Clinical trial NCT02744352
Conditions: Distal Radius Fracture Post Operative Pain Control
Keywords: infraclavicular brachial plexus block quality of recovery score pain score disability assessment of shoulder and hand questionnaire
Sponsor: University of Pennsylvania
Start date: 2016-10-01; Completion date: 2018-10-05
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare infraclavicular brachial plexus shot single shot block to continuous catheter nerve block done in adult patients who have under gone surgery to repair distal radius fractures. Visual analogue scores, opioid consumption, quality of recovery and quality of sleep up to 72 hours post operatively will be used for comparison.

Detailed description:
If the patient is willing to participate and signs the consent, he/she will be randomized to one of the two treatment groups:

1. Single shot block
2. Continuous catheter

In the institution investigators usually advocate for regional anesthesia and intravenous sedation for the repair of open fracture of the distal radius.

Patients will be monitored during block performance with standard ASA monitors. All patients will receive 2 L of oxygen via a nasal cannula. Sedatives will be titrated to effect. Midazolam 1-2 mg, and fentanyl 50-100 mcg will be used for sedation.

Block time out will be preformed according to standard operating procedure. All blocks will be done under ultrasound guidance. Sonosite S nerve machine will be used with a low frequency curvilinear (C5) US probe with 2-5 MHZ frequency. Both single shot and continuous ICB will be performed according to the SOP in the department. Ultrasound survey of the deltopectoral groove below the clavicle will take place. The axillary artery and the three cords (posterior, medial and lateral) of the brachial plexus will be identified in short axis view deeper to the pectoralis minor muscle.

For single shot blocks: A 4 inch 21 gauge single shot (B-Braun) needle will be introduced in-plane towards the posterior cord of the brachial plexus and 1-2 mL of dextrose 5% (D5%) bolus will be used to verify correct placement of the needle in the vicinity of the posterior cord and adequate spread pattern to both lateral and medical cord. 20 ml of of Ropivicaine 0.5% will be injected through the needle with intermittent aspiration after each 5 ml bolus injection.

For the continuous block: A 4 gauge 18 inch tuohy needle ( B -Braun) will be introduced towards the posterior cord as above. When the needle tip and the pattern of spread is confirmed using D5% solution, a 21 gauge catheter will be introduced 2 cm beyond the needle tip under ultrasound visualization. The needle will be withdrawn over the catheter. Injection of a total of 20 ml of ropivacaine 0.5% ( in divided 5 ml boluses with intermittent aspiration) will take place through the catheter while observing the spread of local anesthetic under ultrasound. The catheter hub will be affixed to the upper lateral chest with sterile occlusive dressings and an anchoring device.

Block success will be defined as a change in cutaneous sensation to touch with an alcohol pad in the posterior, medial and lateral cord distribution over the forearm and the hand within 30min after injection. Subjects with successful catheter placement per protocol and nerve block onset will be retained in the study. Subjects with a failed catheter insertion or misplaced catheter indicated by a lack of sensory changes will have their catheter replaced or will be single shot blocked and withdrawn from the study.

Intraoperative sedation will consist of intermittent boluses of midazolam (1-2 mg), fentanyl (50-100 mcg) and propofol infusion, titrates to sedation and patient comfort (25-50 mcg/kg/min).

All patients will receive prophylaxis for postoperative nausea and vomiting (PONV) during surgery. The protocol for prophylaxis against PONV includes administration of 4 mg of dexamethasone after induction of anesthesia and 4 mg of ondansetron 20 minutes before recovery from anesthesia. Dexamethasone is withheld if the patient has poorly controlled diabetes mellitus (DM). Uncontrolled DM will be defined as random blood glucose above 250 mg/dl.

Arms: arm 1: Subjects will receive 60 hour continuous infraclavicular brachial plexus block (0.2% of ropivacaine at 8 milliliter/hour) with initial four intermittent 5ml bolus (20ml) of 0.5% Ropivicaine given preoperatively to help with operative and postoperative pain arm 2: Subjects will receive single shot infraclavicular brachial plexus block with 20ml bolus of 0.5% ropivicaine given preoperatively to help with operative and postoperative pain
Interventions: intervention 1: 20ml bolus of 0.5% ropivicaine intervention 2: 0.2% of ropivacaine at 8 milliliter/hour
Intervention descriptions: intervention 1: Local anesthetic intervention 2: Local anesthetic

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
University of Pennsylvania 
Protocol 
NCT02744352 
Madaan, Anmol 
5-29-2018 
 


Comparison between single shot versus continuous infraclavicular brachial plexus block 
for postoperative analgesia after distal radius fracture, a prospective randomized open 
label study         
Pain control following fracture surgery is closely associated with overall patient 
satisfaction (1). Systemic analgesia (intravenous or oral) are not site specific and may be 
associated with undesirable side effects such as nausea, constipation, and pruritus. 
Peripheral blocks provide not only intraoperative anesthesia and pain control but also 
offer the advantage of lasting analgesic effect into the post-operative period. However, 
as these blocks wear off, some patients experience a high level of pain. This “rebound 
phenomenon” has been described and is considered by some authors as one of the 
shortcoming of single shot peripheral nerve blocks in multiple orthopedic surgical 
settings (2). Extension of the analgesic benefits of the peripheral nerve blocks can be 
achieved in the ambulatory settings using continuous perineural ambulatory catheters 
(3). Use of regional anesthesia for repair of distal radius fracture has been associated 
with improved pain scores and improved functional outcomes when compared to 
general anesthesia (4).The impact of extension of these benefits in the settings of distal 
radius fractures on patient satisfaction, the quality of pain management, quality of 
recovery, and functional outcome is not entirely known. This study aims to compare the 
effect of single shot infraclavicular brachial plexus blocks to continuous peripheral nerve 
blocks on pain scores after surgery.  
Study Objectives: 
1- Measure visual analogue scores every 8 hours for 72 hours after surgery. Pain 
scores will be recorded by patients in a pain diary (see appendix)  
2- Measure opioid requirements for the first 3 days after surgery 
3- Measure patient satisfaction with their pain management.  
4- Measure the quality of recovery (QOR) at 24 and 72 hours. using the QOR-9 
questionnaire.( see appendix) 
5- Measure the quality of sleep in the first two nights after surgery using a sleep 
questionnaire ( see appendix) 
6- Functional outcomes will be assessed at 3 months follow up during the office 
visit or through administration of the disability assessment of shoulder and hand 
questionnaire, range of motion of the wrist and fingers will be recorded. (see 
appendix) 
This study tests the hypothesis that patients receiving continuous ICB will have lower 
pain scores, will use less opioids, will sleep better the first two nights after surgery and 
will be more satisfied with their pain control regimen after surgery. 
Methods: 
Study design: prospective, randomized, unblinded study with a parallel design and an 
allocation ratio of 1 to 1 for the treatment groups.  
Inclusion Criteria: Patients scheduled for open reduction and internal fixation of a distal 


radius fracture with American Society of Anesthesiologists (ASA) physical status I -III, 
mentally competent and able to give consent for enrollment in the study.  
Exclusion criteria: 
Allergy to local anesthetics. Impaired kidney functions and patient with coagulopathy 
will be also excluded. Patients opting to go under general anesthesia and those refusing 
the block will be excluded from the study. Chronic pain syndromes and patients with 
chronic opioid use defined as use of regular daily doses of systemic narcotics for the 
past 6 months prior to the surgery. BMI of 40 or more 
Recruitment: 
Patients will be identified from the surgical schedule the day before surgery and will be 
contacted by one of the study investigators to scan for eligibility for enrollment. Study 
aims and procedures will be explained to patients. Patients will be consented the 
morning of their surgery by one of the study investigator or the research coordinator. 
25 patients will be enrolled in each study group with a total of 50 patients. Patients will 
be randomized to one of two study groups.  
Group A will be named SS group, group B will be named the continuous infraclavicular 
block (CICB) group. 
Randomization: 
A computer generated randomization table will be used for patient allocation to one of 
the two study groups; The SS group, or the CICB group. Randomization will be done in 
blocks of 10 patients. Patients’ assignments will be written in a sealed envelope that is 
only open after patient consent for the study. 
The study will be unblinded. Patients, nurses in the recovery room, and the research 
coordinator will be aware of the nature of patient assignment. Currently, most patients 
presenting with distal radius fracture at PPMC will receive a single shot brachial plexus 
block for intraoperative anesthesia. We offer the continuous block option to patients 
with history of chronic pain or previous adverse reactions to oral opioids. Also these 
practices may vary depending on surgeon and anesthesiologist preference. Access to 
analgesic medications will not be restricted by any means for both study groups 
because of the study procedures.  
Statistical Analysis: Statistical analyses will be preformed using STATA 13 statistical 
software, Dallas, TX. Demographic data will be analyzed using student’s T test or fisher’s 
exact test as appropriate. Repeated measurements (pain scores) will be analyzed by 
repeated measures ANOVA or ANOVA on ranks, with further paired comparisons at each 
time interval performed using the t-test or Mann-Whitney U-test as appropriate. 
Categorical data will be analyzed using X2 analysis or Fisher’s exact test where 


applicable. Normally distributed data will be presented as means ± SE of the mean 
(SEM), non normally distributed data are presented as medians ± quartiles (interquartile 
range) and categorical data will be presented as raw data and as frequencies. The α 
level for all analyses was set as P<0.05. 
Study procedures: 
In our institution we usually advocate for regional anesthesia and intravenous sedation 
for the repair of open fracture of the distal radius. Patients will be approached and 
consented for the study by one of the study staff. 
Once consented their group assignment will be revealed to the anesthesiologist 
assigned to the room who will be performing the block 
Patients will be monitored during block performance with standard ASA monitors. All 
patients will receive 2 L of oxygen via a nasal cannula. Sedatives will be titrated to effect. 
Midazolam 1-2 mg, and fentanyl 50-100 mcg will be used for sedation. 
Block time out will be preformed according to standard operating procedure. 
All blocks will be done under ultrasound guidance. Sonosite S nerve machine will be 
used with a low frequency curvilinear (C5) US probe with 2-5 MHZ frequency. Both 
single shot and continuous ICB will be performed according to the SOP in our 
department. Ultrasound survey of the deltopectoral groove below the clavicle will take 
place. The axillary artery and the three cords (posterior, medial and lateral) of the 
brachial plexus will be identified in short axis view deeper to the pectoralis minor 
muscle.  
=========== 
 For single shot blocks: A 4 inch 21 gauge single shot (B-Braun) needle will be introduced 
in-plane towards the posterior cord of the brachial plexus and 1-2 mL of dextrose 5% 
(D5%) bolus will be used to verify correct placement of the needle in the vicinity of the 
posterior cord and adequate spread pattern to both lateral and medical cord. 20 ml of 
of Ropivicaine 0.5% will be injected through the needle with intermittent aspiration 
after each 5 ml bolus injection. 
For the continuous block: A 4 gauge 18 inch touhy needle ( B –Bruan) will be introduced 
towards the posterior cord as above. When the needle tip and the pattern of spread is 
confirmed using D5% solution, a 21 gauge catheter will be introduced 2 cm beyond the 
needle tip under ultrasound visualization. The needle will be withdrawn over the 
catheter. Injection of a total of 20 ml of ropivacaine 0.5% ( in divided 5 ml boluses with 
intermittent aspiration) will take place through the catheter while observing the spread 
of local anesthetic under ultrasound. The catheter hub will be affixed to the upper 
lateral chest with sterile occlusive dressings and an anchoring device.  
 
Block success will be defined as a change in cutaneous sensation to touch with an 
alcohol pad in the posterior, medial and lateral cord distribution over the forearm and 
the hand within 30min after injection. Subjects with successful catheter placement per 
protocol and nerve block onset will be retained in the study. Subjects with a failed 
catheter insertion or misplaced catheter indicated by a lack of sensory changes will have 
their catheter replaced or will be single shot blocked and withdrawn from the study.  


Intraoperative sedation will consist of intermittent boluses of midazolam (1-2 mg), 
fentanyl (50-100 mcg) and propofol infusion, titrates to sedation and patient comfort 
(25-50 mcg/kg/min).  
All patients will receive prophylaxis for postoperative nausea and vomiting (PONV) 
during surgery. The protocol for prophylaxis against PONV includes administration of 4 
mg of dexamethasone after induction of anesthesia and 4 mg of ondansetron 20 
minutes before recovery from anesthesia. Dexamethasone is withheld if the patient has 
poorly controlled diabetes mellitus (DM). Uncontrolled DM will be defined as random 
blood glucose above 250 mg/dl 
Protocol for postoperative analgesia: At the conclusion of surgery, the catheters will be 
connected to a pump that will infuse local anesthetic. Ropivicaine 0.2% at a basal rate of 
5 ml/hour and a patient administered  on demand bolus of 5 ml with lock out interval 
every 60 minutes. In the PACU, intermittent boluses of hydromorphone will be used as 
needed. Postoperative analgesia will follow the current oral prescription protocol. Drugs 
that are used for postoperative analgesia include oxycodone/acetaminophen (5/325 
mg) one to two tablets every four to 6 hours as needed by the patient with oxycodone 
5-10 mg oxycodone oral tablets every 4 hours as needed for break through pain.  
Patients will be followed up daily by the acute pain service resident as per our routine 
clinical practice for follow up for ambulatory perineural catheters. Patients will take out 
the catheter themselves at home as per protocol. 
 
Sample Size Calculation: A power analysis done prior to enrollment showed that the 
number of patients needed to detect a 1-point change in pain score (p<0.05 significance 
level) was thirty-eight patients. While a 1-point change in pain score may not be 
clinically significant, we wanted the study to have enough power to detect between a 1-
2 point pain score difference. Assuming a dropout rate of 20%, we will enroll fifty 
patients. Sample size estimate followed a previously published study comparing single 
shot versus continuous popliteal block for pain control after ankle fracture (5). 
 
Study duration:  
We plan to begin enrollment in October 2015. The enrollment of all subjects is projected 
to be completed in October 2016 with data analysis to follow. The study is expected to 
be completed by January 2017.The length of participation for each subject will be three 
months total – 3 months as follow up data will be collected during the follow up office 
visits. 
 
Measurements: 
1- Visual analogue scores every 8 hours for 72 hours after surgery. Pain scores will 
be recorded by patients in a pain diary  
2- Measure opioid requirements for the first 3 days after surgery 
3- Measure patient satisfaction with their pain management.  
4- Measure the quality of recovery at 24 and 72 hours 
5- Measure the quality of sleep in the first two nights after surgery. sleep quality 
questionnaire is adapted from the insomnia severity index (6) and we added 


another questions asking about the frequency of waking up at night because of 
pain after surgery (7, 8) 
6- Functional outcomes will be assessed at 3 months follow up during the office 
visit or through administration of the quick disability assessment of shoulder and 
hand (DASH) questionnaire (9), range of motion of the wrist and fingers will be 
recorded. 
 
1. Elkassabany N, Cai LF, Mehta S, Ahn J, Pieczynski L, Polomano RC, Picon S, Hogg R, Liu 
J. Does regional anesthesia improve the quality of postoperative pain management and 
the quality of recovery in patients undergoing operative repair of tibia and ankle 
fractures? J Orthop Trauma. 2015 Sep;29(9):404-9. 
2. Williams BA, Bottegal MT, Kentor ML, Irrgang JJ, Williams JP. Rebound pain scores as a 
function of femoral nerve block duration after anterior cruciate ligament reconstruction: 
Retrospective analysis of a prospective, randomized clinical trial. Reg Anesth Pain Med. 
2007 May-Jun;32(3):186-92. 
3. Goldstein RY, Montero N, Jain SK, Egol KA, Tejwani NC. Efficacy of popliteal block in 
postoperative pain control after ankle fracture fixation: A prospective randomized 
study. J Orthop Trauma. 2012 Oct;26(10):557-61. 
4. Egol KA, Soojian MG, Walsh M, Katz J, Rosenberg AD, Paksima N. Regional anesthesia 
improves outcome after distal radius fracture fixation over general anesthesia. J Orthop 
Trauma. 2012 Sep;26(9):545-9. 
5. Ding DY, Manoli A,3rd, Galos DK, Jain S, Tejwani NC. Continuous popliteal sciatic nerve 
block versus single injection nerve block for ankle fracture surgery: A prospective 
randomized comparative trial. J Orthop Trauma. 2015 Sep;29(9):393-8. 
6. Morin C. insomnia severity index [Internet]. . Available from: 
https://www.myhealth.va.gov/mhv-portal-
web/anonymous.portal?_nfpb=true&_pageLabel=healthyLiving&contentPage=healthy_l
iving/sleep_insomnia_index.htm 
7. Ilfeld BM, Morey TE, Enneking FK. Continuous infraclavicular brachial plexus block for 
postoperative pain control at home: A randomized, double-blinded, placebo-controlled 
study. Anesthesiology. 2002 Jun;96(6):1297-304. 
8. Ilfeld BM, Morey TE, Wang RD, Enneking FK. Continuous popliteal sciatic nerve block 
for postoperative pain control at home: A randomized, double-blinded, placebo-
controlled study. Anesthesiology. 2002 Oct;97(4):959-65. 
9. [Internet]. http://www.iwh.on.ca/ cited 8/22/2015]. Available from: 
http://dash.iwh.on.ca/system/files/quickdash_questionnaire_2010.pdf English. 

ICF_001.pdf: 
 
 
 
University of Pennsylvania 
Informed 
Consent 
Form 
NCT02744352 
Madaan, Anmol 
8-24-2017 
 


IRB Approved From: 8/24/2017 To: 8/23/2018 
 
UNIVERSITY OF PENNSYLVANIA 
RESEARCH SUBJECT INFORMED CONSENT AND 
HIPAA AUTHORIZATION FORM 
 
Protocol Title: Comparison between single shot versus continuous 
infraclavicular brachial plexus block for postoperative 
analgesia after distal radius fracture, a prospective 
randomized open label study 
(Protocol # xxxxxx) 
 
Principal 
Investigator: 
Nabil M Elkassabany, MD, MSCE 
Department of Anesthesiology 
Hospital of the University of Pennsylvania, 
Philadelphia, PA, 19104 215-662-3761 
 
Emergency 
Contact: 
Nabil M Elkassabany MD MSCE 
(215) 662-3761 
 
 
Why am I being asked to volunteer? 
What is the purpose of this research study? 
You are scheduled to undergo distal radius fracture (wrist) surgery with your 
orthopedic surgeon. To help you with your pain control after surgery, you will 
receive a nerve block to numb up your arm and wrist. It can be numbed up by 
putting numbing medicine around a nerve using ultrasound. 
Receiving the nerve block before wrist fracture surgery and additional sedation 
to make you sleepy during operation is a routine practice at Presbyterian 
Medical Center. 
 
 
v1.2 06/24/2014 
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You are being invited to participate in a research study because you will be having 
surgery to repair a wrist fracture and you will receive a nerve block to numb up 
your arm and wrist as part of your pain control protocol after surgery. Your 
participation is voluntary which means you can choose whether or not you want 
to participate. If you choose not to participate, there will be no loss of benefits to 
which you are otherwise entitled. Before you can make your decision, you will 
need to know what the study is about, the possible risks and benefits of being in 
this study, and what you will have to do in this study. The research team is going 
to talk to you about the research study, and they will give you this consent form 
to read. You may also decide to discuss it with your family, friends, or family 
doctor. You may find some of the medical language difficult to understand. Please 
ask the study doctor and/or the research team about this form. If you decide to 
participate, you will be asked to sign this form. 


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Regional anesthesia - nerve block involves numbing up your arm by injecting 
numbing medication around the nerve that provides feeling to the arm. Patients 
having wrist surgery receive the nerve block in the holding area before surgery. 
The nerve block begins to work about 20 minutes after the needle injection. The 
anesthesiologist has the option to leave a catheter (similar to a thin fishing wire) 
next to the nerve for 48-60 hours. There will be numbing medicine going 
through this catheter to help with your pain control after surgery. 
The purpose of this study is to determine if there is any difference in between 
receiving a single shot of numbing medication versus a catheter left in for 48-60 
hours. We aim to look at recovery outcomes and overall patient satisfaction. 
How long will I be in the study? How many other people will be 
in the study? 
We plan to enroll 50 subjects who are scheduled to distal radius surgery at 
Penn Presbyterian Medical Center. Your expected length of participation is 
about 3 months. The study will follow your progress from the time of your 
surgery until day 3 post operation and again on your 3 month clinical visit post 
operation. 
What am I being asked to do? 
If you sign the consent and agree to participate in this study, you will still 
receive monitored sedation and a nerve block. This is not by any means a 
change from the standard of care for any patient. 
For this study, the nerve block will either be a single shot or a catheter left in 
place for 48-60 hours. All medications used are approved by the Food and Drug 
Administration (FDA). This study wishes to look at the difference in patient 
satisfaction and recovery outcomes between the lengths of time for the 
proposed blocks. 
If you agree to participate: 
You will be randomized to receive either one of two nerve blocks. This is a 
process of chance, similar to being assigned by the flip of a coin. The doses of 
the medicine will be according to the standard of practice in the PPMC. 
By chance you will be assigned to receive one of the following: 
 Ultrasound guided shoulder block by single shot 
 Ultrasound guided shoulder block with catheter for 48-60 hours 
 
You will also be asked to allow the research team to collect data after the 
surgery. This will include information regarding what your pain is after your 
surgery, the amount and type of pain medication you take up to 3 days, and 
how the pain is impacting your recovery and sleep. You will be asked to 
complete questionnaires that will assess your pain, your general well-being, and 
how you are able to control your pain, and how your pain affects your return to 
your daily life. 
A member of the research team will call you after surgery Day 1 and Day 3 
post-operative. If you admitted to the hospital a team member will see you while 
in the hospital. You will be asked about your pain and your general well-being. 


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The research assistant will assist you with completing the questionnaires 
described here: 
Quality of Recovery Scale 
You will be asked to complete this survey a total of three times after your 
surgery. These time points will be 24 hours and 72 hours after your surgery. 
This questionnaire will ask you questions about how you are feeling both 
physically and mentally and how much pain you are feeling. This will take about 
5 minutes to complete. 
Insomnia Severity Index 
This survey asks about your sleeping habits and takes about 3 minutes to 
complete. 
Pain Diary 
You will be given a pain diary to complete up to 72 hours post operatively. 
Information obtained from the pain diary includes pain scores at different times 
during the day and pain medications taken. In order to assess duration of block 
the patients will be asked to write down the time that they first noticed pain as 
well as the time that they needed their first dose of oral pain medication. You will 
also be contacted at home 24 and 72 hours later to obtain pain, analgesic 
consumption, satisfaction, and quality of recovery data. 
You will also rate your pain and tell us about the medication you used to treat this 
pain and if there is anything in particular that makes this pain better or worse. 
The Pain Diary should take about 10 minutes to complete at each time point. 
See the table below for the data that the research team will be collecting and 
the different time points that it will be collected. 
 
 
Pre- 
Regional 
Block 
Immediately 
After the 
Block 
20 mins after 
the block and 
every 20 
minutes while 
in PACU 
At discharge 
time to home 
from the PACU 
Every 6 hours 
while at home 
for 72 hours 
after the block 
24 hours 
after the 
block 
Pain 
Scores 
X 
X 
X 
X 
X 
Pain 
medication 
use 
X 
X 
X 
X 
X 
How long 
block 
lasted 
X 
Sleep 
Survey 
X 
Quality of 
Recovery 
X 


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Disabilities of the Arm, Shoulder, and Hand Survey (DASH) 
As part of standard of care you will be seen about 3 months after your surgery 
by your surgeon. At this visit a research team member will give you a survey 
known as the DASH. This survey asks questions about the use and movement 
of your arm, shoulder, and hand after surgery. It takes about 5 minutes to 
complete. 
The medical, surgical, and anesthesia care that you entitled to receive for 
this surgical procedure will not change because you are in this study. All 
before surgery, surgical, and post-surgery care in the recovery room will 
be the same as any other patient undergoing this surgery. 
What are the possible risks or discomforts? 
We do not foresee any risks for participation in this study that are different than 
the standard of care. All medications used for the nerve block are FDA 
approved to be used alone and in combination for anesthesia. 
A risk which is common to all studies which include randomization of patients to 
different treatment groups is the removal of the physician’s choice of block type. 
Since both nerve blocks are safe for the patients enrolled in this study, we do 
not foresee this to be a major risk to patients enrolling in this study. 
*Most patients receive single shot blocks for wrist fractures. We are seeking to 
provide the added benefit of catheters for more patients who are getting wrist 
fracture surgery. 
You will have been screened by both your surgical and anesthesia team for 
allergies to any medications including those commonly used for anesthesia and 
post-surgery pain control. If you have any previous history of allergies to any of 
the medications used for the block or the standard of care post-surgery and 
discharge medications, you will not be able to participate in this study. 
The anesthesia team will have discussed the risks of both general and regional 
(nerve block) anesthesia with you and obtained your consent for each type of 
anesthesia prior to your surgery. 
You will receive care and be monitored throughout and following your surgery 
per hospital standards as would any other non-study subject. (Standard 
protocol is the rules and regulations that must be followed for patient safety and 
quality of care). 
Since a member of the research team will be phoning you at home to assist you 
in the completion of the questionnaires, you may feel some discomfort if it 
occurs at an inconvenient time of the day. 
Risks of breaches of confidentiality are small but nonetheless possible. 
However, we have taken several measures to protect your identity. All study 
data will be stored in confidential research files of the research investigator. 
Records will not contain your name or any other personal identifiers. 


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What if new information becomes available about the study? 
During the course of this study, we may find more information that could be 
important to you. This includes information that, once learned, might cause you 
to change your mind about being in the study. We will notify you as soon as 
possible if such information becomes available. 
What are the possible benefits of the study? 
You may not receive additional benefits from being in this research study. 
The pain control after receiving the block will help with pain control after 
surgery. 
What other choices do I have if I do not participate? 
If you do not participate in this study you will receive the standard of care 
protocol anesthesia regimen per the Penn Presbyterian Medical Center for the 
shoulder surgery procedure. The choice of medications used in your anesthesia 
regimen will be determined by your anesthesia provider. 
Will I be paid for being in this study? 
You will not be paid for participating in this study. 
Will I have to pay for anything? 
There is no fee for participating in this study. You and/or your health insurance 
will be billed for the costs of medical care during this study given these 
expenses would have happened even if you were not in the study, or if your 
insurance agrees in advance to pay. 
What happens if I am injured or hurt during the study? 
We will offer you the care needed to treat injuries directly resulting from taking 
part in this research. We may bill your insurance company or other third parties, 
if appropriate, for the costs of the care you get for the injury, but you may also 
be responsible for some of them. 
There are no plans for the University of Pennsylvania to pay you or give you 
other compensation for the injury. You do not give up your legal rights by 
signing this form. 
If you think you have been injured as a result of taking part in this research 
study, tell the person in charge of the research study as soon as possible. The 
researcher’s name and phone number are listed in the consent form. 
When is the Study over? Can I leave the Study before it ends? 
This study is expected to end after all participants have completed all visits, and 
all information has been collected. If you do enroll in this study and later decide 
to withdraw your consent, whether before or after your procedure, you will be 
asked to notify a member of the study team. Their information can be found on 
page 1 of this consent form. 
If you are unable to complete the procedure with the study medications, the 
anesthesiologist will withdraw you from the study and make sure you are able to 
complete your procedure. You will be sedated during this process and unable to 
participate in decisions, as is typical of patients undergoing procedures with 
sedation. 


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Who can see or use my information? How will my personal 
information be protected? 
We will do our best to make sure that the personal information in your medical 
record will be kept private. However, we cannot guarantee total privacy. Your 
personal information may be given out if required by law. If information from this 
study is published or presented at scientific meetings, your name and other 
personal information will not be used. 
What is an Electronic Medical Record? 
An Electronic Medical Record (EMR) is an electronic version of the record of 
your care within a health system. An EMR is simply a computerized version of a 
paper medical record. 
Since you are receiving care or have received care within the University of 
Pennsylvania Health System (UPHS) (outpatient or inpatient) and are 
participating in a University of Pennsylvania research study, results of research- 
related procedures (i.e. laboratory tests, imaging studies and clinical 
procedures) may be placed in your existing EMR maintained by UPHS. 
Once placed in your EMR, these results are accessible to appropriate UPHS 
workforce members that are not part of the research team. Information within 
your EMR may also be shared with others who are determined by UPHS to be 
appropriate to have access to your EMR (e.g. health insurance company, 
disability provider, etc). 
What personal health information is collected and used in this 
study, and might also be disclosed? 
The following personal health information will be collected, used for research, 
and may be disclosed during your involvement with this research study: 
 Name, address, telephone 
number, date of birth 
 Personal and family medical 
history 
 Current and past medications 
or therapies 
 Results of tests and procedures you 
will undergo during this research study 
as described in the informed consent 
form. 
 Medical record number 
 All information in the Medical Record 
Why is your personal contact and health information being 
used? 
Your personal contact information is important for the research team to contact 
you during the study. Your personal health information and results of tests and 
procedures are being collected as part of this research study. In some 
situations, your personal health information might be used to help guide your 
medical treatment. 
Which of our personnel may use or disclose your personal 
health information? 
The following individuals may use or disclose your personal health information 
for this research study: 
 The Principal Investigator and the Investigator’s study team 


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 Authorized members of the workforce of the UPHS and the School of 
Medicine, and University of Pennsylvania support offices, who may need 
to access your information in the performance of their duties (for 
example: for research oversight and monitoring, to provide treatment, to 
manage accounting or billing matters, etc.). 
Who, outside of UPHS and the School of Medicine, might receive 
your personal health information? 
As part of the study, the Principal Investigator, the study team and others listed 
above, may disclose your personal health information, including the results of 
the research study tests and procedures. This information may be disclosed to 
those listed below: 
Regulatory and safety oversight organizations 
 The Office of Human Research Protections 
 The University of Pennsylvania Institutional Review Board 
If your personal health information is disclosed to others outside of UPHS or the 
School of Medicine, it may no longer be covered by federal privacy protection 
regulations. The Principal Investigator or study staff will inform you if there are 
any additions to the list above during your active participation in the trial. Any 
additions will be subject to University of Pennsylvania procedures developed to 
protect your privacy. 
A description of this clinical trial will be available on 
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. 
How long may UPHS and the School of Medicine be able to use 
or disclose your personal health information? 
Your authorization for use of your personal health information for this specific 
study does not expire. Your information may be held in a research repository 
(database). However, UPHS and the School of Medicine may not re-use or re- 
disclose information collected in this study for a purpose other than this study 
unless: 
 You have given written authorization to do so 
 The University of Pennsylvania’s Institutional Review Board grants 
permission after ensuring that appropriate privacy safeguards are in 
place 
 As permitted by law 
Will you be able to access your records? 
During your participation in this study, you might not be able to access some or 
all of your medical records. For example, access to portions of your medical 
records may be denied in studies where your knowledge of study results 
included in such records could affect the reliability of the study. You will have 
access to your medical record information when the study is over or earlier, if 
possible. The Principal Investigator is not required to release research 
information to you that is not part of your medical record. 


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Can you change your mind? 
Yes, at any time you may withdraw your approval to allow the use and 
disclosure of your personal health information as described here. You must do 
so in writing to the Principal Investigator at the address on the first page. Even if 
you withdraw your permission, your personal health information that was 
collected before we received your written request may still be used and 
disclosed, as necessary for the study. If you withdraw your permission to use 
your personal health information, you will also be withdrawn from the research 
study. 
Who can I call with questions, complaints or if I’m concerned 
about my rights as a research subject? 
If you have questions, concerns or complaints regarding your participation in 
this research study or if you have any questions about your rights as a research 
subject, you should speak with the Principal Investigator listed on page one of 
this form. If a member of the research team cannot be reached or you want to 
talk to someone other than those working on the study, you may contact the 
Office of Regulatory Affairs with any question, concerns or complaints at the 
University of Pennsylvania by calling (215) 898-2614. 
 
 
A copy of this consent form will be given to you. 
 
 
 
Name of Subject 
Signature of Subject 
Date 
(Please Print) 
 
 
 
Name of Person Obtaining 
Signature 
Date 
Consent (Please Print) 
When you sign this form, you are agreeing to take part in this research study. 
This means that you have read the consent form, your questions have been 
answered, and you have decided to volunteer. Your signature also means that 
you are permitting the University of Pennsylvania to use your personal health 
information collected about you for research purposes within our institution. You 
are also allowing the University of Pennsylvania to disclose that personal health 
information to outside organizations or people involved with the operations of this 
study.