Clinical trial NCT02865928
Conditions: Outpatient Breast Surgery Mastopexy Augmentation Revision
Sponsor: Northwell Health
Start date: 2017-09-05; Completion date: 2019-11-25
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blinded, placebo-controlled trial of serratus plane blocks in subjects undergoing outpatient unilateral or bilateral breast surgery. Ninety subjects will be enrolled into the study at presurgical testing. Subjects will be stratified based on surgery type and randomized to receive a serratus plane block with either bupivicaine HCL or placebo. All patients will receive standard intraoperative anesthesia and standard postoperative pain control. The primary endpoint is the amount of opioid administered postoperatively. Secondary endpoints include postoperative pain intensity at timed intervals, amount of opioid administered intraoperatively and postoperatively, incidence of nausea and vomiting, time to discharge and patient satisfaction

Detailed description:

Arms: arm 1: Ultrasound guided serratus plane block with bupivacaine HCl. arm 2: Placebo injection on operated side, same technique as experimental group.
Interventions: intervention 1: Bupivicaine HCl intervention 2: Normal Saline
Intervention descriptions: intervention 1: Ultrasound guided serratus plane block with bupivicaine intervention 2: Same injection technique as intervention arm with normal saline

Protocol documents:
Prot_SAP_000.pdf: 
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SERRATUS PLANE BLOCK FOR POST-OPERATIVE PAIN 
CONTROL IN BREAST SURGERY 
A Randomized, Double Blind, Placebo-controlled Study at Long Island Jewish Medical Center 
and Center for Advanced Medicine 
Principal Investigator: 
Judith Aronsohn, MD 
Anesthesiology 
Long Island Jewish Medical Center 
270-05 76th Avenue,  
New Hyde Park, NY 11040 
 
Funding Sponsor: 
 
Not Applicable 
Study Product: 
Bupivicaine HCl 
Protocol Number: 
15-246 
IND/IDE  Number: 
IND Exempt 
 
 
 
 
 
 
 
 
 
 
 


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LIST OF ABBREVIATIONS 
 
AE 
Adverse event 
cm 
Centimeter  
DSMB 
Data Safety Monitoring Board 
FDA 
Food and Drug Administration 
ID 
Identification 
IRB 
Institutional Review Board 
IV 
Intravenous 
kg 
Kilogram 
m 
Meter 
ME 
Morphine equivalents 
mg 
Milligram 
mL 
Milliliter 
MME 
Morphine Milligram Equivalent 
NSAID 
Non-steroidal anti-inflammatory drugs 
PACU 
Post-anesthesia care unit 
PCA 
Patient-controlled analgesia 
PHI 
Protected health information 
PI 
Principal investigator 
 
 
 
 
 
 
 
 
 
 
 


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CONFIDENTIAL 
 
This document is confidential and the property of Northwell Health.  No part of it may be 
transmitted, reproduced, published, or used by other persons without prior written 
authorization from the study sponsor. 
 


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STUDY SUMMARY 
Title 
SERRATUS PLANE BLOCK FOR POST-OPERATIVE PAIN 
CONTROL IN OUTPATIENT BREAST SURGERY 
Short Title 
Serratus Plane Block 
Protocol Number 
15-246 
Phase 
4 
Methodology 
Double-blind, Randomized, Placebo Control Design  
Study Duration 
18 Months 
Study Center(s) 
Single-center  
Objectives 
Efficacy of Serratus Plane Block for postoperative pain management 
after breast surgery. Determine if use provides superior pain control to 
standard of care, as evidenced by decreased opioid consumption.  
Secondary objectives include assessments of pain, incidence and 
severity of opioid related adverse events including postoperative nausea 
and vomiting at regular time intervals, antiemetic use and overall 
patient experience and satisfaction. 
Number of Subjects 
90 
Diagnosis and Main 
Inclusion Criteria 
Breast Surgery 
Study Product, 
Dose, Route, 
Regimen 
Bupivicaine HCL, 20mL bolus of drug or placebo, 0.25% of 
bupivicaine.HCl or  0.9% saline, respectively will be administered 
underneath the fascia of the serratus muscle using ultrasound 
guidance. 
Duration of 
administration 
Single bolus before surgery 
Reference therapy 
Placebo 
Statistical 
Methodology 
Analysis of covariance (ANCOVA) with  “type of surgery”  as a 
covariate will be used to compare mean ME between the two groups.  


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1. 
INTRODUCTION AND BACKGROUND 
This document is a protocol for a human research study. This study is to be conducted according 
to US and international standards of Good Clinical Practice (FDA Title 21 part 312 and 
International Conference on Harmonization guidelines), applicable government regulations and 
Institutional research policies and procedures.  
 
Breast surgery is a common procedure performed in women. Management of postoperative pain 
following breast surgery is a significant challenge, but essential for reducing functional 
compromise and time needed for recovery. Some women who undergo breast surgery also go on 
to develop  chronic pain syndromes. In addition to factors such as demographic characteristics and 
the type of surgery performed, poorly controlled, severe postoperative pain has been shown to be 
a risk factor for chronic postoperative pain after breast surgery (Fassoulaki et al. 2008, Iohom G 
et al. 2006). This chronic pain syndrome, once thought to be quite rare, is now considered a 
common occurrence with a prevalence of 10%-50% for patients reporting some level of chronic 
pain, with about 5% to 10% reporting severe or disabling pain (Kehlet et al 2006, Meretoja et al 
2014).  
 
In particular, breast surgery with general anesthesia is associated with significant postoperative 
pain, nausea, and vomiting, which can negatively impact patients’ perioperative experience, 
prolonging their length of the hospital stay and result in progression to persistent pain [Vadivelu 
et al 2008]. In these cases, the use of opiate medication is very common and often complicated by 
side effects including nausea, vomiting, and constipation, and rarely complicated by more severe 
side effects such as decreased respiratory drive and low oxygen saturation.  
 
Regional anesthesia, achieved through the use of nerve blocks, has been applied broadly to a 
variety of surgeries with excellent results in reducing the incidence of postoperative pain, opioid 
consumption, and related side effects such as nausea and vomiting (Hadzic  2007,   Ketner et al 
2011). As our knowledge of anatomy advances, new targets are being discovered for regional 
anesthesia. Exploring these targets enables the surgeon and anesthesiologist to provide specific 
anesthesia to the area being operated on while minimizing complications and systemic exposure 
to narcotics. Regional block techniques such as epidural [Lynch et al 1995], intercostal [Atanassoff 
et al 1994], interpleural [Dravid and Paul 2007] and paravertebral [Schnabel et al 2010] blocks are 
all acceptable techniques developed and used for breast surgery. For example, studies on thoracic 
parvertebral blocks for breast surgery found they provide meaningful postoperative analgesia at 
rest and upon arm movement in the immediate postoperative period and reduced fentanyl and 
postoperative analgesic requirements compared to placebo controls [Agarwal et al 2015, Faria and 
Gomez 2015]. However, this technique has also been associated with rapid rises in plasma 
concentrations of the anesthetic agents injected [Behnke et al 2002], an unreliable block 
(The inclusion of these covariates in the model is in accordance with 
ICH E9 Section 5.7 guidelines.)   


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distribution for single injections [Cheema et al 1995, 2003],  a reported  failure rate of 6 to 12% 
and  in rare cases pneumothorax or transient Horner’s syndrome [Batra et al 2011].   
 
The serratus plane block was developed  as an alternative, safe, easily performed and effective 
block for providing pain relief while minimizing the liklihood of side effects assosciated with more 
invasive nerve block techniques nerve block techniques [Blanco, Parras et al. 2013, Blanco et al 
2011].  Preliminary studies of use of this block report a prolonged numbness using a relatively 
small amount of local anesthetic as compared to the large volumes of local anesthetics required to 
provide similarly prolonged results using alternative techniques such as intercostal, interpleural 
and thoracic paravertebral blocks (Johnson et al 1990, Seltzer et al 1987, Karmakar et al 2005). 
Local anesthetics have been found to be very rapidly absorbed from the intercostal, interpleural 
and paravertebral spaces resulting in a potential for local anesthetic toxicity. The serratus muscle 
is a superficial and easily identified muscle and it has been proposed that the risk of local anesthetic 
toxicity after a serratus plane block is lower than most alternative regional techniques because a 
smaller dose of anesthetic is injected under ultrasound into a less vascularized area (Tighe 2013, 
Blanco et al 2013). While found to be effective in several case studies, larger studies are required 
to validate the  introduction  of the Serratus Plane Block to routine clinical practice.  The potential 
of this technique is underlined by the  six active clinical trials currently underway to assess its 
analgesic efficacy following thorascopic and breast surgery [https://clinicaltrials.gov/].  
 
2. 
HYPOTHESIS 
We hypothesize that the use of serratus plane blocks for ambulatory breast surgery postoperative 
analgesia will provide improved pain relief while resulting in decreased opioid usage and opioid-
related adverse events such as nausea and vomiting, thus improving patient recovery and 
satisfaction. 
 
3. 
SPECIFIC AIMS 
The primary objective of this study is to determine if the use of serratus plane blocks placed before 
outpatient breast surgery, provide superior pain control to standard of care, as evidenced by 
decreased opioid consumption.  
 
Secondary objectives include assessments of pain, anti-emetic use, incidence and severity of 
opioid related-adverse events including postoperative nausea and vomiting and overall patient 
experience and satisfaction. 
  
4. 
OBJECTIVE 
The authors propose a randomized, double blinded, multi-surgeon, prospective, placebo-controlled 
study to evaluate the effectiveness of a single shot serratus plane block  in reducing postoperative 
pain, nausea, narcotic use, and PACU length of stay in patients undergoing ambulatory breast 
surgery.  


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5.  DRUG INFORMATION 
a. 
Product Description: Bupivacaine HCL (2.5mg/mL, AuroMedics Pharma, Dayton, NJ) is 
a sterile, isotonic solution containing Bupivacaine hydrochloride in water for injection in various 
available concentrations. Bupivacaine is related chemically and pharmacologically to the amide-
type local anesthetics, including mepivacaine and lidocaine.    
 
b. 
Clinical Pharmacology: Local anesthetics block the generation and the conduction of nerve 
impulses (1) by increasing the threshold for electrical excitation in a nerve, (2) by slowing the 
propagation of the nerve impulse, and (3) by reducing the rate of rise of the action potential. 
Systemic absorption of local anesthetics results in resolution of the local effects. The rate of 
systemic absorption of bupivacaine is dependent upon the total dose of drug administered, the 
route of administration, and the vascularity of the administration site. Local anesthetics including 
bupivacaine are distributed to some extent to all body tissues, with high concentrations found in 
highly perfused organs. Amide-type local anesthetics, such as bupivacaine, are metabolized 
primarily in the liver via conjugation with glucuronic acid. Elimination of the drug depends largely 
upon the availability of plasma protein binding sites in the circulation to carry it to the liver where 
it is metabolized. The kidney is the main excretory organ for most local anesthetics and their 
metabolites.    
 
c. 
Indications and Usage: For the production of local or regional anesthesia or analgesia for 
surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for 
obstetrical procedures. 
 
d. 
Dosage and Guidelines for Administration: The dose of any local anesthetic administered 
often varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, 
the number of neuronal sergments to be blocked, the depth of ansethesia and degree of muscular 
relaxation required, the duration of anesthessia desired, individual tolerances, and the physical 
condition of the patient. The smallest dose and concentration required to produce the desired result 
should be administered. FDA information recommends 225 mg as the maximum dose. Goodman 
& Gilman (2004) also suggests a maximum dose of Bupivacaine 2mg/kg or 225mg, which should 
not be exceeded. The total dose of Bupivacaine over 24 hours should not exceed 400mg. In this 
study, one (unilateral) or two (bilateral)  20mL bolus of drug or placebo, 0.25% of bupivicaine 
HCl (in 0.9% saline) or  0.9% saline, respectively will be administered underneath the fascia 
of the serratus muscle for each subject using ultrasound guidance. The total amount of 
bupivicaine administered will be  50mg  for unilateral procedures or 100mg for bilateral 
procedures. An individual dose will not exceed 100mg and patients weighing less than 50kg will 
be excluded. 
e. 
 As there is a potential risk of severe life-threatening adverse effects associated with the 
administration of Bupivacaine HCl products, the serratus plane block will be administered in the 


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OR, where trained personnel and equipment are available to promptly treat patients who show any 
evidence of neurological or cardiac toxicity as is standard of care with all local anesthetic 
products. Please note the use of Bupivacaine in this study is on-label and an investigational new 
drug application (21 CFR Part 312) is not required. Bupivacaine HCL in this study is IND Exempt 
because the results will not be submitted to FDA to support a new indication or change to 
advertising, the planned use does not increase risks or decrease the acceptability of risks to the 
subjects, and the use does not require any changes to the approved formulation, dosage, or route 
of administration.  
 
f. 
Toxicity and Known Side Effects: The incidences of adverse neurologic reactions 
associated with the use of local anesthetics may be related to the total amount of   anesthetic 
administered, the particular drug used, the route of administration, and the physical status of the 
patient. Neurologic effects following infiltration of soft tissue may include persistent anesthesia, 
paresthesias, weakness, and paralysis. Central nervous system reactions are characterized by 
excitation and/or depression. Restlessness, anxiety, dizziness, tinnitus, blurred vision, or tremors 
may occur, possibly proceeding to convulsions. However, excitement may be transient or absent, 
with depression being the first manifestation of an adverse reaction. This may quickly be followed 
by drowsiness merging into unconsciousness and respiratory arrest. Other central nervous system 
effects may be nausea, vomiting, chills, and constriction of the pupils. Toxic blood concentrations 
depress cardiac conductivity and excitability, which may lead to atrioventricular block, ventricular 
arrhythmias, and cardiac arrest, sometimes resulting in fatalities. In addition, myocardial 
contractility is depressed and peripheral vasodilatation occurs, leading to decreased cardiac output 
and arterial blood pressure. Allergic-type reactions are very rare and may occur as a result of 
hypersensitivity to the local anesthetic or to other formulation ingredients. These reactions are 
characterized by signs such as urticaria, pruritus, erythema, angioneurotic edema (including 
laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive 
sweating, elevated temperature, and possibly anaphylactic-like symptoms (including severe 
hypotension). 
 
g. 
Precautions and Contraindications: Caution should be taken to avoid overdosage or 
accidental intravascular injection of Bupivacaine. Convulsions and cardiac arrest have occurred 
following accidental intravascular injection of Bupivacaine and other amide-containing products. 
Bupivacaine should be avoided in patients with an allergy to amide-type local anesthetics. Amide-
type local anesthetics, such as bupivacaine, are metabolized by the liver and should be used 
cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their 
inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma 
concentrations and will be excluded from this study. Bupivicaine is also known to be excreted by 
the kidney and risk of toxic reactions to this drug may be greater in patients with impaired renal 
function. Patients with renal disease will be excluded from this study. 


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h. 
Drug Preparation: 
Sterile plastic syringes of Bupivacaine and normal saline will be ascetically prepared (0.25% of 
bupivicaine.HCl or  0.9% saline) from clinical supply upon receipt of study physician’s 
order. Syringes will be labeled by the unblinded study pharmacist from LIJ pharmacy with the 
protocol number, the subject ID (a unique randomization number generated by the Biostatistics 
Unit (ML, MA, also unblinded)), the date of preparation and expiration. Test articles will be 
checked by a second member of LIJ pharmacy to ensure that the test article assignment is 
appropriate.  
 
i. 
Study Drug Accountability. 
An accurate and current accounting of the dispensing and return of study drug for each subject will 
be maintained on an ongoing basis by the unblinded pharmacist. The subject number of study drug 
dispensed will be recorded on the Investigational Drug-Biologic Accountability Log and one of 
the labels will be removed and fixed to the log. The PI will verify these documents throughout the 
course of the study. Any returned syringes of study drug will not be used, relabeled or reassigned 
for use by another subject. Syringes will be discarded following use. 
 
6. 
BENEFITS 
This study may result in potential direct benefit to individuals that receive the bupivacaine HCL 
because it is believed that it will lead to the improvement of postoperative patient outcomes 
following surgery compared to standard of care procedures. This study may also lead to changes 
in future clinical care of patients undergoing breast surgery. Potential benefits of this study include 
expanding options for postoperative pain control, decreased need for postoperative narcotics, 
decreased post-operative pain, decreased need of antiemetics due to decreased nausea, and 
decreased PACU length of stay.  
 
7. 
DISCOMFORTS AND RISKS 
A major cause of adverse reactions to this group of drugs is excessive plasma levels, which may 
be due to over dosage, unintentional intravascular injection, or slow metabolic degradation. As 
there is a potential risk of severe life-threatening adverse effects associated with the administration 
of bupivacaine or any bupivacaine-containing product, this drug will be administered in a setting 
where trained personnel and equipment are available to promptly treat patients who show evidence 
of an adverse event. Although very rare, another potential risk includes an allergic reaction to local 
anesthetic or formulation ingredients. The most common adverse reactions to bupivacaine are 
nausea, constipation, and vomiting.  
As a result of participation in this study (in addition to the risks associated with the surgery itself), 
participants are at risk for the following side effects:: 


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a. 
Risks associated with bupivacaine (investigational arm only): 
- 
Allergic reaction  (including headache, dizziness, nausea, vomiting, hives and itching), 
nausea, constipation, vomiting, and toxicity 
b. 
Risks associated with injection 
- 
Pain 
- 
Infection 
- 
Bleeding 
- 
Hematoma/Bruising 
- 
Nerve injury 
- 
Pneumothorax 
- 
Unsuccessful block 
c. 
Risks associated with data collection 
- 
Breach of confidentiality. 
 
All patients who exhibit these signs and/or symptoms will be evaluated and treated accordingly by 
the admitting service. This research may involve risks to patients which are currently 
unforeseeable. All patients will be told about any new information that might change their 
decisions to be in this study. Patients will be asked to sign a new consent form if this occurs.  
 
8. 
SUBJECT SELECTION AND WITHDRAWAL 
 
a. 
Subject Recruitment and Screening: 
At pre-surgical testing, approximately one week before surgery, potential subjects will be screened 
and recruited into the trial. 
 
b. 
Inclusion Criteria: 
- 
Female. 
- 
Age 18-75 years. 
- 
ASA I-III. 
- 
Non-pregnant. 
- 
Undergoing outpatient breast surgery requiring general anesthesia, including but not 
limited to   reconstruction with tissue expanders or implants and  reconstruction revision. 
 
c. 
Exclusion Criteria: 
- 
Unable to provide informed consent.  
- 
Patients who are preganant or nursing. 
- 
ASA IV-V. 
- 
Alcohol or narcotic dependence in the last 2 years. 


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- 
Concurrent condition requiring regular use of analgesia that may confound post-surgical 
assessments as determined by principle investigator. 
- 
Hepatic disease. 
- 
Allergies to amide anesthetics as determined from medical history or patient self-report. 
- 
Evidence of infection at injection site. 
- 
Contraindication to pain medications such as  acetominophen, morphine, oxycodone, 
keterolac, dilaudid, Toradol. 
- 
Body weight <50kg. 
- 
BMI>50kg/m2. 
- 
History of hypotension. 
- 
Abnormal  renal (creatinine > 1.5 mg/dL) function. 
- 
Heart block. 
- 
Any physical, mental or medical condition, that in the opinion of the investigator, makes 
study participation inadvisable. For example, chronic pain conditions, significant medical 
disease, laboratory abnormalities or condition(s) that could impact a subject’s ability to 
communicate with the study staff, complete study activities such as provide pain scores, or 
would otherwise contradict study participation 
 
d. 
Informed Consent 
Informed consent will be obtained for all surgical procedures and for participation in this study. 
Patients without capacity to provide informed consent will be excluded from the study. At pre-
surgical testing, subjects screened will be recruited into the trial.  Those wishing to participate will 
sign the informed consent form. Subjects who sign a consent form will be randomly assigned on 
the day of their surgery to have either placebo or bupivacaine serratus plane block. Subjects will 
be allowed to keep the consent form to review and sign on the day of surgery if they require 
additional time to consider participation in the study.  Informed consent will be conducted as 
follows: During their pre-surgical testing appointment, the anesthesiologist or pre-surgical testing 
physician will discuss the following:  
- 
the purpose/objective of the study; 
- 
the study design (e.g., the number of participants); 
- 
the details of each pain management regimen (including their risks and benefits); 
- 
how patients are assigned to the investigational and control groups (i.e., randomly); 
- 
the methods by which the study will monitor the patient’s pain;  
- 
risks/benefits; 
- 
participation in this study is not required for receipt of either postoperative analgesia; 
regimen; 
- 
patients may withdraw from this study at their discretion; 
- 
 
9. 
EXPERIMENTAL DESIGN 
 


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a. 
Overview: 
This is a randomized, double-blind, placebo-controlled trial of serratus plane block in subjects 
undergoing unilateral or bilateral breast surgery at Long Island Jewish Medical Center. Ninety 
subjects will be enrolled into the study at presurgical testing approximately one week before their 
surgery. Subjects will be stratified based on surgery type and randomized to receive a serratus 
plane block with either bupivicaine HCL or normal saline in a 1:1 ratio. All patients will receive 
standard intraoperative anesthesia and standard postoperative pain control.  
- 
Control Group: Each patient in the control group will receive standard intra-operative 
general anesthesia and standard post-operative pain control as a well a placebo injection of normal 
saline on the operated side(s) using the same technique as the serratus plane block. 
- 
Investigational Group: Each patient in the investigational group will receive serratus 
plane blocks on the operated side(s) using bupivicaine HCl. This will be in addition to standard of 
care intra-operative anesthesia and standard of care post-operative pain control. One (unilateral) 
or two (bilateral)  20mL bolus of drug, 0.25% of bupivicaine.HCl, will be administered underneath 
the fascia of the serratus muscle for each subject using ultrasound guidance. The total amount of 
bupivicaine administered will be  50mg or 100mg for unilateral and bilateral procedures, 
respectively. 
 
b. 
Randomization: 
The Biostatistics Unit (BU) will develop a computer-generated randomization list that utilizes a 
permuted block design, and will develop and implement a well-documented double-blind 
randomization procedure.  Details of the procedure, including required record keeping, will be 
further developed upon approval of this protocol. 
A unique randomization number will be generated by the Biostatistics Unit for each subject in the 
trial with the format RZxyyy.  The randomization number will be a 4-digit number with the 
following format:  the 1st digit (x) will designate the TYPE OF SURGERY [1=Breast 
reduction/mastopexy, 2=Breast augmentation, 3= Revisions & Other] and the last 3 digits (yyy) 
will be numbered sequentially starting with “001”.  For example, the third subject randomized to 
“Breast augmentation” will have the randomization number RZ2003. 
Subjects will be randomized to either Placebo (saline) or Bupivacaine injection as described below.  
Randomization will be double blind.  Preparation of blinded injection is described below. 
 
c. 
Blinding and Injection Preparation: 
Sterile, sealed, plastic syringes of clinically available supply of  normal saline (0.9% ) and 
bupivacaine.HCl (0.25% ) will be prepared asceptically by the unblinded study pharmacist (Z. 
Faynblatt)  at Long Island Jewish Medical Center Pharmacy upon receipt of study physician’s 
orders. The study pharmacist will have access to the full randomization scheme and will prepare 
the sterile syringe with a 2-part tear off label. Both parts of the label  will contain a  randomly 
generated 4-digit number generated by the Biostatistics Unit. In addition to noting the number, one 


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of these labels will be attached to the drug accountability paperwork when the drug is dispensed. 
The second part of the label will remain affixed to the syringe and will be attached to data 
collection sheet by the study anesthesiologist administering the drug. Syringes will be prepared 
upon receipt of study physicians orders. Any test articles to be administered will be checked by 
the pharmacist and a second member of LIJ pharmacy. 
 
 
d. 
Surgery: 
All breast surgery will be performed under general anesthesia as per standard of care. The type of 
surgery and laterality will be recorded. 
1. 
Opioids will be utilized at the discretion of the study anesthesiologist for intraoperative 
pain control.  
2. 
Regardless of whether a subject is enrolled in the investigational arm or control arm of the 
study, the breast surgery will take place in the usual fashion. 
3. 
Prior to surgery, upon receipt of physician’s orders, the randomization system will be 
accessed by the pharmacist and the treatment and randomization/subject ID number will 
be obtained. The syringe will be prepared and the randomization/subject ID number will 
be confirmed to match the randomization system by a 2nd member of the pharmacy staff.  
4. 
This syringe (prepared upon receipt of physician’s orders) will be collected from pharmacy 
and brought to the OR. 
5. 
For patients enrolled in the investigational arm of the study, prior to surgery, following 
induction of general anesthesia, serratus plane block (20mL bolus of drug, 0.25% of 
bupivicaine HCl will be administered underneath the fascia of the serratus muscle for 
each subject using ultrasound guidance) will be performed on the operated side(s) (See 
section “Investigational Study Group” for further details). 
6. 
For patients enrolled in the control arm of the study, prior to surgery, a placebo injection 
of normal saline will be performed on the operated side(s) using the same technique as 
the serratus plane block with bupivicaine (0.9% saline administered underneath the 
fascia of the serratus muscle for each subject using ultrasound guidance).  
 
 
e. 
Investigational Study Group 
1. 
In the operating room before surgery, patients enrolled in the investigational study group 
will receive an injection of bupivacaine as a serratus plane block on the operated side(s) in 
the standard fashion.  
2. 
After the surgery is complete, patients will be awoken from general anesthesia, extubated, 
and transferred to the PACU.  
3. 
Patients will receive oral standard post-operative pain and nausea management on an as-
needed basis in the PACU.  
 


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f. 
Control Study Group 
1. 
For patients enrolled in the control study group, the procedure takes place in the usual 
fashion. Patients in this group undergo a placebo injection of normal saline on the operated 
side(s) at the same time, using the same technique as the serratus plane block. 
2. 
After the procedure is complete, patients will be awoken from general anesthesia, 
extubated, and transferred to the PACU.  
3. 
Patients will receive oral standard post-operative pain and nausea management on an as-
needed basis in the PACU.  
 
g. 
Data Collection: 
In addition to basic demographic information, the patients post-operative course will be reviewed. 
Information to be collected: 
1. 
Medical record number; 
2. 
Date of surgery; 
3. 
Type of Surgery 
4. 
Race/Ethnicity 
5. 
Length of PACU stay (hours); 
6. 
Age at time of surgery (years); 
7. 
Height (cm); 
8. 
Weight (kg); 
9. 
Body mass index (kg/m2); 
10. 
Indication for procedure; 
11. 
Surgical procedure(s) performed; 
12. 
Attending breast surgeon (for patients having concurrent breast surgery) 
13. 
Attending plastic surgeon 
14. 
Length of procedure (hours); 
15. 
Perioperative intravenous administration (including dose) of fentanyl, Tylenol, and 
Toradol; 
16. 
Postoperative intravenous administration (including total dose) of morphine, dilaudid, 
Tylenol, toradol, and other analgesic agents; 
17. 
Postoperative oral administration (including total dose) of Percocet, morphine, dilaudid, 
Tylenol, Toradol, and other anlagesic agents; 
18. 
Postoperative oral and IV use of antiemetics (Zofran, etc). 
19. 
Self-reported pain score using the 0–10 Numeric Pain Rating Scale. 
20. 
Self-reported nausea score using the 0–10 Numeric Pain Rating Scale. 
21. 
Vomiting episodes 
22. 
Past medical history including diabetes mellitus, history of neuropathy (of any etiology), 
history of seizures, pre-existing pain conditions, and regular (defined as use > 3 times 
weekly) analgesic use (including type of analgesic used), allergies or adverse reactions to 
NSAIDs or opiates; 


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The study will collect pain and nausea scores in the PACU every 30 minutes up to 4 hrs and at 1 
hr intervals after 4 hours for the duration of PACU stay. With respect to timing of collection of 
scores, time zero will be PACU admission and all time intervals for pain score assessment will be 
determined using this time as a reference.  Investigators will also follow up within one week of 
surgery to determine patient satisfaction and collect pain scores documented by patients following 
discharge. 
 
h. 
Endpoints: 
1. 
Amount of narcotic administered(morphine miligram equivalents). 
The primary endpoint will be narcotic usage for the first 4 postoperative hours. 
Postoperatively, oral and IV rescue medication will be administered to both groups upon 
request as per standard of care.  The use of narcotics will also be recorded intra-operatively, 
for the duration of PACU and hospital stay and up until the end of postoperative day one. 
Consumption of rescue medication will be converted to the morphine equivalent (ME) dose 
for analysis.  Analysis will be performed on both groups to allow comparison of effect of 
block with placebo and bupivicaine on total opioid consumption. 
2. 
Postoperative  Pain.  
Postoperatively, pain intensities at rest and on movement will be assessed every 30 minutes 
in the PACU for the first four hours and at hourly intervals up until PACU discharge, using 
the visual analog scale (VAS) with two anchor points; 0 being no pain and 10 being the 
worst pain imaginable. Following discharge patients will be asked to record their pain upon 
and one hour after taking their pain medication up until the end of the first postoperative 
day.  
3. 
Postoperative Nausea (Incidence and rating). 
Evaluation will be performed at every 30 minutes in the PACU for the first four hours and 
at hourly intervals up until PACU discharge using a standard 11-point verbal rating scale, 
for which “0” represents “no nausea” and 10 represents “worst nausea imaginable.” 
Significant nausea is defined as a score of > 4.  
4. 
Vomiting. 
This will be recorded throughout PACU stay until discharge. Vomiting will be measured 
as the number of emetic and retching (recorded separately) episodes occurring at least 1 
minute apart during entire PACU stay. Severe vomiting will be defined as 3 or more 
episodes during a given time interval. Vomiting and retching episodes will be counted as 
necessary up to PACU discharge. 
5. 
Amount of antiemetic administered. 
Amount of antiemetic administered intra-operatively, during PACU and hospital stay will 
be recorded.  
6. 
PACU Length of Stay. 
7. 
Patient Experience and Satisfaction. 


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Patient satisfaction with postoperative pain and and overall patient satisfaction with their 
surgical experience will be assessed within one week following discharge with a follow up 
phone call using a 5-point categorical scale. 
 
i. 
Statistical Considerations 
1. 
Brief Summary: This is a double blind randomized, placebo controlled trial of Bupivicaine 
vs Placebo for the treatment of post-op pain following oupatient breast surgery. 
2. 
Primary Endpoint: Narcotics usage (IV or PO) for first 4 hours in the PACU, expressed 
as morphine equivalents (ME) .   
 
3. 
Secondary Endpoints: Narcotic usage for the duration of PACU and hospital stay and up 
to postoperative day one, antiemetic administration in PACU (no, yes); PACU length of 
stay,  Self-reported pain using the 0–10 Numeric Pain Rating Scale  during the first 4 hours 
of PACU stay, hospital stay and up until the end of the first postoperative day.  Self-
reported nausea, vomiting episodes during PACU stay and patient satisfaction with pain 
management.  
4. 
Statistical Methods:   
Primary - Analysis of covariance (ANCOVA) with  “type of surgery” as a covariate will 
be used to compare mean ME between the two groups.  (The inclusion of these covariates 
in the model is in accordance with ICH E9 Section 5.7 guidelines.)  Data transformation 
(presumably a log transform) will be considered in order to achieve the required 
assumptions of normality and equal variance. 
Secondary – The chi-square test will be used to compare anti-emetic rates and patient 
satisfaction.  ANCOVA will be used to compare LOS. pain and nausea scores. 
5. 
Intention to Treat (ITT):  The ITT population will be defined as all subjects who are 
randomized.  All primary analyses will be carried out on the ITT population.  
6. 
Sample Size Consderations: A two-sample t-test approach is used as a reasonable 
simplification of the ANCOVA method.  Based on previous data, it is expected that the 
Placebo group will average 12 ME (SD=4) of narcotics in the PACU.  A reduction of 20% 
to 9.6 ME in the Bipuvacaine group would be clinically significant.  A sample size of n=45 
subjects per group (total 90) will yield 80% power to detect such a reduction (alpha=0.05, 
2-tailed t-test). 
7. 
Interim Analysis: There will be no interim analysis for early stopping of the trial.  
 
j. 
Adverse events 
An adverse event (AE) is any untoward medical occurrence in a clinical investigation of a 
patient administered a pharmaceutical product and that does not necessarily have a causal 
relationship with the treatment. An AE therefore is any unfavorable and unintended sign 
(including an abnormal laboratory finding), symptom or disease temporally associated with 
the administration of an investigational product, whether or not related to the 
investigational product. An unexpected AE is one of a type not identified in nature, 


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severity, or frequency in the study protocol or of greater severity or frequency than 
expected based on the information in the study protocol.  
AEs will be reported in the patient’s medical record and reviewed by the PI, who records, 
reviews, evaluates, and manages all AEs. Any unanticipated problems which occur will be 
primarily addressed by the principal investigator and other physician investigators. Serious 
AND Unanticipated AND possibly, probably or definitely related AEs will be reported to 
the IRB as per their specific reporting requirements. Modifications to the protocol, if 
required, will be determined by the PI in cooperation with the IRB. Abnormal results of 
diagnostic procedures are considered to be AEs if the event: 
- 
results in study withdrawal 
- 
is associated with a serious adverse event 
- 
is associated with clinical signs or symptoms 
- 
leads to additional treatment or to further diagnostic tests 
- 
is considered by the investigator to be of clinical significance 
 
Adverse events will be classified as serious or non-serious.  A serious adverse event is any 
AE that is:  
- 
fatal 
- 
life-threatening 
- 
requires or prolongs hospital stay 
- 
results in persistent or significant disability or incapacity 
- 
a congenital anomaly or birth defect 
- 
an important medical event 
Important medical events will be defined as those that may not be immediately life 
threatening, but are clearly of major clinical significance.   They may jeopardize the 
subject, and may require intervention to prevent one of the other serious outcomes noted 
above.  All adverse events that do not meet any of the criteria for serious will be regarded 
as non-serious adverse events.  
1.  
Preexisting Condition 
A preexisting condition is one that is present at the start of the study.  A preexisting 
condition will be recorded as an adverse event if the frequency, intensity, or the character 
of the condition worsens during the study period. 
2. 
General Physical Examination Findings 
At screening in pre-surgical testing, any clinically significant abnormality will be recorded 
as a preexisting condition.  At the end of the study, any new clinically significant 
findings/abnormalities that meet the definition of an adverse event must also be recorded 
and documented as an adverse event.  
3. 
Post-study Adverse Event 


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All unresolved adverse events will be followed by the investigator until the events are 
resolved, the subject is lost to follow-up, or the adverse event is otherwise explained. The 
investigator will instruct each subject to report any subsequent event(s) that the subject, 
or the subject’s personal physician, believes might reasonably be related to participation 
in this study.  The investigator will notify the IRB of any death or adverse event 
occurring at any time after a subject has discontinued or terminated study participation 
that may reasonably be related to this study.   
Abnormal Laboratory Values 
A clinical laboratory abnormality will be documented as an adverse event if any one of 
the following conditions is met:  
- 
The laboratory abnormality is not otherwise refuted by a repeat test to confirm the 
abnormality 
- 
The abnormality suggests a disease and/or organ toxicity 
- 
The abnormality is of a degree that requires active management; e.g. change of 
dose, discontinuation of the drug, more frequent follow-up assessments, further diagnostic 
investigation, etc. 
4. 
Hospitalization, Prolonged Hospitalization or Surgery 
Any adverse event that results in hospitalization or prolonged hospitalization will be 
documented and reported as a serious adverse event unless specifically instructed otherwise 
in this protocol.  Any condition responsible for surgery should be documented as an adverse 
event if the condition meets the criteria for an adverse event. The condition, hospitalization, 
prolonged hospitalization, or surgery will be reported as an adverse event in the following 
circumstances: 
- 
Hospitalization or prolonged hospitalization for diagnostic or elective surgical procedures 
for a preexisting condition.  Surgery will not be reported as an outcome of an adverse 
event if the purpose of the surgery was elective or diagnostic and the outcome was 
uneventful. 
- 
Hospitalization or prolonged hospitalization required to allow efficacy measurement for 
the study. 
- 
Hospitalization or prolonged hospitalization for therapy of the target disease of the study, 
unless it is a worsening or increase in frequency of hospital admissions as judged by the 
clinical investigator. 
k. 
Recording of Adverse Events 
 At each contact with the subject, the investigator will seek information on adverse events by 
continuous monitoring while subject is under anesthesia, specific questioning and, as appropriate, 
by examination.  Information on all adverse events will be recorded immediately in the source 
document, and also in the appropriate adverse event module of the case report form (CRF).  All 
clearly related signs, symptoms, and abnormal diagnostic procedures results will be recorded in 


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the source document, though should be grouped under one diagnosis. All adverse events occurring 
during the study period will be recorded.  The clinical course of each event will be followed until 
resolution, stabilization, or until it has been determined that the study treatment or participation is 
not the cause.  Serious adverse events that are still ongoing at the end of the study period will be 
followed up to determine the final outcome.  Any serious adverse event that occurs after the study 
period and is considered to be possibly related to the study treatment or study participation will be 
recorded and reported immediately. 
l. 
Reporting of Serious Adverse Events 
Reports of all serious adverse events (including follow-up information) will be submitted to the 
IRB according to their policies.  Copies of each report and documentation of IRB notification and 
receipt will be kept in the research binder. 
m. 
Unblinding Procedure 
The unblinding procedure will ensure that the identity of the investigational medicinal product is 
only revealed as far as necessary.  The subject’s treatment will be revealed when it is necessary to 
ensure the subject’s safety and/or this information would be instrumental in further treatment 
decisions during a medical emergency and/or a suspected unexpected serious adverse event. 
Pharmacy personnel with access to the randomization scheme will be contacted using a designated 
telephone number. If a subject’s treatment is unblinded, this will be reported to the IRB as per 
guidelines and documented on the CRF (date and initials of investigator) with details of the time 
and reason for unblinding.  
n. 
Stopping Rules  
This study will be stopped prior to its completion if: (1) the intervention is associated with adverse 
effects that call into question the safety of the intervention; (2) any new information becomes 
available during the trial that necessitates stopping the trial; or (3) other situations occur that might 
warrant stopping the trial. 
o. 
Medical Monitoring/ Data and Safety Monitoring Plan 
In accordance with federal guidelines, this study requires a DSMP. It is the responsibility of the 
Principal Investigator to oversee the safety of the study at his/her site.  This safety monitoring will 
include careful assessment and appropriate reporting of adverse events as noted above, as well as 
the construction and implementation of a site data and safety-monitoring plan. Medical monitoring 
will include a regular assessment of the number and type of serious adverse events. 
The PI has appointed an independent Safety Officer/Medical Monitor to fulfill the data and safety 
monitoring responsibilities. The director of Regional Anesthesia at Northwell Health and medical 
director of Franklin Hospital, Dr. Joseph Marino MD, will serve as the data and safety monitor 
along with Khang Nguyen, who will offer ancillary support to the monitoring responsibilities.  Dr. 
Marino does not have any scientific, financial, or other conflict of interest related to the study and 
is not responsible for any patient care at Long Island Jewish Medical Center. Safety will be 


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monitored after the first 5 patients and at 6 month intervals afterwards by the study team and the 
Safety Officer/Medical Monitor throughout the duration of the study. The PI will prepare a safety 
report for these regular reviews comprised of adverse events and the actions taken. The PI will 
contact the Medical Monitor for ad hoc reviews of any unanticipated safety events.  The study 
protocol will be carried out in accordance with OHRP/FDA/NIH guidelines and requirements. In 
the event of a serious adverse event during the study protocol, it will be reported immediately to 
the PI, the co-investigators, and the Medical Monitor. Serious AND Unanticipated AND possibly, 
probably or definitely related AEs will be reported to the IRB by the principal investigator as well 
as to all members of the research team. Data will also be reviewed to determine if aspects of the 
study need to be changed or stopped. In addition, the monitor will review any and all deviations, 
adverse events and unanticipated problems that may occur to determine their relatedness to the 
study, their severity, and whether they require study changes. In addition, any unanticipated 
problems will be reported to the IRB as per their specific reporting requirements. Anticipated 
deviations will be submitted to the IRB for approval as a protocol exception prior to its initiation, 
unless required to eliminate apparent immediate hazards.   
The primary concern when administering local anesthetics is the development of local anesthetic 
toxicity or anaphylaxis. With respect to this study, the risks of local anesthetic toxicity after a 
serratus plane block is lower than most alternative regional techniques because a smaller dose of 
anesthetic is injected under ultrasound into a less vascularized area (Tighe 2013, Blanco et al 
2013). With respect to anaphylasis, patients with a suspected allergy to local anesthetics based on 
medical history and patient self report will be excluded from the study. Subjects will also be 
continuously monitored in the OR during the bupivicaine injection and for the duration of surgery 
for these potential adverse events by: electrocardiogram, blood pressure and arterial oxygen 
saturation. The PI (or another designated Investigator in his absence) will be notified of any 
abnormal results so that standard of care safety measures outlinedare implemented. The primary 
physician will also be notified of any abnormal results and any changes to the subject’s care, and 
will also be provided with the test results. The use of single-shot regional anaesthetic techniques 
is associated with few complications. The expected risks are as follows: 
Allergic reaction, toxicity and effects associated with injection: 
Monitoring: following first 5 subjects enrolled and at 6 month intervals. 
Actions: If there is any indication of allergy to local anesthetics in patient medical records or 
patient reports allergy at screening, subject will not be enrolled. If there is any indication of allergic 
reaction during injection, injection will be discontinued immediately but patient will continue to 
be followed until end of study. Signs of allergy at any study visit, such as headache, dizziness, 
nausea, vomiting, hives and itching will be recorded as AEs. With respect to toxicity investigators 
will use slow, incremental injections of local anesthetic, while monitoring the patient for signs of 
toxicity. Early recognition of the toxicity and early discontinuation of the administration is of 
crucial importance. Any signs of toxicity such as hypotension, severe hypotension, reduced cardiac 
output, and/or malignant arrhythmias will result in the administration of local anesthetics being 


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stopped immediately and patient parameters will be continuously assessed until the patient is 
completely asymptomatic and stable and the event recorded as an AE. Events associated with 
injection include block failure, pain, infection, bruising/hematoma, nerve injury, and 
pneumothorax.  Symptoms of injection related events will be treated and checked at appropriate 
intervals in addition to any other clinical testing requested by primary physician. 
The clinical course of each event will be followed until resolution, stabilization, or until it has been 
determined that the study treatment or participation is not the cause. 
  
p. 
Discontinuation of Study / Subject Withdrawal 
Patients may withdraw from this study at their discretion. The study may be discontinued at any 
time at the discretion of the PI.  
 
10. DATA HANDLING AND RECORD KEEPING 
Any paper documents that contain PHI (e.g., link between the ID to subjects’ identifiers) will be 
stored in a locked cabinet within the anesthesiology research office, separately from any de-
identified research documents. IRB-approved personnel will be the only individuals with access 
to any research documents containing PHI.  
Any electronic documents that contain PHI will be stored on REDCap. The Feinstein Institute for 
Medical Research will be used as a central location for data processing and management. 
Vanderbilt University, with collaboration from a consortium of institutional partners, has 
developed a software toolset and workflow methodology for electronic collection and management 
of research and clinical trial data. REDCap (Research Electronic Data Capture) data collection 
projects rely on a thorough study-specific data dictionary defined in an iterative self-documenting 
process by all members of the research team with planning assistance from the Biostatistics Unit 
of the Feinstein Institute for Medical Research. The iterative development and testing process 
results in a well-planned data collection strategy for individual studies. REDCap servers are 
housed in a local data center at the Feinstein and all web-based information transmission is 
encrypted. REDCap was developed specifically around HIPAA-Security guidelines and is 
recommended to Northwell Health researchers by both our Clinical Research Service, Research 
Compliance Office and Institutional Review Board. REDCap has been disseminated for use locally 
at other institutions and currently supports 1,244 active institutional partners and other institutions 
in 87 countries (www.project-redcap.org).  
No PHI or research data will be stored on any Portable Electronic Devices (e.g., laptops, tablets, 
flash drives, etc.). 
Any research data that will be emailed will be de-identified and encrypted. PHI will not be emailed 
to any commercial email addresses (e.g., Gmail, Yahoo, Hotmail). 
Data safety will be monitored on an ongoing basis by the PI and in the event that a problem occurs, 
the problem will be managed by the PI and reported to the IRB according to requirements 
 


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11. DATA DISCLOSURE/PUBLICATION 
Investigators intend to publish the results of this study. Any published results will only include 
an aggregate of de-identified data. No protected health information will be disclosed outside of 
Northwell Health for the purposes of this research.  
 
Protected health information may be shared with: 
- 
The Institutional Review Board (IRB) at Northwell Health; 
- 
Doctors and staff at the hospital where this research study will take place; 
- 
Doctors and staff at other institutions that are participating in the research study; 
- 
Data and Safety Monitor(s), independent expert(s) that review the information from this 
research throughout the study; and/or 
- 
Governmental entities that have the right to see or review your protected health 
information, such as the U.S. Office of Human Research Protections and the FDA. 
 
Protected health information will only be used and/or given to others to perform this research; to 
study the results; and to determine if the research was done correctly. All reasonable efforts will 
be made to maintain confidentiality (in accordance with the measures outlined above). 
 
13. CONFLICT OF INTEREST 
The investigators have no conflicts of interest to report.  
 
14.  BIBLIOGRAPHY  
Agarwal RR, Wallace AM, Madison SJ, Morgan AC, Mascha EJ, Ilfeld BM. Single-injection 
thoracic paravertebral block and postoperative analgesia after mastectomy: a retrospective cohort 
study. J Clin Anesth. 2015 Aug; 27(5):371-4. doi: 10.1016/j.jclinane.2015.04.003. 
 
Atanassoff PG, Alon E, Weiss BM. Intercostal nerve block for lumpectomy: superior postoperative 
pain relief with bupivacaine. J Clin Anesth. 1994 Jan-Feb;6(1):47-51. 
 
Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan; 
27(1):5-11. 
 
Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. 
Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011 
 
Blanco, R., T. Parras, J. G. McDonnell and A. Prats-Galino (2013). "Serratus plane block: a novel 
ultrasound-guided thoracic wall nerve block." Anaesthesia 68(11): 1107-1113. 
 
Cheema SP, Ilsley D, Richardson J, Sabanathan S. A thermographic study of paravertebral 
analgesia. Anaesthesia. 1995 Feb;50(2):118-21. 


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Cheema S, Richardson J, McGurgan P. Factors affecting the spread of bupivacaine in the adult 
thoracic paravertebral space. Anaesthesia. 2003 Jul;58(7):684-7. 
 
Dravid RM, Paul RE. Interpleural block - part 1. Anaesthesia. 2007 Oct;62(10):1039-49. 
 
Dravid RM, Paul RE. Interpleural block - part 2. Anaesthesia. 2007 Nov;62(11):1143-53. Review. 
 
Faria SS, Gomez RS. Clinical application of thoracic paravertebral anesthetic block in breast 
surgeries. Rev Bras Anestesiol. 2015 Mar-Apr;65(2):147-54 
 
Fassoulaki A, Melemeni A, Staikou C, Triga A, Sarantopoulos C. Acute postoperative pain 
predicts chronic pain and long-term analgesic requirements after breast surgery for cancer. 
Acta Anaesthesiol Belg. 2008;59(4):241-8. 
 
Goodman and Gilman's The Pharmacological Basis of Therapeutics, 12th edn. McGraw-Hill: New 
York, 2011, pp 1323–50. 
 
Hadzic, A. and New York School of Regional Anesthesia. (2007). Textbook of regional anesthesia 
and acute pain management. New York, McGraw-Hill, Medical. 
 
Iohom G, Abdalla H, O'Brien J, Szarvas S, Larney V, Buckley E, Butler M, Shorten GD. The 
associations between severity of early postoperative pain, chronic postsurgical pain and plasma 
concentration of stable nitric oxide products after breast surgery. Anesth Analg. 2006 
Oct;103(4):995-1000. 
 
Karmakar MK, Ho AM, Law BK, Wong AS, Shafer SL, Gin T. Arterial and venous 
pharmacokinetics of ropivacaine with and without epinephrine after thoracic paravertebral block. 
Anesthesiology. 2005 Oct;103(4):704-11. 
 
Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. 
Lancet. 2006 May 13;367(9522):1618-25. Review. 
 
Lynch EP1, Welch KJ, Carabuena JM, Eberlein TJ. Thoracic epidural anesthesia improves 
outcome after breast surgery. Ann Surg. 1995 Nov;222(5):663-9. 
 
Meretoja TJ, Leidenius MH, Tasmuth T, Sipilä R, Kalso E. Pain at 12 months after surgery for 
breast cancer. JAMA. 2014 Jan 1;311(1):90-2.  
 


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Ong CK, Lirk P, Seymour RA, Jenkins BJ. The efficacy of preemptive analgesia for acute 
postoperative pain management: a meta-analysis. Anesth Analg. 2005;100(3):757-73, table of 
contents. 
 
Schnabel A, Reichl SU, Kranke P, Pogatzki-Zahn EM, Zahn PK.Efficacy and safety of 
paravertebral blocks in breast surgery: a meta-analysis of randomized controlled trials. Br J  
Anaesth. 2010 Dec;105(6):842-52. 
 
Seltzer JL, Larijani GE, Goldberg ME, Marr AT. Intrapleural bupivacaine--a kinetic and dynamic 
evaluation. Anesthesiology. 1987 Nov; 67(5):798-800 
 
Tighe SQ, Karmakar MK. Serratus plane block: do we need to learn another technique for thoracic 
wall blockade? Anaesthesia. 2013 Nov; 68(11):1103-6. 
 
Vadivelu N, Schreck M, Lopez J, Kodumudi G, Narayan D.Pain after mastectomy and breast 
reconstruction. Am Surg. 2008 Apr;74(4):285-96.  
 
Vallejo MC, Phelps AL, Sah N, et al. Preemptive analgesia with bupivacaine for segmental 
mastectomy. Reg Anesth Pain Med. 2006;31(3):227-32. 
 
 

ICF_001.pdf: 
Version:  9/19/19
IRB #: 15-246
Page 1 of 8
Northwell Health
Campus: Long Island Jewish Medical Center
                and Center for Advanced Medicine
Consent for Participation in a Research Study
Title: Serratus Plane Block for Post-operative Pain Control in Breast Surgery
Principal Investigator: Judith Aronsohn, MD 
About this research 
You are being asked to participate in a research study.  
This consent form will give you information about the study to help you decide whether you want to 
participate.  Please read this form, and ask any questions you have, before agreeing to be in the study.
Important Information 
This information gives you an overview of the research.  More information about these topics may be 
found in the pages that follow.  
Why am I being asked 
to provide my consent?
This is a research study, which is different than personal medical care.  
Scientists do research to answer important questions which might help 
change or improve the way we do things in the future. 
Do I have to join this 
research study?
No. Taking part in this research study is voluntary.  You may choose not 
to take part in the study or may choose to leave the study at any time.  
Deciding not to participate, or deciding to leave the study later, will not 
result in any penalty or loss of benefits to which you are entitled.
Why is this research 
study being done?
The purpose of this research study is to study the effects of a bupivacaine 
HCL “serratus plane block” on pain after a breast surgery operation. A 
serratus plane block is a type of anesthesia in which the drug bupivacaine 
HCL is injected into the muscles of the chest to numb the chest and 
breasts. The goal of this study is to determine whether this serratus plane 
block lowers the amount of pain you have after your operation.
What will happen to 
me during the study?
If you agree to participate in this study, you will be randomly assigned to 
either receive the bupivacaine HCL serratus plane block or receive a 
placebo injection of normal saline (salt water). A placebo is a liquid that 
looks like the study drug, but has no real medicine in it. The study is also 
double-blinded. This means that neither you nor the researchers directly 
involved in the study procedures will be allowed to know whether or not 
you received the bupivacaine HCL serratus plane block until the study is 
complete. 
After you are asleep from the general anesthesia being given to you as 
part of your standard of care breast surgery, a small amount of either 
bupivacaine HCL or placebo will be injected into the muscles of your 
chest by the anesthesiologist using an ultrasound machine. The 
ultrasound will be used to ensure that the injection is correctly placed into 
 
 IRB APPROVED
 
September 19, 2019


Version:  9/19/19
IRB #: 15-246
Page 2 of 8
the serratus muscle. After the injection of either bupivacaine HCL or 
placebo, the surgery will be performed as usual. 
During the procedure, you will receive a 20 ml injection of your assigned 
drug (Bupivacaine HCL in normal saline or placebo consisting of normal 
saline only) to each side of your chest that is undergoing surgery. During 
surgical recovery, you will be asked to provide an assessment of your 
pain and how nauseated you feel throughout your hospital stay. 
How long will I 
participate?
The study procedures will last for up to one week after your surgery. The 
study procedures will last approximately 4-12 minutes during your 
surgery. You will then undergo study assessments during your stay in the 
hospital. In addition, you will receive a follow-up phone call within one 
week of your surgery. 
Will taking part 
expose me to risks?
If you have an allergy to bupivacaine or any pain medications, please 
notify a study investigator. Although allergies to bupivacaine are very 
rare, they can be fatal. Allergic reactions include headache, dizziness, 
nausea, vomiting, hives (skin rash), and itching. Common side effects of 
bupivacaine include nausea, vomiting, and constipation. There is also a 
risk of the drug not working. Since the study is randomized, your group 
may receive less effective treatment or have more side effects. 
Since the drug will be injected into your chest, there are risks associated 
with the injection procedure. The risks of receiving an injection are 
bleeding, infection, pain at the injection site, bruising, hematoma 
(swelling), and nerve injury. There is also a risk of getting a collapsed 
lung because of the injection to the chest. However, this risk is 
significantly minimized by the use of an ultrasound machine to see the 
muscle of your chest and to correctly guide the needle. 
Please see the risks section of the consent form for more information and 
for a more detailed list of the risks associated with this study.
Are there any benefits 
to participation?
If you are randomized to receive bupivacaine HCL, you may directly 
benefit from participation by having less pain and nausea after your 
surgery, a shorter hospital stay, and better medical outcomes compared to 
standard of care treatment. However, this cannot be guaranteed. In 
addition, this research study may benefit individuals in the future by 
supporting the use of a bupivacaine HCL serratus plane block as an 
effective way to control post-operative pain for all individuals 
undergoing breast surgery. 
What are my 
alternatives to 
participation?  
If you do not join this study, you may undergo the standard of care 
surgical procedure. 
Please review the rest of this document for details about these topics and additional things you 
should know before making a decision about whether to participate in this research.  
 
 IRB APPROVED
 
September 19, 2019


Version:  9/19/19
IRB #: 15-246
Page 3 of 8
Introduction
You are being asked to join a research study. The purpose of a research study is to answer specific 
questions, sometimes about the safety of a drug or device and how well it works.  Being in a research 
study is different from being a patient.  When you are a patient, you and your doctor have freedom in 
making decisions about your healthcare.  When you are in a research study, the researcher will follow 
the rules of the research study as closely as possible, while monitoring your health.
You do not have to be in this study to receive medical care. You should ask questions before you decide 
if you want to participate. You can also ask questions at any time during the study. 
Why is this research study being done?
The purpose of this research study is to study the effects of a bupivacaine HCL “serratus plane block” on 
pain after a breast surgery operation.  
A serratus plane block is a type of anesthesia in which the drug bupivacaine HCL is injected into the 
muscles of the chest to numb the chest and breasts. The goal of this study is to determine whether this 
serratus plane block lowers the amount of pain you have after your operation. The study will also 
evaluate whether it makes you feel less nauseated after your surgery, leads to a shorter hospital stay, 
improves medical outcomes, and improves your overall satisfaction with the surgery. This study will 
help us understand if this serratus plane block should be given to everyone undergoing breast surgery.
Why are you being asked to participate in this study?
You are being asked to participate in this study because you are undergoing breast surgery as part of 
your standard clinical care. 
Why is this research?
This is a research study because we do not know if a bupivacaine HCL serratus plane block will 
decrease the amount of pain you have after your operation. In this study, some individuals will receive 
the bupivacaine HCL serratus plane block in addition to standard pain medications, while some 
individuals will receive the standard pain medications alone. The study will compare the outcomes of 
these individuals to determine whether performing this block is more useful in treating pain than 
standard pain medication alone.
How many people will take part in this study? 
This research study hopes to enroll approximately 90 participants. 
How long will you be in this study? 
If you choose to take part in this study, the study procedures will last for up to one week after your 
surgery. The study procedures will last approximately 4-12 minutes during your surgery. You will then 
undergo study assessments during your stay in the hospital. In addition, you will receive a follow-up 
phone call within one week of your surgery. 
What will happen in this research study?
If you agree to participate in this study, you will be randomized. This means that you will be assigned to 
a group by chance (like flipping a coin). You will have an equal chance of being in either group. You 
will be randomly assigned to either receive the bupivacaine HCL serratus plane block or receive a 
 
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placebo injection of normal saline (salt water). A placebo is a liquid that looks like the study drug, but 
has no real medicine in it. A placebo is often used in research studies because knowing whether you are 
getting the study drug can change the results of the study. 
The study is also double-blinded. This means that neither you nor the researchers directly involved in 
the study procedures will be allowed to know whether or not you received the bupivacaine HCL serratus 
plane block until the study is complete. The study is done this way because knowing whether you are in 
a group can change the results of the study. We will not tell you which group you are in since the 
researchers will not know your group either. However, we can quickly find out which group you are in if 
we ever need to know for your safety. 
After you are asleep from the general anesthesia being given to you as part of your standard of care 
breast surgery, a small amount of either bupivacaine HCL or placebo will be injected into the muscles of 
your chest by the anesthesiologist using an ultrasound machine (a machine that uses sound waves to 
create an image of the structures inside of your body). The ultrasound will be used to ensure that the 
injection is correctly placed into the serratus muscle. After the injection of either bupivacaine HCL or 
placebo, the surgery will be performed as usual. You will receive the same amount of anesthesia during 
the surgery and the same amount of pain relief medicine and anti-nausea medicine after your surgery as 
you would receive if you didn’t participate in this study. However, the study will record the type and 
amount of medication you take following your surgery. 
During the procedure, you will receive a 20 ml injection of your assigned drug (Bupivacaine HCL in 
normal saline or placebo consisting of normal saline only) to each side of your chest that is undergoing 
surgery. If you are randomized to receive bupivacaine HCL, each 20 ml injection will contain 50 mg of 
bupivacaine HCL. Therefore, you will receive a total of 50 mg of bupivacaine HCL if you are having 
surgery on one side of your chest and a total of 100 mg of bupivacaine HCL if you are having surgery 
on both sides of your chest. If you are randomized to receive placebo, you will only receive a 20 ml 
injection of normal saline to each side of your chest that is undergoing surgery.  
During surgical recovery, you will be asked to provide an assessment of your pain and how nauseated 
you feel throughout your hospital stay. You will be asked to provide these assessments every 30 minutes 
for the first 4 hours and then each hour until you are discharged. A researcher will then contact you 
within one week of discharge to obtain information about your pain and overall satisfaction with the 
surgery. After the collection of this information and relevant information from your medical records 
regarding your health, your participation in this study is considered complete. 
What are the risks and discomforts of the research study? 
If you have an allergy to bupivacaine or any pain medications, please notify a study investigator. 
Although allergies to bupivacaine are very rare, they can be fatal. Allergic reactions include headache, 
dizziness, nausea, vomiting, hives (skin rash), and itching. Common side effects of bupivacaine include 
nausea, vomiting, and constipation. There is also a risk of the drug not working. Since the study is 
randomized, your group may receive less effective treatment or have more side effects. 
Since the drug will be injected into your chest, there are risks associated with the injection procedure. 
The risks of receiving an injection are bleeding, infection, pain at the injection site, bruising, hematoma 
(swelling), and nerve injury. There is also a risk of getting a collapsed lung because of the injection to 
 
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the chest. However, this risk is significantly minimized by the use of an ultrasound machine to see the 
muscle of your chest and to correctly guide the needle. If your lung were to collapse, a tube would be 
inserted into your chest to re-expand your lung. 
Although the injection procedure will add 4-12 minutes to your surgery, it is not believed that this 
additional time under anesthesia will pose a significant risk to you. 
There are no risks associated with the completion of the pain and nausea scores. There is also a risk of a 
breach of confidentiality if unauthorized individuals obtain access to protected health information. The 
study team will take all reasonable measures to minimize this risk from occurring.
As with any new procedure or treatment, there might be side effects that are unknown at this time. You 
will be closely watched for side effects.  You should report any unusual events to the study staff.  
What are the benefits of this research study?
If you are randomized to receive bupivacaine HCL, you may directly benefit from participation by 
having less pain and nausea after your surgery, a shorter hospital stay, and better medical outcomes 
compared to standard of care treatment. However, this cannot be guaranteed. 
In addition, this research study may benefit individuals in the future by supporting the use of a 
bupivacaine HCL serratus plane block as an effective way to control post-operative pain for all 
individuals undergoing breast surgery. 
If you do not want to take part in this research study, what are your other choices?
If you do not join this study, you may undergo the standard of care surgical procedure. 
Are there any costs for being in this research study? 
The study drug and study procedures will be provided to you at no cost. However, you or your insurance 
company will be responsible for costs associated with your standard of care procedures. 
Will you receive any payments for participating in this research study?
You will not receive any money or compensation for participating in this research study.
What are your rights as a research participant?
Your participation in this project is voluntary. The quality of your medical care will be the same, 
whether you join, refuse to join, or decide to leave the study. If you do not join the study, you will not be 
penalized or lose benefits to which you are entitled. If you join the study, you may withdraw at any time 
without prejudice to your future care at Northwell Health. 
What happens if you are injured while participating in this study?
If you are hurt from being in the study, you will receive medical care and treatment as needed from 
Northwell Health. However, you will be responsible for the costs of such medical treatment, directly or 
through your medical insurance or other forms of medical coverage. No money will be given to you. 
 
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Could you be taken off the study before it is over?
It is also possible that your participation in this study may end without your consent.  This decision may 
be made by a researcher or the Institutional Review Board (IRB- the committee that oversees research at 
this institution).   
Reasons for withdrawal may include: failure to follow instructions, it is not in your best interest to 
continue on this study, or the study is stopped. If you withdraw from this study or are withdrawn from 
the study, any data already collected will continue to be used.  However, no new data will be collected.  
What happens if new information is learned?
You will be told of any new findings that may change your decision to continue to participate. Your 
consent to continue to take part in this study may be obtained again.  
What information will be collected and used for this study?
If you agree to be in this study, we will collect health information that identifies you. We may collect the 
results of tests. We will also collect information from your medical record. We will only collect 
information that is needed for the research. This information has been described in this consent form. If 
you sign this consent form, you are giving us permission to collect, use and share your health 
information. This permission is called authorization. If you do not want to provide authorization, then 
you cannot participate in this research study.
Who else will see your information? 
Study records that identify you will be kept private. You will not be identified in study records or 
publications disclosed outside of Northwell Health, except as detailed below.  
Investigators might share information collected from this research study with:

other researchers, and

clinical staff not involved in the study who may be involved in your care. 
The following reviewers may access your study and medical records to make sure that this study is 
being done properly: 

Representatives from federal and state government oversight agencies such as the Office for 
Human Research Protections (OHRP) and FDA.

Representatives from the Northwell Health Human Research Protection Program (the group of 
people that oversee research at this institution).
We will do our best to protect the privacy of your records, but it is possible that once information is 
shared with people listed on this form, it will be released to others. If this happens, your information 
may no longer be protected by the federal law. In the future, we may publish results of this study in 
scientific journals and may present it at scientific meetings. If we do we will not identify you. If the 
researchers learn about potential serious harm to you or someone else or other public health concerns, it 
will be shared with the appropriate authorities. 
Will you be able to access your records?
If your research records are used for decisions related to your clinical care, then you have the right to 
review this information and request changes. This is limited to information about your treatment, and 
 
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does not include information related to procedures or tests that are for research purposes only. You may 
access this information only after the study analysis is complete. You have the right to know who has 
and who will see your records. To request this information, please call the Human Research Protection 
Program at 516-465-1910.  
How long will your health information be kept?
There is no limit on the length of time we will keep your information for this research because it may be 
analyzed for many years. We will keep it as long as it is useful, unless you decide you no longer want to 
take part or we close the study.  You are allowing access to this information indefinitely.  
Can you change your mind?
If you change your mind about being in the study, you may withdraw at any time. If you want us to stop 
collecting your health information, you need to send a letter to the researcher at the following address:
Judith Aronsohn, MD
Department of Anesthesiology
Northwell Health
270-05 76th Avenue, Room B-341 
New Hyde Park, NY 11040
Your letter needs to say that you have changed your mind and do not want the researcher to collect and 
share your health information. You may also need to leave the research study if we cannot collect any 
more health information. We may still use the information we have already collected. We need to know 
what happens to everyone who starts a research study, not just those people who stay in it. 
Will my information be used for research in the future?
Information collected from you for this research may be used for future research studies or shared with 
other researchers for future research.  If this happens, information which could identify you will be 
removed before any information or specimens are shared.  Since identifying information will be 
removed, there will not be an additional consent for future research.  By consenting to participate in this 
study you are agreeing to allow your de-identified specimens and/or data to be used by future 
researchers without additional consent.  
Will information about this study be available to the public?
A description of this clinical trial will be available on http://www.Clinical Trials.gov, as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this website at any time.
Does the investigator of this study receive money if you take part?  
The investigators on this study do not receive money for your participation in this study.
Who can answer your questions about this study?
If you have any questions about the study, about side effects of the study, or about injuries caused by 
research, you may call Judith Aronsohn, MD at (718) 470-5382. If you need emergency care, dial 911 or 
go to the nearest Emergency Room. 
 
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If you have questions about your rights as a research participant, concerns about being in the study, or 
would like to offer input, you may contact the Human Research Protection Program at (516) 465-1910. 
A signed copy of this consent form will be given to you.
Summation/Signature
You have read the above description of the research study. You have been told of the risks and benefits 
involved and all your questions have been answered to your satisfaction. A member of the research team 
will answer any future questions you may have. You voluntarily agree to join this study and know that 
you can withdraw from the study at any time without penalty. By signing this form, you have not given 
up any of your legal rights. 
 
________________________________________________       
Printed Name of Participant
________________________________________________
____________
Signature of Participant
Date
________________________________________________        
Printed Name of Witness
________________________________________________
____________
Signature of Witness
Date
 
Investigator’s Statement 
In addition to advising the above participant of other appropriate alternatives, I have offered an 
opportunity for further explanation of the risks and discomforts which are or may be associated with this 
study, and to answer any further questions relating to it. 
________________________________________________       
Printed Name of Investigator
________________________________________________
____________
Signature of Investigator
Date
 
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