Clinical trial NCT03936387
Conditions: Pain, Postoperative
Keywords: erector spinae block regional anesthesia sternotomy ropivacaine
Sponsor: Boston Children's Hospital
Start date: 2019-07-01; Completion date: 2019-09-12
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Overall Aim: To evaluate the feasibility and potential benefits of investigating bilateral continuous erector spinae blocks (BESB) for postoperative pain management in a small cohort of children undergoing surgical sternotomy prior to planning an appropriately powered, randomized, controlled trial of the same.

Hypothesis: The investigators' primary hypothesis is that utilizing bilateral erector spinae blocks for post-sternotomy pain is a feasible intervention for consideration in a larger trial by demonstrating a 75% or greater successful intervention completion rate without any major adverse outcomes.

Detailed description:
Regional anesthesia-and pediatric regional anesthesia in particular-is a rapidly evolving subfield of anesthesia practice driven with considerable urgency by the growing recognition that even appropriate perioperative narcotic administration can have significant derogatory long-term effects.

Regional anesthetics can provide targeted, continuous analgesia to select dermatomes with minimal additional patient risk and as such have become routine components of opioid-sparing intraoperative and postoperative pain management plans for surgical patients at BCH. In addition to the postulated benefit of reducing overall opioid exposure and potentially reducing the risk for long term physiologic and behavioral dependence upon opioids, regional anesthetics may allow for earlier extubation after selected surgeries, shorter ICU, PACU and inpatient admissions, earlier mobilization, fewer gastrointestinal complications, and improved patient satisfaction scores.

Despite a robust literature supporting the safety and efficacy of regional anesthesia for postoperative pain control across a broad range or surgery types, patient demographics and underlying comorbidities, there are certain classes of surgeries that have (to date) not benefitted from the advantages that regional anesthetics may provide, most notably spine surgery and cardiac surgery.

Concerns have been expressed with regard to regional anesthetics for cardiac surgeries in particular (this being the primary surgical type associated with sternotomies in a pediatric populations), given that most patients are pharmacologically anticoagulated to some extent during their procedures and are thus at increased risk for bleeding. This is further complicated in the pediatric cardiac surgical population as many of these children are intubated for an extended period of time and therefore may not have particularly reliable neurological exams in the setting of neuraxial regional anesthetics-potentially resulting in unrecognized acquired neurological defecits. While there is emerging evidence of improved outcomes with neuraxial regional anesthetics in adult cardiac surgery patients, this has not trickled down to the pediatric population, likely for some of these reasons.

The investigators at BCH are fortunate to have one of the largest concentrated pediatric cardiac surgical populations in the US along with an active, and well organized regional anesthesia service. Because of this, the investigators are in a unique position to more thoroughly evaluate the effectiveness and safety of regional anesthetics in children following cardiac surgery. Furthermore it is thought to be critical that institutions such as BCH take a leading role in documenting the effects of regional anesthesia on the most important outcome measures when considering perioperative medicine. These include: overall pain management, surgical healing, functional recovery, long term pain symptoms, and emotional/behavioral outcomes after surgery.

Recently, the erector spinae block (ESB) has become popular for providing analgesia after a number of anterior chest and abdominal procedures. This is a simple interfascial plane block that can reliably provide unilateral chest and/or abdominal wall analgesia. It has been described in numerous case reports and one case series as an effective block for management of unilateral thoracotomies, unilateral rib fractures, unilateral abdominal incisions and most notably, when used bilaterally, for management of post-sternotomy pain. New case reports and series involving the ESB are being published almost weekly at this point with a growing literature specific to cardiac surgical applications. Indeed a randomized controlled trial to investigate the analgesic efficacy of bilateral erector spinae plane (BESP) blocks compared with conventional treatment for pain after cardiac surgery in adult patients was published recently (2018) with promising results.

As an interfascial plane block in a compressible anatomical space, the ESB is thought to be safe in anticoagulated (or recently anticoagulated) patients. It is fast becoming a preferred anesthetic option for these pharmacologically or otherwise coagulopathic patients as opposed to neuraxial (e.g. epidural) and paraneuraxial blocks (i.e. paravertebral) nerve blocks, which are largely contraindicated in this setting.

Given the ESB's potentially favorable risk profile versus the other blocks that would subserve the same dermatomes (i.e. it is technically less challenging, more distant from critical structures, and thought to be safe in anticoagulated patients) it could provide both a safer and easier to perform regional anesthesia option for many patients. In particular, it offers a new option for a subset of anticoagulated patients for whom other regional techniques (epidural, paravertebral) are contraindicated. This is particularly true for the populations of pediatric cardiac surgical patients at BCH if used bilaterally.

Indeed, given the current information available related to the ESB, the regional anesthesia service at BCH has begun employing it when possible in circumstances when a neuraxial or paravertebral block(s) would commonly be used but is/are relatively or absolutely contraindicated. Patients undergoing thoracotomies while anticoagulated for cardiopulmonary bypass, aortic clamping, etc. have been successfully managed with unilateral continuous ESBs. In addition, thoracotomies in patients with acquired (e.g. dilutional) and other pathologic coagulopathies have been managed with ESBs. As such, the ESB has been adopted for routine use in specific patient populations at BCH and has even occasionally been utilized in lieu of the more longstanding routine PVBs or epidural blocks for patients without contraindication for such.

Retrospective review of BCH outcomes data for 67 ESBs done for a variety of surgeries and populations has not revealed any significant differences between PVBs and ESBs in terms of adverse events, postoperative opiate use, median pain scores, or other standard outcomes measures. As this data is observational in nature, it is difficult to draw firm conclusions as to the efficacy of the two blocks. However, since there are distinct known and described advantages associated with regional anesthetics for postoperative pain management, it would be prudent to evaluate these blocks in a controlled, randomized, trial. Prior to such a trial, a pilot study to evaluate the feasibility of such a trial is warranted.

As such, the investigators propose to evaluate the feasibility of investigating bilateral continuous erector spinae blocks (BESB) for patients undergoing surgical sternotomy by means of a pilot study. For this study, 'feasibility' will be defined primarily as a successful intervention completion rate of 75% or greater of all subjects with no major adverse outcomes. Secondary measures of feasibility will include aggregate 'data integrity' as defined by successful collection of 75% or greater of all possible data points for successfully completed subjects as well as 'efficient intervention duration' as evaluated by intervention completion time being less than 40 minutes.

Arms: arm 1: Bilateral erector spinae block catheters are placed at end of the sternotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. Patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH.
Interventions: intervention 1: Ropivacaine
Intervention descriptions: intervention 1: Erector spinae blocks: T4/5 transverse process is identified with the ultrasound transducer in a parasagittal orientation; the needle tip is advanced until it contacts the transverse process, just below the erector spinae muscle complex; the erector spinae muscle is visualized to be elevated up off of the transverse process with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus. Repeated on contralateral side.

Protocol documents:
Prot_SAP_001.pdf: 
 
 
 
 
Title: Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy 
Pain Management: A Pilot Study  
 
NCT03936387 
 
 
IRB-P00031524 
 
Initial approval date: 
5/13/2019 
Latest approval date:  2/16/2021 
 
Brusseau, Roland 
Boston Childrens Hospital 
 
Date of document upload: 3/10/2021 


Document date: 2/16/2021 
1 
 
CHeRP IRB Additional Protocol Information: 
     In addition to the CHeRP SmartForms, all protocols must include the following sections. 
If a section is not applicable for the current protocol please indicate why this is the case. 
Please note that a complete protocol* consists of the CHeRP forms and the information 
provided in this form. 
 
TITLE:  
Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management: 
A Pilot Study 
 
A. Specific Aims/Objectives:  
Overall Aim: To evaluate the feasibility and potential benefits of investigating bilateral 
continuous erector spinae blocks (BESB) for postoperative pain management in a 
small cohort of children undergoing surgical sternotomy prior to planning an 
appropriately powered, randomized, controlled trial of the same. 
Hypothesis: The investigators’ primary hypothesis is that utilizing bilateral erector 
spinae blocks for post-sternotomy pain is a feasible intervention for consideration in a 
larger trial by demonstrating a 75% or greater successful intervention completion rate 
without any major adverse outcomes. 
B. Background and Significance:  
Regional anesthesia—and  pediatric regional anesthesia in particular—is a rapidly 
evolving subfield of anesthesia practice driven with considerable urgency by the 
growing recognition that even appropriate perioperative narcotic administration can 
have significant derogatory long-term effects. 
Regional anesthetics can provide targeted, continuous analgesia to select 
dermatomes with minimal additional patient risk and as such have become routine 
components of opioid-sparing intraoperative and postoperative pain management 
plans for surgical patients at BCH. In addition to the postulated benefit of reducing 
overall opioid exposure and potentially reducing the risk for long term physiologic and 
behavioral dependence upon opioids, regional anesthetics may allow for earlier 
extubation after selected surgeries, shorter ICU, PACU and inpatient admissions, 
earlier mobilization, fewer gastrointestinal complications, and improved patient 
satisfaction scores. 
Despite a robust literature supporting the safety and efficacy of regional anesthesia 
for postoperative pain control across a broad range or surgery types, patient 
demographics and underlying comorbidities, there are certain classes of surgeries that 


Document date: 2/16/2021 
2 
have (to date) not benefitted from the advantages that regional anesthetics may 
provide, most notably spine surgery and cardiac surgery. 
Concerns have been expressed with regard to regional anesthetics for cardiac 
surgeries in particular (this being the primary surgical type associated with 
sternotomies 
in 
a 
pediatric 
populations), 
given 
that 
most 
patients 
are 
pharmacologically anticoagulated to some extent during their procedures and are thus 
at increased risk for bleeding.1-5 This is further complicated in the pediatric cardiac 
surgical population as many of these children are intubated for an extended period of 
time and therefore may not have particularly reliable neurological exams in the setting 
of neuraxial regional anesthetics—potentially resulting in unrecognized acquired 
neurological defecits. While there is emerging evidence of improved outcomes with 
neuraxial regional anesthetics in adult cardiac surgery patients,6 this has not trickled 
down to the pediatric population, likely for some of these reasons.  
We are fortunate at BCH to have one of the largest concentrated pediatric cardiac 
surgical populations in the US. We also have an active, and well organized regional 
anesthesia service.  Because of this, we are in a unique position to more thoroughly 
evaluate the effectiveness and safety of regional anesthetics in children following 
cardiac surgery. Furthermore we feel it is critical that institutions such as BCH take a 
leading role in documenting the effects of regional anesthesia on the most important 
outcome measures when considering perioperative medicine. These include: overall 
pain management, surgical healing, functional recovery, long term pain symptoms, 
and emotional/behavioral outcomes after surgery.  
Recently, the erector spinae block (ESB) has become popular for providing analgesia 
after a number of anterior chest and abdominal procedures.7-10 This is a simple 
interfascial plane block that can reliably provide unilateral chest and/or abdominal wall 
analgesia.11 It has been described in numerous case reports and one case series as 
an effective block for management of unilateral thoracotomies, unilateral rib fractures, 
unilateral abdominal incisions and most notably, when used bilaterally, for 
management of post-sternotomy pain.12,13 New case reports and series involving the 
ESB are being published almost weekly at this point with a growing literature specific 
to cardiac surgical applications.14,15 Indeed a randomized controlled trial to investigate 
the analgesic efficacy of bilateral erector spinae plane (BESP) blocks compared with 
conventional treatment for pain after cardiac surgery in adult patients was published 
recently (2018) with promising results.16 
As an interfascial plane block in a compressible anatomical space, the ESB is thought 
to be safe in anticoagulated (or recently anticoagulated) patients.17  It is fast becoming 
a preferred anesthetic option for these pharmacologically or otherwise coagulopathic 
patients as opposed to neuraxial (e.g. epidural) and paraneuraxial blocks (i.e. 
paravertebral) nerve blocks, which are largely contraindicated in this setting.  
Given the ESB’s potentially favorable risk profile versus the other blocks that would 
subserve the same dermatomes (i.e. it is technically less challenging, more distant 
from critical structures, and thought to be safe in anticoagulated patients) it could 
provide both a safer and easier to perform regional anesthesia option for many 


Document date: 2/16/2021 
3 
patients.12  In particular, it offers a new option for a subset of anticoagulated patients 
for whom other regional techniques (epidural, paravertebral) are contraindicated. This 
is particularly true for the populations of pediatric cardiac surgical patients at BCH if 
used bilaterally. 
Indeed, given the current information available related to the ESB, the regional 
anesthesia service at BCH has begun employing it when possible in circumstances 
when a neuraxial or paravertebral block(s) would commonly be used but is/are 
relatively or absolutely contraindicated. Patients undergoing thoracotomies while 
anticoagulated for cardiopulmonary bypass, aortic clamping, etc. have been 
successfully managed with unilateral continuous ESBs.18   In addition, thoracotomies 
in patients with acquired (e.g. dilutional) and other pathologic coagulopathies have 
been managed with ESBs. As such, the ESB has been adopted for routine use in 
specific patient populations at BCH and has even occasionally been utilized in lieu of 
the more longstanding routine PVBs or epidural blocks for patients without 
contraindication for such. 
Retrospective review of BCH outcomes data for 47 ESBs done for a variety of 
surgeries and populations has not revealed any significant differences between PVBs 
and ESBs in terms of adverse events, postoperative opiate use, median pain scores, 
or other standard outcomes measures. As this data is observational in nature, it is 
difficult to draw firm conclusions as to the efficacy of the two blocks. However, since 
there are distinct known and described advantages associated with regional 
anesthetics for postoperative pain management, it would be prudent to evaluate these 
blocks in a controlled, randomized, trial. Prior to such a trial, a pilot study to evaluate 
the feasibility of such a trial is warranted. 
As such, we propose to evaluate the feasibility of investigating bilateral continuous 
erector spinae blocks (BESB) for patients undergoing surgical sternotomy by means 
of a pilot study. For this study, ‘feasibility’ will be defined primarily as a successful 
intervention completion rate of 75% or greater of all subjects with no major adverse 
outcomes. Secondary measures of feasibility will include aggregate ‘data integrity’ as 
defined by successful collection of 75% or greater of all possible data points for 
successfully completed subjects as well as ‘efficient intervention duration’ as 
evaluated by intervention completion time being less than 40 minutes.  
C. Preliminary Studies  
While the PVB and, increasingly, the ESB are commonly used for postoperative 
management of numerous thoracic procedures in adults and children, there is little 
prospective data available evaluating the efficacy of these blocks and no prospective 
data at all that we are aware of evaluating the utility of such blocks for management 
of post-sternotomy pain in a pediatric population. 
Retrospective studies and case reports of varying quality exist and they suggest that 
ESBs are efficacious and low risk, but very few prospective data exist. The ESB has 
been described as having utility in the adult perioperative environment for patients 
undergoing breast surgery19, shoulder surgery20, thoracotomy/thoracoscopic 
surgery9,21, thoracic spinal surgery,22 and ventral abdominal surgery7.  Two case 


Document date: 2/16/2021 
4 
reports have also described its utility in treating patients with chronic pain in the 
thoracic dermatomes.23  As noted above, there is at least one published prospective 
study in adults,16 but similar studies in pediatric patients are yet to be undertaken. IN 
general, there is much less published evidence in children; however there are case 
reports and case series describing its use for patients undergoing thoracic and 
abdominal surgery12,24-26.   
Large retrospective analyses of multiple pediatric regional anesthesia registries do 
exist and consistently report a very favorable safety profile for the provision of regional 
anesthetics in the pediatric population. A recent (2015) consensus statement from the 
American and European Societies of regional anesthesia (ASRA and ESRA) reported 
the risk profile of administering regional anesthetics to anesthetized children, citing a 
risk of postoperative neurologic symptoms of 0.93/1000 cases (>90% of which resolve 
completely within 1 month) and a rate of local anesthetic systemic toxicity of 
0.08/10000 cases.27 
As noted above, analysis of the retrospective outcomes data for the 47 BCH patients 
treated with ESBs following unilateral thoracotomy does not reveal significant 
differences in common outcome measures including postoperative opioid 
consumption or pain scores as recorded by nurses in our inpatient units.  While the 
numbers at BCH are small, there is no evidence that either of this block type is 
associated with any greater risk than that demonstrated by aggregate data from the 
various pediatric regional anesthesia registries. Information currently available 
suggests that regional blockade, when performed properly, carries a very low risk of 
morbidity and mortality in appropriately selected infants and children.28 Furthermore, 
we have found no evidence of increased adverse events present in the ESB patients 
when compared to the patients receiving other regional anesthetics in our local 
analysis. Indeed, two abstracts addressing the safety and efficacy of ESB blocks in 
BCH patients have recently been accepted for presentation at the major regional 
anesthesia conference in the US.29,30 
 
D. Design and Methods  
(1) 
Study Design 
We propose a pilot study. This will be a 10-patient pilot study to evaluate the feasibility 
of bilateral continuous erector spinae blocks (BESB) for patients undergoing surgical 
sternotomy. ‘Feasibility’ will be defined primarily as a successful protocol completion 
rate of 75% or greater of all subjects with no major adverse outcomes. Secondary 
feasibility outcomes will include aggregate ‘data integrity’ as defined by successful 
collection of 75% or greater of all possible data points for successfully completed 
subjects as well as ‘efficient intervention duration’ as evaluated by intervention 
completion time being less than 40 minutes.  Children and adolescents aged 3-21 
years of age will be recruited from Boston Children’s Hospital. 
 (2) 
Patient Selection, Inclusion/Exclusion Criteria and Recruitment Method  
Patients from BCH who meet the criteria below will be considered for recruitment: 


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5 
Inclusion Criteria:  
1. Scheduled as part of the cardiac surgical ERAS program. 
2. Scheduled for a primary sternotomy. 
3. Ages 5-21 years. 
Exclusion Criteria:  
1. Patients undergoing reoperative procedures. 
2. Significant scoliosis or other anatomic contraindications to ESB.  
3. History of bleeding or current therapeutic dose anticoagulant use. 
4. Significant intraoperative hemodynamic instability or bleeding, as ascertained 
by clinicians taking care of the patient. 
5. Patients with severe neurodevelopmental delays.  
6. Patients with previous chronic pain syndromes.  
7. Patients with a history of opioid treatment at any point in the 2 months prior to 
surgery.  
8. Lack of parental consent and/or child assent. 
Recruitment Method: 
We plan to include national and international pediatric patients who are scheduled for 
in-patient surgery at BCH over a period of 1 year. Patients will be recruited by 
members of the study staff. Each morning, a designated member of the study staff 
will review the upcoming surgical schedule to identify pediatric cases that fit the 
study criteria (procedure type and age). If these criteria are met, the case will be 
sent to an investigator for further clinical review. A final eligibility decision will be 
made by the PI. 
1. Outpatients with procedures scheduled >2 weeks from identification: Patients 
will be sent information on the study (cover letter, brochure, consent form) up 
to 2 weeks prior to their surgery or scheduled preoperative visit.  This will be 
sent either by USPS mail or by secure electronic mail if an e-mail is on file. 
2. Outpatients with procedures scheduled 2 weeks or less from identification: 
Patients will be contacted by secure electronic email and/or given informational 
materials at their preoperative visit if we are unable to send mailers reliably VIA 
USPS.  We will allow at least a day for them to consider participating in the 
study. 
3. Outpatient telephone follow-up: Patients sent information packets either by 
USPS or secure electronic email may be contacted by telephone to confirm 
receipt of the materials and answer any initial questions after such time as they 
would normally be expected to have received and reviewed the packets (the 
next week for USPS and no sooner than 1 day following email). If materials 
have not been received, patients will be given the opportunity to have those 
materials sent or be contacted at a preoperative visit.  
4. Inpatients with no planned discharge and/or preoperative clinic appointments: 
Patients who are already inpatient will be approached on the patient floor or 
other inpatient encounter with study information. We will approach as soon as 
we have confirmed eligibility and will provide them with recruitment materials 


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6 
prior to their day of surgery and allow at least 24 hours for a decision to be 
made.  
5. International patients: For international patients, recruitment materials will not 
be mailed internationally. If an e-mail is available for an eligible international 
patient, a secure e-mail via BCH server will be sent if the family is noted to be 
English-speaking. The e-mail will include all approved recruitment documents. 
If we are unable to reach an international family via e-mail, eligible international 
patients and their families will be approached and provided materials in the 
preoperative clinic. At this time we will provide information about the study, 
answer all questions and allow at least 24 hours for them to consider 
participating in the study. 
6. Consent will be obtained either at the time of preoperative visit or on the day of 
surgery or at the bedside for those who are inpatient without pre-op 
appointments. If a patient expresses interest but does not sign consent at the 
preoperative visit, these patients may be contacted by phone prior to their 
surgery to assess their interest in participation. 
 
 
 (3) 
Description of Study Treatments or Exposures/Predictors   
Participants will have their medical record reviewed following enrollment for 
demographic information including: gender, age, weight and height, procedure, 
surgeon, laterality (if applicable), and current and historical medication use.  
 
Enrolled patients will have bilateral erector spinae blocks (with catheters for 
postoperative local anesthetic infusion) placed by the investigators in a sterile fashion 
after of the surgical procedure is complete as follows: 
 
• 
The patient is placed in a lateral decubitus position (left or right), with all 
pressure points padded in routine fashion. 
• 
The area for intervention is prepped with a chlorhexidine solution, and sterile 
drapes are applied to demarcate the block placement area. 
• 
The T4/5 transverse process on one side is identified with the ultrasound 
transducer in a parasagittal orientation. 
• 
An 18g Tuohy needle is advanced to the target area under direct ultrasound 
visualization. The needle tip is advanced until it contacts the transverse 
process, just below the erector spinae muscle complex. 
• 
Normal saline is injected to confirm appropriate needle tip position.  The erector 
spinae muscle is visualized to be elevated up off of the transverse process with 
normal saline injection 
• 
With confirmation of appropriate needle tip position, the initial local anesthetic 
bolus is injected using a weight-based dosing protocol (generally 0.75ml/kg of 
straight 0.2% ropivacaine).  
• 
Following the bolus injection, a catheter is threaded into the space occupied by 
the local anesthetic bolus. 


Document date: 2/16/2021 
7 
• 
Catheter tip position is verified by one or more of the following: ultrasound 
visualization of the catheter tip, ultrasound visualization of instilled normal 
saline and/or ultrasound visualization of a small hyperechoic (i.e. bright on 
ultrasound) injection of air. 
• 
With the catheter tip position identified, the catheter is tunneled to a cutaneous 
exit point approximately 2-3cm from the incision using a Crawford needle. 
• 
The catheter is dressed in standard fashion with an adhesive catheter anchor, 
Dermabond, Mastisol, Tegaderm and tape. 
• 
This is repeated for the contralateral side. To the extent possible, this will be 
done without repositioning in a contralateral decubitus position. 
• 
A label indicating that each catheter is a nerve-block catheter with its laterality 
and date of placement noted is applied to each catheter. 
• 
Catheter placement is complete. 
• 
Postoperative infusion of local anesthetic (per weight based protocol) via the 
nerve block catheter is initiated (the standard infusion is straight 0.2% 
ropivacaine @ 0.25ml/kg/hr with a usual combined max rate of 15ml/hr). 
 
All patients will have access to rescue opiates as needed by means of the standard 
PCA/NCA demand protocols utilized at BCH.  In addition, all patients will be followed 
by the Acute Pain Service at BCH, enabling access to additional assessment, catheter 
and infusion management and opioid treatment as needed 24 hours a day, 7 days a 
week. Floor/ICU nursing personnel are encouraged to call the Acute Pain Service if 
they feel pain management is not adequate in any case – this will be reinforced for 
patients included in this trial. In addition, one of the primary investigators will be 
available for consultation 24 hours a day to the Acute Pain Service for any desired 
consultation on study patients. 
 
 
E. Definition of Primary and Secondary Outcomes/Endpoints  
 
Feasibility: 
Primary: 
• Feasibility: ‘Feasibility’ will be defined primarily as a successful intervention 
completion rate of 75% or greater of all subjects with no major adverse 
outcomes. 
 Secondary: 
• Data integrity: Data integrity will be considered satisfactory if there is successful 
collection of 75% or greater of all collectible catheter follow-up data points, in 
aggregate, for successfully completed subjects. 
• Efficiency: The treatment will be considered to have an ‘efficient intervention 
duration’ if the intervention completion time is found to be less than 40 minutes. 


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8 
 
F. Data Collection Methods   
All patients will be assigned a unique personal identifier that will not be linked to any 
patient identifying information. Data will be collected during the study in case report 
forms and then will be entered into a password-protected, secure database or 
automatically collected via the Regional Anesthesia Outcomes Database and 
uploaded to that same database. 
While in the OR, the time required for installing and dressing the catheters, functional 
assessments, and any complications during placement will be recorded. The surgical 
procedure and the total surgical time will also be recorded along with any relevant 
surgical complications. 
Each subsequent day of the study (Day 1=24 hours, Day 2 =48 hours), the catheter 
will be assessed for following adverse events: Presence or absence of catheter 
dislodgement (catheter out or no longer in a clinically effective position), catheter 
occlusion, catheter leakage (presence of local anesthetic under occlusive dressing), 
skin irritation (presence of hyperemic cutaneous reaction not present at dressing 
placement), and catheter infection (presence of purulent material) by a member of the 
study team. Intubation status (including extubation time, where indicated), catheter 
boluses and catheter rate adjustments (if present) will be recorded. Patients’ costs 
and charges will be collected electronically in order understand the healthcare value 
of this novel pain management strategy 
Research information collected on paper (or other physical media) during the study 
will be stored in locked cabinets with access limited to the Principal Investigator and 
research personnel affiliated with the study. Information that has been generated as, 
or transferred to, electronic media will be kept on password protected, secured data 
servers. All health information is protected by HIPAA (Health Insurance Portability and 
Accountability Act) and all health records will be kept confidential. Patients’ birthdate, 
name, and all other identifying information will be removed when analyzing and 
reporting the data. Any personal identifying information will be stored separately from 
the other information provided by or about the patient and no personal identifying 
information will be reported in any publications or presentations. Identifying 
information will be kept in a password protected, secure file with limited access by 
research personnel. Once data collection is complete, identifying information will be 
destroyed. 
 
G. Data Management Methods 
All relevant information retrieved from the electronic medical record, by the PI and/or 
a member of the research team will be translated into an electronic form. Data 
collected in paper case report forms will be entered into a standard, secured database 
for intake and checking, and will be protected by encryption and password. Only 
authorized users are permitted access to the data files, and daily server back-up 
activities are executed to ensure data safety. All data will be stored on a password-


Document date: 2/16/2021 
9 
secured research computer, and all data entered into the computers will be password 
protected.  Procedures to ensure accurate and reliable data collection will include well-
designed data forms and training.  
 
H. Study Timeline 
We plan to enroll a total of 10 patients in the pilot study.  We will then match enrolled 
patients from the pilot study to patients within the enhanced recovery after cardiac 
surgery (ERAS Cardiac) program (IRB # P00029161) in a 1:2 ratio for a total of 30 
patients altogether. All patients in this study will already be part of the enhanced 
recovery after cardiac surgery clinical program (a quality improvement program). We 
anticipate that it would take approximately 8 months to complete enrollment and data 
collection for this study. 
 
I.  Adverse Event Criteria and Reporting Procedures  
Adverse or unanticipated events will be reported as required to the Boston Children’s 
Hospital IRB by the PI according to institutional reporting requirements. 
An Adverse Event refers to any untoward medical occurrence whether or not it is 
considered intervention-related. 
As noted above, analysis of the retrospective outcomes data for the 47 BCH patients 
treated with ESBs demonstrates no evidence that this block type is associated with 
any greater risk than that demonstrated by aggregate data from the various pediatric 
regional anesthesia registries. Information currently available suggests that regional 
blockade, when performed properly, carries a very low risk of morbidity and mortality 
in appropriately selected infants and children.28 
Nevertheless, as there exist little prospective outcomes data related to the ES block, 
we will implement a rigorous system to follow and report any adverse events, including 
interim analyses by a non-blinded statistician, as described below: 
 
Adverse Event Monitoring: 
Adverse outcomes will be carefully tracked for all patients enrolled in the 
study.   Enrollment will be halted and the IRB informed by the PI if any of the following 
conditions are met: 
 
• 1 of any of the following serious adverse events: 
o Patient death. 
o Pneumothorax 
o Hematoma at the site of the catheter/block—causing pain or any 
neurological symptoms for the patient. 
o Persistent neurologic symptoms lasting more than 3 days after a single 
shot block or catheter is removed. 


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10 
o Local anesthetic systemic toxicity (any symptoms leading to this diagnosis 
by a study team participant) 
 
• 
 >2 of any of the following minor/moderate adverse events in aggregate: 
o Persistent bleeding at the site of the catheter insertion or block placement.  
o Leakage of local anesthetic from the catheter insertion site that leads to 
discontinuation of the catheter infusion. 
o Redness or superficial infection of the catheter site or site of the block 
placement.  
o Skin irritation at the site of the catheter insertion or block placement that 
results in greater than 3 cm of induration or is associated with pain.   
If there is a pause for any of the above reasons, continuance of the protocol will be at 
the discretion of the IRB in consultation with the study team. No individual care data will 
be reported unless there is a serious adverse effect. Reports will be done in an 
aggregated fashion.  
 
Special note regarding ropivacaine: 
Ropivacaine use in ESB catheters is the standard for clinical management in this 
patient population at this institution. It is routinely used at BCH for all nerve blocks and 
regional anesthetics. Known potential adverse advents of this mode of delivery of this 
medication include hypersensitivity, allergic reaction, hypotension and cardiac 
arrhythmias if injected intravascularly. The presence of any of these will be assessed 
by the primary anesthesiologist intraoperatively and treated appropriately at the time 
of block placement and initial bolus and further assessed for such daily by members 
of the research team and Acute Pain Service. Any occurrence of a possible adverse 
event or events will be documented and reported to the DSMB, the IRB and the 
Department of Anesthesia Quality Assurance Physician as appropriate. In the event 
of a serious adverse event, it will be reported to the DSMB and IRB immediately and 
the study halted until a thorough investigation into the cause can be made. 
The relative safety of ropivacaine for use in regional anesthesia is supported by the 
information contained the Pediatric Regional Anesthesia Network (PRAN) database. 
The PRAN is a consortium of major pediatric centers in North America that manages 
a prospective data registry on pediatric regional anesthesia. From their database, 
which at this time comprises more than 130,000 pediatric regional anesthetics from 
numerous major centers in the US and Canada, ropivacaine is documented to be used 
in greater than 85% of pediatric regional with a safety profile at least equivalent to, if 
not better than, bupivacaine.31  
Further, ropivacaine is very well studied in pediatrics. There is an extensive body of 
prospective 
clinical 
trials 
and 
clinical 
outcomes 
studies 
on 
ropivacaine 
pharmacokinetics, safety and clinical outcomes from infancy through adolescence.   
Our prescribing practices at BCH in the Regional Anesthesia and Acute Pain Services 
are derived from that body of PK information and consensus recommendations.   


Document date: 2/16/2021 
11 
We therefore regard ropivacaine as the established standard of care for pediatric 
regional anesthesia and have selected it for use in this study. 
 
J.  Quality Control Method  
Data quality control will be assured through automated and manual methods. The 
study database enhances data quality through required entry fields for critical data 
and automatic flags for missing or out-of-range data. Efforts will be made to minimize 
data entry error by the development of a user-friendly database and all data entry will 
be double-checked with the source files. Data will be audited for accuracy by 
investigators after being entered into the database.  
 
K.  Data Analysis Plan 
At the time of data analysis, datasets will be downloaded from the standard, secure 
database and merged into Statistical Analysis Systems 9.3 (or more recent) for 
purposes of analysis. Missing data will be accounted for when the data is coded into 
respective variables. 
Descriptive statistics will be generated in order to summarize demographic 
characteristics of patients enrolled. Data will be evaluated subsequently with regard 
to the above-mentioned criteria for ‘feasibility.’    
Adverse events and complications (if any) associated with the blocks will be recorded 
and categorized. 
Matched groups will be compared for demographic data, Patients costs and charges, 
risk factors, diagnosis, procedure, and cardiopulmonary bypass and clamp times to 
ensure their similarities. Once data collection is complete, identifying information will 
be destroyed. 
 
L.  Sample Size Considerations  
As this is not a powered study but rather a pilot study to evaluate the feasibility of a 
protocol, no power analysis has been performed. The investigators believe, given their 
experience with this block in other surgical populations, that a cohort of 10 patients 
will be satisfactory to assess the primary outcome of ‘feasibility.’ However, the 
investigators recognize that the sample size is such that no statistically significant 
conclusions related to potential benefits may be realizable. Nevertheless, such data 
should be sufficient to power a more formal study. 
 
M.  Study Organization  
Drs. Morgan Brown, Roland Brusseau, Andrea Gomez Morad, Viviane Nasr and 
Nathalie Roy will serve as principal investigators. Patient screening, recruitment, 


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12 
enrollment, and data collection will be performed by a designated member of the 
research team. 
 
N.  Potential Benefits 
There are no known direct benefits to the patients partaking in the study. Currently no 
data exists to recommend these blocks over conventional management. The results 
of this study may allow the investigators to develop an appropriately powered, 
randomized controlled trial to evaluate the utility of this intervention which might be 
used to inform such management decisions for future patients. 
 
O.  Privacy Provisions 
Information will only be made available to individuals who are part of the research 
team. Any results from tests performed for research purposes will not be placed in the 
medical record. Medical information collected for this study will only become part of 
your child’s medical record if the information is determined to be pertinent to the care 
your child receives at Children’s Hospital Boston. Disclosure of personal information 
may occur only when required by law.   
 
P.  Confidentiality Provisions 
All identifying information such as dates of birth, names, and medical record numbers 
will be removed from the study database. All patients will be assigned to an ID number 
that will not be linked to any patient identifying information. Data collected for research 
purposes will not be entered into patient’s medical record. All data will be electronically 
secured in a password protected private folder. Only research investigators and 
personnel affiliated with the study will have access to patient information.  
Every effort will be made by research staff to keep patient information confidential. To 
ensure patient confidentiality, all research data will be secured in locked filing cabinets 
in a locked office. Any publications that result from this study will not be linked with 
personal identifiable information that would disclose the identity of study subjects. 
 
Q.  References 
 
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4. 
Mychaskiw G, 2nd, Heath BJ. Regional anesthesia and pediatric cardiac surgery. Anesth Analg 
2000;91:1562. 


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