Clinical trial NCT04867369
Conditions: Tendonitis
Sponsor: NYU Langone Health
Start date: 2021-07-14; Completion date: 2023-11-11
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A phase IV, randomized, single-blind, single-center study measuring the effects of Pecs II block with 0.25% bupivacaine versus surgeon infiltration with 0.25% bupivacaine on postoperative pain control and opioid utilization in participants who undergo open subpectoral tenodesis.

Detailed description:

Arms: arm 1: 80 patients scheduled for open biceps tenodesis arm 2: 80 patients scheduled for open biceps tenodesis
Interventions: intervention 1: Bupivacaine 20mL 0.5% intervention 2: Bupivacaine 20mL 0.25% intervention 3: Bupivacaine up to 15mL 0.25%
Intervention descriptions: intervention 1: Interscalene nerve block with 20 mL 0.5% bupivacaine. intervention 2: Pecs II fascial plane block with 20 mL 0.25% bupivacaine. intervention 3: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.

Protocol documents:
Prot_SAP_000.pdf: 
Official Title: 
Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps 
Tenodesis  
NCT Number:
NCT04867369
Study Number:
20-01978 
Document Type:
Protocol and Statistical Analysis Plan
Date of the 
Document: 
 
December 4, 2023 


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PECS II BLOCK VERSUS SURGEON INFILTRATION FOR OPEN 
SUBPECTORAL BICEPS TENODESIS
A phase IV, randomized, single-blind, single-center study measuring the effects of Pecs II block with 0.25% 
bupivacaine versus surgeon infiltration with 0.25% bupivacaine on postoperative pain control and opioid 
utilization in participants who undergo open subpectoral tenodesis.
Principal Investigator:
David Furgiuele, MD, FASA
Department of Anesthesiology, Perioperative Care and Pain Med
NYU Langone Health 
NYU Langone Orthopedic Hospital 
301 East 17th Street 
New York, NY 10003
David.Furgiuele@nyulangone.org
O: (212) 598-6085 
Additional Investigators:
Mandeep Virk, MD
Department of Orthopedic Surgery
NYU Langone Health 
NYU Langone Orthopedic Hospital 
301 East 17th Street 
New York, NY 10003
Mandeep.Virk@nyulangone.org
O: (646) 754-2100
Thomas Youm, MD
Department of Orthopedic Surgery
NYU Langone Health 
NYU Langone Orthopedic Hospital 
301 East 17th Street 
New York, NY 10003
Thomas.Youm@nyulangone.org
212-348-3636


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Young Kwon, MD, PhD
Department of Orthopedic Surgery
NYU Langone Health 
NYU Langone Orthopedic Hospital 
333 East 38th Street, 4th floor
New York, NY 10003
Young.Kwon@nyulangone.org
O: 646-501-7223
Kirk Campbell, MD
Department of Orthopedic Surgery
NYU Langone Health 
NYU Langone Orthopedic Hospital 
301 East 17th Street 
New York, NY 10003
Kirk.Campbell@nyulangone.org
646-356-9407
Guillem Gonzalez-Lomas, MD
Department of Orthopedic Surgery
NYU Langone Health 
NYU Langone Orthopedic Hospital 
301 East 17th Street 
New York, NY 10003
Guillem.Gonzalez-Lomas@nyulangone.org
O: 646-501-7223
NYULMC Study Number:
S20-01978
Study Product:
N/A
ClinicalTrials.gov Number:
Pending
Amended Version: 
11/22/2023


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Statement of Compliance 
This study will be conducted in accordance with the Code of Federal Regulations on the Protection of Human 
Subjects (45 CFR Part 46), 21 CFR Parts 50, 56, 312, and 812 as applicable, any other applicable US government 
research regulations, and institutional research policies and procedures. The International Conference on 
Harmonisation (“ICH”) Guideline for Good Clinical Practice (“GCP”) (sometimes referred to as “ICH-GCP” or 
“E6”) will be applied only to the extent that it is compatible with FDA and DHHS regulations. The Principal 
Investigator will assure that no deviation from, or changes to the protocol will take place without prior 
agreement from the sponsor and documented approval from the Institutional Review Board (IRB), except 
where necessary to eliminate an immediate hazard(s) to the trial participants. All personnel involved in the 
conduct of this study have completed Human Subjects Protection Training. 
 
 


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Table of Contents 
STATEMENT OF COMPLIANCE ....................................................................................................................III
PROTOCOL SUMMARY.................................................................................................................................. 7
1 
BACKGROUND AND SPECIFIC AIMS ................................................................................................ 8
1.1 
SPECIFIC AIMS ............................................................................................................................................................................... 9
1.2 
STATISTICAL HYPOTHESIS ........................................................................................................................................................... 9
1.3
OBJECTIVES AND PURPOSE..........................................................................................................................................................9
2
STUDY DESIGN AND ENDPOINTS....................................................................................................9
2.1 
DESCRIPTION OF STUDY DESIGN .............................................................................................................................................. 10
2.2 
SCHEMATIC OF STUDY DESIGN.................................................................................................................................................. 11
3 
STUDY ENROLLMENT AND WITHDRAWAL .................................................................................. 12
3.1 
INCLUSION CRITERIA.................................................................................................................................................................. 12
3.2
EXCLUSION CRITERIA .................................................................................................................................................................12
3.3 
VULNERABLE SUBJECTS ............................................................................................................................................................. 12
3.4 
RECRUITMENT AND CONSENT................................................................................................................................................... 12
3.5 
DURATION OF STUDY PARTICIPATION..................................................................................................................................... 13
3.6 
TOTAL NUMBER OF PARTICIPANTS AND SITES ...................................................................................................................... 13
3.7 
PARTICIPANT WITHDRAWAL OR TERMINATION ................................................................................................................... 13
3.8 
PREMATURE TERMINATION OR SUSPENSION OF STUDY ...................................................................................................... 13
4 
STUDY PROCEDURES AND SCHEDULE .......................................................................................... 13
4.1 
STUDY PROCEDURES/EVALUATIONS....................................................................................................................................... 13
 
4.1.1
STUDY SPECIFIC PROCEDURES............................................................................................................................................ 13
 
4.1.2
STANDARD OF CARE STUDY PROCEDURES ........................................................................................................................ 14
4.2 
STUDY SCHEDULE ........................................................................................................................................................................ 14
 
4.2.1
SCREENING............................................................................................................................................................................. 14
 
4.2.2
ENROLLMENT/BASELINE .................................................................................................................................................... 14
 
4.2.3
FOLLOW-UP PHONE CALL (POD 1 AND POD 3) ............................................................................................................ 14
 
4.2.4
WITHDRAWAL/EARLY TERMINATION VISIT ................................................................................................................... 14
4.3 
CONCOMITANT MEDICATIONS, TREATMENTS, AND PROCEDURES ..................................................................................... 15
5 
RISKS AND BENEFITS .................................................................................................................... 15
5.1
POTENTIAL RISKS........................................................................................................................................................................15
5.2 
POTENTIAL BENEFITS ................................................................................................................................................................. 15
6 
STATISTICAL ANALYSIS ................................................................................................................ 16
6.1 
GENERAL APPROACH .................................................................................................................................................................. 16
6.2 
ANALYSIS OF ENDPOINTS........................................................................................................................................................... 16
6.3 
SAMPLE SIZE ................................................................................................................................................................................ 16
6.4 
ENROLLMENT/RANDOMIZATION/MASKING PROCEDURES................................................................................................. 17
6.5 
BREAKING THE STUDY BLIND/PARTICIPANT CODE ............................................................................................................. 17
7 
ASSESSMENT OF SAFETY ............................................................................................................... 17
7.1 
DEFINITION OF ADVERSE EVENTS (AE) ................................................................................................................................. 17
7.2 
DEFINITION OF UNANTICIPATED PROBLEMS (UP) ............................................................................................................... 17
7.3 
CLASSIFICATION OF AN ADVERSE EVENT................................................................................................................................ 18
 
7.3.1
SEVERITY OF EVENT ............................................................................................................................................................. 18
 
7.3.2
RELATIONSHIP TO STUDY AGENT....................................................................................................................................... 18
 
7.3.3
EXPECTEDNESS ...................................................................................................................................................................... 19
7.4 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP .................................................................. 19


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7.5 
REPORTING PROCEDURES – NOTIFYING THE IRB ................................................................................................................. 20
7.5.1
UNANTICIPATED PROBLEM REPORTING...........................................................................................................................20
7.6
STUDY HALTING RULES .................................................................................................ERROR! BOOKMARK NOT DEFINED.
7.7 
SAFETY OVERSIGHT .................................................................................................................................................................... 20
8 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ......................................... 20
9 
QUALITY ASSURANCE AND QUALITY CONTROL .......................................................................... 21
10 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................................... 21
10.1
ETHICAL STANDARD...................................................................................................................................................................21
10.2
INSTITUTIONAL REVIEW BOARD1 ...........................................................................................................................................21
10.3 
PARTICIPANT AND DATA CONFIDENTIALITY .......................................................................................................................... 21
11
DATA HANDLING AND RECORD KEEPING .............................................................................. 22
11.1
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES................................................................................................22
11.2
STUDY RECORDS RETENTION ...................................................................................................................................................22
11.3 
PROTOCOL DEVIATIONS............................................................................................................................................................. 23
11.4 
PUBLICATION AND DATA SHARING POLICY............................................................................................................................ 23
12 
STUDY FINANCES ........................................................................................................................... 23
12.1 
FUNDING SOURCE ........................................................................................................................................................................ 23
12.2 
COSTS TO THE PARTICIPANT..................................................................................................................................................... 24
12.3 
PARTICIPANT REIMBURSEMENTS OR PAYMENTS.................................................................................................................. 24
13 
CONFLICT OF INTEREST POLICY ................................................................................................... 24
14 
REFERENCES .................................................................................................................................. 25
15 
ATTACHMENTS .............................................................................................................................. 25
15.1 
OPIOID EQUIVALENTS ................................................................................................................................................................ 25
15.3 
MEDICATION USAGE RECORD ................................................................................................................................................... 27
15.4 
MCGILL PAIN SCALE ................................................................................................................................................................... 28


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List of Abbreviations 
 
ASA 
American Society of Anesthesiologist Score 
 
BMI 
Body Mass Index 
 
DOS 
Day of surgery 
 
VAS 
Visual analog scale 
 
AE 
Adverse event 
 
SAE 
Serious adverse event 
 
IV 
Intravenous 
 
ITT 
Intention-to-treat 
 
PACU 
Post-Anesthesia Care Unit 
 
PEC 
Pectoralis nerve block 
 
PO 
Taken orally 
 
PRN 
Taken as needed 
 
PROMIS 
Patient Reported Outcomes Measurement Information System  
 
CI 
Confidence interval 
 
SD 
Standard deviation; a parameter that characterizes a population distribution 
 
SE 
Standard error 
 
ANOVA 
Analysis of variance; a linear model   
 
NSAID 
Non-steroidal anti-inflammatory drug 


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Protocol Summary
Title
Pecs II Block versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis
Brief Summary 
A phase IV, randomized, single-blind, single-center study measuring the effects of 
Pecs II block with 0.25% bupivacaine versus surgeon infiltration with 0.25% 
bupivacaine on postoperative pain control and opioid utilization in participants 
who undergo open subpectoral tenodesis. 
Phase 
Clinical study phase IV 
Objectives 
To determine if Pecs II block is superior to surgical infiltration in reduction of 
axillary pain after open subpectoral bicep tenodesis, especially in terms of 
duration. 
Methodology 
Phase IV, randomized, single-blind, single-center study 
Endpoint 
Primary Endpoint: 
Opioid utilization for the first 24 hours after surgery, including during surgery, 
calculated as oxycodone equivalent. 
 
Secondary Endpoints:   
Patient reported VAS scores in PACU 
Patient reported VAS scores on POD 1 and POD 3 
Reaction to surgical subpectoral incision (signs include patient movement, 
tachycardia, etc.) 
Skin assessment of sensation in PACU (axilla, distal to surgical dressing) 
Study Duration 
The study will continue until 80 subjects are enrolled per arm, to allow for 
potential dropout and increased power. 
Participant Duration 
Each participant will be enrolled on DOS and complete their final follow up on 
postoperative day three.
Duration of IP 
administration 
Once during surgery 
Population 
80 patients per study arm scheduled for open biceps tenodesis 
Study Sites 
NYU Langone Orthopedic Hospital and NYU Ambulatory Surgery Center at 38th
street 
Number of participants
160
Description of Study 
Agent/Procedure 
Patients in both groups will receive an interscalene nerve block with 20 mL 0.5% 
bupivacaine. Subjects in the Pecs II block group will receive a Pecs II fascial plane 
block with 20 mL 0.25% bupivacaine. The Surgical infiltration group patients will 
receive local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.
Reference Therapy 
Reference is Interscalene block with 0.5% bupivacaine and surgical infiltration 
with bupivacaine 0.25% 
Key Procedures 
Interscalene block with 0.5% bupivacaine, Pecs II block with 0.25% bupivacaine, 
local surgical infiltration with 0.25% bupivacaine  
Statistical Analysis 
Continuous and categorical baseline characteristics will be compared using Hedges 
standardized difference. 
Outcomes will be assessed using an intention-to-treat (ITT) methodology. 
Normally distributed data will be compared using t tests while non-normally 
distributed continuous outcomes will be assessed using the Mann-Whitney U test. 
 


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Key Roles 
 
Principal Investigator:    
David Furgiuele, MD, FASA 
Professor of Anesthesiology 
Department of Anesthesiology, Perioperative care and Pain Medicine 
NYU Langone Orthopedic Hospital 
NYU Langone Health 
301 East 17th street 
New York, NY 10003 
David.Furgiuele@nyulangone.org 
212-598-6085 
 
 
 
Co-Investigator:   
 
Mandeep Virk, MD 
Department of Orthopedic Surgery 
NYU Langone Orthopedic Hospital 
NYU Langone Health 
301 East 17th street 
New York, NY 10003 
Mandeep.Virk@nyulangone.org 
O:(646) 754- 2100 
1 Background and Specific Aims 
 
Biceps tendinopathy can range from inflammatory to degenerative pathology and can often contribute to anterior 
shoulder pain.1 This pain is generally located at the anteromedial aspect of the shoulder in the area of the 
intertubercular groove.2 Surgical treatment by biceps tenodesis can help increase strength and decrease pain in 
patients that have failed non-operative management. Although there are many variations to the surgical approach, 
one approach that has been shown effective is the open subpectoral biceps tenodesis.3
 
For arthroscopic and open shoulder surgeries, assuming there are no contra-indications, anesthesiologists at our 
institution most often perform interscalene brachial plexus blocks along with IV sedation. The brachial plexus 
provides innervation to most of the shoulder joint and adjacent soft tissue. Nerves that require blockade to achieve 
effective analgesia include the subscapular, axillary, lateral pectoral, and suprascapular nerves.4,5 These nerves are 
anesthetized with the interscalene brachial plexus block which targets the C5-6 nerve roots and spares the inferior 
trunk of the brachial plexus. When an open subpectoral biceps tenodesis is being performed, either alone or with 
shoulder arthroscopy, a vertical incision is made along the anteromedial aspect of the arm centered over the 
pectoralis major tendon.5,6 Unfortunately, this area of the upper arm is not anesthetized by the interscalene brachial 
plexus block.  
 
The anteromedial aspect of the upper arm is typically innervated by the medial brachial cutaneous nerve and the 
medial pectoral nerve, which arise from the inferior trunk of the brachial plexus, along with the intercostobrachial 
nerve, which originates from the T2 nerve root. In order to anesthetize this area, one can consider utilizing the Pecs 
II block. The Pectoralis nerve blocks (Pecs) were initially intended for breast surgeries; however, they have also 
become a popular substitute for paravertebral blocks and thoracic epidurals following thoracic and abdominal wall 
surgeries.7 The Pecs I block consists of an injection of local anesthesia between the pectoralis major and minor 


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muscles. This is intended to block the medial and lateral pectoral nerves. The Pecs II block consists of an additional 
fascial injection between the pectoralis minor muscle and the serratus anterior muscle, and anesthetizes the upper 
intercostal nerves. Reynolds previously demonstrated that the Pecs II block is beneficial in decreasing 
postoperative axillary pain during an open biceps tenodesis compared to no block.4 However, patients in that study 
received general anesthesia for the surgery. The alternative to performing a Pecs II block would be surgical 
infiltration of local anesthesia at and around the incision site. Prior to this study, our institution relied heavily on 
this alternative to adequately provide analgesia to the anteromedial upper arm and decrease postoperative axillary 
pain.  
To date, there are few studies on surgical infiltration for open biceps tenodesis. Based on the success of the Pecs II 
block for open bicep tenodesis demonstrated by Reynolds, we propose this randomized controlled study comparing 
a Pecs II block versus surgical infiltration for this procedure. We hope to elucidate which technique will provide 
better pain control after open subpectoral bicep tenodesis surgery. 
1.1 Specific Aims
This study will aim to compare Pecs II block versus surgical infiltration for axillary pain in patients undergoing 
arthroscopic shoulder surgery with an open subpectoral bicep tenodesis.  
 
AIM 1:  To determine if Pecs II block is superior to surgical infiltration in reduction of axillary pain after open 
subpectoral bicep tenodesis, especially in terms of duration. 
 
1.2 Statistical Hypothesis
We hypothesize that patients who receive a Pecs II block will have lower postoperative opioid consumption over 
the first 24 hours (measured in oxycodone equivalents) compared to those who receive surgical infiltration of local 
anesthetic. Furthermore, the Pecs II block patient group will have reduced adverse effects associated with opioids 
such as constipation, nausea, pruritis ileus. Failing to reject the null would signify that the Pecs II block has no 
clinically relevant difference on post-operative opioid consumption outcomes in Open Subpectoral Biceps 
Tenodesis as compared to surgical infiltration of local anesthetic. 
 
 
1.3 Objectives and Purpose 
The goal of this study is to compare the postoperative pain control using a Pecs II block with 0.25% bupivacaine 
to the standard of care of local surgeon infiltration with 0.25% bupivacaine following open subpectoral biceps 
tenodesis, particularly in terms of duration of pain control and adjunctive postoperative analgesic consumption. 
The primary objective will be to compare opioid utilization between the two arms within the first 24 hours after 
surgery, including intraoperatively, as measured by oxycodone equivalents. Our secondary objectives are 
measuring patient reported pain scores in PACU and at 24 hours, reaction to surgical incision, and skin 
assessment of sensation in the PACU. 
 
2 Study Design and Endpoints 
 
 
Arm 1: Experimental 
 
Arm 2: Control 
 
Sample Size: 80  
 
Sample Size:80  
 
Medication: 20ml 0.5% bupivacaine for ISB +  
20ml 0.25 % bupivacaine for Pecs II  
 
Medication: 20ml 0.5% bupivacaine for ISB + 15ml 
0.25% bupivacaine for surgical infiltration  


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2.1 Description of Study Design
RECRUITMENT PHASE/CONSENTING PHASE:
Surgeons will inform eligible patients of the study during their pre-surgical visit in their office. If the patient is 
agreeable, a member of the research team will provide further details and ask the patient to participate on day of 
surgery.  Patients will be made acquainted with the study before DOS during pre-surgical appointments. On DOS 
when they arrive 1.5/2 hours before surgery we (study team members) will consent them and provide ample time 
to discuss and review any questions or concerns they may have.   
 
BASELINE ASSESSMENTS:  
Subjects will complete a baseline global health and pain assessment. 
 
RANDOMIZATION PHASE:  
Subjects scheduled to undergo open subpectoral biceps tenodesis will be randomized to either Pecs II block with 
bupivacaine 0.25% or subpectoral surgical skin infiltration with bupivacaine 0.25%. A randomization scheme will 
be created prior to start of study enrollment using the randomizer.org website to generate the assignment. Block 
randomization is commonly used in clinical trial design to reduce bias  and achieve balance in the allocation of 
participants to treatment arms throughout the course of the study. Randomized block design allows us to account 
for variables so that observed differences are largely due to true differences between  treatments and not to the 
variable. The greatest variable affecting the PECS study is surgical technique and it could possibly vary throughout 
the duration of the study.  We will create blocks of four patients and in each block, two patients will be assigned to 
the PECS II group, and two to the infiltration group. Thus, patients in both groups with be evenly spread from the 
beginning 
to 
the 
end 
of 
the 
study 
period. 
  
A  research coordinator will place  the randomization results in sealed opaque envelopes prior to recruitment.  Each 
subject enrolled in the study will be assigned a number and the sealed envelope assigning the  subject to the PECS 
II versus surgical infiltration arm will be opened on  the day of surgery after the patient has signed consent agreeing 
to  participate in the study. 
 
 
 
TREATMENT PHASE:  
Patients in both groups will receive an interscalene nerve block with 20 mL 0.5% bupivacaine. Subjects in the Pecs 
II block group will receive 20mL 0.25% bupivacaine; 20ml will be injected between pectoralis minor and serratus 
anterior muscles. The subpectoral surgical skin infiltration group will receive 15mL bupivacaine 0.25% by the 
surgeon. These medications will be obtained from the operating room omnicell. Neither the anesthesiologist nor 
surgeon will be blinded to the patient’s group assignment, as they are the ones administering the treatment.  All 
other stakeholders (patient, other caregivers, and research staff collecting the data) will be blinded to the patient’s 
group assignment. 
 
POST-OPERATIVE PHASE:  
After initial recruitment, subjects’ pain will be assessed via visual analog scale (VAS) by nursing staff during the 
post-operative period as per standard of care. The VAS pain scores are collected and documented in the patient’s 
electronic medical record. Additionally, a standardized regimen of pain medication will be given to all subjects who 
are enrolled. The pain medications given to patients are standard of care medications and vary based on pain level. 
This is determined by the clinical staff caring for each patient.  While the patient is in the PACU, an authorized 
research member will visit the patient and obtain a pain score using the Numeric Rating Scale (NRS) and McGill 
Pain Scale. Skin testing in the axilla will be done in PACU prior to discharge to evaluate the presence or absence of 
sensation in that area. Data on PACU opioid use documented in EPIC will be collected. On POD1 and POD 3, a phone 
call to the patient will be made to collect additional data on oxycodone use at home as well as an NRS score at 24 
and 72 hours after surgery.  


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2.2
Schematic of Study Design
160 subjects: Obtain informed consent. Screen potential subjects by inclusion and 
exclusion criteria; obtain history, document.
Randomize
80 Subjects: Pecs II block with 
20 ml 0.25% bupivacaine
80 Subjects: local surgeon 
infiltration with 15mL 
0.25% bupivacaine
Assess reaction to skin incision, opioid requirements
Assess pain score, skin sensation test, continue opioid requirement 
assessment, administer pain questionnaire
Phone calls to patient on POD1 and 3 to collect additional data on 
oxycodone use following discharge
Final Assessments: Opioid 
requirements, pain scores, pain 
questionnaire, skin sensation test
Intraoperative 
Measurements
Enrollment
PACU 
Measurements
After discharge 
measurements
Data compilation


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3
Study Enrollment and Withdrawal
The researchers will approach patients scheduled for shoulder arthroscopy with open biceps tenodesis who are 
eligible for participation in the study. Anesthesiology attendings, fellows, residents, and authorized researchers 
will consent and enroll patients pre-operatively.  
3.1 Inclusion Criteria
1. Patients between 18 and 75 years of age 
2. Patients undergoing shoulder arthroscopy with open subpectoral biceps tenodesis 
 
3.2 Exclusion Criteria
1. Patients younger than 18 and older than 75; 
2. Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer; 
3. Patients who are allergic to oxycodone; 
4. Patients with diagnosed or self-reported cognitive dysfunction; 
5. Patients with a history of neurologic disorder that can interfere with pain sensation; 
6. Patients with a history of drug or recorded alcohol abuse; 
7. Patients who are unable to understand or follow instructions; 
8. Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart 
disease; 
9. Patients with an allergy or contraindication to any of the medications used in the study, or patients with a 
contraindication to any study procedures; 
10. Patients with a BMI over 45;  
11. Any patient that the investigators feel cannot comply with all study related procedures; 
12. NYU Langone Health students, residents, faculty or staff members. 
3.3 Vulnerable Subjects
No vulnerable populations will be enrolled in this study.  
3.4 Recruitment and Consent
This study will utilize EPIC to identify subjects and use Redcap in addition to the firewall protected shared drive to 
manage and store relevant data.   
 
Process of Consent 
The consent for participation will be obtained on day of surgery in pre-operative holding room by the regional 
anesthesiology fellows, Attending Physicians, or authorized researchers that are members of the study team. 
Extensive discussion of risks and possible benefits of participation will be provided to the participants and their 
families. Consent forms will be IRB-approved, and participants will be asked to read and review the document. The 
investigator will explain the research study to the participant and answer any questions that may arise. All 
participants will receive a verbal explanation suited to their comprehension of the purposes, procedures and 
potential risks as well as their rights as research participants. Participants will have the opportunity to carefully 
review the written consent form and ask questions prior to signing. The participants will have the opportunity to 
discuss the study with their surrogates or think about it prior to agreeing to participate. The participant will sign 
the informed consent document prior to any procedures being done specifically for the study. The participants may 
withdraw consent at any time throughout the course of the trial. A copy of the signed informed consent document 
will be given to the participants for their records. The rights and welfare of the participants will be protected by 
emphasizing that the quality of their medical care will not be adversely affected if they decline to participate in this 
study. If you we are unable to obtain consent at an earlier time, subjects will be given a copy of the informed consent 
form at their pre-surgical visit to allow them time to read through it, discuss with their relatives, and contact the 
study team with any questions prior to their surgery. 
 


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writing by the study sponsor 
Interventional Template Version: 11 January 2019 
A copy of the signed informed consent document will be given to the patient, placed in the patient’s electronic 
medical record and the original copy will be stored in the research regulatory binder.  Any alteration to the 
standard consent process (e.g., us.e of a translator, consent document presented orally, etc.) and the justification 
for such alteration will likewise be documented.  
 
Capacity will be assessed through the subject’s ability to express understanding of the information being presented 
to them. The subject will be asked to state back the goals of the study and that they are willing to participate in their 
primary language. 
If a subject requests information regarding opting out of further recruitment for all research, subjects will be 
directed to contact the research coordinator, Ekow Commeh at 212- 263-3851 or Avra Hammerschlag at 212-266-
5835. 
 
3.5 Duration of Study Participation
The study will remain open until 80 patients are recruited for each intervention arm of the study. The actual subject 
participation length will be four days. 
3.6 Total Number of Participants and Sites 
Recruitment will end when 160 participants have been enrolled. It is expected that there will be subjects enrolled 
who will be lost to follow up and be evaluated by intention-to-treat. The sites for enrollment will be the NYU 
Langone Orthopedic Hospital and NYU Ambulatory Surgery Center at 38th street. 
3.7 Participant Withdrawal or Termination 
Participants are free to withdraw from participation in the study at any time upon request. An investigator may 
terminate participation in the study if: 
 
1. 
Any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation occurs such that 
continued participation in the study would not be in the best interest of the participant 
2. 
The participant meets an exclusion criterion (either newly developed or not previously recognized) that 
precludes further study participation 
3.8 Premature Termination or Suspension of Study 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. If the 
study is prematurely terminated or suspended, the PI will promptly inform the IRB and will provide the reason(s) 
for the termination or suspension. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
1. 
Determination of unexpected, significant, or unacceptable risk to participants; 
2. 
Demonstration of efficacy that would warrant stopping; 
3. 
Insufficient compliance to protocol requirements; 
4. 
Data that are not sufficiently complete and/or evaluable; or 
5. 
Determination of futility 
4 Study Procedures and Schedule 
4.1 Study Procedures/Evaluations
4.1.1 Study Specific Procedures 
Patients will be screened for eligibility by the surgical team during their pre-surgical office visit. Surgeons will 
explain the study to the eligible patient. 
 
If patients are agreeable to participation, a research team member will provide further details and ask for 
participation on day of surgery. Informed consent will be obtained on day of surgery when the patient is in the 


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pre-operative holding room by an authorized research member. Patient will complete a baseline global health and 
pain assessment. 
 
Patients in both groups will receive an interscalene nerve block with 15mL 0.5% bupivacaine. Subjects in the Pecs 
II block group will receive a Pecs II fascial plane block with 20mL 0.25% bupivacaine. The Pecs II block consists of 
an injection of 20ml of 0.25% bupivacaine 1:200,000 between the pectoralis minor and the serratus anterior 
muscles. This will be accomplished using ultrasound guidance to identify the appropriate anatomic structures and 
ensure appropriate needle localization prior to injection of 20 mL 0.25% bupivacaine 1:200,000. 
 
Postoperatively, pain will be assessed via visual analog scale (VAS) by nursing staff during the post-operative 
period as per standard of care. The VAS pain scores are collected and documented in the patient’s electronic 
medical record. Additionally, while the patient is in the PACU, an authorized research member will visit the 
patient and administer a pain questionnaire (NRS and McGill Pain scale). Skin testing in the axilla will be done in 
PACU prior to discharge. Data on PACU opioid use documented in EPIC will be collected. 
 
4.1.2 Standard of Care Study Procedures 
The subjects receiving standard of care procedures will undergo local surgeon infiltration of the surgical field 
with 15 mL of 0.25% bupivacaine 1:200,000. The OR nurse will obtain the local anesthetic from the operating 
room omnicell. 
4.2 Study Schedule
4.2.1 Screening  
 
Screening Visit (Pre-surgical office visit -30 to -1 days)  
 Review medical history to determine eligibility based on inclusion/exclusion criteria. 
 Review medications history to determine eligibility based on inclusion/exclusion criteria. 
 Perform medical examinations needed to determine eligibility based on inclusion/exclusion criteria. 
 Schedule study visits for participants who are eligible and available for the duration of the study. 
 Provide participants with further details regarding their participation on day of surgery and follow up. 
 
4.2.2 Enrollment/Baseline 
 
Enrollment/Day of surgery (Visit 1, Day 0) 
 Obtain informed consent of potential participant verified by signature on study informed consent form. 
 Verify inclusion/exclusion criteria. 
 Complete baseline global health and pain assessment 
 Randomize to Pecs II or surgical infiltration treatment group 
 Perform surgery with analgesic intervention determined by randomization 
 Record vital signs, opioid usage, results of examinations, other pain assessments. 
 Continue observation in PACU preceding discharge, including administration of VAS scores, pain 
questionnaire, and opioid usage monitoring. 
4.2.3 Follow-Up Phone call (POD 1 and POD 3) 
1. Phone call to patient to collect additional data on opioid use following discharge, on POD 1 and 3 after surgery 
4.2.4 Withdrawal/Early Termination Visit 
Subjects may discontinue their participation in the study at any time. As there is only a single intervention, and the 
safety of this is not in question, further follow up will not be required if a subject decides to terminate their 
participation in the study. 


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4.3 Concomitant Medications, Treatments, and Procedures 
All concomitant prescription medications taken during study participation will be recorded on the case report 
forms (CRFs). For this protocol, a prescription medication is defined as a medication that can be prescribed only 
by a properly authorized/licensed clinician. Medications to be reported in the CRF are concomitant prescription 
medications, over-the-counter medications and non-prescription medications. 
5 Risks and Benefits  
5.1
Potential risks 
Medication:  
 
The potential risks associated with bupivacaine include neurologic and cardiac toxicity, if injected intravascularly. 
However, the risk is very low because a trained anesthesiologist using ultrasound guidance will perform the PECS 
II block and a trained orthopedic surgeon will be performing the skin infiltration. US guidance allows the 
anesthesiologist to see and avoid blood vessels when administering the medication. Additionally, the syringe of the 
local anesthetic will be aspirated prior to injection by the anesthesiologist and surgeon to ensure that the block 
needle tip is not intravascular. A PEC II block is fascial plane block and not a nerve block. The local anesthetic will 
be injected between the pectoralis major and serratus anterior muscle.  The risk of nerve injury or intravascular 
injection in the PECS II is therefore similar to the surgical infiltration arm of the study. Allergic reactions to local 
anesthetic is possible however, any subjects with a history of allergies to local anesthetic will be excluded from the 
study.  
 
Procedure:  
 
Pecs II: 
 
The potential risks associated with Pecs II include bleeding, nerve damage, pleural injury, infection at injection site, 
intravascular injection, and local anesthetic systemic toxicity. LAST is generally secondary to intravascular 
injection. The likelihood of this occurring is low due to the expertise of the anesthesiologist and use of ultrasound 
guidance. 
 
Surgical infiltration:
 
The potential risks associated with surgical infiltration include bleeding, nerve damage, pleural injury, infection at 
injection site and local anesthetic systemic toxicity. However, the likelihood is low due to the expertise of the 
surgeon performing the injection, the sterile environment, and the safe practice of clinicians.  
 
 
5.2 Potential benefits  
 
Study subjects may experience better pain control, improved satisfaction, decreased need for opioids and reduced 
incidence of side effects. If the study is not inconclusive, the study’s results may benefit future patients by 
showcasing Pecs II block improves pain control in the first 24 hours of an Open Subpectoral Biceps Tenodesis.  
Additionally, advocate for the use of Pecs II block as the standard of care for peri- and postoperative pain control in 
future patients undergoing Open Subpectoral Biceps Tenodesis.  


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6
Statistical Analysis 
6.1
General Approach  
The primary analysis will follow the intention-to-treat (ITT) principle in order to evaluate the true outcome of the 
intervention as experienced by the patient who is blinded to the intervention. 
 
Continuous and categorical baseline characteristics will be compared using Hedges standardized difference 
Normally distributed data will be compared using t tests while non-normally distributed continuous outcomes will 
be assessed using the Mann-Whitney U test. 
 
It is anticipated that the data for some subjects will be incomplete for various reasons:  missing daily-diary entries, 
refusal to answer a question on the questionnaire, onset of illness, loss-to-follow-up, etc. All occurrences of 
incomplete data will be investigated to carefully document the reasons for the missing data. If the primary outcome 
(amount of opioid utilization for the first 24 hours after surgery) cannot be ascertained with a reasonable degree 
of certainty, the patient will be excluded from the data analysis. 
 
6.2 Analysis of Endpoints 
Primary Endpoints: 
1. Opioid utilization for the first 24 hours after surgery, including during surgery, calculated as oxycodone 
equivalent. 
 
Secondary Endpoints: 
1. Patient reported NRS scores in PACU and at 24 hours 
2. Patient Reported NRS scores on POD 1 and POD 3 
3. Reaction to surgical subpectoral incision (signs include patient movement, tachycardia, etc.) 
4. Skin assessment of sensation in PACU (axilla, distal to surgical dressing) 
 
Normally distributed data such as the primary outcome variable will be compared using the two-sample t-test. In 
the case that the data are not normally distributed, the Wilcoxon rank-sum test will be used instead. Categorical 
variable will be compared using the Chi-Squares unless other tests such as the Fisher’s exact test are more 
appropriate. 
All endpoints will be evaluated as fits the data set with graphical figures such as scatter plots, box-and-whisker 
plots, and frequency histograms to visualize the distribution of these outcomes and their relationships to covariates 
and treatment assignment. When appropriate descriptive graphical and tabular methods will also be estimated and 
presented in a graphical figure. 
 
6.2.1 
Baseline Descriptive Statistics 
The following patient data will be recorded: age, gender, height, weight, date of admission, date of discharge, 
laterality, surgical approach, implants used, duration of surgery, contamination, ASA, comorbidities (smoking, 
cardiac history, diabetes etc.), and medications. This information will be accessible in the patient’s medical record.  
6.3 Sample Size
80 subjects will be enrolled 
 
Based on published reports (Reynolds et al) and our clinical experience, we estimate that patients in the Pecs group 
will use only 25 mg of oxycodone-equivalent, while patients receiving the infiltration will use 32 mg. Using a 2-
sided, 2-
0.05 and assuming a common SD of 13, a power analysis revealed that 72 
subjects were needed per group for a power of 0.90. We chose to enroll 80 subjects per arm to allow for potential 
dropout and an increased power. 


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6.4
Enrollment/Randomization/Masking Procedures 
We will utilize randomization.com to generate a block randomization assignments for all 160 participants. Someone 
that is not a stakeholder in the study will make randomization envelopes, which include the study ID number, the 
treatment assignment, and dosage specifics. These randomization envelopes will then be distributed to the 
anesthesiologist pre-operatively by the authorized researcher after informed consent is obtained. 
6.5 Breaking the Study Blind/Participant Code 
If there is any adverse event related to the drug, we will break the blind for the subject and randomization will be 
disclosed to the patient. 
7
Assessment of Safety
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the 
course of the study.  Intercurrent illnesses or injuries should be regarded as adverse events.  Abnormal results of 
diagnostic procedures are considered to be adverse events if the abnormality: 
 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 
7.1 Definition of Adverse Events (AE) 
Serious Adverse Event 
Adverse events are 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 are 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. For example, drug overdose or abuse, a seizure that did not result in in-patient 
hospitalization, or intensive treatment of bronchospasm in an emergency department would typically be 
considered serious.  
 
All adverse events that do not meet any of the criteria for serious should be regarded as non-serious adverse 
events.  
7.2 Definition of Unanticipated Problems (UP) 
 
Unanticipated Problems Involving Risk to Subjects or Others 
Any incident, experience, or outcome that meets all of the following criteria:  
 
Unexpected in nature, severity, or frequency (i.e., not described in study-related documents such as the 
IRB-approved protocol or consent form, the investigators brochure, etc) 
 
Related or possibly related to participation in the research (i.e., possibly related means there is a 
reasonable possibility that the incident experience, or outcome may have been caused by the procedures 
involved in the research) 
 
Suggests that the research places subjects or others at greater risk of harm (including physical, 
psychological, economic, or social harm). 


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This definition could include an unanticipated adverse device effect, any serious adverse effect on health or safety 
or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death 
was not previously identified in nature, severity, or degree of incidence in the investigational plan or application 
(including a supplementary plan or application), or any other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of subjects (21 CFR 812.3(s)). 
 
7.3 Classification of an Adverse Event
7.3.1
Severity of Event
For AEs not included in the protocol defined grading system, the following guidelines will be used to describe 
severity. 
 Mild – Events require minimal or no treatment and do not interfere with the participant’s daily activities. 
 Moderate – Events result in a low level of inconvenience or concern with the therapeutic measures. 
Moderate events may cause some interference with functioning. 
 Severe – Events interrupt a participant’s usual daily activity and may require systemic drug therapy or 
other treatment. Severe events are usually potentially life-threatening or incapacitating. 
 
7.3.2 Relationship to Study Agent 
 
The clinician’s assessment of an AE's relationship to study agent (drug, biologic, device) is part of the documentation 
process, but it is not a factor in determining what is or is not reported in the study. If there is any doubt as to whether 
a clinical observation is an AE, the event should be reported. All AEs must have their relationship to study agent 
assessed. In a clinical trial, the study product must always be suspect. To help assess, the following guidelines are 
used. 
 
1. Related – The AE is known to occur with the study agent, there is a reasonable possibility that the study 
agent caused the AE, or there is a temporal relationship between the study agent and event. Reasonable 
possibility means that there is evidence to suggest a causal relationship between the study agent and the AE. 
2. Not Related – There is not a reasonable possibility that the administration of the study agent caused the 
event, there is no temporal relationship between the study agent and event onset, or an alternate etiology 
has been established. 
 
For all collected AEs, the clinician who examines and evaluates the participant will determine the AE’s causality 
based on temporal relationship and his/her clinical judgment. The degree of certainty about causality will be graded 
using the categories below. 
 
1. Definitely Related – There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event, including an abnormal laboratory test result, 
occurs in a plausible time relationship to drug administration and cannot be explained by concurrent 
disease or other drugs or chemicals. The response to withdrawal of the drug (dechallenge) should be 
clinically plausible. The event must be pharmacologically or phenomenologically definitive, with use of a 
satisfactory rechallenge procedure if necessary. 
2. Probably Related – There is evidence to suggest a causal relationship, and the influence of other factors is 
unlikely. The clinical event, including an abnormal laboratory test result, occurs within a reasonable time 
after administration of the drug, is unlikely to be attributed to concurrent disease or other drugs or 
chemicals, and follows a clinically reasonable response on withdrawal (dechallenge). Rechallenge 
information is not required to fulfill this definition. 
3. Possibly Related – There is some evidence to suggest a causal relationship (e.g., the event occurred within a 
reasonable time after administration of the trial medication). However, other factors may have contributed 


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to the event (e.g., the participant’s clinical condition, other concomitant events). Although an AE may rate 
only as “possibly related” soon after discovery, it can be flagged as requiring more information and later be 
upgraded to “probably related” or “definitely related,” as appropriate. 
4. Unlikely to be related – A clinical event, including an abnormal laboratory test result, whose temporal 
relationship to drug administration makes a causal relationship improbable (e.g., the event did not occur 
within a reasonable time after administration of the trial medication) and in which other drugs or 
chemicals or underlying disease provides plausible explanations (e.g., the participant’s clinical condition, 
other concomitant treatments). 
5. Not Related – The AE is completely independent of study drug administration, and/or evidence exists that 
the event is definitely related to another etiology. There must be an alternative, definitive etiology 
documented by the clinician. 
 
7.3.3
Expectedness
The PI, Dr. Furgiuele, will be responsible for determining whether an AE is expected or unexpected. An AE will be 
considered unexpected if the nature, severity, or frequency of the event is not consistent with the risk information 
previously described for the study agent. 
 
7.4 Time Period and Frequency for Event Assessment and Follow-Up 
 
The occurrence of an AE or SAE may come to the attention of study personnel during study visits and interviews 
of a study participant presenting for medical care, or upon review by a study monitor. All AEs including local and 
systemic reactions not meeting the criteria for SAEs will be captured on the appropriate RF. Information to be 
collected includes event description, time of onset, clinician’s assessment of severity, relationship to study 
product (assessed only by those with the training and authority to make a diagnosis), and time of 
resolution/stabilization of the event. All AEs occurring while on study must be documented appropriately 
regardless of relationship. All AEs will be followed to adequate resolution. 
 
Any medical condition that is present at the time that the participant is screened will be considered as baseline 
and not reported as an AE. However, if the study participant’s condition deteriorates at any time during the study, 
it will be recorded as an AE. UPs will be recorded in the data collection system throughout the study. 
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event at each 
level of severity to be performed. AEs characterized as intermittent require documentation of onset and duration 
of each episode. 
 
The PI will record all reportable events with start dates occurring any time after informed consent is obtained 
until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At each study visit, the 
investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome 
information until resolution or stabilization.  
 
All unresolved adverse events should be followed by the investigator until the events are resolved, the subject is 
lost to follow-up, or the adverse event is otherwise explained.  At the last scheduled visit, the investigator should 
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 should notify the study 
sponsor 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.  The sponsor should also be notified if the investigator 
should become aware of the development of cancer or of a congenital anomaly in a subsequently conceived 
offspring of a subject that has participated in this study.  
 


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7.5
Reporting Procedures – Notifying the IRB 
7.5.1 Unanticipated Problem Reporting 
 
Incidents or events that meet the OHRP criteria for UPs require the creation and completion of an UP report form. 
It is the site investigator’s responsibility to report UPs to their IRB. The UP report will include the following 
information: 
 
1.
Protocol identifying information: protocol title and number, PI’s name, and the IRB project number;
2.
A detailed description of the event, incident, experience, or outcome;
3.
An explanation of the basis for determining that the event, incident, experience, or outcome represents 
an UP; 
4.
A description of any changes to the protocol or other corrective actions that have been taken or are 
proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline: 
 
 
UPs that are SAEs will be reported to the IRB within 7 days of the investigator becoming aware of the 
event. 
 
Any other UP will be reported to the IRB within 7 days of the investigator becoming aware of the 
problem. 
 
All UPs should be reported to appropriate institutional officials (as required by an institution’s written 
reporting procedures), the supporting agency head (or designee), and OHRP within 7 days of the IR’s 
receipt of the report of the problem from the investigator. 
7.6 Safety Oversight 
 
It is the responsibility of the Principal Investigator, and co-investigator, David Furgiuele, MD 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. Adverse Events such as development of an allergy to local anesthetic, inadvertent intravascular 
injection of local anesthetic and infection at site of injection will be reviewed every three months. Serious adverse 
events are rare and are unlikely to occur but if a serious adverse event occurs, steps will be taken to address it.  
Study recruitment will cease temporarily while a data safety monitoring team convenes to review the event. 
Medical monitoring will include a regular assessment of the number and type of serious adverse events. 
 
8 Source Documents and Access to Source Data/Documents 
Source data is all information, original records of clinical findings, observations, or other activities in a clinical 
trial necessary for the reconstruction and evaluation of the trial.  Source data are contained in source documents.  
Examples of these original documents, and data records include: hospital records, clinical and office charts, 
laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded 
data from automated instruments, copies or transcriptions certified after verification as being accurate and 
complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records 
kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial. It is 
acceptable to use CRFs as source documents. If this is the case, it should be stated in this section what data will be 
collected on CRFs and what data will be collected from other sources. 
 
The study case report form (CRF) is the primary data collection instrument for the study.  All data requested on 
the CRF must be recorded.  All missing data must be explained.  If a space on the CRF is left blank because the 
procedure was not done or the question was not asked, write “N/D”.  If the item is not applicable to the individual 
case, write “N/A”.  All entries should be printed legibly in black ink.  If any entry error has been made, to correct 


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such an error, draw a single straight line through the incorrect entry and enter the correct data above it.  All such 
changes must be initialed and dated.  DO NOT ERASE OR WHITE OUT ERRORS.  For clarification of illegible or 
uncertain entries, print the clarification above the item, then initial and date it. 
 
Access to study records will be limited to IRB-approved members of the study team. The investigator will permit 
study-related monitoring, audits, and inspections by the IRB/EC, the sponsor, government regulatory bodies, and 
University compliance and quality assurance groups of all study related documents (e.g. source documents, 
regulatory documents, data collection instruments, study data etc.).  The investigator will ensure the capability for 
inspections of applicable study-related facilities (e.g. pharmacy, diagnostic laboratory, etc.). 
 
Participation as an investigator in this study implies acceptance of potential inspection by government regulatory 
authorities and applicable University compliance and quality assurance offices. 
9
Quality Assurance and Quality Control
QC procedures will be implemented beginning with the data entry system and data QC checks that will be run on 
the database will be generated. Any missing data or data anomalies will be communicated to the site(s) for 
clarification/resolution. 
 
Following written SOPs, the monitors will verify that the clinical trial is conducted and data are generated, 
documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory 
requirements (e.g., Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)). 
 
The investigational site will provide direct access to all trial related sites, source data/documents, and reports for 
the purpose of monitoring and auditing by the sponsor, and inspection by local and regulatory authorities. 
 
10 Ethics/Protection of Human Subjects 
10.1 Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with Regulations for the Protection of 
Human Subjects of Research codified in 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, and/or the ICH E6. 
10.2 Institutional Review Board
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to 
the IRB for review and approval. Approval of both the protocol and the consent form must be obtained before any 
participant is enrolled. Any amendment to the protocol will require review and approval by the IRB before the 
changes are implemented to the study. All changes to the consent form will be IRB approved; a determination will 
be made regarding whether previously consented participants need to be re-consented. 
10.3 Participant and Data Confidentiality 
Information about study subjects will be kept confidential and managed according to the requirements of the Health 
Insurance Portability and Accountability Act of 1996 (HIPAA).  Those regulations require a signed subject 
authorization informing the subject of the following:  
 What protected health information (PHI) will be collected from subjects in this study 
 Who will have access to that information and why 
 Who will use or disclose that information  
 The rights of a research subject to revoke their authorization for use of their PHI.  
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, retains the 
ability to use all information collected prior to the revocation of subject authorization.  For subjects that have 
revoked authorization to collect or use PHI, attempts should be made to obtain permission to collect at least vital 
status (i.e. that the subject is alive) at the end of their scheduled study period. 


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Participant confidentiality is strictly held in trust by the participating investigators, their staff, and the sponsor(s) 
and their agents. Therefore, the study protocol, documentation, data, and all other information generated will be 
held in strict confidence. No information concerning the study or the data will be released to any unauthorized third 
party without prior written approval of the sponsor. 
 
The study monitor, other authorized representatives of the sponsor, representatives of the IRB or pharmaceutical 
company supplying study product may inspect all documents and records required to be maintained by the 
investigator, including but not limited to, medical records (office, clinic, or hospital) and pharmacy records for the 
participants in this study. The clinical study site will permit access to such records. 
 
The study participant’s contact information will be securely stored at each clinical site for internal use during the 
study. At the end of the study, all records will continue to be kept in a secure location for as long a period as dictated 
by local IRB and Institutional regulations. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be 
transmitted to and stored at NYU Langone Medical Center. This will not include the participant’s contact or 
identifying information. Rather, individual participants and their research data will be identified by a unique study 
identification number. The study data entry and study management systems used by clinical sites and by NYU 
Langone Medical Center research staff will be secured and password protected. At the end of the study, all study 
databases will be de-identified and archived at the NYU Langone Medical Center. 
 
 
 
11 Data Handling and Record Keeping 
11.1 Data Collection and Management Responsibilities 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site PI. The 
investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation of data. 
Black ink is required to ensure clarity of reproduced copies. When making changes or corrections, cross out the 
original entry with a single line, and initial and date the change. DO NOT ERASE, OVERWRITE, OR USE 
CORRECTION FLUID OR TAPE ON THE ORIGINAL. 
 
Copies of the electronic CRF (eCRF) will be provided for use as source documents and maintained for recording 
data for each participant enrolled in the study. Data reported in the eCRF derived from source documents should 
be consistent with the source documents or the discrepancies should be explained and captured in a progress 
note and maintained in the participant’s official electronic study record. 
 
Clinical data (including AEs, concomitant medications, and expected adverse reactions data) and clinical 
laboratory data will be entered into Redcap. The data system includes password protection and internal quality 
checks, such as automatic range checks, to identify data that appear inconsistent, incomplete, or inaccurate. 
Clinical data will be entered directly from the source documents. 
11.2 Study Records Retention
Study documents will be retained for the longer of 3 years after close-out, 5 years after final 
reporting/publication. 
 


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11.3 Protocol Deviations
A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or Manual of Procedures (MOP) 
requirements. The noncompliance may be either on the part of the participant, the investigator, or the study site 
staff. As a result of deviations, corrective actions are to be developed by the site and implemented promptly. 
 
These practices are consistent with ICH E6: 
1. 4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3 
2. 5.1 Quality Assurance and Quality Control, section 5.1.1 
3. 5.20 Noncompliance, sections 5.20.1, and 5.20.2. 
 
It is the responsibility of the site PI/study staff to use continuous vigilance to identify and report deviations 
within 7 working days of identification of the protocol deviation, or within 7 working days of the scheduled 
protocol-required activity. 
 
Protocol deviations must be reported to the local IRB per their guidelines. The site PI/study staff is responsible 
for knowing and adhering to their IRB requirements. Further details about the handling of protocol deviations 
will be included in the MOP. 
 
11.4 Publication and Data Sharing Policy 
 
The International Committee of Medical Journal Editors (ICMJE) member journals have adopted a clinical trials 
registration policy as a condition for publication. The ICMJE defines a clinical trial as any research project that 
prospectively assigns human subjects to intervention or concurrent comparison or control groups to study the 
cause-and-effect relationship between a medical intervention and a health outcome. Medical interventions 
include drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, and the like. Health 
outcomes include any biomedical or health-related measures obtained in patients or participants, including 
pharmacokinetic measures and adverse events. The ICMJE policy, and the Section 801 of the Food and Drug 
Administration Amendments Act of 2007, requires that all clinical trials be registered in a public trials registry 
such as ClinicalTrials.gov, which is sponsored by the National Library of Medicine. Other biomedical journals are 
considering adopting similar policies. For interventional clinical trials performed under NIH IC grants and 
cooperative agreements, it is the grantee’s responsibility to register the trial in an acceptable registry, so the 
research results may be considered for publication in ICMJE member journals. The ICMJE does not review specific 
studies to determine whether registration is necessary; instead, the committee recommends that researchers who 
have questions about the need to register err on the side of registration or consult the editorial office of the 
journal in which they wish to publish. 
 
FDAAA mandates that a "responsible party" (i.e., the sponsor or designated principal investigator) register and 
report results of certain "applicable clinical trials": 
 
1. Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I investigations of a product 
subject to FDA regulation; 
2. Trials of Devices: Controlled trials with health outcomes of a product subject to FDA regulation (other than 
small feasibility studies) and pediatric postmarket surveillance studies. 
3. NIH grantees must take specific steps to ensure compliance with NIH implementation of FDAAA. 
 
12 Study Finances 
12.1 Funding Source 
There is no funding source available.   


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12.2 Costs to the Participant
There are no expected costs to the subjects.
12.3 Participant Reimbursements or Payments
Participants will not receive any financial compensation for participation in this study.
 
 
13 Conflict of Interest Policy
 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical industry, is 
critical. Therefore, any actual conflict of interest of persons who have a role in the design, conduct, analysis, 
publication, or any aspect of this trial will be disclosed and managed. Furthermore, persons who have a perceived 
conflict of interest will be required to have such conflicts managed in a way that is appropriate to their 
participation in the trial. The study leadership has established policies and procedures for all study group 
members to disclose all conflicts of interest and will establish a mechanism for the management of all reported 
dualities of interest.  
 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or financial gain 
greater than the minimum allowable by their institution, etc.) must have the conflict reviewed by the NYU 
Langone Conflict of Interest Management Unit (CIMU) with a Committee-sanctioned conflict management plan 
that has been reviewed and approved by the study sponsor prior to participation in this study. All NYULMC 
investigators will follow the applicable conflict of interest policies. 
 
 


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14 References
1. Nho SJ, Strauss EJ, Lenart BA, Provencher MT, Mazzocca AD, Verma NN, Romeo AA. Long head of the biceps 
tendinopathy: diagnosis and management. J Am Acad Orthop Surg. 2010 Nov;18(11):645-
56.doi:10.5435/00124635-201011000-00002. PMID: 21041799. 
2. Mazzocca AD, Rios CG, Romeo AA, Arciero RA. Subpectoral biceps tenodesis with interference screw fixation. 
Arthroscopy. 2005 Jul;21(7):896. doi: 10.1016/j.arthro.2005.04.002. PMID: 16012508. 
3. Levy DM, Meyer ZI, Campbell KA, Bach BR Jr. Subpectoral Biceps Tenodesis. Am J Orthop (Belle Mead NJ). 
2016 Feb;45(2):68-74. PMID: 26866316 
4. Reynolds JW, Henshaw DS, Jaffe JD et al. Analgesic benefit of Pectoral Nerve Block II Blockade for Open 
subpectoral biceps tenodesis: A randomized, prospective, double-blinded, controlled trial. Anesthesia 
Analgesia. 2019 26; 129 (2): 538-542 
5. Tran DQ, Elgueta MF, Aliste J, et al Diaphragm-Sparing Nerve Blocks for Shoulder Surgery. Regional Anesthesia 
& Pain Medicine 2017;42:32-38. 
6. Arena C, Dhawan A. Mini-open Subpectoral Biceps Tenodesis Using a Suture Anchor. Arthrosc Tech. 
2017;6(5):e1625-e1631. Published 2017 Sep 18. doi:10.1016/j.eats.2017.06.019 
7.
https://www.nysora.com/regional-anesthesia-for-specific-surgical-procedures/thorax/pectoralis-serratus-
plane-blocks/ accessed Oct 10, 2020 
8.
Blanco R. The ‘pecs block’: a novel technique for providing analgesia after breast surgery. Anesthesia. 2011; 
66:847-848 
9. Blanco R, Farjardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel 
approach to breast surgery. Rev Esp Anestesiol Reanim. 2012;59:470-475 
 
15 Attachments 
These documents are relevant to the protocol, but they are not considered part of the protocol.  They are stored 
and modified separately. As such, modifications to these documents do not require protocol amendments. 
15.1 OPIOID EQUIVALENTS  
 
Notes from Lamplot (2013) 
 
OPIOID AND ROUTE
DOSE (MG) 
CONVERSION FACTOR
MORPHINE IM/IV
10
1.0 
HYDROMORPHONE IM/IV
1.67
6.0 
HYDROCODONE ORAL 
30
0.3 
TRAMADOL ORAL
100
0.1
OXYCODONE ORAL 
20
0.5 
VICODIN 5/500
6 tabs 
1.7 
 
 
 
 
 
 
 
 
 
 
Opioid
Oral Equianalgesic Dose (mg)


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Buprenorphine
0.3
Oxymorphone
1.5
Butorphanol
2
Hydromorphone 
2
Oxycodone
7
Hydrocodone
10
Morphine
10
Methadone
10-20
Tramadol 
40 
Propoxyphene 
43-45
Codeine
80 
Meperidine
100 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
16.2: Baseline Assessment


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1.
Medication Usage Record
Thank you for participating in our research study and helping us improve pain control for 
patients undergoing Open Subpectoral Biceps Tenodesis. 


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Patient: ______________________
Pain medication:  Percocet 
Please record the following information in the log below: 
1. Time when you take your pain medication 
2. How many pills you took at each time 
3. Pain score on a scale of 0-10 (0 being no pain and 10 being the worst pain imaginable)
4. Any additional pain medications (such as Advil), therapies (such as ice packs) and side 
effects (such as itching or nausea). 
 
Time
Number of pills of 
Percocet
Pain Score 
(scale of 0-10)
Additional pain medications, 
therapy or side effects 
 
 
 
 
 
 
 
What was your pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain) 24 
hours after the end of surgery, i.e., on ______________ at ________ ? 
 
 
1.
McGill Pain Scale 
 


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