Clinical trial NCT03822182
Conditions: Rotator Cuff Tear Pain, Postoperative
Keywords: liposomal bupivicaine interscalene block
Sponsor: Indiana University
Start date: 2018-10-24; Completion date: 2020-01-22
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This document is a protocol for a human research study. This study is to be conducted according to United States standards of Good Clinical Practice in accordance with applicable Federal regulations and institutional research policies and procedures.

Liposomal bupivacaine (LB) has been shown to decrease post-operative pain and narcotic use when administered perioperatively as a local injection during arthroplasty procedures. Studies have also demonstrated that LB used in conjunction with dexamethasone may increase the duration of effectiveness of LB. This study seeks to evaluate if there is a difference in post-operative pain and narcotic use when LB is administered in an interscalene block during outpatient rotator cuff repair surgery. Furthermore, this study aims to determine if the addition of dexamethasone with LB results in a prolonged decrease in post-operative pain and a reduction in narcotic use.

Detailed description:
Outpatient surgery has become the gold standard for arthroscopic rotator cuff repair. Innovations in pain management with regional anesthesia and multimodal techniques have greatly contributed to this transition over the past several decades. Despite overall improvements, uncontrolled postoperative pain leads to prolonged ambulatory stays, increased patient dissatisfaction, unexpected admissions to the hospital or visits to the Emergency Room after surgery, and a greater incidence of complications. Furthermore, in the wake of the "opioid epidemic", concerns with narcotic consumption and addiction have become heightened with regulations and laws recently enacted making prescribing and managing postoperative pain ever more difficult.

Interscalene nerve blockade for shoulder procedures has become an increasingly common technique to provide perioperative pain control with good efficacy, low complication rates and reduced narcotic consumption. While the utilization of ultrasound to help administer the block has aided in the accuracy providing a more consistent analgesic effect, its overall short duration (12-24 hours) remains one of the major limitations of this technique. Modalities to prolong its effect have included use of indwelling catheters and the addition of perineural dexamethasone.

Recently, liposomal bupivacaine (LB) (Exparel) was approved for single shot interscalene administration by the FDA. This medication has been purported to provide up to 72 hours of extended release of bupivacaine via its multivesicular and honeycomb-like structure that predictably breaks down resulting in a slow and sustained release of the medication.9 Although numerous studies have been conducted and several meta-analyses performed looking at the overall efficacy of local injections of LB for operative procedures in an inpatient setting, no study to date has independently assessed its efficacy in the new perineural indication for outpatient shoulder surgery. Furthermore, no study to date has compared the use of LB to the use of LB with dexamethasone in a perineural indication to see if the duration of efficacy is further prolonged with the addition of dexamethasone. All existing literature is in regard to use of liposomal bupivacaine injected locally within the surgical site. This will be the first study to examine the perineural use of LB for outpatient shoulder surgery, and to determine if there is a prolonged decrease in pain and a decrease in narcotic consumption with the use of LB with dexamethasone when delivered as an interscalene block in an ambulatory setting.

Utilizing a prospective randomized controlled trial, this study seeks to evaluate if there is a difference in post-operative pain and narcotic use when LB is administered in an interscalene block during outpatient rotator cuff repair surgery. Furthermore, this study aims to determine if the addition of dexamethasone with LB results in a prolonged decrease in post-operative pain and an overall reduction in narcotic use.

Primary Aims \& Objective

Aim 1a: To determine if the use of LB in an interscalene block decreases patient-reported post-operative visual analogue pain scale (VAS) in patients undergoing outpatient rotator cuff surgery

Hypothesis: There will be a decrease in the visual analogue pain scale for up to 72 hours post-operatively among participants who receive LB or LB plus dexamethasone, as compared to the control group (bupivacaine plus dexamethasone).

Objective: Utilizing a prospective randomized controlled trial, post-operative patient-reported VAS pain (on a scale of 1-10) will be collected 3 times per day (every 8 hours) for 5 post-operative days (PODs), corresponding to a total of 120 hours after surgery. For each 24-hour period (corresponding to each POD), the pain scores will be averaged and compared between the three treatment groups (control, LB, and LB plus dexamethasone) for each of the 5 PODs.

Aim 1b: To determine if the use of LB plus dexamethasone in an interscalene block decreases patient-reported post-operative VAS pain for a longer duration than the LB or the control group (bupivacaine plus dexamethasone) in patients undergoing outpatient rotator cuff surgery

Hypothesis: There will be a decrease in visual analogue pain scale for greater than 72 hours post-operatively among participants who receive LB plus dexamethasone, as compared to the LB and the control group (bupivacaine plus dexamethasone).

Objective: Utilizing a prospective randomized controlled trial, post-operative patient-reported visual analogue pain scale (on a scale of 1-10) will be collected 3 times per day (every 8 hours) for 5 post-operative days (PODs), corresponding to a total of 120 hours after surgery. For each 24-hour period (corresponding to each POD), the pain scores will be averaged and compared between the three treatment groups (control, LB, and LB plus dexamethasone) for each of the 5 PODs.

Secondary Aims \& Objectives

Aim 2a: To determine if there is a difference in time at which post-operative narcotics are first used among three groups receiving different interscalene blocks (LB plus dexamethasone, LB, and control) in patients undergoing outpatient rotator cuff surgery.

Hypothesis: Narcotic use will begin at a later time among those receiving LB plus dexamethasone, as compared to the LB and the control group (bupivacaine plus dexamethasone).

Objective: Utilizing a prospective randomized controlled trial, narcotic use will be collected at 8-hour increments for a total of 5 post-operative days (PODs), corresponding to a period of 120 hours post-surgery. The 8-hour time period during which a participant first begins using a narcotic will be recorded and compared between three treatment groups (control, LB, and LB plus dexamethasone).

Aim 2b: To determine if there is a difference in patient-reported post-operative narcotic use (measured in morphine equivalents) among three groups receiving different interscalene blocks (LB plus dexamethasone, LB, and control) in patients undergoing outpatient rotator cuff surgery.

Hypothesis: There will be a decrease in cumulative narcotic use (measured in morphine equivalents) among participants who receive LB plus dexamethasone, as compared to the LB and the control group (bupivacaine plus dexamethasone).

Objective: Utilizing a prospective randomized controlled trial, post-operative patient-reported narcotic use (measured by the number of tablets ingested and converted to morphine equivalents) will be collected 3 times per day at 8-hour increments for a total of 5 post-operative days (PODs), corresponding to a total of 120 hours after surgery. For each 24-hour period (corresponding to each POD), narcotic use will be tabulated and compared between three treatment groups (control, LB, and LB plus dexamethasone). Furthermore, cumulative narcotic use during the 5-day (120 hour) study period will be calculated and compared between three treatment groups (control, LB, and LB plus dexamethasone).

Arms: arm 1: Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone. arm 2: Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline arm 3: Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline
Interventions: intervention 1: liposomal bupivicaine intervention 2: Dexamethasone
Intervention descriptions: intervention 1: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:

Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline intervention 2: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.

Protocol documents:
Prot_SAP_007.pdf: 
 
 
Date: 
 November 19. 2019 
 
 
 
Title:  
A Prospective Randomized Controlled Trial Examining the 
Effectiveness of a Single Shot of Liposomal Bupivicaine for 
Reducing Post-operative Pain and Narcotic Use in Outpatient 
Rotator Cuff Surgery 
 
NCT: 
 03822182 
 
 
 
 
Principal investigator:  Brian Badman, MD 
 
 
Study site address: 
American Health Network 
 8607 E US Hwy 36, Avon, IN 46123 
 
Phone: 
 
 
 (317)208-3866 
 
 
 
 
 
 


 
 
Table of Contents: 
 
4 
Introduction 
5 
Background Information and Scientific Rationale 
5 
Summary of Previous Pre-clinical Studies/ Relevant Clinical Studies 
5 
Summary of Epidemiological Data 
5 
Rationale 
5 
Study Objectives 
5 
Primary Objective 
5 
Secondary Objectives 
6 
Study Design 
6 
Research Design 
6 
Study Agent, Device, and/or Intervention Description 
6 
Sample Size 
7 
Subject Selection 
7 
Inclusion Criteria 
7 
Exclusion Criteria 
8 
Study Outcome Measures (Endpoints) 
8 
Study Procedures 
9 
Subject Recruitment and Screening 
9 
Randomization 
9 
Study Visits 
10 
Study Duration 
11 
Specimen Collection, Preparation, Handling and Shipping 
11 
Data Quality Plan 
11 
Statistical Analysis Plan 
11 
Potential Risks and Benefits 
12 
Potential Risks 
12 
Mitigation of Risks (Note: for studies with significant risk) 
12 
Potential Benefits 
12 
Early Withdrawal of Subjects 
12 
When and How to Withdraw Subjects 
12 
Data Collection and Follow-up for Withdrawn Subjects 
13 
Adverse Event Reporting: 
13 


 
 
Adverse Events 
13 
Recording of Adverse Events 
15 
Notification of Adverse Events 
15 
Safety Monitoring Plan (applicable for significant risk studies) 
15 
Safety Monitoring: 
15 
Data and Safety Monitoring Board 
15 
Ethical Considerations 
16 
Conflict of Interest 
16 
Funding Source 
16 
Subject Stipends or Payments 
16 
Publication Plan 
16 
References 
17 
 
 


 
 
Introduction 
 
This document is a protocol for a human research study. This study is to be conducted according 
to United States standards of Good Clinical Practice in accordance with applicable Federal 
regulations and institutional research policies and procedures.  
 
Liposomal bupivacaine (LB) has been shown to decrease post-operative pain and narcotic use 
when administered perioperatively as a local injection during arthroplasty procedures. Studies 
have also demonstrated that LB used in conjunction with dexamethasone may increase the 
duration of effectiveness of LB. This study seeks to evaluate if there is a difference in post-
operative pain and narcotic use when LB is administered in an interscalene block during 
outpatient rotator cuff repair surgery. Furthermore, this study aims to determine if the addition of 
dexamethasone with LB results in a prolonged decrease in post-operative pain and a reduction in 
narcotic use.  
 
Background Information and Scientific Rationale 
 
Outpatient surgery has become the gold standard for arthroscopic rotator cuff repair.   
Innovations in pain management with regional anesthesia and multimodal techniques have 
greatly contributed to this transition over the past several decades. Despite overall improvements, 
uncontrolled postoperative pain leads to prolonged ambulatory stays, increased patient 
dissatisfaction, unexpected admissions to the hospital or visits to the Emergency Room after 
surgery, and a greater incidence of complications.11,16,20,26,27,30,36,39-42,49,   Furthermore, in the 
wake of the “opiod epidemic”, concerns with narcotic consumption and addiction have become 
heightened with regulations and laws recently enacted making prescribing and managing 
postoperative pain ever more difficult.58 
 
Interscalene nerve blockade for shoulder procedures has become an increasingly common 
technique to provide perioperative pain control with good efficacy, low complication rates and   
reduced narcotic consumption.12,15,28,34,35,54 While the utilization of ultrasound to help administer 
the block has aided in the accuracy providing a more consistent analgesic effect, its overall short 
duration (12-24 hours) remains one of the major limitations of this technique.18,28,35  Modalities 
to prolong its effect have included use of indwelling catheters and the addition of perineural 
dexamethasone.2,10,12,15,25,29,32,51  
 
Recently, liposomal bupivacaine (LB) (Exparel) was approved for single shot interscalene 
administration by the FDA.  This medication has been purported to provide up to 72 hours of 
extended release of bupivacaine via its multivesicular and honeycomb-like structure that 
predictably breaks down resulting in a slow and sustained release of the medication.9 Although 
numerous studies have been conducted and several meta-analyses performed looking at the 
overall efficacy of local injections of LB for operative procedures in an inpatient setting, no 
study to date has independently assessed its efficacy in the new perineural indication for 
outpatient shoulder surgery.6,8,22,44,52  Furthermore, no study to date has compared the use of LB 
to the use of LB with dexamethasone in a perineural indication to see if the duration of efficacy 
is further prolonged with the addition of dexamethasone.  All existing literature is in regard to 
use of liposomal bupivacaine injected locally within the surgical site. This will be the first study 


 
 
to examine the perineural use of LB for outpatient shoulder surgery, and to determine if there is a 
prolonged decrease in pain and a decrease in narcotic consumption with the use of LB with 
dexamethasone when delivered as an interscalene block in an ambulatory setting. 
 
 
Study Objectives 
 
Utilizing a prospective randomized controlled trial, this study seeks to evaluate if there is a 
difference in post-operative pain and narcotic use when LB is administered in an interscalene 
block during outpatient rotator cuff repair surgery. Furthermore, this study aims to determine if 
the addition of dexamethasone with LB results in a prolonged decrease in post-operative pain 
and an overall reduction in narcotic use.  
 
 
 
Primary Aims & Objective 
 
 
Aim 1a: To determine if the use of LB in an interscalene block decreases patient-reported post-
operative VAS pain in patients undergoing outpatient rotator cuff surgery 
 
Hypothesis: There will be a decrease in VAS pain for up to 120 hours post-operatively among 
participants who receive LB or LB plus dexamethasone, as compared to the control group 
(bupivacaine plus dexamethasone). 
 
Objective: Utilizing a prospective randomized controlled trial, post-operative patient-reported 
VAS pain (on a scale of 1-10) will be collected 3 times per day (every 8 hours) for 5 post-
operative days (PODs), corresponding to a total of 120 hours after surgery. For each 24-hour 
period (corresponding to each POD), the pain scores will be averaged and compared between the 
three treatment groups (control, LB, and LB plus dexamethasone) for each of the 5 PODs.  
 
 
Aim 1b: To determine if the use of LB plus dexamethasone in an interscalene block decreases 
patient-reported post-operative VAS pain for a longer duration than the LB or the control group 
(bupivacaine plus dexamethasone) in patients undergoing outpatient rotator cuff surgery 
 
Hypothesis: There will be a decrease in VAS pain for greater than 72 hours post-operatively 
among participants who receive LB plus dexamethasone, as compared to the LB and the control 
group (bupivacaine plus dexamethasone). 
 
Objective: Utilizing a prospective randomized controlled trial, post-operative patient-reported 
VAS pain (on a scale of 1-10) will be collected 3 times per day (every 8 hours) for 5 post-
operative days (PODs), corresponding to a total of 120 hours after surgery. For each 24-hour 
period (corresponding to each POD), the pain scores will be averaged and compared between the 
three treatment groups (control, LB, and LB plus dexamethasone) for each of the 5 PODs.  
 


 
 
Secondary Aims & Objectives 
 
Aim 2a: To determine if there is a difference in time at which post-operative narcotics are first 
used among three groups receiving different interscalene blocks (LB plus dexamethasone, LB, 
and control) in patients undergoing outpatient rotator cuff surgery. 
 
Hypothesis: Narcotic use will begin at a later time among those receiving LB plus 
dexamethasone, as compared to the LB and the control group (bupivacaine plus dexamethasone). 
 
Objective: Utilizing a prospective randomized controlled trial, narcotic use will be collected at 8-
hour increments for a total of 5 post-operative days (PODs), corresponding to a period of 120 
hours post-surgery. The 8-hour time period during which a participant first begins using a 
narcotic will be recorded and compared between three treatment groups (control, LB, and LB 
plus dexamethasone).  
 
 
Aim 2b: To determine if there is a difference in patient-reported post-operative narcotic use 
(measured in morphine equivalents) among three groups receiving different interscalene blocks 
(LB plus dexamethasone, LB, and control) in patients undergoing outpatient rotator cuff surgery. 
 
Hypothesis: There will be a decrease in cumulative narcotic use (measured in morphine 
equivalents) among participants who receive LB plus dexamethasone, as compared to the LB and 
the control group (bupivacaine plus dexamethasone). 
 
Objective: Utilizing a prospective randomized controlled trial, post-operative patient-reported 
narcotic use (measured by the number of tablets ingested and converted to morphine equivalents) 
will be collected 3 times per day at 8-hour increments for a total of 5 post-operative days 
(PODs), corresponding to a total of 120 hours after surgery.  For each 24-hour period 
(corresponding to each POD), narcotic use will be tabulated and compared between three 
treatment groups (control, LB, and LB plus dexamethasone).  Furthermore, cumulative narcotic 
use during the 5-day (120 hour) study period will be calculated and compared between three 
treatment groups (control, LB, and LB plus dexamethasone).  
 
 
 
Study Design 
 
The study design is a randomized double-blind randomized controlled trial.  
 
Research Design 
 
Patients will be randomly assigned to one of three treatment groups (see Intervention 
Description). Patients will randomly select one of 78 sealed envelopes they will give to the 
anesthesiologist for administration the day of surgery.  Patients will be blinded to the medication 
utilized as well as the treating surgeon (PI). A consecutive series of patients will be enrolled to 
prevent selection bias. A single surgeon will be performing all procedures to minimize 


 
 
variability.  Unfortunately, it would not be feasible to have the same anesthesiologist for each 
procedure; however, this study will use a core team of anesthesiologists, each with multiple years 
of experience performing the ultrasound guided blocks. Furthermore, the medications and 
dosages for each treatment group are clearly outlined, and the method of administration is the 
same for all groups. The research team will ensure that each anesthesiologist understands the 
randomization protocol and will be trained on how to follow the instructions outlined in this 
study protocol.  
 
Data Collection will occur post-operatively for 5 days. Data will be collected at 16 timepoints, 
corresponding to 8-hr time intervals for a period of 120 hours (see Study Visits). Data will be 
collected using CareSense, a smart phone application that uses a text message system to collect 
information. Patients will be notified by text alert 3 times per day (8am, 2pm and 8pm) asking to 
rate their pain on a scale of 0-10 (VAS).  Patients will also respond to the number of pain pills 
taken in the slotted time span. All patients will be prescribed the same narcotic regimen 
(oxydone IR) barring any allergies encountered.  Alerts will be sent starting the evening of 
surgery (8pm) and then continued for 120 hours. Patients who fail to respond to the text alert will 
be notified by the data collection system and contacted via phone by study personnel. Patients 
lacking smartphone technology will all be notified via telephone and also asked to keep a 
personal log to capture the information needed. 
 
 
 
Data Management 
 
The CareSense database is password protected and HIPPA compliant data collection system 
currently utilized by the lead physician (Dr. Badman).  Patients upon enrollment will be assigned 
an ID to allow for data tracking within the application.  Primary data will be collected via the 
web-based system and stored electronically and encrypted under password protection. The 
principal investigator will only have access to the database. At the conclusion of the study, the 
data will be exported to a password-protected encrypted Excel file on a password-protected 
computer. Once the data have been checked for accuracy and prior to statistical analysis, patient 
identifiers will be removed from the data set. The de-identified password-protected Excel 
spreadsheet will be provided to a statistician who will import the file into SPSS for analysis. 
 
 
Study Agent, Device, and/or Intervention Description  
 
The medication administered in the interscalene block is the intervention in this study. There are 
three different types of interscalene blocks that will be administered in order to compare the 
independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study 
participants will be randomized into one of three groups. The treatment groups are listed below:  
 
Group 1 (Control) 
Group 2 
Group 3  
30 ml of 0.5% bupivacaine 
and 0.4ml (4 mg) of 
dexamethasone 
15ml 0.5% bupivacaine 
and 10ml (133mg) of LB 
15ml 0.5% bupivacaine and 
10ml LB (Exparel) and 


 
 
(Exparel) and 5.4ml 
normal saline 
0.4ml (4 mg) dexamethasone 
and 5ml normal saline 
 
The LB (Exparel) has been FDA approved for use as an interscalene brachial plexus nerve block 
to produce post-surgical regional analgesia following shoulder surgery in adults. Patients in 
Groups 2 and 3 will receive LB. The 15mg dose of LB chosen for this study is the same dose that 
was utilized in the protocol of Study 402C-327, which was the study elicited for FDA approval 
for the use of Exparel in interscalene nerve block. This dose also closely mimics the present 
standard of care (30ml of 0.5%  bupivacaine with 4mg dexamethasone) in volume which is 
essential, as significant changes in volume can alter the impact of dermatomes blocked by the 
local anesthetic. The addition of standard bupivacaine was included in Groups 2 and 3 as it 
provides immediate onset (versus the delay seen with LB), allowing for better anesthetic 
management during surgery and alleviating pain immediately after surgery.  Finally, normal 
saline was added to groups 2 and 3 to have equal injectable volume in each arm. 
 
Dexamethasone is utilized in Group 3 to prolong the duration of amide local anesthetics. (ref) 
Study 402-C-327 only examined the independent use of LB, and did not utilize dexamethasone 
to prolong the duration of the block. Although the use of dexamethasone is standard of care in 
our institution, the utilization of dexamethasone is not a universally accepted practice. Several 
studies have demonstrated conflicting evidence regarding its overall utility to enhance peripheral 
nerve blockade. Furthermore, it can pose issues with glucose levels in insulin resistant and 
diabetic patients.  Accordingly, if there is no proven benefit to including it into the mix in 
conjunction with the liposomal bupivacaine, it would be advantageous to remove it from 
treatment recommendations.  The intent, therefore is to look at the two groups and determine if 
there are significant differences in pain and narcotic use between the LB and LB plus 
dexamethasone groups.  
 
 
Sample Size 
 
Previous studies have shown large effect sizes of greater than f=0.75 when comparing daily post-
operative VAS pain45 and cumulative narcotic use between LB and a control group. 45,59 
However, the effect sizes for differences in VAS pain and narcotic use between LB and LB plus 
dexamethasone has not been reported, but it is anticipated that they would be smaller than those 
found between LB and control group comparisons. For an analysis of variance (ANOVA) test, a 
sample size of 22 participants per group would be required, given an effect size of f=0.40, a 
power of 80%, and a two-tailed alpha level of 0.05. However, to account for 15% subject 
attrition, a total of 26 patients per group will be enrolled, yielding a total of 78 participants.  
 
 
Subject Selection 
 
Patients who meet the following criteria will be included in the study: 


 
 
 
Inclusion Criteria 
1. Age 18 and older 
2. Primary diagnosis of rotator cuff tear 
3. Able to provide informed consent 
4. Is willing and able to accept text messages 
 
Patients who meet the following conditions will be excluded from participation:  
 
Exclusion Criteria 
1. Known allergies to the study medications. 
2. Known narcotic or alcohol abuse (< 3 months) 
3. Revision rotator cuff surgery 
4. Contraindication to regional anesthesia 
5. Current narcotic regimen or contract with pain management specialist 
6. Diagnosed with any of the following co-morbidities  
a. Pre-existing coagulation disorder 
b. Diabetic patients 
 
 
Study Outcome Measures (Endpoints) 
 
Primary Endpoint: Patient-reported post-operative VAS pain (on a scale of 1-10), measured post 
operatively, in 8-hour increments, for a total of 120 hours post-surgery 
Patients will be prompted via text message to provide VAS pain every 8 hours. If a 
response text message is not received, a phone call will be made to obtain the information. 
Patients who do not have a smart phone will receive a phone call or keep a personal log of 
VAS pain.  
 
Secondary Endpoint: Patient-reported post-operative opioid use (converted to morphine 
equivalents), collected post operatively, in 8-hour increments, for a total of 120 hours post-
surgery 
Patients will be prompted via text message to provide the amount of narcotics (number of 
pills converted to morphine equivalents) taken over the course of the previous 8 hours. If a 
response text message is not received, a phone call will be made to obtain the information. 
Patients who do not have a smart phone will receive a phone call or keep a personal log of 
narcotic use.  
 
 
 
Study Procedures 
 
Subject Recruitment and Screening 
 


 
 
Participants will be recruited from the clinical practice of Dr. Brian Badman. Patients who 
present for an office visit and are diagnosed with a rotator cuff tear requiring outpatient surgical 
intervention will screened for eligibility for participation in the study. If a patient is eligible for 
the study, Dr. Badman will discuss the study with the patient and obtain informed consent during 
the routine office visit.  
 
 
Randomization 
 
This is a double-blinded study, thus, neither the surgeon nor the patient will know which type of 
interscalene block is used. A total of 78 envelopes containing   will be generated consisting of 26 
with Group 1”, 26 with “Group 2” and 26 with “Group 3” designation.  Envelopes will be sealed 
and randomly chosen by the anesthesiologist prior to surgery.  The anesthesiologist will 
randomly select one of the envelopes which will determine the treatment group and indicate 
medications that will be included in the interscalene block. Once the recipe is verified, the name 
of the patient will be added to the envelope along with the treatment group, and the envelope will 
be sealed. The treatment group and name of patient will be kept confidential until completion of 
the study.  Envelopes will be opened at end of study for data collection and analysis purposes 
with patient information deidentified.  They will be stored in a locked container at the surgery 
center only accessible by the chief of staff.  It is not possible to blind the anesthesiologist, as the 
liposomal bupivacaine is a cloudy fluid and will be obvious to the administering physician.  It is 
also prudent that the anesthesiologist is aware of the medication being administered for proper 
perioperative management of the patient.  Patients will be blinded to the medication utilized as 
well as the treating surgeon.  All anesthesiologists (sub-investigators) in the study are skilled and 
expertly trained in regional anesthesia using ultrasound guidance.   
 
 
 
 
Study Visits/ Study Duration  
 
Participants enrolled in this study will receive a peri-operative injection and be followed for a 
period of 120 hours, post-operatively. Three times per day (in 8 hour increments), patients will 
self-report VAS pain and indicate their narcotic use (number of tablets injested). Data concerning 
pain and narcotic use will be collected via text message (or phone if patients fail to respond to 
text messages). 
 
Post-operative day (POD) 
Data Collection Timepoint 
Data to be Collected 
POD 1 
8 hrs 
VAS Pain; narcotics used 
16 hrs 
VAS Pain; narcotics used 
24 hrs 
VAS Pain; narcotics used 
POD 2 
32 hrs 
VAS Pain; narcotics used 
40 hrs 
VAS Pain; narcotics used 
48 hrs 
VAS Pain; narcotics used 
POD 3 
56 hrs 
VAS Pain; narcotics used 


 
 
64 hrs 
VAS Pain; narcotics used 
72 hrs 
VAS Pain; narcotics used 
POD 4 
80 hrs 
VAS Pain; narcotics used 
88 hrs 
VAS Pain; narcotics used 
96 hrs 
VAS Pain; narcotics used 
POD 5 
104 hrs 
VAS Pain; narcotics used 
112 hrs 
VAS Pain; narcotics used 
120 hrs 
VAS Pain; narcotics used 
 
The enrollment period for study participation is anticipated to last for 12 months only for data 
analysis.  
 
Specimen Collection, Preparation, Handling and Shipping 
 
N/A 
 
Statistical Analysis Plan 
 
After data checking and validation are completed, the analysis of the data will begin with 
examination of the distribution of each of the study variables. In this process, outliers will be 
identified and evaluated for inclusion in the final study database. Appropriate summary statistics 
will be calculated. Means and standard deviations will be reported for normally distributed 
continuous variables, a median and range will be tabulated for continuous variable that are not 
normally distributed, and frequencies and percentages will be provided for categorical variables. 
The remainder of the analysis will correspond to the specific aims provided above. 
 
Specific Aims 1a-b: To determine if there is a difference in mean VAS pain between the control 
group, LB group, and LB plus dexamethasone groups, up to 120 hours post-operatively 
If data are normally distributed, analysis of variance (ANOVA) with Tukey’s HSD pairwise 
comparisons will be used to compare VAS pain between the three groups at each PODs 1-5. If 
data are not normally distributed, then Kruskal-Wallis with Dunn’s multiple comparisons tests 
will be used. 
 
Specific Aim 2a: To determine if there is a difference in time at which post-operative narcotics 
are first used among three groups receiving different interscalene blocks (LB plus 
dexamethasone, LB, and control)  
The data collection timepoint (8-hour interval) during which narcotic use begins will be 
compared between groups. If data are normally distributed, analysis of variance (ANOVA) 
with Tukey’s HSD pairwise comparisons will be used to compare time of first narcotic use 
between the three groups. If data are not normally distributed, then Kruskal-Wallis with 
Dunn’s multiple comparisons tests will be used. 
 
Aim 2b: To determine if there is a difference in patient-reported post-operative narcotic use 
(measured in morphine equivalents) among three groups receiving different interscalene blocks 
(LB plus dexamethasone, LB, and control)  


 
 
If data are normally distributed, analysis of variance (ANOVA) with Tukey’s HSD pairwise 
comparisons will be used to compare narcotic use (converted to morphine equivalents) 
between the three groups at each PODs 1-5. Cumulative narcotic use during all 5 PODs will 
also be compared between groups. If data are not normally distributed, then Kruskal-Wallis 
with Dunn’s multiple comparisons tests will be used. 
 
Potential Risks and Benefits 
 
Potential Risks 
 
 
This research is collecting data on a combination of medicines which are routinely used for nerve 
blocks. They are all FDA approved. The following risks can be related to the procedure, study 
analysis, and medications given: 
 
1. Risk of nerve block: Interscalene nerve block is a routine component of anesthesia for 
shoulder surgery. Like any medical procedure, there are risks associated with interscalene 
block. These risks include both occasional and unlikely risks. Occasional risks include 
block failure (pain immediately following the procedure), a spread of the numbing agent 
beyond its intended site causing unintended symptoms (including temporary eyelid 
droop, pupil dilation, hoarseness, and shortness of breath), and bruising at the injection 
site. Unlikely risks have been described with interscalene block. These include 
introduction of infection, damage to the lung requiring placement of a chest tube, 
injection of numbing agent into the bloodstream which can lead to heart failure and 
death, result in death and permanent nerve injury. Fortunately, these risks are extremely 
rare. Ultrasound guidance is utilized by the anesthesiologist to help accurately place the 
medications around the nerves and lessen these risks. 
2. Risk of text alerts:  A HIPPA compliant and password protected database called 
CareSense is the application that will help gather and collect the data.  Texting is not a 
secure form of communication and there is a risk of loss of privacy by entering the data.  
Measures to lessen these risks include using a password protected database and all 
personal information will be deidentified with your name removed.  In addition, the only 
information you will provide will be regarding pain level and number of pain pills taken.  
Your phone number will be kept confidential and not shared with any outside party. 
3. Risks of medications: Patients may have unknown allergies to one or more of the 
medications in the interscalene injection.  Common side effects for each medication 
utilized are listed below. 
a. Bupivicaine: Common side effects can include nausea, vomiting, chills, shivering, 
headache, dizziness, anxiety, ringing in the ears and blurred vision. 
b. Dexamethasone: Common side effects can include increased appetite, insomnia 
(difficulty sleeping), heartburn, increased blood sugar levels, irritability, nausea, 
bloating, headache and dizziness. 


 
 
c. Exparel: Common side effects can include dizziness, nausea, constipation, 
vomiting, itching, headache, and constipation.  
 
Potential Benefits 
 
An individual benefit from this study is that patients will be monitored closely via text messages 
three times per day; thus if any side effects or complications occur related to interscalene block, 
the PI will be alerted. Additionally, knowledge gained from this study will allow investigators to 
determine the most effective treatment methods for minimizing post-operative pain and narcotic 
use in patients who undergo outpatient rotator cuff surgery. These findings will benefit future 
patients.  
 
Adverse Event Reporting: 
Adverse Events 
Recording of Adverse Events 
At each contact with the subject, the investigator will seek information on adverse events by 
specific questioning and, as appropriate, by examination.  Information on all adverse events 
should be recorded immediately.  All clearly related signs, symptoms, and abnormal diagnostic 
procedures results should recorded in the source document. 
 
Notification of Adverse Events 
All adverse events will be reported according to WIRB guidelines. 
 
Ethical Considerations 
N/A 
 
Funding Source 
N/A 
 
Subject Stipends or Payments 
N/A 
 
Publication Plan 
The paper will be submitted for publication in the Journal of Shoulder and Elbow Surgery or the 
Journal of Bone and Joint Surgery upon completion. 
 
 
 


 
 
References: 
 
 
1. 
Allen, G.C., St. Amand, M.A., Lui, A.C., Johnson, D.H., Lindsay, M.P. Postarthroscopy analgesia with 
intraarticular bupivacaine/morphine. A randomized clinical trial. Anesthesiology. 1993;79:475–480. 
 
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Backes, J.R., Bentley, J.C., Politi, J.R., Chambers, B.T. Dexamethasone reduces length of 
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ICF_006.pdf: 
 
 
 
Date: 
 November 19. 2019 
 
Title:  
A Prospective Randomized Controlled Trial Examining the 
Effectiveness of a Single Shot of Liposomal Bupivicaine for 
Reducing Post-operative Pain and Narcotic Use in Outpatient 
Rotator Cuff Surgery 
NCT: 
 03822182 
 
Principal investigator:  Brian Badman, MD 
 
 
Study site address: 
American Health Network 
 8607 E US Hwy 36, Avon, IN 46123 
 
Phone: 
 
 
 (317)208-3866 
 
 
 
 
 
 
 
 
 


 
 
RESEARCH SUBJECT CONSENT FORM 
 
 
What should I know about this research? 
• Someone will explain this research to you. 
• This form sums up that explanation. 
• Taking part in this research is voluntary. Whether you take part is up to you. 
• You can choose not to take part. There will be no penalty or loss of benefits to which you 
are otherwise entitled. 
• You can agree to take part and later change your mind. There will be no penalty or loss of 
benefits to which you are otherwise entitled. 
• If you don’t understand, ask questions. 
• Ask all the questions you want before you decide. 
Why is this research being done? 
The purpose of this research is to evaluate the differences in pain scores and opioid medication 
use in patients undergoing rotator cuff repair with different methods of regional anesthesia.  
Interscalene regional anesthesia (nerve block in the shoulder area) has proven to relieve pain 
after this surgery.  This technique involves introducing a needle under ultrasound guidance and 
placing medication around the nerves exiting your neck to numb them and provide pain relief 
after surgery.  Historically, bupivacaine, a short acting numbing agent, has been the medication 
placed around the nerves during the block.  This medication alone typically wears off in 4-6 
hours.  Dexamethasone, a steroid medication, has frequently been combined with the 
bupivacaine as it has been shown to lengthen the duration of the numbing effect.  These two 
medications, therefore, are currently the medications routinely used for nerve blocks at our 
surgery center.  Recently, liposomal bupivacaine (Exparel) was approved by the FDA for 
interscalene administration for the shoulder nerve block.  This is a medication that is thought to 
provide a longer lasting numbing effect. We want to compare the standard medications 
(bupivacaine and dexamethasone) to bupivacaine and Exparel OR Bupivacaine with Exparel and 
dexamethasone to see if there is a difference in pain scores and narcotic use after surgery and to 
see if Exparel has a longer lasting effect (see table below).  About 78 subjects will take part in 
this research. 


 
 
How long will I be in this research? 
We expect that your taking part in this research will last 120 hours (5 days). 
What happens to me if I agree to take part in this research? 
You will be put into a study group by chance (like picking an envelope).  
You cannot choose your study group. Both you and your surgeon (Dr. Badman) will be blinded 
to the group you are randomized to.  This means that both Dr. Badman and you will not know 
what group you are placed in and the process of picking a group will be by chance.  You will 
select an envelope (beginning with a total of 78) that has been sealed which has your group noted 
on the inside.  After selecting the envelope you will give this to the anesthesiologist who will 
administer the block and place the selected medications based on which group you randomly 
selected and noted from the card sealed in the envelope.  Only the anesthesiologist will know 
what medications are given and your name will then be resealed back in the envelope to allow 
for data analysis at the completion of the study.  This will be sealed and stored in a locked 
container at the surgery center until the study is finalized and all 78 patients are enrolled. After  
surgery, you will be prescribed a standard regimen of pain medications consisting of oxycodone 
IR 5mg tablets that will be taken as needed. These will be prescribed as 1-2 tablets every 4-6 
hours as needed for moderate to severe pain. You will keep track of how many pain pills you 
take in an 8 hour period for 5 days after surgery. 
 
Group 1 (Control) Standard  
Group 2 
Group 3  
 
30 ml of 0.5% bupivacaine 
and 0.4ml (4 mg) of 
dexamethasone 
15ml 0.5% bupivacaine 
and 10ml of Exparel 
(133mg) and 5.4ml 
Normal Saline 
15ml 0.5% bupivacaine and 
10ml Exparel and 0.4ml  (4 
mg) dexamethasone and 5ml 
Normal Saline 
 
26 subjects 
26 subjects 
26 subjects 
 
 
During the research, you and the study doctor will not know which group you are in. (Your study 
doctor can find out in case of an emergency). 
What are my responsibilities if I take part in this research? 
If you take part in this research, you will be responsible to:  
Receive the text message and respond rating your pain on a scale of 0-10.  


 
 
0 being no pain and 10 being severe pain in your shoulder. These texts messages will alert on 
your phone (or tablet) 3 times a day, at 8am, 2pm and 8pm.   
You will also be responsible to respond to the number of pain pills taken via text. A total of 16 
data points will be collected. The first alert will occur at 8pm the evening of your surgery. 
Text alerts for both pain scores and numbers of pain pills taken in an 8 hour period will be sent 
via a secure text alert system for 5 days following your surgery.  These responses are kept secure 
in a password protected and encrypted online database called CareSense which will only be 
accessible to Dr. Badman and research staff. 
 
What are the risks of taking part in the study? 
This research is collecting data on a combination of medicines which are routinely used for nerve 
blocks. They are all FDA approved. The following risks can be related to the procedure, study 
analysis, and medications given: 
1. Risk of nerve block: Interscalene nerve block is a routine component of anesthesia for 
shoulder surgery. Like any medical procedure, there are risks associated with interscalene 
block. These risks include both occasional and unlikely risks. Occasional risks include 
block failure (pain immediately following the procedure), a spread of the numbing agent 
beyond its intended site causing unintended symptoms (including temporary eyelid 
droop, pupil dilation, hoarseness, and shortness of breath), and bruising at the injection 
site. Unlikely risks have been described with interscalene block. These include 
introduction of infection, damage to the lung requiring placement of a chest tube, 
injection of numbing agent into the bloodstream which can lead to heart failure and 
death, result in death and permanent nerve injury. Fortunately, these risks are extremely 
rare. Ultrasound guidance is utilized by the anesthesiologist to help accurately place the 
medications around the nerves and lessen these risks. 
2. Risk of text alerts:  A HIPPA compliant and password protected database called 
CareSense is the application that will help gather and collect the data.  Texting is not a 
secure form of communication and there is a risk of loss of privacy by entering the 
information on your phone. One way to protect your privacy on your phone is to lock it 
with a password. Check with your phone carrier to find out what you can do to protect the 
information on your phone.  
3. Risks of medications: Patients may have unknown allergies to one or more of the 
medications in the interscalene injection.  Common side effects for each medication 
utilized are listed below. 
a. Bupivicaine: Common side effects can include nausea, vomiting, chills, shivering, 
headache, dizziness, anxiety, ringing in the ears and blurred vision. 


 
 
b. Dexamethasone: Common side effects can include increased appetite, insomnia 
(difficulty sleeping), heartburn, increased blood sugar levels, irritability, nausea, 
bloating, headache and dizziness. 
c. Exparel: Common side effects can include dizziness, nausea, constipation, 
vomiting, itching, headache, and constipation.  
 
Will I be paid for participation? 
You will not be paid for participating in this study. 
Will it cost me money to take part in this research? 
Your insurance company will be billed as usual for your surgery. You will be responsible for 
costs your insurance does not cover. There will be no added cost to you for inclusion in this 
research. There is no added cost for individual study groups or for the group being administered 
Exparel. Based on your cell phone data plan, there may be fees associated with the text alerts that 
you may incur. 
Will being in this research benefit me? 
We cannot promise any benefits to you or others from your taking part in this research; however, 
possible benefits to you include improved pain relief after your shoulder repair because of the 
nerve block. Possible benefits to others include improved and longer pain relief, possibly making 
oral narcotics less necessary once we review the data from this study. 
What other choices do I have besides taking part in this research? 
Your alternative is to not take part in the research. Standard procedure is that you will still 
receive a regional block during your surgery and routine pain management after surgery. 
How will my information be protected? 
Efforts will be made to keep your personal information confidential.  We cannot guarantee 
absolute confidentiality.  Your personal information may be disclosed if required by law.  No 
information which could identify you will be shared in publications about this study.   
Methods to protect your information will include storing the sealed envelopes in a locked 
container at the surgery center which will only be accessible by the chief of staff until entire 
enrollment of the study.  Your information entered is also being stored in a password protected 
database called CareSense which is HIPPA compliant and only accessible by Dr. Badman and 
research staff.  All identifiable information including your name will be removed at the end of 
the study to allow for data analysis by Dr. Badman and research staff. All information will be 
kept confidential. 


 
 
Organizations that may inspect and/or copy your research records for quality assurance and data 
analysis include groups such as the study investigator and his/her research associates, the Indiana 
University Institutional Review Board or its designees, and (as allowed by law) state or federal 
agencies, specifically the Office for Human Research Protections (OHRP), and the Food and 
Drug Administration (FDA), etc. who may need to access your medical and/or research records.  
A description of this clinical trial will be available on ClinicalTrials.gov, as required by U.S. 
law.  This website will not include information that can identify you.  At most, the website will 
include a summary of the results.  You can search this website at any time.  
 
Will my information be used for research in the future? 
 
Information collected from you for this study may be used for future research studies or shared 
with other researchers for future research.  If this happens, information which could identify you 
will be removed before any information is shared.  Since identifying information will be 
removed, we will not ask for your additional consent. 
Who will pay for my treatment if I am injured?  
 
In the event of physical injury resulting from your participation in this study, necessary medical 
treatment will be provided to you and billed as part of your medical expenses.  Costs not covered 
by your health care insurer will be your responsibility.  Also, it is your responsibility to 
determine the extent of your health care coverage.  There is no program in place for other 
monetary compensation for such injuries.  However, you are not giving up any legal rights or 
benefits to which you are otherwise entitled.   
Who can answer my questions about this research? 
If you have questions, concerns, or complaints, or think this research has hurt you or made you 
sick, talk to the research team at the phone number listed above on the first page. After business 
hours, please call [the on call physician at 317-208-3866. 
 
In the event of an emergency, you may contact Dr. Badman at 317-208-3866. 
 


 
 
For questions about your rights as a research participant, to discuss problems, complaints, or 
concerns about a research study, or to obtain information or to offer input, please contact the IU 
Human Subjects Office at 800-696-2949 or at irb@iu.edu. 
Can I be removed from this research without my approval? 
The person in charge of this research can remove you from this research without your approval. 
Possible reasons for removal include: 
• It is in your best interest 
• You have a known allergy to the medication or a contraindication for regional anesthesia 
as deemed by the anesthesiologist 
• You fail to reply to the required text alerts 
We will tell you about any new information that may affect your health, welfare, or choice to 
stay in this research. 
What happens if I agree to be in this research, but I change my mind 
later? 
If you decide to leave this research, contact the research team so that the investigator can: Please 
do so in writing or verbally to Dr. Badman.  
 
PARTICIPANT’S CONSENT 
In consideration of all of the above, I give my consent to participate in this research study.  I will 
be given a copy of this informed consent document to keep for my records.  I agree to take part 
in this study. 
 
Participant’s Printed Name: 
 
 
Participant’s Signature: 
Date: 
 
 
Printed Name of Person Obtaining Consent:  
 
 
 


 
 
Signature of Person Obtaining Consent: 
Date: