Clinical trial NCT03636542
Conditions: Phrenic Nerve Paralysis
Sponsor: University of Minnesota
Start date: 2018-08-01; Completion date: 2020-06-03
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the movement of the diaphragm after an interscalene block with liposome bupivacaine (LB) compared to interscalene block (IB) with bupivacaine. This study will evaluate if there is a possible prolonged phrenic nerve paralysis when using liposome bupivacaine in an interscalene block, using ultrasound.

Detailed description:
This study will be run concurrently with two other studies comparing bupivacaine to Liposomal Bupivacaine in shoulder surgeries. We will use already randomized patients for our randomization process. For this study in particular we will use an ultrasound machine to scan the diaphragm of any patient who had an Interscalene Block for Total Shoulder Arthroplasy or Rotator Cuff Repair. Patients are to be scanned in an upright sitting position and scanned from a low intercostal or subcostal approach using the liver or spleen as an acoustic window. M Mode will be applied and the range of diaphragmatic movement from the resting expiratory position to deep inspiration (sigh test) will be recorded as was the range of diaphragmatic movement from resting expiratory position when quickly inspiring through the nose (sniff test). The blocks will be done regardless of the study as they are standard of care for pain control. The only intervention is ultrasound examination of the patient's diaphragm at baseline, 3 hours post block in recovery room and on post-operative day 1, and basic spirometry to record FEV1 and FVC via a portable spirometer at the same time points. If patients did stay in hospital on postoperative day 2 we would also evaluate their diaphragm function.

Arms: arm 1: These patients receive an interscalene block with liposomal bupivacaine. arm 2: These patients receive an interscalene block with bupivacaine.
Interventions: intervention 1: liposomal bupivacaine intervention 2: bupivacaine
Intervention descriptions: intervention 1: Experimental intervention 2: Active comparator

Protocol documents:
Prot_SAP_000.pdf: 
PROTOCOL TITLE: Evaluation of diaphragm movement after an Interscalene block 
VERSION DATE: 3 5/9/2019 
 
Page 1 of 14 
Revised: 1/19/2018 
 
 
 


PROTOCOL TITLE: Evaluation of diaphragm movement after an Interscalene block 
VERSION DATE: 3 5/9/2019 
 
Page 2 of 14 
Revised: 1/19/2018 
Protocol Title 
Evaluation of diaphragm movement after an Interscalene block 
Principal 
Investigator/Faculty 
Advisor 
Name: Jason Habeck 
Department: Anesthesiology 
Telephone Number: 612-624-9990 
Email Address: habe0073@umn.edu 
Student 
Investigator 
Name: 
Current Academic Status (Student, Fellow, Resident): 
  
Department: 
Telephone Number: 
Institutional Email Address: 
Scientific 
Assessment 
 
IND/IDE # (if 
applicable) 
n/a 
IND/IDE Holder 
n/a 
Investigational Drug 
Services # (if 
applicable) 
n/a 
Version 
Number/Date: 
3 5/9/2019 
 
PROTOCOL COVER PAGE 
 
 
 
 


PROTOCOL TITLE: Evaluation of diaphragm movement after an Interscalene block 
VERSION DATE: 3 5/9/2019 
 
Page 3 of 14 
Revised: 1/19/2018 
 
REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
3 
5/9/19 
Adjusted inclusion criteria to 
include those who are not enrolled 
in the TSA study.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


PROTOCOL TITLE: Evaluation of diaphragm movement after an Interscalene block 
VERSION DATE: 3 5/9/2019 
 
Page 4 of 14 
Revised: 1/19/2018 
1.0 
Table of Contents 
 
1.0 
Objectives 
7 
2.0 
Background 
7 
3.0 
Study Endpoints/Events/Outcomes 
7 
4.0 
Study Intervention(s)/Investigational Agent(s) 
7 
5.0 
Procedures Involved 
8 
6.0 
Data and Specimen Banking 
9 
7.0 
Sharing of Results with Participants 
9 
8.0 
Study Population 
10 
9.0 
Vulnerable Populations 
10 
10.0 Local Number of Participants 
11 
11.0 Local Recruitment Methods 
11 
12.0 Withdrawal of Participants 
13 
13.0 Risks to Participants 
13 
14.0 Potential Benefits to Participants 
13 
15.0 Statistical Considerations 
13 
16.0 Confidentiality 
14 
17.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
14 
18.0 Provisions to Protect the Privacy Interests of Participants 
15 
19.0 Compensation for Research-Related Injury 
15 
20.0 Consent Process 
16 
21.0 Setting 
19 
22.0 Multi-Site Research 
19 
23.0 Resources Available 
20 
24.0 References 
21 
 


PROTOCOL TITLE: Evaluation of diaphragm movement after an Interscalene block 
VERSION DATE: 3 5/9/2019 
 
Page 5 of 14 
Revised: 1/19/2018 
ABBREVIATIONS/DEFINITIONS 
● LB liposome bupivacaine 
● ISB interscalene block 
● TSA total shoulder arthroplasty 
● RCR rotator cuff surgery 
 
 
 


PROTOCOL TITLE: Evaluation of diaphragm movement after an Interscalene block 
VERSION DATE: 3 5/9/2019 
 
Page 6 of 14 
Revised: 1/19/2018 
2.0 
Objectives 
2.1 Purpose: To evaluate the movement of the diaphragm after an interscalene 
block with liposome bupivacaine (LB) compared to interscalene block (IB) 
with bupivacaine.  This study will evaluate if there is a possible prolonged 
phrenic nerve paralysis when using liposome bupivacaine in an interscalene 
block, using ultrasound.  
3.0 
Background 
3.1 Significance of Research Question/Purpose: To date there is no previous 
study looking at diaphragm movement after an Liposomal Bupivacaine 
Interscalene Block.  It is important to see how long the phrenic nerve is 
affected by this block if at all.   
3.2 Preliminary Data: We have not routinely examined that patient’s diaphragm 
via ultrasound after ISB at M Health.   Patients have not been readmitted 
for breathing problems with our current practice.  
3.3 Existing Literature: There is no previous literature in LB ISB.  Urmey et al. 
showed 100% phrenic nerve block post ISB. But others (Renes et al) have 
evaluated it using bupivacaine and found that lower doses resulted in less 
diaphragm blockade. Cuvillon showed that those with a catheter had 66% 
phrenic nerve paralysis at 24 hours.  
4.0 
Study Endpoints/Events/Outcomes 
4.1 Primary Endpoint/Event/Outcome: The primary study endpoint will be 
diaphragm excursion (movement in cm) from rest to sigh in a sitting 
position.  
4.2 Secondary Endpoint(s)/Event(s)/Outcome(s): The secondary endpoint will 
be the diaphragm excursion (movement in cm) from rest to a quick 
inspiratory breath.  
4.3 Secondary Endpoint(s)/Event(s)/Outcome(s): Evaluation of baseline FEV1, 
FVC (or FEV6) and FEV1/FVC ratio via spirometry. 
5.0 
Study Intervention(s)/Investigational Agent(s) 
5.1 Description: This study will be run concurrently with two other studies 
comparing bupivacaine to Liposomal Bupivacaine in shoulder surgeries. We 
will either use already randomized patients for our randomization process or 
if they are not enrolled in either RCR or TSA study we will randomize them 
to one of the two groups. For this study in particular we will use an 
ultrasound machine to scan the diaphragm of any patient who had an 
Interscalene Block for Total Shoulder Arthroplasy or Rotator Cuff Repair. 
Patients are to be scanned in an upright sitting position and scanned from a 
low intercostal or subcostal approach using the liver or spleen as an acoustic 
window. M Mode will be applied and the range of diaphragmatic movement 
from the resting expiratory position to deep inspiration (sigh test) will be 


PROTOCOL TITLE: Evaluation of diaphragm movement after an Interscalene block 
VERSION DATE: 3 5/9/2019 
 
Page 7 of 14 
Revised: 1/19/2018 
recorded as was the range of diaphragmatic movement from resting 
expiratory position when quickly inspiring through the nose (sniff test). The 
blocks will be done regardless of the study as they are standard of care for 
pain control.  The only intervention is ultrasound examination of the 
patient’s diaphragm at baseline, 3 hours post block in recovery room and on 
post-operative day 1, and basic spirometry to record FEV1 and FVC via a 
portable spirometer at the same time points.  If patients did stay in hospital 
on postoperative day 2 we would also evaluate their diaphragm function.   
5.2 Drug/Device Handling: n/a 
5.3 Biosafety: n/a  
5.4 Stem Cells: n/a 
 
6.0 
Procedures Involved 
6.1 Study Design: This is a prospective  study 
Study Procedures: All patients who are enrolled in our TSA or RCR studys fit the criteria 
of being scheduled for overnight shoulder surgery and having an ISB with or without LB. 
The patients will already be randomized into either an ISB with bupivacaine or with 
bupivacaine and LB. If the patient is not enrolled or does not fit inclusion criteria for the 
RCR or TSA study they will then be randomized to either bupivacaine or liposome 
bupivacaine ISB.  The patients will perform spirometry (one large exhale into a 
spirometer) and have an ultrasound examination of their diaphragm at baseline prior to 
the block, in PACU after their procedure, and on postoperative day 1 (24 hours after 
ISB).  Diaphragmatic movement will be evaluated by real-time M-mode ultrasonography 
of the hemidiaphragm using a 17-mm 1- to 5-MHz broadband phased array US probe. 
Patients are to be scanned in an upright sitting position and scanned from a low 
intercostal or subcostal approach using the liver or spleen as an acoustic window. M 
Mode will be applied and the range of diaphragmatic movement from the resting 
expiratory position to deep inspiration (sigh test) will be recorded as well as the range of 
diaphragmatic movement from resting expiratory position when quickly inspiring 
through the nose (sniff test). This will occur three times, at baseline prior to surgery, in 
the recovery room, and on the ward on postoperative day 1. All nerve blocks will be 
confirmed to be functional via a sensory skin test prior to surgery or in the recovery room 
prior to the recovery room evaluation. 
6.2 Study Duration: The patients will be in the study for 2 days.  The duration of 
the study should be 3 months to enroll the 22 patients.  
6.3 Individually Identifiable Health Information: PHI will be recorded but once 
data collection is done then the phi will be removed and replaced with 
unique identifier.  This is just to ensure we see the correct patient for the 
data collection.   
6.4 Use of radiation: n/a  
6.5 Use of Center for Magnetic Resonance Research: n/a  
7.0 
Data and Specimen Banking 


PROTOCOL TITLE: Evaluation of diaphragm movement after an Interscalene block 
VERSION DATE: 3 5/9/2019 
 
Page 8 of 14 
Revised: 1/19/2018 
7.1 Storage and Access: the data will be kept in the University box.  Data is kept 
for 7 years.   
7.2 Data: The data kept will be patient demographics such as weight, BMI, age, 
sex.  Also, block medications and volume used, time of injection, surgical 
procedure, range of diaphragm movement at baseline, in recovery room, and 
on postoperative day 1 and spirometry at baseline, in recovery and 
postoperative day 1.  
7.3 Release/Sharing: data will be kept with the PI and co-I 
8.0 
Sharing of Results with Participants 
8.1    No results will be shared with participants.  
9.0 
Study Population 
9.1 Inclusion Criteria: All patients age 18 years and older who are scheduled for  
shoulder surgery with interscalene block and remain in the hospital for more 
than 24 hours that are being randomized into a bupivacaine versus LB ISB 
block study or those who are not enrolled in the TSA or RCR study but are 
having shoulder surgery with ISB and planned to spend one night in the 
hospital.   
9.2 Exclusion Criteria: Non-English speaking patients.  
9.3 Screening: On the week to day prior to surgery patients will be identified 
from surgical case list.  Then prior to or on day of surgery patients will be 
asked to participate in the study and given enough time to decide to 
participate and ask questions.  
10.0 Vulnerable Populations 
10.1 Vulnerable Populations:  
☐ Children 
☐ Pregnant women/Fetuses/Neonates 
☐ Prisoners 
☐ Adults lacking capacity to consent and/or adults with diminished capacity 
to consent, including, but not limited to, those with acute medical 
conditions, psychiatric disorders, neurologic disorders, developmental 
disorders, and behavioral disorders 
☐ Approached for participation in research during a stressful situation such 
as emergency room setting, childbirth (labor), etc. 
☐ Disadvantaged in the distribution of social goods and services such as 
income, housing, or healthcare 
☐ Serious health condition for which there are no satisfactory standard 
treatments 


PROTOCOL TITLE: Evaluation of diaphragm movement after an Interscalene block 
VERSION DATE: 3 5/9/2019 
 
Page 9 of 14 
Revised: 1/19/2018 
☐ Fear of negative consequences for not participating in the research (e.g. 
institutionalization, deportation, disclosure of stigmatizing behavior) 
☐ Any other circumstance/dynamic that could increase vulnerability to 
coercion or exploitation that might influence consent to research or 
decision to continue in research 
☐ Undervalued or disenfranchised social group 
☐ Members of the military 
☐ Non-English speakers 
☐ Those unable to read (illiterate) 
☐ Employees of the researcher 
☐ Students of the researcher 
x None of the above 
10.2 Additional Safeguards:  
11.0 Local Number of Participants 
11.1 Local Number of Participants to be Consented: 40 patients consented with 
goal of 22 patients enrolled in the study 
12.0 Local Recruitment Methods 
12.1 Recruitment Process: No recruitment posters.  Only recruit from surgical 
lists. Patients will be recruited from the group of adult surgical patients at 
the University of Minnesota undergoing shoulder surgery and receiving an 
interscalene block scheduled for overnight stay that elected to participate in 
another ISB bupivacaine versus LB shoulder study. Patients will be 
approached at the preoperative assessment clinic or surgeon’s clinic at the 
Clinic and Surgery Center if possible by a research staff member to 
determine their interest in participation.  If they decide to be a participant 
they will be consented and given a copy of their consent form for their 
records and a consent will be scanned and placed into EPIC.   These patients 
will have significant time to review the study with research staff as well as 
the physicians performing the procedure due to the fact they arrive several 
hours prior to their scheduled surgery.  All subjects will have enough time to 
ask questions about the study and the potential risks involved regardless of 
which venue they are consented. 
12.2 Identification of Potential Participants: Patients will be identified by 
members of the treatment team in either the surgeon’s clinic, pre-assessment 
clinic, or preoperative area. Patients who have opted out of research will not 
be asked to participate in the study. Patients will be approached to consent 
for the study by a surgeon, anesthesiologist, or member of the research 
team. Patients who agree to participate in the study will sign both a study 


PROTOCOL TITLE: Evaluation of diaphragm movement after an Interscalene block 
VERSION DATE: 3 5/9/2019 
 
Page 10 of 14 
Revised: 1/19/2018 
consent and HIPAA authorization allowing the use of specified information 
contained in medical records for research purposes. 
12.3 Recruitment Materials: n/a 
12.4 Payment: n/a 
13.0 Withdrawal of Participants 
13.1 Withdrawal Circumstances: Subjects who have consented prior to the day of 
surgery and for some reason choose not to participate will be withdrawn and 
a notation will be made in the study records and these people will be 
considered screen failures.  The surgeon may choose to withdraw the patient 
from the study prior to surgery for  any medical reason or if they suffer a 
major life threatening  adverse event. 
13.2 Withdrawal Procedures: If the patient is withdrawn from study prior to the 
procedure, they will be noted in study records as screen failures. If they 
undergo the procedure and they decide they no longer want to be a part of 
the study or withdrawn by the physician, they will be withdrawn and no 
further data will be collected.  This will also be noted in the study 
documentation. 
13.3 Termination Procedures: If the study is terminated for any reason, or there 
is more than 5 % major adverse events the data that is already collected will 
be stored in a secure location only accessible to research personnel on this 
study. No further data will be collected if the study is terminated.  Risks to 
Participants 
13.4 Foreseeable Risks: There is a risk of loss of privacy as well as 
inconvenience the patient as we will ultrasound them prior to and after 
surgery. Otherwise this is a minimal risk study 
13.5 Reproduction Risks: n/a 
13.6 Risks to Others: n/a 
14.0 Potential Benefits to Participants 
14.1 Potential Benefits: There are no potential benefits to the patient from this 
study.  
15.0 Statistical Considerations 
15.1 Data Analysis Plan: We will use the average of the three US exams for each 
timed measurement as the definitive measurement.  We will also use FEV1, 
FVC (or FEV6) and FEV1/FVC (or FEV6) ratio for each time period as a 
secondary measurement. This data will be be given to the statistician who 
will compare those in the LB ISB group to the bupivacaine ISB group to 
evaluate for differences (if any) between the movement of the diaphragms in 
each group.  


PROTOCOL TITLE: Evaluation of diaphragm movement after an Interscalene block 
VERSION DATE: 3 5/9/2019 
 
Page 11 of 14 
Revised: 1/19/2018 
15.2 Power Analysis: We assumed a 5% rate of block at 24 hours in bupivacaine 
and a 66% block for liposome bupivacaine.  With an alpha of 0.05 and 
power of 80% we determined we need 9 patients in each group.  Assuming 
we would have 20% patients drop out, screen fail, or discharge early we 
planned to enroll 11 per group for total of 22 patients.  
15.3 Statistical Analysis: This study will be analyzed by our staff biostatistician.  
The data will be de-identified and shared with him in box.  The statistician 
will be provided the protocol so they are able to analyze for primary and 
secondary objectives. 
15.4 Data Integrity: All patients will be assigned a unique patient identifier. The 
data that will be sent to the statistician will be de-identified.   
16.0 Confidentiality 
16.1 Data Security: All paper documents and consent forms will be stored in a 
locked cabinet in the anesthesia research office in B573 Mayo. All study 
data will be stored electronically in Box and only the PI and members of the 
research team will have access to the data. 
17.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
17.1 Data Integrity Monitoring.  
The PI, co-investigators, and research assistants will all have access to the study data 
stored in the University’s Box storage system. All the research assistants have 
experience collecting pain scores and other relevant study information. The PI of 
the study will periodically review the study data to ensure accuracy and 
completeness of study data. 
1.1 
Data Safety Monitoring. The Department of Anesthesiology has 
established a Data and Safety Monitoring Committee consisting of several staff 
anesthesiologists which include persons who are board certified as pain 
specialists. Data will be transmitted in box to persons on the board on a monthly 
basis for review.  If there are patterns of adverse events, the board will meet as 
needed and provide recommendations. 
All safety data will be collected on a case report form and transferred into an 
excel spreadsheet that will be stored in box. Also, all phone call data will be 
collected on a case report form and transferred into excel in box.  
All data will be collected by research assistants on a daily basis.  Subjects are 
monitored at several intervals on day of surgery and daily . 
The data will be reviewed on a regular basis (weekly) by the PI and research 
staff.  If there are consistent complications noted a meeting will be convened by 
the DSMB for recommendations. 
The statistical tests for analyzing the safety data to determine whether harm is 
occurring. 


PROTOCOL TITLE: Evaluation of diaphragm movement after an Interscalene block 
VERSION DATE: 3 5/9/2019 
 
Page 12 of 14 
Revised: 1/19/2018 
The statistician uses R or SAS for analysis.  Most likely a regression analysis will 
be performed to see which event is most likely the contributor for the 
complications.  Also a chi-square analysis can be performed.  All is very 
dependent on data variability. 
A fatal or serious adverse event that is attributable to either the delivery or the 
study medication itself. 
Provisions to Protect the Privacy Interests of Participants 
Protecting Privacy: Patients will be asked if this is a good time to have the 
ultrasound study. .  All patients will have the right to refuse when contacted.  
Access to Participants: All patients are required to sign a consent that states their 
privacy of the data being collected.  In addition, they are required to sign a 
HIPAA consent that further describes the data being collected.  It also describes 
that all data is de-identified and stored in a secure database.  They will be 
informed that data is stored and reviewed in box which is HIPAA compliant and 
that only study personnel have access.  Patients are part of the PI and co I job at 
the University.   
 
18.0 Compensation for Research-Related Injury 
Compensation for Research-Related Injury: In the event that this research activity 
results in an injury, treatment will be available, including first aid, emergency 
treatment and follow-up care as needed. Care for such injuries will be billed in the 
ordinary manner, to the patient and/or insurance company.  
 
18.1 Contract Language: n/a 
19.0 Consent Process 
19.1 Consent Process (when consent will be obtained):  
Patients will be identified in the pre-operative time period by the block 
anesthesiologist or research team and if possible will be consented by the 
research coordinator or research assistant.   If patients have more questions 
and do not want to sign at their clinic will be asked if it is allowable for a 
study staff member to contact them prior to surgery via phone to clarify if 
they have any questions.  On the day of surgery, if the patient has not 
already signed consent and is still interested in participating in the study 
will be presented with consent and Health and Insurance Portability and 
Accountability Act (HIPAA) forms.  The patient will review the forms with 
the research staff, or anesthesiologist.  Subjects will be reminded that 
participation is completely voluntary, and that they may stop participation 
at any time without question or penalty.  The research staff or 
anesthesiologist will answer any questions that the subjects may have 


PROTOCOL TITLE: Evaluation of diaphragm movement after an Interscalene block 
VERSION DATE: 3 5/9/2019 
 
Page 13 of 14 
Revised: 1/19/2018 
about the study.  If the patient decides to participate, they will be asked to 
sign the consent and HIPAA forms.  One copy will be saved for study 
records, and the subject will be provided with a copy of the forms for their 
own records. Waiver or Alteration of Consent Process (when consent will 
not be obtained):  
Non-English Speaking Participants: n/a. 
19.2 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 
years of age): 
● 
n/a 
19.3 Cognitively Impaired Adults, or adults with fluctuating or diminished 
capacity to consent: 
● 
n/a 
19.4 Adults Unable to Consent: 
● 
Permission: n/a 
● 
Assent: n/a 
● 
Dissent: n/a  
20.0 Setting 
1.2 Research Sites: Patients will be consented in the surgeon’s clinic or pre 
assessment clinic.  The surgical procedures will take place at the Fairview 
riverside campus.   
20.1 International Research: n/a 
21.0 Multi-Site Research 
● 
n/a 
22.0 Resources Available 
23.0 Resources Available: Research assistants are available to aid in consent and data 
acquisition. All research assistants will be familiar with the study protocol and have 
experience working with similar studies. 
  
We plan to enroll 22 subjects.  The plan is to screen 40 subjects to research this target 
population.  This center performs approximately 500 shoulder procedures 
annually. 
We plan to conduct this study over 3 months.  Enrollment and data collection will be 
completed at this time.  Statistical Analysis will take approximately two months 
to complete. 
 All procedures will be performed in the clinical facilities at the MHealth Clinics and 
Surgery Center and at the West and East Bank. Data storage and analysis will be 
done using desktop equipment which is available at the Research Office B573 
Mayo. 


PROTOCOL TITLE: Evaluation of diaphragm movement after an Interscalene block 
VERSION DATE: 3 5/9/2019 
 
Page 14 of 14 
Revised: 1/19/2018 
23.1 References 
Renes et al. Ultrasound guided low dose interscalene brachial plexus block 
reduces the incidence of hemidiaphragmatic paresis.  Reg Anesth Pain Med. 
2009;34:498-502 
Urmey WF, talts Kh, Sharrock Ne: one hundred percent incidence of 
hemidiaphragmatic paresis associated with interscalene brachial plexus 
anesthesia as diagnosed by ultrasonography. Anesth Analg 1991; 72:498–3 

ICF_001.pdf: 
Approved for use by UMN IRB
Effective on 5/17/2019
IRB Study Number: STUDY00003353
Consent Form
Page 1 of 6   
Version Date: 3 5/9/2019
Title of Research Study: Evaluation of diaphragm movement after an 
Interscalene block
Investigator Team Contact Information: Dr. Jason Habeck
For questions about research appointments, the research study, research results, or other 
concerns, call the study team at: 
Investigator Name: Dr. Jason Habeck
Investigator Departmental Affiliation: 
Anesthesiology
Phone Number: 612-624-9990
Email Address: habe0073@umn.edu
Study Staff: Melissa Cohen, Jason Hall, Ryan 
Eskuri, Ken Kiberenge
Phone Number: 612-625-7116
Email Address: cohen045@umn.edu
Supported By: This research is not supported by any company.  
Financial Interest Disclosure:  The primary investigator does not have any financial interest. 


Approved for use by UMN IRB
Effective on 5/17/2019
IRB Study Number: STUDY00003353
Consent Form
Page 2 of 6   
Version Date: 3 5/9/2019
Key Information About This Research Study
The following is a short summary to help you decide whether or not to be a part of this research study. 
More detailed information is listed later on in this form. 
What is research?
Doctors and investigators are committed to your care and safety. There are important differences 
between research and treatment plans:
●
The goal of research is to learn new things in order to help groups of people in the future. 
Investigators learn things by following the same plan with a number of participants, so they do 
not usually make changes to the plan for individual research participants. You, as an individual, 
may or may not be helped by volunteering for a research study.  
●
The goal of clinical care is to help you get better or to improve your quality of life. Doctors can 
make changes to your clinical care plan as needed.
Your doctor, who is also responsible for this research study, is interested in both your clinical care and 
the conduct of this research study. You have the right to discuss this study with another person who is 
not part of the research team before deciding whether to participate in the research.
Why am I being asked to take part in this research study?
We are asking you to take part in this research study because you are receiving an interscalene block 
with liposome bupivacaine for shoulder surgery. 
What should I know about a research study?
●
Someone will explain this research study to you.
●
Whether or not you take part is up to you.
●
You can choose not to take part.
●
You can agree to take part and later change your mind.
●
Your decision will not be held against you.
●
You can ask all the questions you want before you decide.
Why is this research being done?
The purpose of this study is to evaluate the movement of the diaphragm after an interscalene block with 
liposome bupivacaine.  The diaphragm is a muscle that helps your lung function normally when you 
breath.  Sometimes when we perform a nerve block (interscalene block) to numb your shoulder the 
nerve that controls the diaphragm(the phrenic nerve) is affected.  We want to see if there is prolonged 
phrenic nerve paralysis when using liposome bupivacaine in an interscalene block.   Liposomal 
bupivacaine is a long acting anesthetic. It is liposome encapsulated bupivacaine which allows for 
prolonged release of bupivacaine over a 72-hour period. Currently it is the standard of care to use this 
medication in an interscalene block at the University of Minnesota. However, it’s effects on diaphragm 
function has not been adequately evaluated. Thus we want to see if a long acting numbing agent has a 
longer effect on blocking the nerve for the muscle of the diaphragm. 
How long will the research last?
We expect that you will be in this research study for 2 days following shoulder surgery. However, we will 


Approved for use by UMN IRB
Effective on 5/17/2019
IRB Study Number: STUDY00003353
Consent Form
Page 3 of 6   
Version Date: 3 5/9/2019
continue to monitor your chart for adverse events up to 30 days post-procedure.
What will I need to do to participate?
You will be asked to consent to all for a staff member to ultrasound your diaphragm and perform 
spirometry. There will be a baseline evaluation prior to your nerve block, there will be an evaluation 
while you are in the recovery room, and another evaluation on the first postoperative day while on the 
hospital ward.  
More detailed information about the study procedures can be found under “What happens if I say yes, I 
want to be in this research?”
Is there any way that being in this study could be bad for me?
You risk having your day interrupted by the anesthesia team to perform the ultrasound evaluation. 
There is also a risk of loss of privacy if you participate in this study.
Will being in this study help me in any way?
We cannot promise any benefits to you or others from your taking part in this research. 
What happens if I do not want to be in this research?
You do not have to participate in this research. Choosing not to be in this study or to stop being in this 
study will not result in any penalty to you or loss of benefit to which you are entitled. This means that 
your choice not to be in this study will not negatively affect your right to any present or future medical 
care.
 If you choose not to participate you would still receive the interscalene block as is the standard of care 
for patients undergoing shoulder surgery.
Detailed Information About This Research Study
The following is more detailed information about this study in addition to the information listed above.
How many people will be studied?
We expect 40 patients will be enrolled in this research study.
What happens if I say “Yes, I want to be in this research”?
If you choose to take part in this research you will consent for allowing your diaphragm (a muscle that 
supports lung function during breathing) to be ultrasounded (evaluated with a machine that looks inside 
your body). All patients who have had an interscalene block (nerve block that numbs your shoulder) 
with bupivacaine or liposome bupivacaine (a long acting numbing agent) are eligible.  You will perform 
spirometry (a breathing exercise through a machine) and have an ultrasound examination of your 
diaphragm at baseline,  in the recovery room and on postoperative day 1 (24 hours after interscalene 
block).  Diaphragmatic movement will be evaluated and to be examined in an upright sitting position 
and scanned on your side.  The range of diaphragmatic movement from the resting expiratory position 
to deep inspiration (sigh test) will be recorded as well as the range of diaphragmatic movement from 
resting expiratory position when quickly inhaling through the nose (sniff test). This will occur three 
times.  At baseline prior to surgery, in the recovery room, and on the ward on postoperative day 1.


Approved for use by UMN IRB
Effective on 5/17/2019
IRB Study Number: STUDY00003353
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What are my responsibilities if I take part in this research?
You will be responsible for taking a sigh breath and a sniff type breath for the ultrasound examination 
and once for spirometry. 
What happens if I say “Yes”, but I change my mind later?
You can leave the research study at any time and your care will not be affected by your decision.  
Choosing not to be in this study or to stop being in this study will not result in any penalty to you or loss 
of benefit to which you are entitled. This means that your choice not to be in this study will not 
negatively affect your right to any present or future medical care.
If you stop being in the research, information about you that has already been collected may not be 
removed from the study database. You will be asked whether the investigator can collect information 
from your routine medical care, such as your medical records. If you agree, this information will be 
handled the same as the information obtained for the research study. 
What are the risks of being in this study?  Is there any way being in this study could be 
bad for me? (Detailed Risks)
You risk having your day interrupted by the anesthesia team to perform the ultrasound evaluation. There 
is also a risk of loss of privacy if you participate in this study.
What do I need to know about reproductive health and/or sexual activity if I am in this 
study?  
The ultrasound should have no effect on your reproductive health or sexual activity.  
Will it cost me anything to participate in this research study?
You will not be billed for the use of ultrasound to evaluate your diaphragm function or the spirometry, 
therefore there are no extra cost to the you for your participation. 
What happens to the information collected for the research?
Efforts will be made to limit the use and disclosure of your personal information, including research 
study and medical records, to people who have a need to review this information. We cannot guarantee 
complete confidentiality. Organizations that may inspect and copy your information include the 
Institutional Review Board (IRB), the committee that provides ethical and regulatory oversight of 
research, and other representatives of this institution, including those that have responsibilities for 
monitoring or ensuring compliance. 
The sponsor, monitors, auditors, the IRB, the University of Minnesota Research Compliance Office and 
other University compliance units, the US Office of Research Integrity (ORI), the US Office for the 
Protection of Human Research Protections (OHRP), the US Food and Drug Administration (FDA) may be 
granted direct access to your medical records to conduct and oversee the research. By signing this 
document you are authorizing this access. We may publish the results of this research. However, we will 
keep your name and other identifying information confidential.


Approved for use by UMN IRB
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A description of this clinical trial will be available at http://www.ClinicalTrials.gov, as required by U.S. 
Law. This Web site will not include information that can identify you. At most, the Web site will include a 
summary of the results. You can search this Web site at any time.
Will anyone besides the study team be at my consent meeting?  
You may be asked by the study team for your permission for an auditor to observe your consent 
meeting. Observing the consent meeting is one way that the University of Minnesota makes sure that 
your rights as a research participant are protected. The auditor is there to observe the consent meeting, 
which will be carried out by the people on the study team. The auditor will not document any personal 
(e.g. name, date of birth) or confidential information about you. The auditor will not observe your 
consent meeting without your permission ahead of time.   
Whom do I contact if I have questions, concerns or feedback about my experience?
This research has been reviewed and approved by an IRB within the Human Research Protections 
Program (HRPP). To share feedback privately with the HRPP about your research experience, call the 
Research Participants’ Advocate Line at 612-625-1650 or go to 
https://research.umn.edu/units/hrpp/research-participants/questions-concerns. You are encouraged to 
contact the HRPP if: 
●
Your questions, concerns, or complaints are not being answered by the research team.
●
You cannot reach the research team.
●
You want to talk to someone besides the research team.
●
You have questions about your rights as a research participant.
●
You want to get information or provide input about this research.
Will I have a chance to provide feedback after the study is over? 
The HRPP may ask you to complete a survey that asks about your experience as a research participant. 
You do not have to complete the survey if you do not want to. If you do choose to complete the survey, 
your responses will be anonymous.  
If you are not asked to complete a survey, but you would like to share feedback, please contact the 
study team or the HRPP. See the “Investigator Contact Information” of this form for study team contact 
information and “Whom do I contact if I have questions, concerns or feedback about my experience?” of 
this form for HRPP contact information.
Can I be removed from the research?
The person in charge of the research study or the sponsor can remove you from the research study 
without your approval. We will tell you about any new information that may affect your health, welfare, 
or choice to stay in the research.
What happens if I am injured while participating in this research?
In the event that this research activity results in an injury, treatment will be available, including first aid, 
emergency treatment and follow-up care as needed.  Care for such injuries will be billed in the ordinary 
manner, to you or your insurance company.  If you think that you have suffered a research related injury 
let the study physicians know right away.  


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Will I be compensated for my participation? 
No compensation will be provided for participation in this study.
Use of Identifiable Health Information
We are committed to respect your privacy and to keep your personal information confidential.  When 
choosing to take part in this study, you are giving us the permission to use your personal health 
information that includes health information in your medical records and information that can identify 
you. For example, personal health information may include your name, address, phone number or social 
security number. Those persons who get your health information may not be required by Federal 
privacy laws (such as the 1099 Rule) to protect it. Some of those persons may be able to share your 
information with others without your separate permission. Please read the HIPAA Authorization form 
that we have provided and discussed. 
The results of this study may also be used for teaching, publications, or for presentation at scientific 
meetings.  
Your signature documents your permission to take part in this research.  You will be provided a copy of 
this signed document.
_______________________________________________      __________________
Signature of Participant                                                               Date
_______________________________________________
Printed Name of Participant
____________________________________________            __________________
Signature of Person Obtaining Consent                                     Date
______________________________________________________
Printed Name of Person Obtaining Consent