Comparison Between Serratus Plane Block And Local Surgical Infiltration In Robotic Video Assisted Thoracoscopic Surgery- A Randomised Controlled Trial
Phase: PHASE4
Conditions: Lung Cancer
Sponsor: Icahn School of Medicine at Mount Sinai

Comparison Between Serratus Plane Block And Local Surgical Infiltration In Robotic Video 
Assisted Thoracoscopic Surgery- A Randomised Controlled Trial  
PI: Dr. Yan Lai 
NCT03642457 
Document Date: 7-8-2017

 
Protocol Name: 
COMPARISON BETWEEN PECS BLOCK AND LOCAL 
SURGICAL INFILTRATION IN ROBOTIC VIDEO ASSISTED 
THORACOSCOPIC SURGERY- A RANDOMISED 
CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD. 
 
Date Revised: 
07/08/2017 
Study Number: 
IF2058656/HSM# 17-00611/GCO#17-1294 
 
1 
Revised 9/2/14 
HRP-503 PROTOCOL TEMPLATE  
Note that, depending on the nature of your research, certain questions, directions, or entire sections below may 
not be applicable. Provide information if and when applicable, and in cases where an entire section is not 
applicable, indicate this by marking the section “N/A”.  Do not delete any sections. 
For any items below that are already described in the sponsor’s protocol, the investigator’s protocol,  the grant 
application, or other source documents, you may simply reference the title and page numbers of these 
documents in the sections below, rather than cutting and pasting into this document. Do not refer to the Sample 
Consent document, or information on the application form in this document.. 
Keep an electronic copy of this version of the document. You will need to modify this copy when making changes. 
 
Brief Summary of Research (250-400 words):  
Robotic video-assisted thoracoscopic surgery (VATS) is increasingly being used as 
it is a less invasive surgery compared to traditional methods, but the acute pain at an 
early stage after VATS has a major impact on perioperative outcomes. Effective 
post operative analgesia is believed to reduce morbidity, quicken recovery, improve 
patient outcome and reduce hospital costs.  The site and extent of the incision 
influences the degree of pain due to disruption of intercostal nerves as well as 
inflammation of chest wall and pleura. Neuraxial and systemic opioids have been a 
gold standard as a part of multimodal analgesia for thoracic surgeries. Numerous 
modalities have been studied: thoracic paravertebral nerve blocks, thoracic epidural 
analgesia, intercostal nerve blocks, patient controlled analgesia (PCA), cryo-
analgesia, transcutaneous electrical nerve stimulation (TENS), inter-pleural blocks, 
stellate ganglion blocks, long thoracic nerve blocks, and infiltration under direct 
vision by the surgeon.  
Pectoral nerve blocks or PECS block is an emerging regional technique that has 
proven to be effective in comparison to paravertebral blocks in patients undergoing 
breast surgery and mastectomy with reduced perioperative opioid consumption and 
improved pain scores. 
The lateral pectoral nerve, medial pectoral nerve, intercostal nerves and long 
thoracic nerve are all targets for the PECS block.  It can be safely performed under 
ultrasound guidance. 

 
Protocol Name: 
COMPARISON BETWEEN PECS BLOCK AND LOCAL 
SURGICAL INFILTRATION IN ROBOTIC VIDEO ASSISTED 
THORACOSCOPIC SURGERY- A RANDOMISED 
CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD. 
 
Date Revised: 
07/08/2017 
Study Number: 
IF2058656/HSM# 17-00611/GCO#17-1294 
 
2 
Revised 9/2/14 
 
The purpose of our study is to evaluate the difference in quality of analgesia 
between efficacy of PECS block and local surgical infiltration by surgeon as 
measured by patient opioid consumption and pain scores.  
 
1)Objectives 
Research 
Question: 
Does 
PECS 
block 
provide 
superior 
analgesia 
in               
comparison with surgeon injected local infiltration into the wound in a robotic assisted     
VATS? 
Primary outcome: The amount of opioid consumption (in mg IV morphine equivalents) 
postoperatively up to 24 hours after the end of procedure.  The degree of postoperative 
pain in terms of VAS at rest and on cough on arrival to PACU, 2 hours later, discharge 
from PACU, 6 hours, 12 hours, 18 hours and 24 hours after surgery.      
 
Secondary outcome: 
Time to first dose of narcotic administration, PACU or ICU length of stay, and patient 
satisfaction. 
 
2)Background 
   See above. There have been several studies regarding efficacy of local infiltration of 
wound in thoracic surgery for pain control.  PECS block is a novel technique used in pain 
control in patients undergoing mastectomy. But there have been no study to date 
comparing the use of local infiltration and PECS block in thoracic surgery. 
 
   3)Setting of the Human Research 
Prospective triple blinded randomized control trial undergoing robotic assisted 
VATS. The research study will take place at Mount Sinai West hospital. The site PI 
is Yan Lai, MD, MPH. 
 

 
Protocol Name: 
COMPARISON BETWEEN PECS BLOCK AND LOCAL 
SURGICAL INFILTRATION IN ROBOTIC VIDEO ASSISTED 
THORACOSCOPIC SURGERY- A RANDOMISED 
CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD. 
 
Date Revised: 
07/08/2017 
Study Number: 
IF2058656/HSM# 17-00611/GCO#17-1294 
 
3 
Revised 9/2/14 
 
 
4)Resources Available to Conduct the Human Research 
For n=100, the feasibility of recruitment is manageable. With the HIPAA waiver 
requested, the surgeon will provide investigators (both of whom are physicians 
within the department of Anesthesiology) with information of eligible patients. The 
surgeon will also provide study information (protocol, consent, general information) 
to patients in the surgeon’s office.  After the operating room schedule has been 
reviewed for potential participants in the study the contact information will be 
obtained through the surgeon’s office.  Subjects will be called by the department of 
Anesthesiology when their surgery is scheduled. A member of the research team 
will contact the patient to explain the study, confirm participation, and answer any 
questions.  On the day of the surgery, the subject will meet the research team in the 
holding area.  The team will finalize participation and ask the subject to sign study 
consent forms.  The staff members on this protocol are all employees of Mount 
Sinai and will either be a resident or attending physicians that are included on the 
IRB protocol. There are two primary members of the research personnel: 
a)Yan Lai, MD, MPH – Roles for Dr. Lai in this study include serving as primary 
investigator      responsible for study design and planning, data collection, subject 
recruitment, manuscript writing and preparation, data analysis, safety monitoring, 
and responding to adverse events and/or complications. He is certified in PPHS/IRB 
protocols, all Citi/IRB required training in human subject protection, and has prior 
clinical research experience. He is also a board certified anesthesiologist and 
assistant professor of anesthesiology with the Icahn School of Medicine and the 
Mount Sinai Health System. 
     b)Poonam Pai. B.H MD – Roles for Dr. Pai include serving as primary research 
coordinator involved in data collection, subject recruitment, manuscript writing and 
preparation, data analysis, safety monitoring, and responding to adverse events 
and/or complications.  She has completed all of her required CITI training to be IRB 
certified and has experience in clinical research. In addition she has been a resident 
physician in anesthesiology with the Icahn School of Medicine in good standing for 
the previous two years going on her third. 

 
Protocol Name: 
COMPARISON BETWEEN PECS BLOCK AND LOCAL 
SURGICAL INFILTRATION IN ROBOTIC VIDEO ASSISTED 
THORACOSCOPIC SURGERY- A RANDOMISED 
CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD. 
 
Date Revised: 
07/08/2017 
Study Number: 
IF2058656/HSM# 17-00611/GCO#17-1294 
 
4 
Revised 9/2/14 
There are institutional processes to ensure that all persons assisting with the protocol will 
be well informed.  The research personnel will conduct regular meetings and department 
email updates to review the results and safety data of the study.  The research personnel 
will initiate the formation of a safety monitoring board for adverse effects, complications, 
or complaints from patient subjects. 
 
5)Study Design 
Prospective triple blinded randomized control trial. With the HIPAA waiver requested, the 
surgeon will provide the investigators (both of them are physicians within the Department 
of Anesthesiology) with information of eligible patients. The surgeon will also provide 
study information (protocol, consent, general information) to patients in the surgeon’s 
office.  After the operating room schedule has been reviewed for potential participants in 
the study the contact information will be obtained through the surgeon’s office.  Subjects 
will be called by the department of Anesthesiology when their surgery is scheduled. A 
member of the research team will contact the patient to explain the study, confirm 
participation, and answer any questions.  On the day of the surgery, the subject will meet 
the research team in the holding area.  The team will finalize participation and ask the 
subject to sign study consent forms.  All patients will be provided with copies of the IRB 
protocol and consent if they wish to have it. Copy of the consent form will be sent in a 
secured email to the potential subject. The email will be secured by entering in [SECURE] 
in the e-mail subject line.  Once recruited blinding assessments will be done by the study 
team.  
 
Patients will be assigned randomly using a computer-generated table of numbers to 
either PECS (Pecs group) or placebo (placebo group). Block team will perform all 
blocks. Resident anesthesiologist will know the group allocation but will not be 
involved in the study and prepare the placebo and anesthetic solutions. Patients 
assigned to PECS block group will receive 30ml 0.25% bupivacaine under 
ultrasound guidance on the side of surgery. Otherwise, the patient, surgeon, and 
anesthesiologist in the case will be blinded.  At the conclusion of the surgery prior to 
skin closure, all the patients will receive 20ml of local anesthetic infiltration as per 
surgeon’s current practice. 
a) Recruitment methods:   See above. 

 
Protocol Name: 
COMPARISON BETWEEN PECS BLOCK AND LOCAL 
SURGICAL INFILTRATION IN ROBOTIC VIDEO ASSISTED 
THORACOSCOPIC SURGERY- A RANDOMISED 
CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD. 
 
Date Revised: 
07/08/2017 
Study Number: 
IF2058656/HSM# 17-00611/GCO#17-1294 
 
5 
Revised 9/2/14 
b)Inclusion and Exclusion Criteria 
   Inclusion criteria: ASA (American Society of Anesthesiology) class I-IV, age 18-75. 
   Exclusion criteria: ASA class V, morbid obesity, patient refusal, patients with chronic 
pain or on pain medications, allergy to LA, patients receiving any additional regional 
techniques, coagulopathy, patients receiving systemic anticoagulation, local infection, and 
procedures anticipated to last more than 5 hours.  
c)Number of Subjects 
 We intend to have an n=100. Based on a confidence level of 95% with a Z score of 
1.96, standard deviation of .5 and a confidence interval of 10% our sample size 
should be 96. For ease of statistical calculations we rounded up to 100 patients. 
Based on previous literature pertaining to local infiltration in thoracic surgery and 
postoperative analgesia using PECS block in breast surgery, we found studies 
included anywhere from 85 to 113 patients which is consistent with our calculations.  
 
ss = 
Z 2 * (p) * (1-p) 
c 2 
 
Where: 
Z 
= 
Z 
value 
(1.96 
for 
95% 
confidence 
level)  
p = percentage picking a choice, expressed as decimal (.5 used for sample size needed) 
c = confidence interval, expressed as decimal  (e.g., .01= ±1) 
 
Sample size= [(1.96^2)(.5)(.5)]/(.1^2)=96 subjects 
For effect size, we expect a Cos d medium effect of 0.5. The estimate for sample 
sizes was obtained by using the first set of pain scores obtained in the PACU. 
 
 

 
Protocol Name: 
COMPARISON BETWEEN PECS BLOCK AND LOCAL 
SURGICAL INFILTRATION IN ROBOTIC VIDEO ASSISTED 
THORACOSCOPIC SURGERY- A RANDOMISED 
CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD. 
 
Date Revised: 
07/08/2017 
Study Number: 
IF2058656/HSM# 17-00611/GCO#17-1294 
 
6 
Revised 9/2/14 
d)Study Timelines 
     2017-2018 and subsequent data analysis. The subject’s participation will be from 
time of enrollment in the pre-operative period until first postoperative day. 
Estimated date of enrollment completion will be when 100 eligible subjects are 
enrolled in final data analysis.  Estimate date for study completion will be June 
2018. 
 
e)Endpoints 
The primary endpoints will be the amount of opioid consumption (in mg IV morphine 
equivalents) postoperatively up to 24 hours after the end of procedure and the degree of 
postoperative pain in terms of VAS at rest and on cough on arrival to PACU, 2 hours later, 
discharge from PACU, 6 hours, 12 hours, 18 hours and 24 hours after surgery.   
Secondary end points – Time to first dose of narcotic administration, PACU or ICU length 
of stay, and patient satisfaction. 
 
Conclusion of data analysis and evaluation of significance of findings will follow 
completion of data collection on primary and secondary outcomes. 
 
f)Procedures Involved in the Human Research 
Prospective randomized controlled trial and data analysis only. PECS block and 
local wound infiltration. Intraoperative care of the patient will be provided by an 
anesthesia team member who is a part of the Mount Sinai System. The anesthesia 
provider will not be aware of the randomization of the patient.  Standard post-
operative orders will be written for patients during their time in the PACU. Orders 
include oxycodone, fentanyl and hydromorphone.  
 
g)Specimen Banking 
       N/A 
  

 
Protocol Name: 
COMPARISON BETWEEN PECS BLOCK AND LOCAL 
SURGICAL INFILTRATION IN ROBOTIC VIDEO ASSISTED 
THORACOSCOPIC SURGERY- A RANDOMISED 
CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD. 
 
Date Revised: 
07/08/2017 
Study Number: 
IF2058656/HSM# 17-00611/GCO#17-1294 
 
7 
Revised 9/2/14 
h)Data Management and Confidentiality 
Data collected in excel file to be de-identified after initial collection. Excel file be 
subsequently encrypted and shared only between the two above listed investigators 
via secure Mount Sinai electronic mail.   
The information included in the data will be medical record number, age, gender, ASA 
class, type of surgery, pain score assessments; time to first narcotic, total narcotic use and 
pain scores up to 24 hours after surgery. Only the research personnel will have access to 
the data. The data will be stored as a hard copy files and on a secure spreadsheet. The 
research personnel is responsible for the receipt of the data. The PI will keep the hard 
copies secure and any electronic data will be encrypted. No personal identifiers will be 
used. The data will undergo statistical analysis. 
 
i)Provisions to Monitor the Data to Ensure the Safety of Subjects 
        Part I: Elements of Data and Safety Monitoring Plan 
 
MSSM Principal Monitor: 
 
Last Name: Lai 
First Name: Yan 
Academic Title: Attending Physician, Assistant Professor 
Department: Anesthesiology 
Mailing Address: Mount Sinai West 1000 10th Avenue, New York, NY 10019 
Phone: 212-523-6915 
Fax:  
E-mail: ylai@chpnet.org 
 
 
MSSM Additional Monitor: 
 
Last Name: Pai B.H 
First Name: Poonam 
Academic Title: Research Personnel, Physician 
Department: Anesthesiology 
Mailing Address: Mount Sinai West 1000 10th Avenue, New York, NY 10019 
Phone: 212-523-6915 
Fax:  

 
Protocol Name: 
COMPARISON BETWEEN PECS BLOCK AND LOCAL 
SURGICAL INFILTRATION IN ROBOTIC VIDEO ASSISTED 
THORACOSCOPIC SURGERY- A RANDOMISED 
CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD. 
 
Date Revised: 
07/08/2017 
Study Number: 
IF2058656/HSM# 17-00611/GCO#17-1294 
 
8 
Revised 9/2/14 
E-mail: phebbalasankatte@chpnet.org 
 
The principal monitor is a board certified anesthesiologist thus minimizing the risk to the 
subjects and further optimizing their health and wellbeing. Adverse events will be 
monitored as a standard of care everyone receives regardless of participation in the study. 
The safety and data information will be reviewed on a daily basis until the desired sample 
size is achieved. All temporary and/or permanent suspensions will be reported.  
 
j)Withdrawal of Subjects 
 Patients may withdraw from the study at any given time by contacting any member 
of the research study group. Data will not be collected on patients who wish to 
withdraw. Patient do not need to withdraw consent in writing. 
6)Risks to Subjects 
If patients are injured or made sick from taking part in this research study, medical care 
will be provided. Generally, this care will be billed to the patient or their insurance in the 
ordinary manner and the patient will be responsible for all treatment costs not covered 
insurance, including deductibles, co-payments and coinsurance.  This does not prevent the 
patient from seeking payment for injury related to malpractice or negligence. Contact the 
investigator for more information. 
 
As with any medication, there is a possibility of an allergic reaction. Although rare, 
possible complications include LA toxicity, hypersensitivity reaction, bleeding or 
local site infection, chance of pneumothorax. All anesthesiologists involved in 
patient care will be prepared for the prevention and rescue for any complications 
involving local anesthetic injections. 
 
7)Provisions for Research Related Harm/Injury 
If patients are injured or made sick from taking part in this research study, medical care 
will be provided. Generally, this care will be billed to the patient or their insurance in the 
ordinary manner and the patient will be responsible for all treatment costs not covered 
insurance, including deductibles, co-payments and coinsurance.  This does not prevent the 

 
Protocol Name: 
COMPARISON BETWEEN PECS BLOCK AND LOCAL 
SURGICAL INFILTRATION IN ROBOTIC VIDEO ASSISTED 
THORACOSCOPIC SURGERY- A RANDOMISED 
CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD. 
 
Date Revised: 
07/08/2017 
Study Number: 
IF2058656/HSM# 17-00611/GCO#17-1294 
 
9 
Revised 9/2/14 
patient from seeking payment for injury related to malpractice or negligence. Contact the 
investigator for more information. 
 
8)Potential Benefits to Subjects 
It is important to know that patients may not get any benefit from taking part in this 
research. However, possible benefits may be improved knowledge about how the different 
forms of analgesia affect pain control in thoracic surgery. There is potential for better pain 
control for the surgery. 
 
9)Provisions to Protect the Privacy Interests of Subjects 
Patients will be appropriately educated about the research study. Any questions or 
concerns they have will be adequately addressed and patients will have the option to 
decline participation. Patients will be given as much time as they need to review the 
consent form. The study personnel will be approaching the subjects. Privacy will be 
maintained by not including any identifiers such as names or addresses in the data 
collected.  
The identities of human subjects whose data is being studied will be de-identified as 
per HIPAA Privacy Rule. 
 
10)Economic Impact on Subjects 
Patients will not incur any additional cost for participating in the study. The 
medications used are part of a standard anesthetic regimen that will be billed to 
subject’s insurance as bundled standard of anesthesia care.  The cost of the 
procedure is overall unaffected.   
 
11)Payments to Subjects 
 Patients will not be reimbursed for their participation. 
 
12)Consent Process 

 
Protocol Name: 
COMPARISON BETWEEN PECS BLOCK AND LOCAL 
SURGICAL INFILTRATION IN ROBOTIC VIDEO ASSISTED 
THORACOSCOPIC SURGERY- A RANDOMISED 
CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD.
 
Date Revised: 
07/08/2017 
Study Number: 
IF2058656/HSM# 17-00611/GCO#17-1294 
 
10 
Revised 9/2/14 
Informed consent will be obtained prior to the procedure. Both the HRP-090 (SOP) Informed 
Consent Process for Research and the HRP-091 (SOP) Written Documentation of Consent will be followed by 
the 
study 
team. 
These 
documents 
are 
both 
available 
at 
http://icahn.mssm.edu/research/resources/program-for-the-protection-of-
human-subjects/irb-members-palette. 
 
 
13)Process to Document Consent in Writing 
The patients will receive a paper copy of the IRB approved consent packet and will sign in the 
designated areas to confirm consent of participation.  They will have the option of have a copy of 
the consent and may ask for a personal copy of the consent.  
 
14)Vulnerable Populations 
Indicate specifically whether you will include (target) or exclude each of the following 
populations: 
Include 
Exclude 
Vulnerable Population Type 
 
X 
Adults unable to consent 
 
X 
Individuals who are not yet adults (e.g. infants, children, teenagers) 
 
X 
Wards of the State (e.g. foster children) 
 
X 
Pregnant women 
 
X 
Prisoners 
 
15)Multi-Site Human Research (Coordinating Center) 
 
This study will be performed within the Mount Sinai West Hospitals. No additional centers will be 
involved. 
 
16)Community-Based Participatory Research 
 

 
Protocol Name: 
COMPARISON BETWEEN PECS BLOCK AND LOCAL 
SURGICAL INFILTRATION IN ROBOTIC VIDEO ASSISTED 
THORACOSCOPIC SURGERY- A RANDOMISED 
CONTROLLED TRIAL 
Principal Investigator:  
YAN LAI MD,MPH. 
Primary Contact 
Name/Contact Info: 
POONAM PAI B.H MD. 
 
Date Revised: 
07/08/2017 
Study Number: 
IF2058656/HSM# 17-00611/GCO#17-1294 
 
11 
Revised 9/2/14 
This does not apply to our study. 
 
17)Sharing of Results with Subjects 
Results will not be shared with the patients since the study will take time to complete.  Patients 
can request results if they contact the PI by writing. 
 
18)External IRB Review History 
This does not apply to our study. 
 
19)Control of Drugs, Biologics, or Devices 
           Not applicable.  Local anesthetic are routinely used in this setting.