Clinical trial NCT03969875
Conditions: Total Shoulder Arthroplasty Shoulder Osteoarthritis
Keywords: Liposomal bupivacaine Dexamethasone Interscalene catheter Interscalene single shot
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2018-08-18; Completion date: 2022-04-05
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pain management after shoulder surgeries poses a unique challenge to the surgeon as well as the anesthesiologist. Regional anesthesia in the form of interscalene approach to the brachial plexus as an adjunct to general anesthesia or as a sole primary technique comes to one's rescue. Interscalene block either as single shot or as a catheter is an established modality for effective analgesia which facilitates early mobilization helping in physical therapy and early discharge.

With the help of local anesthetic injected as a single shot, analgesia usually lasts less than 24 hours. Recent research in regional anesthesia is advancing towards adjuvants which will prolong the duration of local anesthesia. This has introduced the concept of "multimodal perineural analgesia (MMPNA)" whereby multiple agents with differing mechanisms of action are used with the goal of providing perineural analgesia while avoiding exposure to high and potentially toxic levels of individual agents. Some of the commonly used adjuvants in clinical studies are fentanyl, buprenorphine, morphine, tramadol, magnesium, epinephrine, ketamine, non-steroidal anti-inflammatory drug (NSAID), midazolam, parecoxib, ketorolac, clonidine, dexmedetomidine, dexamethasone, neostigmine and potassium. They find a distinct place in wide spread clinical practice as an off-label use.

Steroids have a long history of safe use in epidural space for treatment of radicular pain due to nerve irritation. Dexamethasone is used routinely as a part of anti- emetic prophylaxis and anti-inflammatory effect. Methyl prednisone was the first steroid to be used as an adjuvant. Dexamethasone was first used as an adjuvant in 2003.

It has been hypothesized that steroids induce a degree of vasoconstriction, thereby reducing local anesthetic absorption, tend to have an opioid sparing effect. Another theory suggests that it increases the activity of inhibitory potassium channels on nociceptive C-fibers (via glucocorticoid receptors), thus decreasing their activity.

Several studies have demonstrated promising results with the use of 8mg of perineural dexamethasone. No neuronal injury has been reported in in vivo studies. Though there are several studies which report usage of dexamethasone in varying doses of 2mg to 8mg, the optimal effective dose of dexamethasone as an adjuvant for nerve block remains unknown. Some studies have suggested perineural is more effective than IV as an adjuvant .

Liposomal bupivacaine, a formulation where bupivacaine is encapsulated into multivesicular liposomes, making it a slow and controlled release from the liposomes, was originally indicated for wound infiltration at the surgical site to provide post-surgical analgesia. Studies have demonstrated efficacy up to 24 hours in femoral nerve block in total knee arthroplasty. Recent approval of liposomal bupivacaine in interscalene block for shoulder surgeries by FDA opens an arena unexplored in the world of regional anesthesia.

Current opioid epidemic, a crisis in health care forces healthcare providers to consider alternate analgesic modalities without compromising patient comfort. Regional anesthesia has revolutionized peri-operative pain management by avoiding opioids and their side effects. Use of adjuvants to the current regional techniques holds promise in postsurgical analgesia.

The researchers propose to compare the analgesic efficacy of liposomal bupivacaine to bupivacaine with dexamethasone as an adjuvant in interscalene block with catheters for shoulder surgeries. Till date, there is not a single study comparing the three in current literature.

Detailed description:
There have been several studies demonstrating efficacy of dexamethasone in prolonging the analgesic effect when administered both perineurally and intra-venously as an adjuvant to local anesthesia demonstrating a dose effect relationship. Liposomal bupivacaine has shown promising results in total knee arthroplasty and there are a limited number of studies demonstrating efficacy in total shoulder arthroplasty.

If by comparing dexamethasone as an adjuvant to bupivacaine and liposomal formulation is deciphered, it can help in avoiding costs associated with liposomal bupivacaine extending post-operative analgesia avoiding narcotics and reducing health care costs. And comparing the two to the standard catheters helps us understand if they have a role in pain management in the future.

Arms: arm 1: Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour. arm 2: Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion. arm 3: Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Interventions: intervention 1: Interscalene catheter intervention 2: Liposomal bupivacaine intervention 3: Dexamethasone intervention 4: Bupivacaine
Intervention descriptions: intervention 1: rescue catheters attached to a PCA pump intervention 2: 10 cc intervention 3: 1 cc of 4mg intervention 4: 0.5% bupivacaine

Protocol documents:
Prot_SAP_000.pdf: 
Comparison of the Analgesic Efficacy of a Single Shot Interscalene Block With 
Liposomal Bupivacaine to Bupivacaine With Dexamethasone as an adjuvant-a 
Randomized Controlled Trial
Dr. Meg Rosenblatt
NCT03969875
Document Date: 6-25-2021


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
1 
Revised  9/2/14 
Brief Summary of Research (250-400 words): 
Pain management after shoulder surgeries pose a unique challenge to 
the surgeon as well as the anesthesiologist. Regional anesthesia in the 
form of interscalene approach to the brachial plexus as an adjunct to 
general anesthesia or as a sole primary technique comes to one’s 
rescue. Interscalene block either as single shot or as a catheter is an 
established modality for effective analgesia which facilitates early 
mobilization helping in physical therapy and early discharge.  
With the help of local anesthetic injected as a single shot, analgesia 
usually lasts less than 24 hours. Though catheter with a slow infusion 
of local anesthesia improves quality of peri-operative pain 
management, it adds days to hospital stay and accompanying 
challenges of risk of catheter migration and additional resources for 
post operative follow up. 
Recent research in regional anesthesia is advancing towards adjuvants which 
will prolong the duration of local anesthesia.  This has introduced the 
concept of “multimodal perineural analgesia (MMPNA)” whereby multiple 
agents with differing mechanisms of action are used with the goal of 
providing perineural analgesia while avoiding exposure to high and 
potentially toxic levels of individual agents. Some of the commonly used 
adjuvants in clinical studies are fentanyl, buprenorphine, morphine, 
tramadol, magnesium, epinephrine, ketamine, non-steroidal anti-
inflammatory drug (NSAID), midazolam, parecoxib, ketorolac, clonidine, 
dexmedetomidine, dexamethasone, neostigmine and potassium. They find a 
distinct place in wide spread clinical practice as an off label use.  
Steroids have a long history of safe use in epidural space for treatment of 
radicular pain due to nerve irritation. Dexamethasone is used routinely as a 


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
2 
Revised  9/2/14 
part of anti- emetic prophylaxis and anti inflammatory effect. Methyl 
prednisone was the first steroid to be used as an adjuvant. Dexamethasone 
was first used as an adjuvant in 2003. 
It has been hypothesized that steroids induce a degree of vasoconstriction, 
thereby reducing local anesthetic absorption, tend to have an opioid sparing 
effect. Another theory suggests that it increases the activity of inhibitory 
potassium channels on nociceptive C-fibers (via glucocorticoid receptors), 
thus decreasing their activity. 
Several studies have demonstrated promising results with the use of 8mg of 
perineural dexamethasone. No neuronal injury has been reported in in vivo 
studies. Though there are several studies which report usage of 
dexamethasone in varying doses of 2mg to 8mg, the optimal effective dose 
of dexamethasone as an adjuvant for nerve block remains unknown. Some 
studies have suggested perineural is more effective than IV as an adjuvant. 
Hence we propose to study the lowest effective dose of dexamethasone as an 
adjuvant which can be used as an adjuvant to local anesthesia in interscalene 
block for shoulder surgeries. 
Liposomal bupivacaine , a formulation  where bupivacaine is encapsulated 
into multivesicular liposomes, making it a slow and controlled release from 
the liposomes, was originally indicated for wound infiltration at the surgical 
site to provide post surgical analgesia. Studies have demonstrated efficacy 
upto 24 hours in femoral nerve block in total knee arthroplasty. Recent 
approval of liposomal bupivacaine in interscalene block for shoulder 
surgeries by FDA opens an arena unexplored in the world of regional 
anesthesia.  


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
3 
Revised  9/2/14 
Based on the above two options in the current opioid epidemic crisis,  we 
propose to study the analgesic efficacy of liposomal bupivacaine to 
bupivacaine with dexamethasone as an adjuvant in interscalene block for 
shoulder surgeries. Till date, there is not study comparing the two.  
1) Objectives:
Research Question:
Is the analgesic efficacy of liposomal bupivacaine superior to that of
bupivacaine with dexamethasone as an adjuvant in interscalene block?
Primary Outcome: The primary outcomes is the time of analgesia
duration (defined as the onset of sensory discomfort that required
medication) and time of motor recovery (defined as the recovery of full
motor function of both wrist and elbow on the nerve block side). Time to
first analgesic request, NRS at 6 hours, 12 hours, 24 hours and 48 hours,
POD 3, 4, 5, 6, 7 and total narcotic consumption.
Secondary Outcome: arm weakness ( 0 to 24 hours, 24 to 48 hours), 
arm numbness (0 to 24 hours, 24 to 48 hours), nausea, vomiting, 
dizziness, Horner’s syndrome, hoarseness, dyspnea, Intra operative 
narcotic consumption, PACU and hospital length  of stay, pain scores as 
assessed by PT on POD 1, and 2.  


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
4 
Revised  9/2/14 
patient’s satisfaction scores( Yes- I would prefer the same analgesic 
technique the next time or No-I would prefer a different analgesic 
technique) and quality of sleep (good, moderate/average, bad) on POD 0 
and 1.Patient reported outcomes measurement information system 
(PROMIS) baseline global assessment will be conducted prior to surgery 
and post operative pain assessment at first follow up visit. Each patient 
will be assessed by standardized assessment of shoulder function as 
recommnede dby American association of shoulder and elbow surgery. 
2) Background
See above. There have been several studies demonstrating efficacy of
dexamethasone in prolonging the analgesic effect when administered
both perineurally and intra-venously as an adjuvant to local anesthesia
demonstrating a dose effect relationship.
But to date there are no studies regarding the lowest effective optimal
dosing as an adjuvant which can aid in analgesia and also facilitate earlier
discharge from hospital avoiding nerve catheter. If an effective optimal
dosing of dexamethasone as an adjuvant is deciphered, it will help in
avoiding costs associated with liposomal bupivacaine facilitating earlier
discharge and extending post operative analgesia avoiding narcotics.
3) Setting of the Human Research
Prospective triple blinded randomized control trial in patients 
undergoing elective arthroscopic shoulder surgeries. The research 
study will take place at Mount Sinai West hospital. The site PI is 
Meg Rosenblatt MD. 


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
5 
Revised  9/2/14 
4) Resources Available to Conduct the Human Research
For n=100, the feasibility of recruitment is manageable.
Recruitment will be done through a coordination of the operating
schedule and the surgeon’s office.
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 four primary members of the research
personnel:
a) Meg A. Rosenblatt, MD – Roles for Dr. Rosenblatt 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. 
She is certified in PPHS/IRB protocols, all Citi/IRB required 
training in human subject protection, and has prior clinical research 
experience. She is also a board certified anesthesiologist and 
professor and chair of anesthesiology with the Icahn School of 
Medicine and the Mount Sinai Health System. 
b) Yan Lai, MD, MPH – Roles for Dr. Lai in this study include
serving as co-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 


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
6 
Revised  9/2/14 
with the Icahn School of Medicine and the Mount Sinai Health 
System 
Paul Cagle, MD, – Roles for Dr. Cagle in this study include serving 
as co-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 orthopedic 
surgeon 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 three 
years going on her fourth. 
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. 


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
7 
Revised  9/2/14 
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. Subjects will be
called by the department of Anesthesiology when their surgery is
scheduled, and they will be introduced about the study then. The
surgeons will also introduce the study to the patients in their office. 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.  All patients scheduled to undergo
total shoulder repair will be approached and recruited.
On the day of the surgery, the team will finalize participation and ask the 
subject to sign study consent forms. The study will not be introduced to 
the patients on the day of the surgery. 
Once the anesthesiologist team performs a thorough  pre operative 
evaluation, an intravenous catheter will be placed for administering 
medications. 
After placement of standard ASA monitors and 4mg of midazolam 
as sedation all patients will receive single shot interscalene block 
performed by residents under direct supervision of regional 
anesthesiology attending with the help of ultrasound guidance.  


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
8 
Revised  9/2/14 
patients will be randomized using computer generated tables and 
sealed envelopes. A designated resident not involved in the study 
will open the sealed envelope and randomize the patient into the 
following groups: 
Group A—Liposomal bupivacaine(133mg bupivacaine diluted 
normal saline total 25cc) 
Group B---Dexamethasone 4mg in 0.5% Bupivacaine 25cc 
The patients will be transferred to the OR to proceed with the 
surgery. Standard ASA monitors will be placed again and after pre 
oxygenation, general anesthesia  will be induced with propofol and 
fentanyl. Laryngeal mask airway of appropriate size will be 
inserted and patient will be connected to the ventilator for the 
procedure. Maintenance of anesthesia will be achieved with 
sevoflurane and oxygen/air mixture. Once the procedure is 
completed, patients will be extubated and transferred to the 
recovery room(PACU) for post anesthetic care.  
The patient will also receive 4mg of ondansetron intra-venous in 
the OR as prophylaxis for post operative nausea and vomitting. 
Patients, attending anesthesiologists, surgeon and research assistant 
collecting the data will be blinded of the group assignment. The 
medication solution will be prepared by the resident physician. 


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
9 
Revised  9/2/14 
Pain scores in the form of NRS (NUMERICAL RATING SCALE) 
will be assessed on arrival to PACU. Pain scores will also be 
assessed 1 hour after arrival to PACU and at the time of discharge 
from PACU. NRS scores will be assessed on the floors every 6 
hourly during the first 24 hours, 8 hourly and then every 12 hourly 
during the second 24 hours. If NRS scores are more than 5 at any 
time a one-time dose of oxycodone 10mg and Tylenol 1000 mgwill 
be given.  
Once the primary team discharges the patient, a telephone follow -
up every day until resolution of any residual arm 
weakness/numbness will be done by the anesthesia resident 
originally involved in the surgery. 
Patients will also be asked   to note the time to first analgesic 
request in addition to onset of sensory discomfort and motor 
recovery. 
a) Recruitment Methods
See above. 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.
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, and
they will be informed about the study then.


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
10 
Revised  9/2/14 
b) Inclusion and Exclusion Criteria
Inclusion criteria: All patients between age 18-75 years undergoing
primary shoulder arthroscopic procedure. All patients who speak read
and understand English will be included for follow up purposes.
Exclusion criteria included patients with patient refusal, ASA 5,
presence of coagulopathy, severe lung disease, contralateral
diaphragmatic palsy, insulin-dependent diabetes, hepatic
disease/failure, kidney disease/failure, pregnancy, chronic opioid use
(defined as opioid use for >3 months), or allergy to any of the study
medications.
c) Number of Subjects
N= 100, recruit ability is manageable. Based on previous study
conducted by Tandoc et al with estimated average duration of
analgesia at 22 hours with dexamethasone in 0.5% bupivacaine and
assumed average SD of 3 hours, they estimated that 16 patients would
be needed to provide 80% power to conclude absence of effect at the
significance level of 0.05 among treatment groups. To allow for 20%
patient dropouts, 30 subjects per group will be targeted for enrollment.
Data will be expressed as mean ± SD or median with interquartile 
range as appropriate. Categorical data will be analyzed with Fisher 
exact test and chi-square test. The duration of analgesia and motor 
block will be analyzed by the Kaplan-Meier survival analysis and Cox 


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
11 
Revised  9/2/14 
proportional hazards modeling. Subgroup pairwise analyses will be 
conducted via Kruskal-Wallis rank test with Bonferroni correction for 
significance. All analysis will be conducted with intent-to-treat 
approach to minimize the potential effects of dropout. Statistical 
significance will be defined as P<0 .05.  
d) Study Timelines
2018-2019 and subsequent data analysis. The subject’s 
participation will be from time of enrollment to complete 
resolution of arm weakness and motor strength. 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 2019. 
e) Study Endpoints
Primary end point will be the time of first analgesic request for the
first 24 hours post operatively.
Secondary end points will be NRS at 6 hours, 12 hours, 18 hours, 24
hours, 36 hours and 48 hours and oxycodone use.
f) Procedures Involved in the Human Research
Prospective randomized controlled trial and data analysis only.
Ultrasound guided interscalene block with nerve catheter placement.


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
12 
Revised  9/2/14 
g) Specimen Banking
N/A
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 Mt. 
Sinai (chpnet) electronic mail.   
The information included in the data will be medical record number, 
age, gender, ASA class, type of surgery, pain score assessments, 
duration of surgery, anesthesia time, time to first narcotic, total narcotic 
use and pain scores up to 48 hours after surgery. In case of known 
history of type 1 or 2 diabetes, preoperative and post operative finger 
stick will be recorded. Time of administration of study drug, smoking 
status and patient satisfaction scores will also be recorded. 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 
are 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


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
13 
Revised  9/2/14 
Part I: Elements of Data and Safety Monitoring Plan 
MSSM Principal Monitor: 
Last Name: Rosenblatt 
First Name: Meg 
Academic Title: Attending Physician, Professor 
Department: Anesthesiology 
Mailing Address: Mount Sinai West 1000 10th Avenue, New 
York, NY 10019 
Phone: 212-523-6915 
Fax:  
E-mail: meg.rosenblatt@mountsinai.org
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
Last Name: Cagle 
First Name: Paul 
Academic Title: Attending Physician, Professor 
Department: Orthopedics 
Mailing Address: Mount Sinai West 1000 10th Avenue, New 
York, NY 10019 


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
14 
Revised  9/2/14 
Phone: 212-523-6915 
Fax:  
E-mail:
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:  
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.  
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 


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
15 
Revised  9/2/14 
research. In addition, she has been a resident physician in 
anesthesiology with the Icahn School of Medicine in good 
standing for the previous three years going on her fourth. 
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
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 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 


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
16 
Revised  9/2/14 
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. 
8) Potential Benefits to Subjects
It is important to know that you may not get any benefit from 
taking part in this research.  Others may not benefit either. 
However, possible benefits may be improved knowledge about 
how the addition of adjuvant to local anesthesia affects pain 
control in shoulder surgery. There is potential for better pain 
control after 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. 


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
17 
Revised  9/2/14 
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)
Payment to Subjects
Patients will not be reimbursed for their participation. 
12)
Consent Process
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. 


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
18 
Revised  9/2/14 
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: 
I
n
c
l
u
d
e 
E
x
c
l
u
d
e 
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 


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
19 
Revised  9/2/14 
X 
Prisoners 
15)
Multi-Site Human Research (Coordinating Center)
This study will be performed within the Mount Sinai West and 
Mount Sinai Hospital. No additional centers will be involved. 
16)
Community-Based Participatory Research
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


Protocol Title: 
COMPARISON OF THE ANALGESIC EFFICACY OF A 
SINGLE SHOT INTERSCALENE BLOCK WITH 
LIPOSOMAL BUPIVACAINE TO BUPIVACAINE WITH 
DEXAMETHASONE AS AN ADJUVANT-A RANDOMIZED 
CONTROLLED TRIAL 
Principal Investigator 
Name/Contact Info:  
MEG A. ROSENBLATT MD. 
YAN H. LAI MD, MPH. 
JUNPING CHEN MD, PHD 
PAUL J. CAGLE MD 
212-523-6915
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD. 
347-569-4816
Date Revised: 
Study Number: 
20 
Revised  9/2/14 
Not applicable.  Local anesthetics and dexamethasone are routinely 
used in this setting.