facial grimace, and motor agitation. Patients will have as-needed doses 
of oxycodone and/or hydromorphone ordered for analgesia after extubation, unless they have a 
contraindication or allergy, in which case a suitable alternative at equianalgesic doses will be 
ordered. 
 
Materials 
Ultrasound guidance for imaging the relevant anatomy will be obtained using a linear ultrasound 
probe. All PIFB will be performed in a sterile manner, using sterile gloves, sterile ultrasound 
probe cover, sterile short-bevel block needle, and skin cleaning using an aseptic cleaning 
solution prior to placement. All products used are FDA-approved for the above-mentioned 
procedures, and an Investigational New Drug (IND) exemption has been obtained for use of the 
study medications used in this protocol under FDA IND165506. 
 
Measurements 
The time of block placement will be documented as the zero hour time point for the purposes of 
measurements. As described above, to collect data for the primary outcome, research staff will 
elicit patient-reported NRS pain scores with use of incentive spirometry at 6, 12, 18, and 24 
hours post block placement. If patients are not yet extubated at the 6 hour point, they will be 
excluded from the study as mentioned above. Research staff will also collect data for secondary 
outcome measures including, but not limited to: eliciting resting NRS pain scores at 6, 12, 18, 
and 24 hours after block placement; measuring incentive spirometry volumes in triplicate at 6, 
12, 18, and 24 hours; measuring the time after extubation to first opioid administration; time to 
extubation; duration of ICU admission; calculating incidence of nausea and vomiting based on 
the administration of the antiemetics ondansetron, metoclopramide, prochlorperazine, and 
promethazine; assessing delirium based on bedside ICU nurse documentation using Confusion 
Assessment Method in the ICU (CAM-ICU) in the first 24 hours post block placement; and 
measuring patient-reported NRS satisfaction with the analgesic regimen at the 24 hour point (0 
represents completely unsatisfied and 10 represents completely satisfied). 
 
For the NRS pain scores and measurement of incentive spirometer volumes at each 6, 12, 18, and 
24 hours interval, there is a grace period of 1 hour. This is to give the research staff/ ICU nurse 
the flexibility of completing these tasks.  
 
The cumulative 24 hour opioid consumption will be abstracted from the EMR. All opioids will 
be converted to oral morphine milligram equivalents (OMME) to allow for appropriate 
comparison using a widely available dose conversion table.  These metrics will be accessed, 
abstracted, de-identified, and analyzed by research personnel who are blinded to group 
allocation. 
 


Ver 09/11/2023 
There will also be a 30-day post-block phone call follow-up for ongoing opioid use/last use, such 
as frequency and dosage, and pain levels in their day-to-day activities.  
 
Statistical Analysis 
 
Power Analysis 
We define a minimum clinically important difference (MCID) to be a 10% reduction in area 
under the curve for our primary outcome. Given that no current data exist on the anticipated 
duration of PIFB with perineural adjuvants at our institution, we have decided to recruit 10 
patients per arm for a total of 20 patients in this feasibility trial. Based on prior studies involving 
the use of perineural adjuvants with long-acting local anesthetics, we have noted an average 
duration around 20 hours for peripheral blocks performed at other sites with bupivacaine 
containing perineural adjuvants epinephrine, clonidine, and dexamethasone. We have therefore 
chosen 24 hours as the final time point, with serial checks starting at 6 hours post block 
placement to represent clinically important pain trajectories for patients recovering from cardiac 
surgery with sternotomy. 
 
 
Data Analysis 
Demographic information will be collected as mentioned above and compared between the 
groups to verify that randomization balanced important baseline variables between the control 
and experimental groups. For the primary outcome of AUC pain scores with use of incentive 
spirometry for the first 24 hours post block placement, we will compare mean and standard 
deviations of the overall integrated area under the curve using the trapezoid rule. For secondary 
outcomes with continuous variables, such as intubation or ICU duration, t-tests and confidence 
intervals will be calculated. For continuous variables with serial measurements, repeated 
measure analysis of variance (RMANOVA) will be used. Further assistance with statistical 
analysis is being elicited from the Clinical and Translational Science Institute (CTSI), and this 
IRB protocol will be updated with further details after final review with a statistician. 
 
Missing Data Points 
Missing data points for the primary outcome will be imputed by a mixed effects modeling 
framework that allows us to use all available data points to tests hypotheses about differences 
between the two groups at each time point. Models will be implanted using the ‘lme4’ package 
in R statistical software. 
 
 
Human Subjects Protection 
 
Subject Recruitment Methods 
Potential candidates for the study will be identified based on the posting for the surgical 
procedure of cardiac surgery involving sternotomy as mentioned in the inclusion criteria as 
above, provided they lack any of the exclusion criteria. Patients will be approached during their 
preoperative assessment clinic visit, via telephone call, or during their inpatient admission if they 
are scheduled for surgery the following day, and told about the study in detail, including any 
known or possible risks, benefits, and alternatives. They will be advised there will be no 


Ver 09/11/2023 
financial incentive to participate, but potential benefits may include reduced surgical pain for the 
first 24 hours postoperatively.  Written informed consent will be obtained and scanned into the 
EMR during that visit, if they consent, or on the day of surgery, if they need more time to 
deliberate on enrolling. Ample opportunity to ask questions will be given both during this 
preoperative visit and on day of surgery. All patients meeting the aforementioned eligibility 
criteria, regardless of gender, age, race, and ASA physical status, will be offered to participate.  
 
 
Informed Consent 
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only the requisite information required to assess 
the study outcomes, minimizing the collection of any information that could directly identify 
subjects. Each patient will be assigned a unique study identifier that will appear on the data 
collection form, and any protected health information that may directly identify the patient 
corresponding to the unique study identifier will be kept secure with access limited to designated 
study personnel. Following collection of all data, subject identifying information will be 
destroyed at the earliest opportunity, consistent with data validation and study design, producing 
an anonymous data set for analysis. All patient information collected will be kept confidential 
during recruitment as well as the remainder of the study. All identifying protected health 
information will be de-identified in the electronic database during data collection, which will be 
encrypted and secured in the Atrium Health Wake Forest Baptist private servers and only 
accessible by two-factor authenticated, password-protected computers. Only selected research 
personnel who are specifically enrolling patients or collecting or analyzing data will have access 
to the dataset. No reference to any individual participant will appear in reports, presentations, or 
publications that may arise from this study. 
 
Data and Safety Monitoring 
The principal investigators will be responsible for overall monitoring of the data and safety of 
study participants and will be assisted by other members of the research personnel in the 
identification of any safety concerns.  
 
Reporting of Unanticipated Problems, Adverse Events, or Deviations 
Each participating attending anesthesiologist will report to the principal investigators about any 
protocol violations, unanticipated problems with the protocol, or adverse events, which will 
promptly be reported to the IRB and corresponding government agency, if appropriate. 
 
 
 
 
 
 
 


Ver 09/11/2023 
 
 
 
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ICF_000.pdf: 
Official Title:Pecto-intercostal Fascial Block With Perineural 
Adjuvants for Postoperative Analgesia Following Sternotomy in 
Patients Undergoing Cardiac Surgery
NCT05676814
IRB-Approved Date:  3/23/2023


Page 1 of 10
Adult Consent Form
Ver 3/20/2023
Department of Anesthesiology-Section on Regional 
Anesthesiology and Acute Pain Medicine
PECTO-INTERCOSTAL FASCIAL BLOCK (PIFB) WITH PERINEURAL 
ADJUVANTS FOR POSTOPERATIVE ANALGESIA FOLLOWING 
STERNOTOMY IN PATIENTS UNDERGOING CARDIAC SURGERY
Informed Consent Form to Participate in Research
Rawad Hamzi, MD, MS: Principal Investigator
SUMMARY
You are invited to participate in a research study. The purpose of this research is to compare 
postoperative pain relief provided by the Pecto-Intercostal Fascial Block (also known as PIFB) 
when the numbing medications are combined with additional medications than when the block is 
done without the adjuvants. This nerve block has been shown to reduce some of the pain in your 
chest that you will have after the surgery, and we are interested in finding out if we can reduce 
the pain more and for longer. You are invited to be in this study because your surgery involves a 
sternotomy procedure (or an open chest) and you are anticipated to experience pain after your 
surgery. Your participation in this research will involve answering questions about your pain at 6 
hour intervals after your surgery for up to 24 hours. Your total participation in this study will last 
until 24 hours after your surgery. In addition to receiving the nerve block while still asleep, you 
will receive the normal types and doses of pain medications you need after your surgery that you 
would receive if you were not in the study. The nerve block we are studying will be done in 
addition to the other routine postoperative care you would receive, not instead of it, if you agree 
to participate.
Participation in this study will involve being randomized (like the flip of a coin) to receive the 
PIFB block with or without adding the additional medications. You will have an equal chance of 
being randomly assigned to either group. All research studies involve some risks. One risk of this 
study that you should be aware of is the small risk of infection at the needle insertion site where 
the nerve block is performed. This is quite rare, as we do our best to prevent it by performing the 
block under sterile conditions in the operating room, with sterile gloves, needle, and ultrasound 
probe cover, and only after scrubbing your skin with cleaning solution. Another risk to be aware 
of is the small risk of damage to surrounding structures, present with any nerve block or 
procedure. In the case of PIFB, this could include the inner lining of the chest wall called the 
pleura, or small blood vessels inside the chest called the internal thoracic vessels. We minimize 
this risk by using an ultrasound, which allows us to guide the needle throughout the entire block 
procedure. Both of these risks are much lower than 0.5%. A final risk to know about is toxicity 
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from receiving too much numbing medicine, or having it go into the blood, called local 
anesthetic systemic toxicity (LAST). We take this risk very seriously as well, and avoid it by 
using doses of numbing medicine well within the safe margin for you and your body weight, and 
frequent, vigilant monitoring that the medicine never goes directly into the blood. This risk 
would be even rarer than 1 in 2000.
You may experience decreased pain as a result of your participation in this study because this 
nerve block is not normally performed on this surgery population at our hospital yet. However, 
many hospitals throughout the country have started doing them after they have been repeatedly 
shown to be safe and helpful for reducing pain after heart surgery such as yours.
Your participation in this study is voluntary. You do not have to participate in this study if you 
do not want to. There may be other choices available to you. Some other choices may include to 
not receive the PIFB and receive only the usual IV and oral pain medications and other 
analgesics as you would normally receive. You will not lose any services, benefits, or rights you 
would normally have if you choose not to participate.
The remainder of this form contains a more complete description of this study. Please read this 
description carefully. You can ask any questions if you need help deciding whether to join the 
study. If you have questions, suggestions, or concerns regarding this study or you want to 
withdraw from the study please contact the Principal Investigator at 
 (research 
nurse). 
If you have any questions, suggestions or concerns about your rights as a volunteer in this 
research, contact the Institutional Review Board at 
 or the Wake Forest University 
Health Sciences Research Subject Advocate at 
.
INTRODUCTION
You are invited to be in a research study. Research studies help scientist learn new information 
that may help other people in the future. You are being asked to be in this study because you are 
going to have surgery that involves having a sternotomy, meaning an incision through your 
breast bone, and you are expected to experience pain after your surgery. Your participation is 
voluntary. You do not have to be a part of this study if you do not want to. Please take your time 
in making your decision if you would like to join. Ask your study doctor or the study staff to 
explain any words or information contained in this informed consent document that you do not 
understand. You may also discuss the study with your friends and family.
WHY IS THIS STUDY BEING DONE?
The purpose of this research study is to compare pain relief provided by the Pecto-Intercostal 
Fascial Block (also known as PIFB) when the local anesthetic numbing medications are 
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combined with additional medications than when the block is done without the adjuvants.
All of the drugs that are being administered for the PIFB have been approved by the US Food 
and Drug Administration (FDA) as safe medications. We have been safely using the additional 
medications for many years in our nerve blocks without issue, but the additional medications 
have not been formally approved for use in nerve blocks for research purposes. However, these 
drugs are commonly used in common clinical practice at our facility and others as part of our 
postoperative pain regimen in the various blocks that are done, and studies have been done 
showing they are safe to use around nerves. The FDA has reviewed our use of these additional 
medications in our nerve blocks and has determined them to be safe to the point where we have 
been granted an exemption from requiring FDA approval. 
All the PIFB blocks in this study will be done using local anesthetic medications. There is no 
placebo involved in the conduct of this research study. A placebo is a substance that is not 
thought to have any effect on your disease or condition. This means that no matter which group 
you are in, you will receive a nerve block that should help reduce the pain in your chest after the 
surgery.
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
Twenty people at Atrium Health Wake Forest Baptist will take part in this study. In order to 
identify the 20 subjects needed, we may need to consent as many as 30 people, because some 
people will not qualify to be included in the study. For example, if the right side of your heart 
seems to be requiring extra support with medications or devices at the end of your surgery, we 
will need to exclude you from inclusion, because this means you likely will need extra time to 
recover and not be awake as soon after surgery for us to ask you questions about your pain.
WHAT IS INVOLVED IN THE STUDY?
You will be randomized into one of the two study groups described below. Randomization 
means that you are put into a group by chance; it is like flipping a coin, and you will have a 50% 
chance of being in either group. Neither you, the surgeon, nor the study staff assessing you after 
your surgery will know which group you are in or the medication mix you will receive in the 
nerve block. Only the doctor performing the nerve block will know which group you are 
randomized to so they can mix the medications for it. This “blinding” is done to make sure a fair 
evaluation of results can be made. If you or the researchers collecting data know which group 
you were in, this has been shown to bias the results, making the study unreliable. Information 
about which group you are in is available to the researchers if needed in an emergency.
The 2 groups you may potentially be randomized to differ by the medications used in them.  In 
Group 1 the medications include the use of bupivacaine and epinephrine.  Group 2 medications 
include using bupivacaine, epinephrine, dexamethasone and clonidine.  We do not know if the 
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addition of dexamethasone and clonidine enhance the length of time you receive pain relief from 
this nerve block.  This study hope to determine the best combination to use.  
You will be approached during one of the following times: during your pre-anesthesia clinic visit 
before surgery, in your current hospital room if you are in the hospital awaiting surgery, or on 
the phone if research staff missed seeing you during your pre-anesthesia visit. At those times, the 
study will be discussed with you in its entirety. If you are seen prior to the day of surgery, 
written informed consent will be obtained. If you are approached over the phone, then the 
consent will be emailed to you at the address you provide for review prior to the day of surgery.  
Then, on the morning of surgery, you will be seen in the holding room to obtain written informed 
consent where you sign the consent form.
On the day of surgery, you will be seen by research staff in the holding room to review the study 
and to get some baseline information. You will be asked to breathe in through an incentive 
spirometer (a device that measures three times to measure how deeply you are able to inhale). 
This will be compared to after your surgery. You will also be asked to report a baseline pain 
score by rating your current pain level on a scale of 0 to 10, with 0 being no pain and 10 being 
the worst pain imaginable.  You will then be randomized into the study.
You will undergo your surgery as planned by you and your cardiac surgeon. At the end of your 
surgery, after making sure you are still a good candidate, the anesthesiologist will be performing 
the study PIFB. Your surgeon, other research staff, and the ones caring for you in the intensive 
care unit will not know which medications you received. At 6, 12, 18, and 24,  hours after the 
nerve block was placed, you will be asked to provide a pain score on a scale of 0-10, with 0 
being no pain and 10 being the worst pain imaginable, both at rest and with deep inhale using the 
incentive spirometer. After your surgery, you will receive the normal postoperative care that you 
would receive if you were not in the study. That includes receiving IV and oral narcotics to treat 
your pain, as well as non-narcotics, such as acetaminophen and ibuprofen. After the visit at 24 
hours, your participation in this study ends.  
HOW LONG WILL I BE IN THE STUDY?
You will be in the study for about 24 hours after your surgery. You can stop participating at any 
time. If you decide to stop participating in the study, we encourage you to talk to the 
investigators or study staff first.
WHAT ARE THE RISKS OF THE STUDY?
Being in this study involves some risk to you. You should discuss the risk of being in this study 
with the study staff. Risks and side effects related to the PIFB postoperative block we are 
studying include:
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 Risks of medications used in 
nerve block
Nerve blocks are overall very safe. The risks of this type of 
nerve block are as follows: infection at the injection site, 
bleeding (rare), injury to the lung (rare), or allergic reaction 
(rare). Bupivacaine has a low risk (less than 10%) of nausea, 
constipation, or vomiting. Epinephrine has the low risk (less 
than 1%) of causing a fast heartbeat or high blood pressure. 
Clonidine has the low risk (less than 1%) of causing a slow 
heartbeat or low blood pressure. Dexamethasone has the 
small risk (less than 1%) of causing increased blood sugar. 
The nerve blocks are placed into the  nerves along the area of 
your sternal incision while you are still under anesthesia.   
You should discuss the risk of being in this study with the 
study staff.
Confidentiality and privacy
Taking part in this research study may involve providing 
information that you consider confidential or private. Efforts, 
such as coding research records, keeping research records 
secure, and allowing only authorized people to have access to 
research records, will be made to keep your information safe.
There also may be other risks that we cannot predict. You should tell the research staff about all 
the medications, vitamins and supplements you take and any medical conditions you have. This 
may help avoid side effects, interactions and other risks to your health.
Reproductive Risks and other Issues to Participating in Research
Due to unknown risks and potential harm to the unborn fetus, sexually active women of 
childbearing potential must use a reliable method of birth control while participating in this 
study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives, 
OrthoEvra patch, NuvaRing, intrauterine devices (IUD), Nexplanon implant, DepoProvera, tubal 
ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous 
relationship (same partner). An acceptable, although less reliable, method involves the careful 
use of condoms and spermicidal foam or gel and/or a diaphragm with spermicide with Plan B 
used for any noticed condom or diaphragm failures. We encourage you to discuss this issue 
further with your physicians if you have any questions.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
If you agree to take part in this study, there may or may not be direct benefit to you. It is 
anticipated that since you are receiving the nerve block, you should experience a decreased 
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amount of pain after your surgery compared to if you had not received it. We also hope the 
information learned from this study will benefit other people in the future. The benefits of 
participating in this study may be that your pain relief may be better than standard therapy you 
could receive without being in the study. Because individuals respond differently to therapy, no 
one can know in advance if it will be helpful in your particular case.
WHAT OTHER CHOICES ARE THERE?
You do not have to be in this study. You should talk to the researchers about all the choices you 
have. Instead of being in this study, you have these option of receiving the normal IV and oral 
opioids and pain medications to treat your postoperative pain without receiving any nerve block. 
WHAT ARE THE COSTS?
All study costs, including any study products or procedures related directly to the study, will be 
paid for by the study. Costs for your regular medical care, which are not related to this study, 
will be your responsibility.
WILL YOUR RESEARCH RECORDS BE CONFIDENTIAL?
The results of this research study may be presented at scientific or medical meetings or published 
in scientific journals. Your identity and/or your personal health information will not be disclosed 
unless it is authorized by you, required or permitted by law, or necessary to protect the safety of 
yourself or others.  
Your information may be provided to Federal and other regulatory agencies as required. The 
Food and Drug Administration (FDA), for example, may inspect research records and learn your 
identity if this study falls within its jurisdiction.
WILL YOU BE PAID FOR PARTICIPATING?
You will receive no payment or other compensation for taking part in this study.  
WHO IS SPONSORING THIS STUDY?
This study is an investigator initiated clinical trial and has no outside sponsor funding the 
principal investigator for the conduct of this study.  
WHAT HAPPENS IF YOU EXPERIENCE AN INJURY OR ILLNESS AS A 
RESULT OF PARTICIPATING IN THIS STUDY?
Atrium Health Wake Forest University Baptist Medical Center maintains limited research 
insurance coverage for the usual and customary medical fees for reasonable and necessary 
treatment of injuries or illnesses to some participants in certain research studies. To the extent 
research insurance coverage is available under this policy, the reasonable costs of these 
necessary medical services will be paid, up to a maximum of $25,000. To the extent research 
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coverage is not available, you or your insurance company may be charged for the costs of 
medical care. You may receive care at Wake Forest University Baptist Medical Center and/or 
Atrium Health.
If you are injured, the insurer may require information such as your name, social security 
number, and date of birth in order to pay for your care. This is because the insurer is required by 
law to report any payments made to cover the care of any persons who are members of a 
government insurance plan to the Department of Health and Human Services.
You do not give up any legal rights as a research participant by signing this consent form. For 
more information on medical treatment for research related injuries or to report a study related 
illness, adverse event, or injury you should call Dr. Rawad Hamzi at 
or after hours 
at 
.  
WHAT ABOUT MY HEALTH INFORMATION?
In this research study, any information we get from your medical records or other facilities about 
your health or behaviors is considered Protected Health Information. Some of the information we 
will collect for this research study includes: age, race, ethnicity, surgical procedure, medications 
received, and pain scores.
 
If this research study involves the diagnosis or treatment of a medical condition, then Protected 
Health Information collected from you during this study will be placed in your medical record, 
and may be used to help treat you, arrange payment for your care, or assist with the health care 
operations of Atrium Health, Wake Forest University Health Sciences, and their respective 
affiliated entities. 
We will take steps to keep your Protected Health Information private. We will store records of 
your Protected Health Information in a cabinet in a locked office or on a password protected 
computer with two factor authentication required for access.
Your personal health information and information that identifies you (“your health information”) 
may be given to others during and after the study. This is for reasons including carrying out the 
study, determining the results of the study, making sure the study is being done correctly, 
providing required reports, and getting approval for new products. 
Some of the people, agencies and businesses that may receive and use your health information 
are the research sponsor; representatives of the sponsor assisting with the research; investigators 
at other sites who are assisting with the research; central laboratories, reading centers, or analysis 
centers; the Institutional Review Board; representatives of Wake Forest University Health 
Sciences and Atrium Health Facilities; representatives from government agencies such as the 
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Food and Drug Administration (FDA) or the Office of Human Research Protections (OHRP), the 
Department of Health and Human Services (DHHS) and similar agencies in other countries.  
Some of these people, agencies and businesses may further disclose your health information. If 
disclosed by them, your health information may no longer be covered by federal or state privacy 
regulations. Your health information may be disclosed if required by law. Your health 
information may be used to create information that does not directly identify you. This 
information may be used by other researchers. You will not be directly identified in any 
publication or presentation that may result from this study unless there are photographs, 
videotapes, audiotapes or other recorded media which are identify you unless we you’re your 
written authorization.
If required by law or court order, we might also have to share your Protected Health Information 
with a judge, law enforcement officer, government agencies, or others. If your Protected Health 
Information is shared with any of these groups it may no longer be protected by federal or state 
privacy rules.
Any Protected Health Information collected from you in this study that is maintained in the 
research records will be kept for at least 6 years after the study is finished. At that point, any 
research information not already in your medical record will destroyed. Any research 
information entered into your medical record will be kept for as long as your medical record is 
kept by the Medical Center.
You can tell Dr. Hamzi that you want to take away your permission to use and share your 
Protected Health Information at any time by sending a letter to this address:
Rawad Hamzi, MD, MS
However, if you take away permission to use your Protected Health Information you will not be 
able to be in the study any longer. We will stop collecting any more information about you, but 
any information we have already collected can still be used for the purposes of the research 
study.
By signing this form you give us permission to use your Protected Health Information for this 
study.
If you choose to participate in this study, your medical record at Atrium Health, Wake Forest 
University Health Sciences, or their respective affiliated entities will indicate that you are 
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enrolled in a clinical trial. Information about the research and any medications or devices you are 
being given as a participant may also be included in your medical record. Authorization to access 
this part of the medical record will only be available to people who have a need to know this 
information in order to perform their job-related duties. If you are not a patient of these health 
care facilities, a medical record will be created for you anyway to provide access to this 
important information to providers in case of an emergency.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This website will not include information that can identify you. At most, the 
website will include a summary of the results. You can search this web site at any time. 
A medical record will be created for all study participants seen on-site and if a medical record 
doesn’t already exist. Information about your participation in the study will be placed in the 
medical record, along with any routine medical test results that were obtained as part of this 
study. 
WHAT ARE MY RIGHTS AS A RESEARCH STUDY PARTICIPANT?
Taking part in this study is voluntary. You may choose not to take part or you may leave the 
study at any time. Refusing to participate or leaving the study will not result in any penalty or 
loss of benefits to which you are entitled. If you decide to stop participating in the study, we 
encourage you to talk to the investigators or study staff first to learn about any potential health or 
safety consequences. The investigators also have the right to stop your participation in the study 
at any time. This could be because you no longer meet inclusion criteria to participate in the 
study or your condition has worsened.  Information that identifies you may be removed from the 
data that are collected as part of this study and could be used for future research or shared with 
others without additional consent. Clinically relevant research results will be not be directly 
disclosed to you but will be published in lieu of individual contact.
You will be given any new information we become aware of that would affect your willingness 
to continue to participate in the study.
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
For questions about the study or in the event of a research-related injury, contact the study 
investigator, Dr. Rawad Hamzi, at 
 during regular business hours or after hours at 
 after regular business hours.  
The Institutional Review Board (IRB) is a group of people who review the research to protect 
your rights. If you have a question about your rights as a research participant, or you would like 
to discuss problems or concerns, have questions, or want to offer input, or you want to obtain 
additional information, you should contact the Chairman of the IRB at 
 or the 
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Research Subject Advocate at 
.
You will be given a copy of this signed consent form to keep for your records.
SIGNATURES
I agree to take part in this study. I authorize the use and disclosure of my health information as 
described in this consent and authorization form. If I have not already received a copy of the 
Privacy Notice, I may request one or one will be made available to me. I have had a chance to 
ask questions about being in this study and have those questions answered.  By signing this 
consent and authorization form, I am not releasing or agreeing to release the investigator, the 
sponsor, the institution, or its agents from liability for negligence.
Subject Name (Printed):_____________________________
Subject Signature: _________________________________ Date: ________Time:_______ am pm 
Person Obtaining Consent (Printed):_____________________________
Person Obtaining Consent:___________________________ Date:_________ Time:________ am pm
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