Conditions: Pain, Postoperative
Keywords: transversus abdominis plane postoperative pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 14
Healthy volunteers: no

Brief summary:
This clinical trial will examine differences in the effectiveness between three (3) commonly used methods and/or medications used to perform a transversus abdominis plane (TAP) block for post-operative pain control. The transversus abdominis muscle is either side between the lowest rib and the hip bone. Group A subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine injected into the TAP. Group B subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine into the TAP. Group C subjects will be treated with a continuous infusion of the local anesthetic ropivacaine with the ON-Q® pump. There will be no placebo group in this study.

Detailed description:

Arms:
arm 1: Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane. arm 2: Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane arm 3: Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump

Interventions: intervention 1: Bupivacaine intervention 2: Exparel® intervention 3: Ropivacaine
Intervention descriptions: intervention 1: 60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block. intervention 2: 20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block. intervention 3: 40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side.

Protocol document:
Prot_SAP_000.pdf: 
 
 
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TRANSVERSUS ABDOMINIS PLANE (TAP) BLOCK STUDY FOR 
POSTOPERATIVE PAIN CONTROL 
 
Lead Institution 
PI:  Joshua Herskovic, MD 
Midwestern Regional Medical Center 
Department of Anesthesiology 
Zion, IL 
 
Data Analysis Center 
Oncore ERM Data Management and Informatics Staff 
 
 
Protocol Number: MZ2014035_TAP  


 
 
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Table of Contents 
A 
Introduction ......................................................................................................................... 4 
Study Abstract ........................................................................................................................ 4 
Primary Hypothesis ................................................................................................................ 5 
Purpose of the Study Protocol ................................................................................................ 5 
B 
Background ......................................................................................................................... 5 
Prior Literature and Studies .................................................................................................... 5 
Rationale for this Study .......................................................................................................... 6 
C 
Study Objectives ................................................................................................................. 7 
Primary Aim ............................................................................................................................ 7 
Secondary Aim ....................................................................................................................... 7 
Rationale for the Selection of Outcome Measures .................................................................. 7 
D 
Investigational Agent ........................................................................................................... 8 
E 
Study Design ...................................................................................................................... 8 
Overview or Design Summary ................................................................................................ 8 
Subject Selection and Withdrawal .......................................................................................... 9 
E2.a 
Inclusion Criteria ................................................................................................... 9 
E2.b 
Exclusion Criteria .................................................................................................. 9 
E2.c 
Ethical Considerations .........................................................................................10 
E2.d 
Subject Recruitment Plans and Consent Process ................................................10 
E2.e 
Randomization Method and Blinding ....................................................................10 
E2.f 
Risks and Benefits ...................................................................................................10 
Early Withdrawal of Subjects..............................................................................................12 
E2.g 
Data Collection and Follow-up for Withdrawn Subjects ........................................13 
Study Drug/Device.................................................................................................................13 
E3.a 
Description ...........................................................................................................13 
E3.b 
Method for Assigning Subjects to Treatment Groups ...........................................15 
E3.c 
Preparation and Administration of Study Drug .....................................................15 
E3.d 
Subject Compliance Monitoring ...........................................................................16 
E3.e 
Prior and Concomitant Therapy ...........................................................................16 
E3.f 
Packaging/Labeling .................................................................................................16 
E3.g 
Blinding of Study Drug .........................................................................................16 
E3.h 
Receiving, Storage, Dispensing and Return .........................................................17 
F 
Study Procedures ..............................................................................................................17 
Screening for Eligibility ..........................................................................................................17 
Schedule of Measurements ...................................................................................................17 
Safety and Adverse Events ...................................................................................................17 
F3.a 
Safety and Compliance Monitoring ......................................................................17 
F3.b 
Medical Monitoring ...............................................................................................17 
F3.c 
Definitions of Adverse Events ..................................................................................18 
3.d    Classification of Events .............................................................................................18 
F3.d 
Data Collection Procedures for Adverse Events ...................................................18 
F3.e 
Reporting Procedures ..........................................................................................18 
F3.f 
Post-study Adverse Event .......................................................................................18 
F3 Study Outcome Measurements and Ascertainment ..........................................................19 
G 
Statistical Plan ...................................................................................................................19 
Sample Size Determination and Power ................................... Error! Bookmark not defined. 


 
 
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Interim Monitoring and Early Stopping ...................................................................................19 
Analysis Plan .........................................................................................................................19 
Statistical Methods ................................................................................................................20 
Missing Outcome Data ..........................................................................................................21 
Unblinding Procedures ..........................................................................................................21 
H 
Data Handling and Record Keeping ...................................................................................21 
Confidentiality and Security ...................................................................................................21 
Training .................................................................................................................................22 
Case Report Forms and Source Documents .........................................................................22 
Records Retention .................................................................................................................22 
Performance Monitoring ........................................................................................................22 
I 
Study Monitoring, Auditing, and Inspecting ........................................................................22 
Study Monitoring Plan ...........................................................................................................22 
Auditing and Inspecting .........................................................................................................22 
J 
Study Administration ..........................................................................................................22 
Organization and Participating Centers .................................................................................22 
Funding Source and Conflicts of Interest ...............................................................................22 
Subject Stipends or Payments ...............................................................................................23 
Study Timetable ....................................................................................................................23 
K 
Publication Plan .................................................................................................................23 
L 
Attachments .......................................................................................................................24 
Schedule of Measurements Template ...................................................................................24 
M 
References ........................................................................................................................25 
 
 


 
 
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A Introduction 
Study Abstract 
As an anesthesiologist our goal is not only to ensure the patient does well during the operation 
but to also assist in the post-operative recovery period.  Crucial to this is controlling post-op 
pain.  A patient with poorly controlled pain will have trouble ambulating after surgery, taking 
deep breaths, and performing daily activities.  This predisposes the patient to comorbidities 
including infectious processes such as developing pneumonia and impairs the healing response 
which requires adequate oxygen delivery to critical tissue beds.  Furthermore, blocking 
perception of pain prevents development of chronic pain syndromes.  Thus, blocking the 
response to pain plays a critical role in anesthesiology. 
 
Furthermore, opioids are well known immune system suppressants.  Regional analgesic 
techniques that limit the use of opioids for postoperative pain may lower the risk for metastasis 
and recurrence of certain cancers.  The body’s response to the stress of surgical trauma may 
also facilitate a release of tumor cells into the circulation 1-3 General anesthetic agents and 
opioids can suppress the immune response, and may further affect the functions of certain 
cells.1,3 These immune inhibiting effects, combined with the immunosuppression related to acute 
pain may promote the evolution of cancer cells in clinical metastases by providing a conduit for 
tumors to proliferate.1,3 
 
For many of our patients who undergo lower abdominal surgeries we choose a general 
anesthetic along with a regional technique called a TAP (transversus abdominis plane) block. 
The purpose of the latter is to treat the patient’s post-operative pain.  The name of this block is 
derived from relationship of the nerves that provide sensation to the abdomen and the muscle 
layers (namely the internal oblique and the transversus abdominis abdominal muscles) these 
nerves pass through.  This is referred to as the TAP space.  Although the TAP block has existed 
in anesthesia for decades it was not utilized much until the recent introduction of ultrasound 
imaging into anesthesia practice.  Prior to the availability of ultrasound imaging, the TAP block 
was performed blindly and sometimes with inadequate pain relief.  Now via an ultrasound probe 
we can clearly see the muscle layers and visualize the placement of the local anesthetic or 
catheter into the TAP space area.  The goal of this block is to inject, usually under ultrasound 
guidance, a local anesthetic such as Bupivacaine in said space; thus, effectively blunting the 
patients perception of abdominal pain due to incision from surgery.4-6 Depending on the amount 
of drug injected the block can last anywhere between 20-30 hrs, which correlates with the time 
period patients would report the most discomfort from incisional pain.   
 
By placing a small catheter in the TAP space (continuous TAP block), local anesthetic can be 
continuously infused for a period of a few days thus extending the duration of pain relief up to 3 
days.7 Recently, the pharmaceutical drug Exparel has gained acceptance as a local anesthetic 
to be used for local infiltration of incisional sites including infiltrative blocks such as the TAP 
block.  Exparel® combines the local anesthetic Bupivacaine with an injectable liposomal delivery 
system called DepoFoam.  The pharmacokinetics of this delivery system is suggested to 
provide a continuous release of Bupivacaine over 3 days.  Thus, it can be argued if a single 


 
 
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injection of Exparel can provide adequate pain relief over 3 days it can make obsolete the need 
to place a continuous nerve block catheter.  There are significant benefits to this.  It requires 
more skill and time to place a catheter versus a single injection of a local anesthetic for a TAP 
block.  Other benefits are related to the avoidance of catheter maintenance including dressings, 
leakage at catheter insertion site, and the need for additional infusion pumps.  Furthermore, any 
catheter has the possibility of infection or bleeding.   
 
It is the purpose of this study to evaluate the efficacy of methods that allow for continuous 
release of local anesthetic in the TAP space, either via catheter or via injecting Exparel® a slow 
release liposomal space versus the standard single injection Bupivacaine in the TAP space.  
The study shall consist of three (3) arms of which patients will be randomly assigned: 
Continuous TAP block (CTAP) via Catheter, Single Injection TAP block with the slow release 
liposomal Exparel, and Single Injection TAP block with Bupivacaine.   Several parameters will 
be measured with the primary goal being to determine the effectiveness and duration of post-
operative pain relief.8,9 
 
Primary Hypothesis 
Methods that allow for continuous release of local anesthetic in the TAP space will decrease 
total narcotic requirements vs. the standard single shot Bupivacaine control.  A continuous 
release of local anesthetic in the TAP space via catheters over 2 days will result in lower total 
narcotic requirements when compared to the single shot Bupivacaine injection technique when 
measured over 48 hrs.  The Liposomal agent Exparel® which releases the Bupivacaine local 
anesthetic over three days should also allow for a single injection technique that can provide 
similar post-operative pain response to that of the catheter method without the need to place a 
catheter in the TAP space.  Post-operative narcotic requirements are inversely related to post-
operative pain control and patient satisfaction and total narcotic requirements will be 
significantly higher in the single shot group vs. the continuous release groups over 48 hrs. 
Purpose of the Study Protocol 
The purpose of this study protocol is to ensure consistent implementation of this study across all 
study sites. 
B Background 
Prior Literature and Studies 
The analgesic efficacy of the TAP block has been demonstrated in prospective randomized 
trials compared with placebo, in several surgical procedures such as abdominal surgery3, 
hysterectomy2, retro-pubic prostatectomy1, Caesarean section7, laparoscopic cholecystectomy5, 
and appendicectomy6. These studies reported superiority of the TAP block in terms of reduction 
in visual analogue scale scores and narcotic consumption.  In two of the studies, the authors 
suggest the decrease in morphine consumption lasted for 2 days4. However, this difference was 
established during the first 24 hr. and remained stable thereafter. Therefore, we can assume the 
analgesic effect of the TAP block persists for at least 24 hr. and the TAP block should be 


 
 
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considered an integral part of a multimodal analgesic strategy including systemic analgesic 
agents to control residual pain. The fact that the TAP block may contribute to decreasing the 
incidence of narcotic side effects such as nausea and vomiting is also beneficial to the patient's 
rehabilitation.   
Rao Kadam, et al., compared epidural to continuous TAP block, Epidural versus continuous 
transversus abdominis plane catheter technique for postoperative analgesia after abdominal 
surgery10, finding no significant difference in terms of post-operative narcotic requirements. 
Although the study was underpowered, given the accepted and well-studied use of thoracic 
epidural for controlling post-operative pain, this is highly suggestive of the Continuous TAP 
block’s efficacy for controlling post-operative pain. 
Petersen, et al., demonstrated the spread of the TAP sensory block is also partly maintained by 
a continuous 24 hour Ropivacaine infusion via a TAP catheter versus a placebo infusion, 
transversus abdominis plane (TAP) block with 24 hours Ropivacaine infusion via TAP catheters: 
A randomized trial in healthy volunteers7.  
Xan Jacobs, et al., conducted a Retrospective Review of Exparel® in Infiltration-transversus 
Abdominis Plane (i-TAP) Blocks in Hand-assisted Nephrectomy and Colorectal Procedures11.  
These findings suggest that that the use of Exparel® in i-TAP blocks is a useful adjunct to 
postoperative pain control up to 72 hours post-injection in those patients undergoing hand-
assisted abdominal procedures. This study also suggests a favorable safety profile with no 
adverse events related to the use of Exparel in an infiltrative TAP block. 
Although, there is a fair amount of literature and case reports for TAP block for post-op pain; 
there is very little data that goes out as far as 72 hrs.  Furthermore, those studies (albeit limited) 
demonstrate a difference that is not considered statistically significant  between single shot TAP 
block and controls that did not receive TAP block at 72 hrs.  Studies do however show a 
statistically significant difference in narcotic requirements and pain scores at 24 hrs (post-
operative day [POD] #1), and at 48hrs (POD #2) between single shot TAP and placebo 4,12 and 
also between continuous TAP techniques and placebo13.  However, no direct comparison study 
exists between continuous TAP Block techniques and standard single shot Bupivacaine 
technique. Using prior studies as a reference and making the appropriate equianalagesic 
conversions to account for the difference in narcotic potencies used in the various studies we 
can come to the expectation that total hydromorphone (Dilaudid) requirements would be roughly 
50% lower in the continuous catheter TAP technique vs. the standard single shot Bupivacaine 
TAP technique at 48hrs.  We estimate total Hydromorphone requirements over 48 hrs. in the 
control (single shot TAP) to be equal to 4.1mg versus the continuous catheter TAP group 
equaling 2.4 mg.  We would also assume Exparel TAP to be equal to catheter TAP at 2.4 mg.  
Furthermore, Visual Analog Scales as expected follow a similar trend, with the most significant 
difference seen at 48 hrs.4,11-13 
Rationale for this Study 
The rationale for this study is to examine the post-operative pain benefits of continuous release 
TAP techniques (Catheter technique and liposomal slow release Exparel® technique) versus the 


 
 
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standard single shot Bupivacaine injection for TAP block.  Therefore, in this study the standard 
single shot Bupivacaine technique acts as the control. 
Although both modalities of continuous release TAP block have been proven versus placebo to 
provide post-operative pain relief over an extended time period; there is no such study that 
directly compares the standard single shot Bupivacaine technique to the continuous release 
TAP techniques in terms of quality or ability to control post-operative pain.  Given the significant 
increased cost along with in the case of the catheter group skill, procedural time, and 
maintenance management there should be a significant improvement in post-operative pain 
duration versus the single shot Bupivacaine TAP block technique. 
Furthermore, our expectation is that this difference will be most apparent at 48 hrs. as 
discussed above with a reduction in narcotic requirements greater than 40% in the continuous 
catheter TAP group vs. standard single shot Bupivacaine TAP (4.1 mg +/- 3 mg vs. 2.4 mg +/- 
1.3 mg Dilaudid).  This is based on the assumption that the effects of the local anesthetic control 
TAP (single shot Bupivacaine) may last up to 24 hrs.  At 72 hrs, prior studies, although limited, 
have not shown a significant difference between TAP block and placebo groups. 
 
C Study Objectives 
Primary Aim 
The primary aim is to evaluate for any significant difference total post-operative narcotic 
requirements (Dilaudid) required over 48 hrs. in the  continuous catheter TAP block arm vs. the 
single shot Bupivacaine TAP arm and again the slow release Liposomal Exparel® TAP arm vs. 
the single shot Bupivacaine TAP arm.   
Secondary Aim 
The secondary aim will be to evaluate for any significant difference in narcotic requirements at 
other endpoints such as 24 hrs and at 72 hrs.  As discussed before, current studies do not show 
a significant difference when extrapolated out at those end points, albeit there is very little data 
at 72 hrs.  Other quality indicators of recovery in the three arms such as Visual Analog Scores 
(VAS) are expected again to be most significantly different at 48 hrs.  Other quality measures 
that will be recorded include incidence and severity of post-operative nausea and vomiting 
(PONV), time to ambulation, and patient satisfaction with post-operative pain control.  
Rationale for the Selection of Outcome Measures 
Outcome measurements are based on the assumption that narcotic requirements (i.e. 
intravenous Dilaudid Patient-Controlled Analgesia [PCA] use) are inversely related to patient 
satisfaction in regards to their post-operative pain.  Additional factors such as VAS, ambulation, 
performance of daily activities, and anti-emetic pharmaceutical requirements have been chosen 
as quality indicators in regards to post-operative pain control and dependence on narcotics. 


 
 
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D Investigational Agent  
This investigation will use three FDA-approved techniques:  
• 
Bilateral Continuous TAP block via Catheter (One-time bolus of Bupivacaine 0.25% x 
20ml per side followed by continuous infusion of Ropivacaine 0.2% 7 ml/hr. per side x 48 
hrs.);  
• 
Single Injection TAP block with Exparel® (One-time bolus of Bupivacaine 0.25% x 20 ml 
followed by Exparel 133 mg per side); and  
• 
Single Injection TAP block with Bupivacaine 0.25% (25 ml-30 ml volume one-time bolus 
per side).   
E Study Design  
Overview or Design Summary 
It is the purpose of this study to evaluate the efficacy of continuous TAP block via catheter 
versus single shot Bupivacaine TAP block and also to evaluate the efficacy of slow release 
Exparel® versus single shot Bupivacaine The study shall consist of three (3) arms of which 
patients will be randomly assigned: Bilateral Continuous TAP block via Catheter (One time 
bolus of Bupivacaine 0.25% x 20 ml per side followed by continuous infusion of Ropivacaine 
0.2% 7 ml/hr. per side x 48 hrs); Single Injection TAP block with Exparel® ( One time bolus of 
Bupivacaine 0.25% x 20 ml followed by Exparel 133 mg per side); and Single Injection TAP 
block with Bupivacaine 0.25% (25-30 ml volume one time bolus per side).  Several parameters 
will be measured with the primary goal being to determine the effectiveness and duration of 
post-operative pain relief of the newer techniques of extending TAP block duration with the 
current, commonly used standard single shot Bupivacaine technique.  Because a goal of this 
study is to determine which technique of TAP block is most effective for post-operative pain 
control, the three (3) arms of this study will be performed in a manner that is most consistent 
and common with current anesthesia practice.  Because TAP block is typically most effective for 
lower and mid-abdominal incisional pain relief, the nature and height of the incision with regard 
to the umbilicus will also be recorded. 
 
Parameters Measured: 
 
1) Total Post-operative Narcotic Requirements over at 24, 48 and 72hrs. 
 
2) Days of IV PCA use: Time to 1st dose, total IV PCA requirements, POD# 0, 1, 2, & 3, 
additional narcotic use and additional adjuvants 
 
3) PACU narcotic requirements 
 
4) Pain Score:0-10 on post-operative day (POD)# 0, POD #1, POD #2, POD #3 (am, pm, 
Max Pain score per day, Pain score at rest, and Pain score with activity)  
 
5) Day to Ambulation: O=out of bed assisted/unassisted, W= walk with/without assistance 
 
 


 
 
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6) Day of Foley removal 
 
7) Day of first Bowel Movement 
 
8) Anti-emetic Drug (Zofran) requirements. 
 
9) Surgical Incisional height in relation to umbilicus or Type of Surgery (recorded by 
anesthesiologist) 
 
10) Anesthesia provider placing TAP block 
 
11) Patient weight/BMI 
 
12) Day of discharge 
 
Subject Selection and Withdrawal  
Patients who would normally be selected to receive a TAP block, e.g., those patients with an 
abdominal or pelvic incision of the degree that would benefit from a TAP block, will be randomly 
assigned to one of three arms: TAP block via Catheter, TAP block via single shot injection of 
Bupivacaine, TAP block via single shot injection of Exparel.  Patients may elect not to have a 
TAP block performed.  Patients with indwelling TAP block catheters may at any time elect to 
have their TAP block catheters removed prior to the completion of 72 hrs. of treatment.  
E2.a 
Inclusion Criteria 
i 
Participants will have signed a informed consent. 
ii 
Participants will be 18 years or older 
iii 
Scheduled for open abdominal surgery 
iv 
American Society of Anesthesiologists physical status (ASA) 1-3 
E2.b 
Exclusion Criteria 
i 
Participants are not able to understand or provide written informed consent, or for 
children, are unable to assent. 
ii 
The research team deems that the participant may not be able to follow the study 
protocol. 
iii 
Complicated history of chronic opioid use 
iv 
Allergy to local anesthetics  
v 
Contraindication to regional nerve block (bleeding disorder, sepsis or infection at 
site) 


 
 
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vi 
BMI >40 because of difficulty in placing the catheter 
vii 
Pregnancy 
viii 
Complicated history of chronic opioid use including the daily use of opioids for a 
period of greater than 2 weeks prior to surgery 
E2.c 
Ethical Considerations  
This study will be conducted following all local laws and regulations in the conduct of research, 
as well as the International Conference on Harmonisation Good Clinical Practice Guidelines.  
These guidelines provide a unified standard for designing, conducting, recording, and reporting 
trials that involve the participation of human subjects. 
In addition, this study will be reviewed and approved by appropriate Institutional Review Boards 
prior to the initiation of any study procedures.  Any modifications to this protocol will be 
submitted to and approved prior to submission to the appropriate Institutional Review Board(s) 
prior to initiation unless implementation is required to avoid an apparent immediate hazard for 
subjects.  The protocol will undergo continuing review and approval by all IRB’s providing 
ongoing oversight of the study.   
E2.d Subject Recruitment Plans and Consent Process 
Subjects will be consented using a current informed consent form that has been approved by 
the respective study site’s Institutional Review Board.  Subjects will be allowed adequate time to 
read the informed consent, discuss the consent with study staff and others (e.g., family 
members, friends, or any of their health care providers), and have their questions answered 
prior to signing the informed consent.  In some cases, a site may not accrue study subjects but 
serve as a data analysis site so informed consent may be waived for that site. 
Site-specific recruitment plans and consent process are outlined in Attachment L1. 
E2.e Randomization Method and Blinding 
Subjects that would normally be selected to receive a TAP block will be randomly assigned into 
one of the three arms.  A random number generator will be used to generate an equal 
proportion of responses of the three arms.  These responses will be sealed in envelope. The 
anesthesia provider will be allowed to open the envelope and become aware of the selected 
arm after the initiation of anesthesia (this would include the administration of a pre-medication or 
initiation of general anesthesia). Complete blinding is impossible to staff given the visual 
presence of a catheter in some groups versus the lack of catheters in other groups.  In addition, 
the agent Exparel® has a milky color that is obvious to the anesthesia provider injecting it.  
However, the nursing staff on the floor will not be made aware of the use of Exparel® versus 
Bupivacaine in the single injection arms. 
E2.f 
Risks and Benefits 
i 
Risks  


 
 
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Potential physical risks include: 
TAP block is a relatively low risk regional anesthesia technique with a long track record.  
However, any injection or insertion of a catheter into the body carries a slight risk of bleeding, 
bruising at injection or insertion site, and infection at injection or insertion site.  Risks particular 
to an injection of a local anesthetic into the abdominal area would be bowel perforation, local 
anesthetic toxicity, and drug allergy.  These risks are unlikely and similar to an abdominal 
paracentesis.  Furthermore, the author is unaware of any episodes of bowel perforation from the 
administration of a TAP block.  
The following are side effects have been seen with the local anesthetics Bupivacaine and 
Ropivacaine: 
• 
Low blood pressure 
• 
Nausea and/or vomiting 
• 
Slow heartbeat 
• 
Fever 
• 
Pain 
• 
Post-operative complications 
• 
Low blood hemoglobin (anemia) 
• 
Tingling of the fingers or toes 
• 
Headache 
• 
Itching 
• 
Back pain 
• 
Retention of urine or low urine 
output 
• 
Dizziness 
• 
Decreased touch sensation 
• 
Anxiety 
• 
Chest pain 
• 
Low blood potassium 
• 
Shortness of breath 
• 
Muscle cramps 
• 
Urinary tract infection
The following are side effects have been seen with Exparel®
• 
Nausea 
• 
Constipation 
• 
Vomiting 
• 
Fever 
• 
Dizziness 
• 
Swelling of the arms or legs 
• 
Anemia (including post-operative 
or due to bleeding) 
• 
Low blood pressure 
• 
Itching 
• 
Rapid heartbeat 
• 
Headache 
• 
Insomnia 
• 
Muscle spasms 
• 
Back pain 
• 
Sleepiness 
• 
Procedure pain 
 
Potential psychological risks include: 
Catheter leakage at insertion site may cause dissatisfaction in that specific study arm.  
Also leakage may cause perceived risk of catheter dysfunction to the patient.  Because 
leakage can occur in a fully functioning catheter this may influence patients reported 
post-op pain response.  Also, due to the slightly increased risk of infection in the catheter 
group, any signs of infection would cause significant dissatisfaction in that specific arm.  
In addition, the visual sight of catheters along with a pump may cause the patient anxiety 
along the feeling of additional tubes preventing daily activity.  This will be minimized by 


 
 
 
 
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maintaining a clean dressing over the catheter site and the use of a fanny pack the 
patient wears at their waist side that will contain the OnQ® infusion system.  
 
Potential social risks include: 
There is a possible social risk of embarrassment or reputational standing while 
responding to questionnaires or interviews. 
Using trained interviewers and maintaining your records in locked cabinets or secure 
computer files will minimize this risk. 
ii 
Benefits 
The benefits that the subject may get from being in this study are improved post-
operative pain response and quicker recovery time following surgery.  A patient with 
improved post-operative pain will be at lower risk for pulmonary infection and circulatory 
issues because they will ambulate sooner along with decreased degree of pulmonary 
atelectasis.  Decreased dependence on narcotics will also lead to faster recovery of 
bowel function.  This overall will lead to increased patient satisfaction and earlier 
discharge from the hospital.  
Early Withdrawal of Subjects  
Subjects may be withdrawn for the following reasons: 
Subjects may be withdrawn from the study early due to complications secondary to the 
surgery itself such as sepsis, bowel dysfunction unrelated to narcotic use, and the need 
for further exploratory surgery.   
Catheter dysfunction due to dislodgment or severe leakage may also precipitate early 
withdrawal from the study.  Bleeding, infection, or need to anti-coagulate may cause 
premature need to remove the catheters from the patients.  In these cases, the data will 
continue to be recorded as in the other arms; however, time of catheter removal will also 
be recorded. 
Failure to perform an adequate block will also cause withdrawal from the study.  
Reasons for said failure would include: inability to visualize TAP space on ultrasound 
and surgical site preventing use of bilateral TAP block. 
Failure to place catheter after successful bolus of local anesthetic would move patients 
from the CTAP group to an un-randomized single shot Bupivacaine arm. Patients will be 
followed until completion of the study.  This data may be analyzed separate or as part of 
the single shot Bupivacaine group.   
Failed block is a withdrawal prior to first study follow up; these patients would need to be 
replaced or moved to an open un-randomized arm.  
Subjects may also be withdrawn from the study if it at any time it is determined that they 
did not meet inclusion exclusion criteria. 
 


 
 
 
 
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iii 
Subject safety 
iv 
Non-compliance with study visit schedule or study regimen 
Subjects may be involuntarily exited from the study for failure to comply with the 
protocol, failure to attend follow-up visits, or for other reasons. The investigator shall 
arrange for an exit visit and complete the case report form for the subject to the 
extent there is data available. 
Subjects may voluntarily withdraw from the study at any time without reason. The 
investigator shall make an effort to obtain an exit visit and complete the case report 
form for the subject to the extent there is data available.  The investigator cannot 
require that an exit interview take place.  
E2.g Data Collection and Follow-up for Withdrawn Subjects  
1) Reason for withdrawal from study (i.e. block failure, catheter failure, drug toxicity, 
sepsis, patient request) 
2) Day of withdrawal from study 
 
Study Drug/Device  
E3.a Description 
The ON-Q® device is considered a non-significant risk device which has been 
marketed for postoperative pain management since 1998.   
Description of Device:  
The ON-Q® Pain Management System (Device), an FDA-cleared disposable 
elastomeric infusion pump designed to deliver local anesthetic to or near the surgical 
sites or nerve bundles to relieve postoperative pain. 
A capillary flow-restricting orifice located at the end of the tubing and the positive 
pressure system of the elastomeric infusion pump maintains a consistent flow rate. 
The pump is filled in a sterile fashion in either pharmacy or the operating room with 
local anesthetic, and connected to a Catheter, which is placed by the 
anesthesiologist or the surgeon, in a sterile fashion, tunneled to an appropriate 
location. The pump offers a continuous regulated infusion at a rate determined by the 
anesthesiologist or surgeon.   It is small, completely portable, and can be attached to 
the patient's gown or worn in a small wait pack to facilitate ambulation.  The device 
used for the Study will be a standard unit of the device as produced for sale, with no 
modifications to the device or changes to the labeling. 
 
Description of Drugs use for other two arms: 
Exparel:  Exparel is an extended release liposome injection of bupivacaine designed 
to achieve long-acting postoperative analgesia.  The drug consists of microscopic, 


 
 
 
 
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spherical, lipid-based particles (the DepoFoam drug delivery system) composed of a 
honeycomb of numerous, nonconcentric, internal aqueous chambers containing the 
encapsulated bupivacaine.  Each chamber is separated from adjacent chambers by 
lipid membranes.  This product was originally named Skye and then following 
transition of ownership of the product by Pacira was termed generically as 
DepoFoam® bupivacaine.   
Ropivacaine Naropintm: Ropivacaine Hydrochloride is a local anesthetic (injectable) 
of similar efficacy to Bupivacaine for use in surgery, postoperative pain management, 
and obstetrical procedures when local or regional anesthesia is needed. It can be 
administered via local infiltration, epidural block and epidural infusion, or intermittent 
bolus.  Although similar to the local anesthetic Bupivacaine, it does have a more 
favorable cardiac toxicity profile when given in large doses. 
Description of standardized protocol for the treatment of breakthrough pain including 
all adjunctive therapies given for pain management: 
Initial rescue IV pain medication will be made available similarly in all three study 
arms and will consist primarily of the IV opioids Dilaudid (or Morphine if patient does 
not tolerate Dilaudid).   
All post-surgical patients are given a Dilaudid (or the equivalent dose of Morphine if 
not tolerated) IV PCA with every 10 minutes bolus function following surgery to be 
initiated immediately upon admission and transfer from the PACU to the floor.  A 
clinician bolus of Dilaudid 0.5 mg every 30 minutes will be made available for 
additional pain control if needed.   
Acetaminophen (Tylenol) will also be made available for treatment of post-operative 
pain on the floor.  
 
Treatment Regimen  
Patients assigned to the study group will randomly be assigned to one of the three 
arms described above.  Patients in the catheter arm will receive a commercially 
available ON-Q® pain management system filled with 0.2% Ropivacaine. The ON-Q® 
system consists of an ON-Q® elastomeric infusion pump that will be connected to an 
end-orifice catheter.  Patients in the catheter arm will receive a 20 ml bolus of 
Bupivacaine via Tuohy needle in the TAP space followed immediately by tunneling of 
a catheter into the TAP space under ultrasound guidanceprior to extubation and 
complete emergence from general anesthesia.  Said catheter will be left to infuse 
continuous local anesthetic site up to post-operative day 3.  Patients in the two (2) 
single injection arms will similarly receive a bilateral injection of study local anesthetic 
(Exparel or Bupivacaine) 25-30ml per side in the TAP space prior to the conclusion 
of surgery under ultrasound guidance.  Intra-operatively patients in all three study 
arms will receive IV fentanyl and IV Acetaminophen 1000mg unless drug allergy or 
intolerance to either medication.  


 
 
 
 
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Initial rescue IV pain medication will be made available similarly in all three study 
arms according to the institution’s protocol for PACU breakthrough pain and will 
consist primarily of IV Dilaudid (or Morphine equivalent if patient does not tolerate 
Dilaudid).  All post-surgical patients are given a Dilaudid (or Morphine if not tolerated) 
IV PCA with q10min bolus function following surgery to be initiated immediately upon 
admission and transfer from the PACU to the floor.  A clinician bolus of Dilaudid 
0.5 mg every 30 minutes (or Morphine equivalent) will be made available for 
additional pain control if needed.  Tylenol will also be made available for treatment of 
post-operative pain on the floor. 
 
E3.b Method for Assigning Subjects to Treatment Groups  
Randomization will occur following the consent process and prior to surgery.  The on-site 
personnel will manage the randomization.  A random number generator will be used to 
assign patients to one of three arms and the anesthesia provider will be unaware of 
which arm the patient is assigned to until after initiation of anesthesia (see section E2.e). 
E3.c 
Preparation and Administration of Study Drug  
Patients in the single shot arms (Bupivacaine 0.25% and Exparel) will receive 
bilateral bolus injections of the local anesthetic t prior to extubation (waking up from 
General Anesthesia).  Patients in the continuous catheter arm will also receive a 
bolus injection of local anesthetic prior to the placement of the catheter.  Those 
patients will also receive a pump.  
1) 
Bupivacaine 0.25% Arm: A total of 60 ml Bupivacaine 0.25% from two 
30 ml vials will be pre-drawn up via 60 ml Syringe.  The syringe will be 
connected and a 10ml flush syringe containing 10ml 0.9 NS will be 
connected to the end of an IV extension set via a 3-way stopcock and 
luer lock connections.  The Bupivacaine 0.25% syringe will also be 
connected to the stopcock. The distal end of the IV connection will be 
maintained sterile and will be connected to the injection needle. Then the 
procedure is as follows: Step 1) The entire setup will be flushed with 
0.9NS via flush syringe. 2) The TAP space will be located under 
ultrasound guidance and verified by using the 0.9% NS flush syringe.  
Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into 
the TAP space (This dose will be decreased to 25ml for patients under 
70 kg). Steps 2 and 3 will be repeated on the opposite side TAP block. 
2) 
Exparel Arm: The entire contents of one 20 ml Exparel vial (266 mg) will 
be drawn up 20 ml syringe.  40ml Bupivacaine 0.25% will be pre-drawn 
into 2x 20 ml syringes and connected to a stopcock. The syringe 
containing the Exparel solution will also be connected to the stopcock. 
The distal end of the IV connection will be maintained sterile and will be 
connected to the injection needle. Procedure Step: 1) The entire setup 


 
 
 
 
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will be flushed with the Bupivacaine syringe.  2) The TAP space will be 
located using the Bupivacaine syringe under ultrasound guidance.  3) 
Once the TAP space, Exparel 133mg will be injected into the TAP 
space. 4.) After injection, the syringe will be exchanged for the 
Bupivacaine syringe and the residual Bupivacaine will be injected into 
the space (~20ml).  Steps 2-4 will be repeated for the opposite side TAP 
block. 
3) 
Continuous Catheter Arm:  A total of 40 ml Bupivacaine 0.25% vials will 
be pre-drawn up via two 20 ml Syringes.  The Bupivacaine 20ml syringe 
will be connected to IV tubing. The distal end of the IV connection will be 
maintained sterile and will be connected to the injection touhy needle.  
Procedure step 1) The entire setup will be flushed with the Bupivacaine 
syringe.  2) The TAP space will be located using the Bupivacaine syringe 
and ultrasound guidance. 3) Once in the TAP space, 5-10ml 
Bupivacaine 0.25% will be injected into the TAP space. The IV extension 
will then be disconnected from the touhy needle and a catheter will then 
be threaded via the touhy needle and into the TAP space.  The proximal 
end of the catheter will then be connected to the distal end of the IV 
extension set and the residual Bupivacaine 0.25% from the 20ml syringe 
will then be injected thru the catheter.  The catheter will then be secured 
and dressed via standard technique for catheter placement.  Steps 2-4 
will then be repeated for the opposite side TAP block.  In the PACU, 
patients will receive a pre-filled ON-Q® system obtained through the 
hospital pharmaceutical department.  The pre-filled ON-Q® system 
contains Ropivacaine 0.2% in a 700 ml container.  The infusion pump 
will be set to run at a rate of 7 ml/hr. per side. 
Breakthrough pain will be managed similarly in all three arms via Dilaudid IV PCA 
every 10 minutes with clinician bolus function of 0.5 mg every 30 minutes. 
E3.d Subject Compliance Monitoring  
The Principal Investigator will oversee compliance with study procedures.  
E3.e Prior and Concomitant Therapy  
N/A 
E3.f 
Packaging/Labeling 
N/A 
E3.g Blinding of Study Drug  
It will be impossible to blind the catheter group from practitioners and floor care nurses 
given the obvious appearance of the catheters.  However, the floor care nursing and 
staff will be blinded between the single injection arms: Exparel and Ropivacaine.  The 


 
 
 
 
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anesthesia provider placing the block will similarly not be blinded given the need to place 
the catheters and the milky coloration of the Exparel drug when compared to 
Bupivacaine. 
E3.h Receiving, Storage, Dispensing and Return  
Study medications will be dispensed from the pharmacy according to usual procedures. 
F Study Procedures  
Screening for Eligibility 
 
We will review the patient’s medical records to determine study eligibility prior to 
obtaining consent of the patient to participate in the study.  No research-specific 
information will be collected prior to the informed consent process.     
The site-specific screening procedures are outlined in Attachment L1. 
 
Schedule of Measurements 
See Attachment L2 for a Table of the Schedule of Measurements/Calendar.  
Safety and Adverse Events  
F3.a 
Safety and Compliance Monitoring 
 
The lead study investigator will monitor the safety and compliance of all study sites 
utilizing the Oncore ERM study management system. 
F3.b 
Medical Monitoring  
i 
Investigator only 
This study is a comparison of three usual care regimens for the prevention and 
treatment of post-operative pain. The Investigator will be responsible for all medical 
monitoring through the course of providing usual patient care. 
ii 
Independent expert to monitor 
The Human Research Protection Program of Medicine and Science monitors all 
investigator-initiated research. Reports of monitoring visits are provided to the Principal 
Investigator and the Director of HRPP.   
iii 
Institutional Data and Safety Monitoring Board 
The Institutional Review Board will provide safety oversight for this study.  


 
 
 
 
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iv 
Independent Data and Safety Monitoring Board 
No Independent Data and Safety Monitoring Board will be created for this study. 
F3.c 
Definitions of Adverse Events 
 
Adverse events will comprise all events that are untoward changes from a subject’s 
baseline condition.   
3.d    Classification of Events  
i 
Relationship 
The investigator will determine the relationship of an adverse event to the TAP Block 
procedure.  
ii 
Severity 
The Investigator will assess the severity of adverse events in accordance with the 
Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. 
iii 
Expectedness 
Adverse events listed in the protocol, IRB-approved informed consent form, or drug 
specific, FDA-approved package inserts will be considered to be foreseeable risks of 
participation in the study.  Other adverse events will be considered unexpected. 
F3.d 
Data Collection Procedures for Adverse Events 
Please see Attachment L2 for data collection form. All adverse event data will be entered 
into Oncore ERM. 
F3.e 
Reporting Procedures 
Serious Adverse Events and adverse events that meet “severe” criteria must be directly 
reported within 24 hours to the Principal Investigator, and the IRB. 
 
Joshua Herskovic M.D. 
847-872-4890 
Joshua.Herskovic@ctca-hope.com 
Department of Anesthesiology 
Midwestern Regional Medical Center 
Zion, IL 
Other adverse events must be entered within 7 days of collection into the Oncore ERM. 
F3.f 
Post-study Adverse Event 
Serious Adverse Events and adverse events that meet “severe” criteria must be directly 
reported within 24 hours to, the Principal Investigator and the IRB. 
 
Joshua Herskovic M.D. 
847 872-4890 


 
 
 
 
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Joshua.Herskovic@ctca-hope.com 
Department of Anesthesiology 
Midwestern Regional Medical Center 
Zion, IL 
 
Other adverse events must be entered within 7 days of collection into the Oncore ERM. 
F3 Study Outcome Measurements and Ascertainment 
 
G Statistical Plan  
Interim Monitoring and Early Stopping 
 
The Principal Investigator will utilize the Oncore ERM study management system to 
monitor the study. 
 
The study may be stopped early for the following reasons: 
· 
withdrawal of funding 
· 
safety issues 
· 
drug has been proven effective and no further testing is needed 
Analysis Plan 
The study is a prospective, randomized, open, active controlled clinical trial.  
Effectiveness of the Continuous TAP (CTAP) via the ON-Q® Pain Management 
System will be evaluated and compared to single shot techniques with respect to 
reductions in postoperative opioid consumption over the first 72 hours 
postoperatively.  Secondary outcomes including hospital length of stay (LOS), time 
in PACU, pain at rest and with activity, return of bowel function, and incidence of 
opioid related side effects will also be evaluated.  
The aims of this study are to compare the efficacy of continuous TAP block via ON-
Q® system versus that of single injection techniques for TAP block regarding opioid 
reduction among patients undergoing major abdominal surgery.  It is hypothesized 
that a continuous TAP block technique reduces pain, the need for opioids as well as 
the expected length of stay relative to those resulting from those subjects receiving 
a single TAP injection of Exparel (liposomal Bupivacaine) or single TAP injection of 
Ropivacaine to treat postoperative pain. 
Study success criteria: 
Based on the above hypothesis this study will be considered successful in 
demonstrating superior efficacy relative to control if consumption of opioids 
postoperative is significantly less among patients randomized to receive a 


 
 
 
 
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continuous TAP block via the ON-Q® system compared to the patients randomized 
to receive a single TAP injection of Exparel (liposomal bupivacaine) or single TAP 
injection of Ropivacaine to treat postoperative pain. However, a finding of no 
difference between the continuous catheter technique and the Exparel arm would 
also be considered beneficial to the advancement of post-operative pain control 
techniques because it would demonstrate similar post-operative pain control can be 
achieved without the extra time and skill required to place a catheter. 
 
Statistical Methods  
Sample Size 
The main objective of study is to compare total opioid consumption between the single 
shot TAP group and the Exparel TAP group with a parallel design. Based on previous 
studies and internal pilots, the mean total opioid consumption (standard deviation) was 
4.1 mg (SD 3 mg) in single shot group and 2.4 mg (SD 1.3 mg) in Exparel TAP group. 
For the sample size calculation, a standard deviation of 3 is used as a conservative 
estimate. To detect a difference in mean opioid consumption between treatment groups, 
4.1 mg vs. 2.4 mg, a sample size of 49 patients per arm is required to achieve 80% 
power with a significance level of 0.05 using a two-sided t-test or Wilcoxon rank-sum test 
depending on normality test. A secondary aim is to examine a difference in mean opioid 
consumption between the single shot TAP group and continuous TAP group. Allowing 
for a 10% dropout rate, a total of 159 participants with 53 participants in each arm will 
therefore need to be recruited into the study. It anticipated that approximately 8 
participants per week will be enrolled into this study, thus the estimated accrual time is 
around 1 year.  
 
Statistical Analysis Plan 
All analyses will be conducted on patients following an intention-to-treat principle, 
including all randomized participants enrolled in three arms, in case of relevant non-
compliance to the treatment and/or impossibility to evaluate the endpoints, a per-
protocol analysis will also be performed, together with an analysis of non-
compliance/non-evaluation.  
Patient characteristics and outcomes data will be summarized by cross-tabulation 
(categorical variables), quartiles (median, ordinal variables), and mean and standard 
deviation (continuous variables). Comparisons between groups will use Chi-square test 
or Fisher’s exact test as appropriate for categorical variables and t-test or Wilcoxon rank-
sum test as appropriate for continuous variables.  
Analyses of primary outcome will examine differences in mean opioid consumption 
between the single shot TAP group and the Exparel TAP group. Analyses of secondary 
outcomes will examine differences in mean opioid consumption between the single shot 
TAP group and continuous TAP group. Treatment groups will be compared using a 


 
 
 
 
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student’s t-test if data are normal distributed or Wilcoxon rank-sum test if not normal 
distributed. 
The differences in mean opioid consumption across three groups (single shot TAP, 
continuous TAP, and Exparel TAP) will be examined with a test of means between 
groups using one-way analysis of variance (ANOVA). A comparison between continuous 
TAP and Exparel TAP will be performed. A t-test will be used if the observations in each 
trial arm are normally distributed; if non-normally distributed, then rank-based methods 
such as Wilcoxon rank-sum test will be employed. 
All tests will be two-sided.  
The overall incidence of serious adverse events and adverse events and number and 
proportion of patients reporting such events will be summarized by treatment group. 
Adverse events will be tabulated and summarized by the number and percentage of 
subjects who experienced the event. 
Missing Outcome Data 
Analysis will be conducted as described in prior section.  Missing data will not be 
included in the analysis; however, may lead to an increase in patients recruited into one 
or more study arms. 
Unblinding Procedures  
This study is not blinded because it will be obvious to all care givers whether or not the 
patient received a continuous block with catheters or not. 
 
H Data Handling and Record Keeping  
Confidentiality and Security 
Data will be collected on the data collection forms located in Attachment L9 and entered 
into the Oncore ERM study management system.   
 
Data collection forms will be stored at each respective study site within a locked cabinet 
in a locked research office. 
 
The Oncore ERM study management system is a secure web-based management 
system that is password-protected.  Access to data is role-specific. 
 
All study sites will observe Health Insurance Portability and Accountability Act (HIPAA) 
Privacy and Security Rule standards. 


 
 
 
 
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Training  
All research team members must complete approved Human Subjects and HIPAA 
training. 
 
All research team members must complete Oncore ERM training. 
Case Report Forms and Source Documents 
Study sites will utilize the data collection forms in Attachment L9 to collect data and will 
enter data into the Oncore ERM study management system.  
Records Retention 
Paper study records will be maintained at the respective study sites for seven years from 
the end date of the study.  At the end of this time period, study records will be shredded.  
Data in the Oncore ERM study management system will be stored for seven years from 
the end date of the study.  At the end of this time period, records will be deleted. 
Performance Monitoring  
The IRB and the Principal Investigator will monitor study performance using the Oncore 
ERM study management system. 
 
I 
Study Monitoring, Auditing, and Inspecting  
Study Monitoring Plan  
The IRB and the Principal Investigator will monitor ongoing study performance using the 
Oncore ERM study management system. 
Auditing and Inspecting  
The IRB will audit and inspect study materials at the study sites as indicated. 
J 
Study Administration 
Organization and Participating Centers 
The Principal Investigator at the lead institution will collaborate with study site Principal 
Investigators to oversee this study. 
Funding Source and Conflicts of Interest 
There are no conflicts of interest among any of the study investigators. 
 
Study investigators must complete institution-specific conflict of interest forms as 
required.   


 
 
 
 
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Subject Stipends or Payments  
Subjects will not be paid for their participation in the study. 
Study Timetable 
The study will last for approximately four months.  This is the estimated time based on 
current operating room patient criteria to enroll ninety patients into the study.   
 
 
 
 
K Publication Plan  
 
Upon completion of study and statistical methods, it would be expected to publish the 
study in an established and well-read peer journal of either Anesthesiology or Surgery.  
Given that an analysis demonstrating a statistically significant difference or no difference 
between any of the study arms would be useful to how anesthesiologist and/or the 
surgical team approach the TAP block, it is highly likely the study would be accepted for 
publication. 
 


 
 
 
 
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L Attachments – TAP Block Pain Management Data Form 
Schedule of Measurements Template (add addition information as needed) 
 
PATIENT INFORMATION 
Initials 
 
Outpatient / SDA   
Patient taking narcotics at home prior to surgery? 
Yes   No 
Inpatient (prior to Surgery)      
PCA    
IV narcotics         (skip if PCA) 
P.O. Narcotics     (skip if PCA) 
Age 
Gender 
M   F 
Race Cauc  Black (Non Hisp)   Hisp  Asian   Other 
ASA 
BMI 
Smoking 
Yes   No 
Diabetes 
Yes   No 
 
Incisional Dermatone Level  Range: 
(Umb=T10) 
 
 
Surgery Duration (minutes)  
PACU Time until nurse gives report 
 
Anesthesiologist performing TAP BLOCK 
 
 
Surgeon 
Date of Surgery 
Hospital Discharge Date 
 
Procedure   Ventral hernia   Expl. Lap 
 Colon     Small Bowel    Anterior Resection     APR  
 Lower Anterior Resection     Prostate 
  TAH 
 HIPEC    Cyto-reductive Surgery      Ileostomy reversal 
 
 Robotic Assisted +/- Hand Assisted   Robitic (no incision)   
L/S Assisted +/- Hand Assisted           L/S (no incision)         
 
 Other__________________________________________ 
 
 Continuous TAP with Ropiv 0.2% 
       
  Single Shot TAP 
 Exparel                0.25% Bupivicaine 
 
 Pre-incision         Post-incision 
 
 
Other:_________________________________ 
Outcomes 
PCA 
PACU 
 
POD 0 
  Y    N 
POD 1 
  Y    N 
POD 2 
  Y     N 
POD 3 
  Y    N 
NARCOTICS 
 
 
 
 
 
MSO4    (mg) total requirements 
 
 
 
 
 
Dilaudid (mg) total requirements 
 
 
 
 
 
Fentanyl (mg) total requirements 
 
 
 
 
 
Anti-emetic Given (+/-) 
 
 
 
 
 
EVENTS 
 
 
 
 
 
Bowel Movement (+/-) (record 1st day only) 
 
 
 
 
 
Urinary Catheter (+/-) (record up to  removal 
 
 
 
 
 


 
 
 
 
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M References 
 
1. 
Biki B, Mascha E, Moriarty DC, Fitzpatrick JM, Sessler DI, Buggy DJ. Anesthetic technique for 
radical prostatectomy surgery affects cancer recurrence: a retrospective analysis. Anesthesiology. 
2008;109(2):180-187. 
2. 
Exadaktylos AK, Buggy DJ, Moriarty DC, Mascha E, Sessler DI. Can anesthetic technique for 
primary breast cancer surgery affect recurrence or metastasis? Anesthesiology. 2006;105(4):660-
664. 
3. 
Sessler DI, Ben-Eliyahu S, Mascha EJ, Parat MO, Buggy DJ. Can regional analgesia reduce the 
risk of recurrence after breast cancer? Methodology of a multicenter randomized trial. 
Contemporary clinical trials. 2008;29(4):517-526. 
4. 
McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy 
of transversus abdominis plane block after abdominal surgery: a prospective randomized 
controlled trial. Anesthesia and analgesia. 2007;104(1):193-197. 
5. 
Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable 
option for postoperative analgesia? A topical review. Acta anaesthesiologica Scandinavica. 
2010;54(5):529-535. 
6. 
Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical 
effectiveness of transversus abdominis plane block. Journal of clinical anesthesia. 2011;23(1):7-
14. 
7. 
Petersen PL, Hilsted KL, Dahl JB, Mathiesen O. Bilateral transversus abdominis plane (TAP) 
block with 24 hours ropivacaine infusion via TAP catheters: A randomized trial in healthy 
volunteers. BMC anesthesiology. 2013;13(1):30. 
8. 
Ayad S, Gonzales JJ, Thunga R. Infiltration of the transversus abdominis plane with EXPAREL 
for postsurgical pain management. Anesthesiology News. 2013;November:1-12. 
9. 
Raj A. Liposomal Bupivacaine Boosts TAP Block. General Surgery News. 2014;41(1):24. 
10. 
Kadam RV, Field JB. Ultrasound-guided continuous transverse abdominis plane block for 
abdominal surgery. Journal of anaesthesiology, clinical pharmacology. 2011;27(3):333-336. 
11. 
Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane 
block provides effective postoperative analgesia in patients undergoing total abdominal 
hysterectomy. Anesthesia and analgesia. 2008;107(6):2056-2060. 
12. 
Rao Kadam V, Van Wijk RM, Moran JI, Miller D. Epidural versus continuous transversus 
abdominis plane catheter technique for postoperative analgesia after abdominal surgery. 
Anaesthesia and intensive care. 2013;41(4):476-481. 
13. 
Omar AM. Postoperative continuous transversus abdominis plane block vs continuous wound 
infusion of levobupivacaine in females undergoing open gynecologic procedures Egyptian Journal 
of Anesthesia. 2013;29(4):383-388. 
 
only) 
Diet  NPO, L=liquid FL=full liquid, N=Normal  
 
 
 
 
Pain (0-10)                                                  am 
At Rest      /  With Activity 
     
    ▐ 
    ▐ 
    ▐ 
    ▐ 
Pain (0-10)                                                  pm 
At Rest     / With Activity 
     
    ▐ 
    ▐ 
    ▐ 
    ▐ 
Ambulation O= out of bed assisted 
W=Able to walk unassisted