Conditions: Osteoarthritis
Keywords: Nerve Block Rehabilitation Knee Replacement, Total
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 111
Healthy volunteers: no

Brief summary:
Total knee replacement is associated with severe post-operative pain. The purpose of this study is to compare two methods of treatment for pain control following Total Knee Replacement with an accelerated physical therapy protocol to aid the achievement of rehab milestones.

Detailed description:
A total of 106 patients undergoing total knee arthroplasty will be randomized into two groups: one to receive only Periarticular injections and the other periarticular injections AND adductor canal block.

Patients will be asked their numeric pain scores before surgery as baseline and at 24 and 48 hours post-operation. Patients also will be asked questions from painOUT questionnaire at 24 and 48 hours.

Time to reach discharge criteria based on physical therapy assessments will also be measured.

Arms:
arm 1: Intra-Operatively

* Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
* Surgeon will perform the periarticular injections:
* First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
* Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine
* Intravenous sedation with midazolam and propofol. arm 2: Intra-Operatively

* Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
* Adductor canal block technique:
* Supine position, after IV sedation
* Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches
* Femoral artery will be identified in the adductor canal deep to the Sartorius muscle
* 15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone
* Local anesthetic will be delivered periarterial between 12 and 6 o'clock
* Intravenous sedation with midazolam and propofol.
* First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
* Second superficial injection prior to closure. 20 ml 0.25% bupivacaine

Interventions: intervention 1: Bupivacaine intervention 2: Morphine intervention 3: Methylprednisolone intervention 4: Cefazolin intervention 5: Normal saline intervention 6: Midazolam intervention 7: Propofol intervention 8: Dexamethasone intervention 9: 8 MHz. Chiba needle, 22 G / 4 inches
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None

Protocol document:
Prot_SAP_001.pdf: 
Date: Monday, August 22, 2016 8:29:18 AM Print Close 
ID: 2014-018 Section: PART I - Study Identification Information 
Help 
VIEW000072 
Study Identification Information 
This is the first step in your Human Research Application. You will automatically be 
guided 
to the appropriate forms needed to complete your submission. 
1.0 Title: 
The Combination of Adductor Canal Block and Periarticular Injection with an 
Accelerated Rehabilitation Protocol. A novel technique for Patients Undergoing 
Total Knee Replacement (ACB PAI) 
* Short Title for EPIC: 
ACB PAI (If Not Applicable, please enter N/A) 
2.0 Description: 
3.0 * Principal Investigator: 
Enrique Goytizolo, M.D. 
4.0 Study Contact: 
Phuong Dinh Mac 
5.0 
Co-Investigators: 
First Name Last Name Organization 
Michael Alexiades, M.D. Arthroplasty: Hip & Knee 
Isabel Armendi Anesthesiology 
Valeria Buschiazzo Anesthesiology 
Jennifer Cheng Anesthesiology 
Jodie Curren, RN Anesthesiology 
Kara Fields Research 
Rupali Joshi Rehabilitation 
David Kim, MD Anesthesiology 
Katherine Lee Anesthesiology 
Yi Lin, MD Anesthesiology 
Thuyvan Luu Anesthesiology 
Phuong Dinh Mac Anesthesiology 
Denesy Mancenido Anesthesiology 
David Mayman, MD Arthroplasty: Hip & Knee 
Iyabo Muse Anesthesiology 
If a name does 
not appear in 
Co-Investigators 
directory, please 
contact 
zhouy@hss.edu 
to have an 
eCAP account 
created. 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injection 
... Page 1 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
Date: Monday, August 22, 2016 8:29:18 AM Print Close 
ID: 2014-018 Section: PART I - Study Identification Information 
First Name Last Name Organization 


Douglas Padgett, MD Arthroplasty: Hip & Knee 
Amar Ranawat, MD Arthroplasty: Hip & Knee 
Edwin Su, MD Arthroplasty: Hip & Knee 
Matthew Titmuss Rehabilitation 
Geoffrey Westrich, MD Arthroplasty: Hip & Knee 
Jacques YaDeau, MD, PhD Anesthesiology 
Angie Zhang Anesthesiology 
6.0 Other Study Staff/Collaborators: 
FirstName LastName Organization Email Role 
There are no items to display 
7.0 * Type of Application: 
Clinical Research Proposal 
Expedited Retrospective Chart Review 
Request for Exemption 
New Registry 
Existing Approved Registry 
Please click 
here to preview 
Exempt 
Categories. 
Click here to 
preview Study 
Designs. 
8.0 Select appropriate funding sources for this study: 
Name 
Other 
Other Funding Sources: 
Anesthesiology Departmental Fund 
Note: If the funding source of the study is 'Industry Funded 
Support' the Clinical Research Administration (CRA) will be 
notified. 
If your study require CRA review, please upload applicable documents: 
Name Version 
There are no items to display 
Help 
Help 
CRP Information 
1.0 The proposal should be submitted to the appropriate Clinical 
Review Panel (CRP) for scientific review. If you are unsure of 
which Clinical Review Panel to select, please contact 
Barbara Bosco at 212.606.1914 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injection 
... Page 2 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
Date: Monday, August 22, 2016 8:29:18 AM Print Close 
ID: 2014-018 Section: PART I - Study Identification Information 
* 
Name 
Anesthesiology 
Help 
Help 


Regulatory Status of Drugs and Devices 
1.0 The regulatory status of the drugs or devices in this research 
proposal is: 
Name 
Approved for use by the FDA, but being studied in an “off-label” indication. 
Please note, in this case, an IND (Investigational New Drug) or IDE 
(Investigational Device Exemption) may be required from the FDA prior to use in 
a research study. If you have this information, please provide it below. If you do 
not have this information, or are uncertain about whether an IND or IDE is 
required, please contact Director of Clinical Research Administration at 
212.774.7154, for assistance. 
Help 
Help 
Drug/Device Details 
1.0 If Drug: 
Dexamethasone Sodium Phosphate 
2.0 If Device: 
Help 
Help 
Pharmacy Involvement / Impact to EPIC 
1.0 
Is this an inpatient study? 
Yes No 
2.0 * Will this study have Investigational Drug Service involvement? 
(Pharmacy will be purchasing/dispensing any medications being 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injection 
... Page 3 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
Date: Monday, August 22, 2016 8:29:18 AM Print Close 
ID: 2014-018 Section: PART I - Study Identification Information 
used and/or study requires placebo and patient randomization) 
Yes No 
3.0 
If the answer to either question is yes, please explain briefly below 
AND contact Mylinh Duong at 646.797.8410 (duongm@hss.edu) or 
Nicole Oliva at 646.797.8324 (OlivaN@hss.edu). 
The study would benefit from having a specific CliniCIS/EPIC order set that 
indicates patient study enrollment. The study order will also include the following: 
*Reminder when writing Rehab orders* 
PT: DOS, TID for POD # 1 & 2 ONLY, as per SOC POD3 onwards 
PT time slots: Between 8-12, 12-4, 4-7 
No CPM 
Help 
Help 
Study Locations 
1.0 Select the Research Facilities where this study will be 
conducted: 
Facility 
HSS 
1.1 If Other, please specify: 


2.0 * Is this a multi-Center study? 
No 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injection 
... Page 4 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Nature of Study 
This section will be reviewed by the appropriate Clinical Review Panel. Each 
of the headings in this section must be addressed. 
Help 
Specific Aims or Research Questions 
1.0 What is the condition or intervention to be studied? 
Total knee replacement is associated with severe post-operative pain. The 
purpose of this study is to compare two methods of treatment for pain control 
following Total Knee Replacement with an accelerated physical therapy protocol 
to aid the achievement of rehab milestones. 
The two pain control methods include: 
1-Perarticular injections during the surgery 
2-Periarticular injections and adductor canal block 
Please click 
Here for 
example. 
2.0 What is/are the research question(s)/specific aim(s)? Pose 
very specific questions that can be addressed within the 
proposed design of the study. Prioritize them in order of 
importance. 
Will the addition of an adductor canal block to peri-articular injections as an 
anesthetic regimen: 
1. Allow for patients to achieve physical therapy discharge criteria earlier? 
2. Reduce the pain NRS scores post-operatively? 
3. Reduce the incidence of opioid related side effects? 
3.0 What is/are the hypothesis(es)? 
We hypothesize that performing an adductor canal block in addition to the 
periarticular injections will improve post-operative pain relief in patients receiving 
such an anesthetic regimen for TKA, allowing for a more rapid progression 
through PT. We hypothesize the reduction in pain in combination with the 
accelerated rehab protocol will aid the achievement of in-patient physical therapy 
milestones; more specifically, patients will meet the PT goal of negotiating stairs 
(via an accelerated PT regimen) 0.5 days earlier than patients who do not 
receive the adductor canal block. 
We further hypothesize that by reducing pain, the patients receiving the adductor 
canal block in addition to the periarticular injections will consume less opioids 
and therefore will experience less opioid related side effects (nausea, vomiting, 
and pruritus). This will also assist progression with PT. 
4.0 Identify and define the primary outcome and when the 
outcome will be measured. If measuring change in post- 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injection 
... Page 5 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Nature of Study 


operative function is the most important, that will be your 
primary outcome. 
Our primary outcome is time when patient is able to meet physical therapy 
discharge criteria, indicated by the ability to independently negotiate stairs- nonreciprocal 
(one leg at a time), with or without rails, and with or without assistive 
device (walker or cane). The primary outcome will be assessed during the 
morning,afternoon, and evening PT sessions of DOS, POD 1 and POD 2. The 
ability for a patient to meet discharge criteria after POD 2 will be assessed once 
a day as part of the standard PT visit. 
5.0 Identify and define the secondary outcome(s) and when they 
will be measured (list additional goals one at a time with their 
corresponding outcomes). 
1) NRS Pain Scores – pre op in the holding area, upon spinal resolution, 24 and 
48 hours after Anesthesia end time 
2) Incidence of nausea, dizziness, and vomiting - upon spinal resolution, 24 and 
48 hours after Anesthesia end time 
3) Incidence of pruritus - upon spinal resolution, 24 and 48 hours after 
Anesthesia end time 
4) Patient satisfaction - upon spinal resolution, 24 and 48 hours after Anesthesia 
end time 
5) PainOUT - upon spinal resolution, 24 and 48 hours after Anesthesia end time 
6) Opioid consumption -24 and 48 hours after Anesthesia end time. With type 
and amount. 
7) Hospital length of stay 
8) KSS scores – acquired through the Total Joint Registry at the surgeon's office 
visit pre-operatively and approximately 6 weeks post operatively 
Length of hospital stay and opioidconsumption will be obtained from Clinicis 
after the patient is discharged from the hospital. 
Help 
Help 
BACKGROUND - Be sure to answer each question individually 
1.0 Explain why these research questions are being asked: 
Several methods of controlling pain had been published in the 
literature including systemic narcotics, epidural analgesia, 
periarticular injections, femoral nerve block, sciatic nerve block, and 
lately the addition of adductor canal block. Several studies had 
been published using periarticular injections, comparing different 
methods of treatment with different primary outcomes. The 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injection 
... Page 6 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Nature of Study 
hypothesis of our study is that the addition of the ACB to the 
periarticular injection is going to decrease the pain, narcotic 
consumption and as a consequence improve rehabilitation leading 
to faster recovery and decrease the time to achieve the Physical 
Therapy criteria for discharge from the hospital. 
Citations: 
1. J. T. YaDeau, E. A. Goytizolo, D. E. Padgett, S. S. Liu, D. J. Mayman, A. S. 
Ranawat, M. C. Rade, G. H. Westric Bone Joint J VOL. 95B, 


No. 5, MAY 2013 
Analgesia after total knee replacement: local infiltration versus epidural 
combined with a femoral nerve blockade 
2. Kelley TC, Adams MJ, Mulliken BD, Dalury DF. 
J Arthroplasty 2013 Sep;28(8):12747. 
Efficacy of multimodal perioperative analgesia protocol with periarticular 
medication injection in total knee arthroplasty: a randomized, doubleblinded 
study. 
3. Nakai T, Tamaki M, Nakamura T, Nakai T, Onishi A, Hashimoto K 
J Orthop 2013 Mar 17;10(2):924 
Controlling pain after total knee arthroplasty using a multimodal protocol with 
local periarticular injections. 
4. Yue DB, Wang BL, Liu KP, Guo WS 
Chin Med (English) 2013 Oct;126(20):38515. 
Efficacy of multimodal cocktail periarticular injection with or without steroid 
in total knee arthroplasty. 
5. Jiang J, Teng Y, Fan Z, Khan MS, Cui Z, Xia Y J Arthroplasty 2013 Dec;28 
(10):18827 
The efficacy of periarticular multimodal drug injection for postoperative pain 
management in total knee or hip arthroplasty. 
6. Lamplot JD1, Wagner ER1, Manning DW2 
J Arthroplasty 2014 Feb;29(2):32934 
Multimodal pain management in total knee arthroplasty: a prospective 
randomized controlled trial. 
7. Ng FY, Ng JK, Chiu KY, Yan CH, Chan CW 
J Arthroplasty 2012 Jun;27(6) 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injection 
... Page 7 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Nature of Study 
Multimodal periarticular injection vs continuous femoral nerve block after 
total knee arthroplasty: a prospective, crossover, randomized clinical trial. 
8. Toftdahl et al Comparison of peri and intraarticular analgesia with femoral 
nerve block after total knee arthroplasty Acta Orthopaedica 2007; 78(2) 172179 
9. Andersen et al A compression bandage improves local infiltration analgesia 
in total knee astrhroplasty Acta Orthopaedica 2008: 79 (6): 806-811 
10. Kerr et al Local Infiltration Analgesia: a technique for the control of acute 
postoperative pain following knee and hip surgery Acta Orthopaedica 2008 79 
(2): 174183 
11. Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, 
Rorabeck CH, McCalden RWJ Bone Joint Surg (Amer) 2006 May;88(5):95963. 
Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A 
randomized trial. 
2.0 What is the background of the topic that you believe is 
important for the reviewer to know in considering this 
protocol, including prior studies by this research team. 
Describe strengths and deficiencies of prior studies; explain 
how this study fits in. Include references. 
Finding an effective analgesic method that will help maintain quadriceps 


muscle strength, will allow patients to tolerate physical therapy earlier and more 
efficiently. Adductor Canal Block (ACB) may be proposed to be an alternative 
nerve block since it does not further compromise quadriceps muscle strength in 
contrast to the traditional femoral block. This is especially significant in 
populations that may have weak quadriceps strength pre-surgery1 and reduced 
quadriceps strength post op due to swelling2. 
Quadriceps muscle strength is significantly reduced after TKR, the 
reason for this is multifactorial. Swelling is a contributing factor1. Quadriceps 
strength is already reduced preop and further reduced by the surgery2. Finding 
an effective analgesic method that will help maintain quadriceps muscle strength, 
which is already compromised, will allow patients to tolerate physical therapy 
earlier and more efficiently. The adductor canal block (ACB) may be proposed to 
be an alternative to the traditional femoral nerve block. 
ACB is predominately a sensory nerve block(3).The adductor canal 
extends from the apex of the femoral triangle to the adductor hiatus.4,5 The nerve 
branches of the adductor canal include the saphenous nerve, which innervates 
the infra patellar skin and the anterior knee capsule, and a nerve to the vastus 
medialis, which provides sensory innervation to the superomedial aspect of the 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injection 
... Page 8 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Nature of Study 
knee and the knee capsule6. When compared with the femoral nerve block, ACB 
has been shown to decrease pain and morphine use and preserve quadriceps 
strength post TKR. There were no episodes of falls associated with use of ACB 
which is an important finding to ensure patient safety 7,8. On the contrary, studies 
have associated femoral nerve with risk of falling postoperatively 9,10,11. 
ACB preserves quadriceps muscle strength better when compared to femoral 
nerve block. In a small study with volunteers, all subjects could be mobilized post 
ACB as compared to only 50% being mobilized with femoral nerve block12. A 
retrospective study of 298 patients undergoing TKA suggests that LIA is 
associated with early ambulation and improved pain control compared with lowdose 
continuous femoral nerve block. The addition of ACB was linked with 
additional increases in early ambulation, a more rapid shift to use of a standard 
low walker, and a higher occurrence of discharge to home instead of rehab13. In 
a randomized controlled pragmatic trial, we investigated whether local infiltration 
analgesia would result in earlier readiness for discharge from hospital after total 
knee replacement (TKR) than patient-controlled epidural analgesia (PCEA) plus 
femoral nerve block. The results demonstrated no difference between the 
groups. We also found that the pain scores at rest and with movement on the 
periarticular group were NRS 3-4 and had a wide range of variability (please see 
below table)14. 
Complications involving injury to the infrapatellar branch of the 
saphenous nerve for patients receiving ACB for TKA were discussed in a 
previous study, but those complications were acknowledged as known 
complications for the surgical procedure15. In relation to this prospective study, 
we believe that the addition of the adductor canal block to the periarticular 
injection will facilitate accomplishment of rehabilitation goals and decrease the 
pain scores even further. 
References 
1. Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. 
Early quadriceps strength loss after total knee arthroplasty. The contributions of 
muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am . 
2005;87: 1047–1053. 


2. Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of 
knee-extension strength is related to knee swelling after total knee arthroplasty. 
Arch Phys Med Rehabil . 2010;91:1770–1776. 
3. Lund J, Jenstrup MT, Jaeger P, Sorensen AM, Dahl JB. Continuous adductorcanal- 
blockade for adjuvant post-operative analgesia after major knee surgery: 
preliminary results. Acta Anaesthesiol Scand . 2011;55:14–19. 
4. Manickam B., Perlas A., Duggan E., Chan VW, Ramlogan R. Feasibility and 
efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. 
Reg Anesth Pain Med . 2009;34:578–580. 
5. Tubbs RS, Loukas M, Shoja MM, Apaydin N, Oakes WJ, Salter EG. Anatomy 
and potential clinical significance of the vastoadductor membrane. Surg Radiol 
Anat . 2007;29:569–573. 
6. Horner G., Dellon AL. Innervation of the human knee joint and implications for 
surgery. Clin Orthop Relat Res . 1994;301:221–226. 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injection 
... Page 9 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Nature of Study 
7. Jenstrup MT, Jaeger P, Lund J, et al. Effects of adductor-canal-blockade on 
pain and ambulation after total knee arthroplasty: a randomized study. Acta 
Anaesthesiol Scand . 2012;56:357–364. 
8. Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. 
Effect of adductor-canal-blockade on established, severe post-operative pain 
after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand . 
2012;56:1013–1019. 
9. Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity 
continuous peripheral nerve blocks and patient falls after knee and hip 
arthroplasty. Anesth Analg . 2010;111:1552–1554. 
10. Johnson RL, Kopp SL, Hebl JR, Erwin PJ, Mantilla CB. Falls and major 
orthopaedic surgery with peripheral nerve blockade: a systematic review and 
meta-analysis. Br J Anaesth . 2013;110:518–528. 
11. Muraskin SI, Conrad B, Zheng N, Morey TE, Enneking FK. Falls associated 
with lower-extremity-nerve blocks: a pilot investigation of mechanisms. Reg 
Anesth Pain Med . 2007;32:67–72. 
12. Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. 
Adductor canal block versus femoral nerve block and quadriceps strength: a 
randomized, double-blind, placebo-controlled, crossover study in healthy 
volunteers. Anesthesiology. 2013 Feb;118 (2):409-15. 
13. Perlas A, Kirkham KR, Billing R, Tse C, Brull R, Gandhi R, Chan VW. The 
impact of analgesic modality on early ambulation following total knee 
arthroplasty. Reg Anesth Pain Med. 2013 Jul-Aug;38 (4):334-9. 
14. YaDeau JT, Goytizolo EA, Padgett DE, Liu SS, Mayman DJ, Ranawat AS, et 
al. Analgesia after total knee replacement: local infiltration versus epidural 
combined with a femoral nerve blockade: A prospective, randomised pragmatic 
trial. Bone Joint J 2013; 95-B: 629–35. 
15. Henningsen MH, Jaeger P, Hilsted KL, Dahl JB. Prevalence of saphenous nerve 
injury after adductor-canal-blockade in patients receiving total knee arthroplasty. Acta 
Anaesthesiol Scand. 2013 Jan;57(1):112- 
3.0 Identify specific gaps in current knowledge that this study is 
intended to fill. 
This project would investigate the effectiveness of this 
particular anesthetic combination through patients’ readiness 
for discharge by physical therapy, in addition to other 


secondary markers, i.e. pain scores, as a gauge. In addition, 
this study would also introduce a new PT regimen and allow 
patients to receive two physical therapy visits instead of one, 
providing the opportunity for a faster progression through 
rehab milestones and therefore the ability to achieve PT 
discharge criteria. 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 10 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Nature of Study 
4.0 How will answering these questions change clinical practice, 
change concepts about the topic or confirm the work of other 
investigators? 
If the peri-articular injection plus adductor canal block regimen improves time to 
readiness to PT discharge, and lowers pain scores then it could change current 
practice guidelines. Reducing the pain after surgery will have an enormous 
implication, including the improvement of patient satisfaction, decrease in 
morbidity, decrease in length of hospital stay, and the possibilities for further 
research. 
In regards to the accelerated rehab protocol, if there is an improvement in time to 
readiness to PT discharge then there could be a change in rehab clinical 
practice. 
5.0 Is this a pilot study that could lead to a more definitive 
protocol or different study? Yes No 
5.1 If you answered No, please explain below: 
This is not a pilot study. It is part of an ongoing series of studies that seek to improve 
postoperative pain in total knee replacement patients. We anticipate that there will be 
future studies, potentially based on this study. 
6.0 Please upload reference or additional document here (if 
needed). 
Name Description 
There are no items to display 
Help 
Help 
Study Design 
1.0 
Observational: 
Name Description 
There are no items to display 
2.0 
Experimental: 
Name Description 
Randomized 
Controlled 
Clinical Trial 
This is the “gold standard” for clinical research. These 
prospective studies have at least two groups. Patients meeting 
strict inclusion/exclusion criteria are enrolled and randomly 
assigned to receive either an experimental intervention or to 
receive what is considered to be an acceptable alternative – 


Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 11 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Nature of Study 
Name Description 
usually the current standard of care or a placebo (e.g., study of 
hylauronic acid injection versus cortisone for arthritis). 
2.1 If Other, please specify: 
N/A 
2.2 If Randomized Controlled Clinical Trial is selected, please 
choose one of the following: 
Name 
Other 
If other, please list name or indicate N/A below: 
Anesthetic Regimen: 
Group 1- Periarticular Injection only group 
Group 2- Periarticular Injection + Adductor Canal Block group 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Recruitment & Enrollment 
Help 
Recruitment 
1.0 
Check all that apply to describe your study population: 
Population 
Patients 
Vulnerable Populations 
There are no items to display 
1.1 If Other, please specify: 
N/A 
2.0 Inclusion Criteria: list characteristics that potential subjects and 
controls need to have. Use a bullet format, if applicable. 
_ Patients with osteoarthritis scheduled for primary tricompartmental total knee 
arthroplasty with a participating surgeon and anesthesiologist 
_ Age 18 to 80 years 
_ Planned use of regional anesthesia 
_ Ability to follow study protocol 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 12 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Recruitment & Enrollment 
_ English speaking (secondary outcomes include questionnaires validated in 
English only) 
3.0 
Exclusion Criteria: list characteristics that would cause you to 
exclude potential subjects and controls. 
Justify any age, ethnicity, language, or gender-based 
exclusion criteria. Use a bullet format, if applicable. 
Hepatic or renal insufficiency 
Patients younger than 18 years old and older than 80 
Patients intending to receive general anesthesia 


Patients planning to go to rehab post operatively 
Patients scheduled to go into the OR after the time agreed upon by Physical 
Therapist* 
Allergy or intolerance to one of the study medications 
Patients with an ASA of IV 
Chronic gabapentin/pregabalin use (regular use for longer than 3 months) 
Chronic opioid use (taking opioids for longer than 3 months) 
Diabetes 
Patients on workers compensation or disability 
*Patients whose spinals are unlikely to resolve by 7:00 pm will be excluded from 
the study because it is not standard of care for physical therapists to see patients 
past 7:00 pm on the day of surgery. 
4.0 Age Range: 
18-80 
5.0 Describe how you will identify and recruit potential subjects 
for participation in the study. 
Following discussion of the study with the surgeon, the investigator in the holding 
area before the surgery will approach the patient. The patient will be given a 
description of the research project. Informed consent will be obtained by an 
attending anesthesiologist co-investigator prior to participation. 
6.0 * Please select enrollment type from following drop down list: 
Over Course of Study 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 13 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Recruitment & Enrollment 
Help 
Help 
Patients 
1.0 Please check the box(es) below that best reflect how 
patients will be identifed and recruited for 
participation. 
How subjects will be identified 
 
Potential subjects will be identified after a review of medical records of 
patients under the care of one or more of the study investigators 
 
Medical records and/or other Institution sources 
(databases,registries,billing records,pathology reports,admission 
logs) will be reviewed to identify potential participants. May involve 
access of records by individuals not involved in the patient's care. 
Potential subjects will be identified by their treating physicians and referred 
to the researchers. Patients' private and identifiable information will not be 
shared prior to receiving permission from the patient to do so. 
Potential subjects will be identified from a registry of individuals interested in 
research opportunities. 
Subjects will roll-over from another research study. 
Potential subjects will self-refer in response to advertisements. 
Help 
Target Enrollment 
1.0 * What is the maximum number of subject you plan to enroll in 
this study at HSS?(Please enter a number) 


114 
2.0 If this is a multi-center study, indicate the projected total 
subject accrual across all sites. 
Help 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Interventions or Observations 
Help 
Interventions and Observations 
1.0 
Be specific and describe the Interventions or 
Observations that will be part of this research project. Include 
a detailed description of the treatment arms, if applicable. 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 14 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Interventions or Observations 
Pre-Operative: 
Both groups will received preoperative meloxicam (7.5mg PO if age 75 or 
older; 15 mg otherwise) + extended release oxycodone (10 mg PO). 
Patients will provide NRS pain scores as well. 
Intraoperative: 
Group 1- Periarticular only group 
A spinal anesthetic with 0.5% bupivacaine (10 or 12.5) will be performed. 
The surgeon will perform the periarticular injections; one deep injection prior 
to cementation and then a second more superficial injection prior to closure. 
The deep injection will consist of bupivacaine 0.5% with epinephrine, 30cc; 
morphine, 8 mg/ml, 1 cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 
500 mg in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 
0.25% bupivacaine. Both groups will receive intraoperative intravenous 
sedation with midazolam and propofol. Patients will not be given 
intravenous opioids or ketamine during the operation. Patients will be given 
2 mg of intravenous Dexamethasone. Patients will be given 4 mg 
Ondansetron and 20 mg Famotidine. 
Group 2- Periarticular + ACB group 
A spinal anesthetic with 0.5% bupivacaine (10 or 12.5) will be performed. 
Then the adductor canal block* technique will be performed; supine 
position, after IV sedation. Ultrasound guided with linear transducer 8 MHz. 
Chiba needle, 22 G / 4 inches. The femoral artery will be identified in the 
adductor canal deep to the Sartorius muscle. The block will consist of 15 cc 
of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone. The 
local anesthetic will be delivered periarterial between 12 and 6 o’clock. The 
surgeon will perform the periarticular injections; one deep injection prior to 
cementation and then a second more superficial injection prior to closure. 
The deep injection will consist of bupivacaine 0.5% with epinephrine, 30cc; 
morphine, 8 mg/ml, 1 cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 
500 mg in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 
0.25% bupivacaine. Patients will not be given intravenous opioids or 
ketamine during the operation. Patients will be given 4 mg Ondansetron 
and 20 mg Famotidine. 
*The block function will be assessed and recorded by the Anesthesiologist postoperatively. 
The assessment of the adductor canal block will be done in the 
Recovery room after the resolution of the spinal anesthesia. We will use a 
alcohol swab to test the cold sensation first on the non operated leg and then on 
the operated one. The test will be performed at the level of the medial maleoli of 


the tibia. If the patient has sensation or no sensation it will be recorded as Block 
NOT working or Block working, respectively. The same procedures will be 
followed for the peri-articular injection only group, so as to not unblind 
participating patients. 
Postoperative: 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 15 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Interventions or Observations 
Analgesia: 
Postoperative analgesia will consist of: acetaminophen(10mg IV 1 hour post 
PACU admission), dexamethasone (10mg IV 1 hours post PACU 
admission), oxycodone (5 mg q 3 hr PRN), acetaminophen (1 g PO q 8 hr), 
ketorolac (15-30 mg IV q 6 hr X 4 doses), meloxicam daily (7.5mg PO if age 
75 or older; 15 mg otherwise, to start after ketorolac is finished), dilauded 
(0.5 mg IV q 5 min X 4 PRN). In cases of severe pain (NRS scores greater 
than 6 for >2 hours), salvage therapy will be available using intravenous 
hydromorphone PCA. Orders for ondansetron (4 mg IV q 8 hr PRN) and 
metoclopramide (10 mg IV q 6 hr PRN) will also be placed, in case patients 
experience nausea. 
Rehabilitation: 
Patients participating in the study will have an accelerated rehab regimen 
until they meet Rehab goals for discharge. They will be seen by a physical 
therapist once on the day of surgery and then three times by a physical 
therapist (until they meet Rehab goals) on post operative day 1 and 2. If 
physical therapy (PT) discharge criteria are not met before POD 3, patients 
will default to the standard PT protocol (1 PT session + 1 Mobility technician 
session). 
REHAB PROTOCOL: 
1. Ambulation: WB: WBAT; walker, progress as appropriate; Day of Surgery- 
OOB to ambulate 
2. TID PT 
3. NO CPM 
4. Jordan Splint: NO ORDER FOR JORDAN SPLINT 
5. Cryotherapy: ICE BAGS ONLY 
6. TED stockings FOR HOME USE 
7. VENO DYNES for INHOUSE 
8. NO DRAINS 
9. Negotiate stairs with one rail + cane or two rails. 
10. Patients can be cleared when independent on a walker OR cane. 
Straight leg test (SLR): 
• Tested with patient in supine with non-operated leg in knee 
flexion, patient is asked to perform a quad set (isometric 
quadriceps contraction) and while maintaining the contraction 
simultaneously lift operated left straight up to 45 degrees (hip 
flexion) or ~ six inches from the floor/bed. 
• Test is considered to be positive if patient is able to perform SLR 
without extension lag (leg below knee unable to hold while 
performing SLR). 
• Negative SLR is indicative of poor quadriceps control. 
Research Staff: 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 16 of 37 


https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Interventions or Observations 
1) DOS, upon spinal resolution: NRS pain scores, painOUT 
2) POD 1, 24-h post-anesthesia end: NRS pain scores, painOUT, Hospital 
DC lag questionnaire 
3) POD 2, 48-h post-anesthesia end: NRS pain scores, painOUT, 
Hospital DC lag questionnaire 
2.0 Will you be collecting human fluid or tissue? Yes No 
If yes, what will you be collecting? Fluid Tissue 
(Intraoperative and/or outpatient collection) 
Help 
Help 
Data Collection 
1.0 Indicate what data will be collected. 
Data will be collected by a research staff member or a co-investigator. Please 
see the data collection sheets for further detail. 
1. Day of Surgery in the holding area - patient demographics (name, age, sex, 
race, BMI); NRS pain score at rest, during ambulation, while bending knee 
2. Day of Surgery upon spinal resolution - Procedure length; ASA classification; 
tourniquiet timel; NRS pain score at rest, during ambulation, while bending knee; 
painOUT; opioid consumption; PT data sheet (assessing lines, nausea, vomiting, 
dizziness, pain NRS post-PT, buckling, transfer details, ambulation details, stair 
details, straight leg raise) 
3.POD 1 - NRS pain score at rest, during ambulation, while bending knee; 
painOUT; opioid consumption; PT data in the morning, afternoon, and evening 
(assessing lines, nausea, vomiting, dizziness, pain NRS post-PT, buckling, 
transfer details, ambulation details, stair details, straight leg raise; was discharge 
criteria met (time and date)?); Hospital DC lag questionnaire 
4.POD 2 - NRS pain score at rest, during ambulation, while bending knee; 
painOUT; opioid consumption; PT data in themorning, afternoon, and 
evening (assessing lines, nausea, vomiting, dizziness, pain NRS post-PT, 
buckling, transfer details, ambulation details, stair details, straight leg raise; was 
discharge criteria met (time and date)?); Hospital DC lag questionnaire 
5. Knee Society Score - Both pre-operatively and at first post operative surgeon's 
office visit (obtained through Total Joint Registry) 
2.0 Who will collect the data: 
Enrique Goytizolo, M.D. 
Jacques YaDeau, MD, PhD IRB Vice Chair 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 17 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Interventions or Observations 
Angie Zhang Research Assistant 
Rupali Joshi Physical Therapist 
Isabel Armendi 
David Kim, MD 
Thuyvan Luu 
Jodie Curren, RN 
Denesy Mancenido Assistant Director, Research 
Yi Lin, MD 
Matthew Titmuss Physical Therapist 


Jennifer Cheng Research Associate 
Valeria Buschiazzo 
Phuong Dinh Mac 
Katherine Lee 
Iyabo Muse Regional Anesthesia fellow 
3.0 When the data will be collected? Include timing of visits(either 
SOC or specifically for the study). 
During the patients' hospital stay and visits to surgeons offices 
4.0 
From what source: 
Medical Records 
Patient 
No Private Office Charts Please specify which private office: 
Yes Registries Please specify which registry: Total Joint 
Other Please specify: 
Help 
Help 
General Methods and Procedures 
1.0 * Are controls included in the study? Yes 
1.1 If yes, describe how they will be matched with the study subjects; 
state whether the controls will have identical data recorded, or describe 
any differences compared to the intervention subjects. 
This is a randomized controlled trial. All patients will have identical 
data recorded. Anesthesia, analgesia, and rehabilitation plans will 
be identical among groups, except for the intervention described 
above (Intervention Section - adductor canal block).The control 
group will receive the periarticular injections and the investigational 
group will receive the periarticular injections and an adductor canal 
block. 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 18 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Interventions or Observations 
2.0 * Are all tests Standard of care? No 
If not, identify which tests are not standard of care. What source of funds 
will be used to pay for them (text box below): 
3.0 * Will surveys/questionnaires be used? Yes 
4.0 * Does the study involve randomization? Yes 
5.0 * Does your study included Placebo or No-Treatment Arm? No 
6.0 * Does your study included Washout of Previous Medication? 
No 
7.0 Data collection sheet should be created for the study and 
uploaded: 
Name Version 
Checklist for Anesthesiologist - ACB PAI.doc 0.01 
GoytizoloACBPAI IRB2014018 UNSTAMPED.pdf 0.01 
Help 
Help 
Surveys & Questionnaires 


1.0 Please add all survey instruments and questionnaires to be 
used in this study: 
Name 
Standard 
Instument 
Upload Instrument Usage of Instrument 
View painOUTyes 
painOUT 
Questionnaire(0.01) 
This instrument will be used to 
acquire secondary outcome 
data. 
Help 
Randomization 
1.0 Please state who will do the Randomization: 
A research assistant not otherwise involved with the study will 
prepare a randomization table. Group assignment will be indicated 
on cards within numbered sealed opaque envelopes. After consent 
is obtained, the envelope will be opened in the operating room, not 
in the presence of the investigators who plan to assess the patients 
postoperatively. 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 19 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Interventions or Observations 
2.0 Please state when the Randomization will be done: 
The randomization will occur once IRB approval has been obtained and prior to 
the start of study enrollment. Randomization has been generated via computer 
randomizer. Randomization will be revealed after the patient gives consent and it 
is obtained in the holding area prior to surgery. At the time consent is obtained 
the anesthesiologist will be given a sealed opaque envelope corresponding to the 
patients study id number and randomization to either treatment or control. 
3.0 Please state how the Randomization will be performed: 
A research assistant not otherwise involved with the study will prepare a 
randomization table using randomizer software. 
4.0 Please state who will insure that the Randomization is carried 
out and if anyone will be blinded to the Randomization group: 
The Research Manager will ensure that the randomization is carried out. 
The physical therapist, nursing, PA, pain team, research staff, as well as 
the study patient will be unaware of which interventional group the study 
patient is in. 
Help 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Sample Size & Data Analysis 
Help 
Sample Size and Data Analysis 
If you are uncertain about how to calculate your sample size and determine appropriate 
data analysis, please contact the Epidemiology and Biostatistics Core at 
biostats@hss.edu 
for assistance in completing this section. 


1.0 
Is this is a case series based only on the patients available 
using descriptive statistics in lieu of a sample size 
calculation? 
* No 
Help 
Help 
Sample Size and Data Analysis 
Support estimates with evidence from the literature of prior studies and perform an 
appropriate sample size calculation. 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 20 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Sample Size & Data Analysis 
For hypothesis testing (e.g., the calculation of p-values using statistical tests), you need 
to 
estimate your available sample size and calculate the effect size that will be detectable 
using your proposed statistical analysis plan. This also applies to a case series where 
you 
plan hypothesis testing. 
1.0 If you have consulted with a statistician, please indicate their 
name: 
Kara Fields 
2.0 Proposed sample size analysis, include the following: 
• Student's t-test, ANOVA, chi-square, regression, etc; 
• Alpha level; 
• Beta or power level; 
• Primary outcome variable estimate (mean +/-s.d. for 
continuous outcome, frequency/percentage for 
categorical variable); 
• Number of groups being compared (use 1 for paired 
analysis within the same subjects); 
• Effect size or change expected between groups; 
• Resulting number per group 
A previous trial at HSS found the standard deviation (SD) in time until ready for 
discharge (based on achievement of PCA, nausea, diet, urination, pain, surgical, 
medical, and PT criteria) for TKR patients receiving periarticular injections to be 
0.83 days (YaDeau, 2013). This SD was considered to be a reasonable estimate 
of the variability in the time until patient is able to independently negotiate stairs 
within the periarticular injection alone group. A 0.5 day difference in mean time 
until patient is able to independently negotiate stairs between the periarticular 
injection alone and periarticular injection + ACB groups was determined to be 
clinically meaningful. With two-sided alpha set at 0.05, power at 0.8, and the 
addition of 10% more patients to account for potential protocol violations, the 
number of patients required for a two-sample t-test is 53 patients per group (106 
patients total*). 
*Our a priori sample size calculation assumed that 96 of 106 enrolled patients 
would adhere to trial protocol. However, ultimately only 92 out of 106 patients 
adhered to trial protocol. Therefore, we plan to continue enrollment up to 114 


patients until 96 patients without protocol deviations are enrolled. 
3.0 
Data Analysis: describe how the primary outcome will be 
analyzed and what types of statistical calculations will be 
used. Do the same for each secondary outcome. Reiterate 
briefly the main analysis to be done, which groups, which 
variables, possible confounders. Address how possible 
confounders will be identified and handled in analysis: 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 21 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART II - Clinical Research Proposal - Sample Size & Data Analysis 
The primary outcome, time until the patient is able to independently negotiate 
stairs, will be compared between the periarticular injection alone and periarticular 
injection + ACB groups with a two-sample t-test or Wilcoxon rank-sum test, 
depending upon the distribution of the data. The precision of the estimate of the 
difference between groups will either be reported as a 95% confidence interval 
for the difference in means or the Hodges-Lehmann estimate of location shift. 
Longitudinal secondary outcome data (NRS pain scores, narcotic consumption, 
incidence of side effects, painOUT score, and patient satisfaction) will be 
compared between groups via the generalized estimating equations (GEE) 
approach. 
Change in KSS, and hospital length of stay will be compared between groups 
with two-sample t-tests or Wilcoxon rank-sum tests, depending upon the 
distribution of the data. 
The success of blinding in each arm will be assessed with the Bang Blinding 
Index’ (Bang H, Flaherty SP, Kolahi J, Park J. Blinding assessment in clinical 
trials: A review of statistical methods and a proposal of blinding assessment 
protocol. Clin Res Regul Aff 2010; 27:42-51.) 
Help 
Help 
Consent Information 
1.0 Describe how, when, and where the consent process will be 
initiated: 
A MD co-investigator will obtain consent from the patient in the holding area prior 
to entering the operating room on the day of surgery. That physician will also 
serve as that patient's anesthesiologist. 
2.0 Who will obtain informed consent from subjects for this 
research? 
First Name Middle Name Last Name Title 
Enrique Goytizolo, M.D. 
Jacques YaDeau, MD, PhD IRB Vice Chair 
Edwin Su, MD 
Amar Ranawat, MD 
Douglas Padgett, MD 
David Kim, MD 
Michael M Alexiades, M.D. MD 
David Mayman, MD 
Yi Lin, MD 
Geoffrey Westrich, MD 
Iyabo Muse Regional Anesthesia fellow 
Help 


ID: 2014-018 Section: PART III - IRB Application - Submission Summary 
Help 
IRB Application 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 22 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART III - IRB Application - Submission Summary 
1.0 Please provide lay abstract: 
The purpose of this study is to compare two methods of treatment for pain 
control following Total Knee Replacement with an accelerated physical 
therapy protocol to aid the achievement of rehab milestones. The two pain 
control methods include: 1-Perarticular injections during the surgery 
and 2-Periarticular injections and adductor canal block. The primary 
outcome is time when patient is able to meet physical therapy discharge 
criteria, indicated by the ability to independently negotiate stairs. 
2.0 * Requested Review Type: 
Expedited 
3.0 Ancillary/Impacted Services Review (select all that apply): 
Note: Do not confuse the committees below with CRP or Research 
Service Chief 
Ancillary Committees 
Nursing 
Pharmacy 
Rehabilitation 
4.0 * Is Genetic Testing involved in this study? No 
Help 
Expedited Qualification 
If you check any of the items below, the study is qualified for EXPEDITED review status 
under federal guidlines. 
1.0 * Select all that apply: 
Question 
 
1. Clinical studies of drugs and medical devices only when: (a) 
Research on drugs for which an investigational new drug application 
(21 CFR Part 312) is not required. (Note: Research on marketed drugs 
that significantly increases the risks or decreases the acceptability of 
the risks associated with the use of the product is not eligible for 
expedited review). OR (b) Research on medical devices for which (i) an 
investigational device exemption application (21 CFR Part 812) is not 
required; or (ii) the medical device is cleared/approved for marketing 
and the medical device is being used in accordance with its 
cleared/approved labeling. 
2. This research involves only the collection of blood samples by finger 
stick, heel stick, ear stick, or venipuncture from healthy, non-pregnant adults 
or children where the amount of blood and frequency does not exceed 
federal regulations for normal clinical care. 
3. This research involves prospective collection of biological specimens for 
research purposes by noninvasive means. 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 23 of 37 


https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART III - IRB Application - Submission Summary 
Question 
4. This research involves the collection of data through noninvasive 
procedures (not involving general anesthesia or sedation) routinely 
employed in clinical practice, excluding procedures involving x-rays or 
microwaves. 
5. This research involves materials (data, documents, records, or 
specimens) that have been collected or will be collected solely for 
nonresearch purposes. 
6. Collection of data from voice, video, digital, or image recordings made for 
research purposes. 
7. This research will be performed on individual or group characteristics or 
behavior (including, but not limited to, research on perception, cognition, 
motivation, identity, language, communication, cultural beliefs or practices, 
and social behavior) or will employ a survey, interview, oral history, focus 
group, program evaluation, human factors evaluation, or quality assurance 
methodologies. 
8. This research involves Continuing Review of study previously approved 
by the convened IRB 
9. This research involves Continuing Review of study which are not 
conducted under an investigational new drug application or investigational 
device exemption where categories two through eight do not apply but the 
IRB has determined and documented at a convened meeting that the 
research involves no greater than minimal risk and no additional risks have 
been identified. 
Help 
Assessment of Research Procedures 
1.0 Describe any potential for direct benefits to participants in this 
study: 
Patients may experience a longer duration of pain relief. If this is the case, pain 
and opioid consumption would be reduced. This could reduce the incidence of 
opioid related side effects and increase patient satisfaction. Study participants 
will also be visited by a physical therapist twice a day and a mobility technician 
once a day on post operative day 1 and 2, providing an additional physical 
therapist visit when compared to the standard of care ( 1 physical therapist visit 
and 1 mobility technician visit per day). The accelerated physical therapy protocol 
may allow patients to meet physical therapy discharge criteria earlier and 
potentially be discharged from the hospital earlier than they would had they not 
been participating in the study. 
2.0 Describe any potential benefits to society: 
Better pain control for total knee replacement would benefit society. If the 
combination of investigational anesthetic regimen along with It would allow 
patients to achieve rehabilitation milestones earlier than average, clinical practice 
could be influenced. 
Help 
Minimal Risk 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 24 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART III - IRB Application - Submission Summary 


The probability and magnitude of harm or discomfort anticipated in 
the research are not greater in and of themselves than those 
ordinarily encountered in daily life or during the performance of 
routine physical or psychological examinations or tests. This 
includes, but is not limited to, administration of non-invasive data 
collection measures, collection of blood samples, collection of 
existing data and observational studies 
1.0 
Please select the applicable tests with standard wording for 
risks from the list below: 
Name Description 
There are no items to display 
Risk of breach of confidentiality, include the following: 
[ADDRESS THE RISK TO PATIENT PRIVACY, AS APPROPRIATE BASED ON 
THE SPECIFIC INFORMATION BEING KEPT IN THE REGISTRY – FOR 
EXAMPLE, “Participation in this research involves the potential risk of a breach 
of confidentiality of your health information that is stored. HSS tries to minimize 
those risks by (i) removing some direct identifiers from information stored [(i.e., 
names, social security numbers, medical record numbers)][MODIFY AS 
NECESSARY]; (ii) securing, in a separate location, and limiting access to 
information linking codes (i.e., linkage codes) assigned to the registry information 
with direct participant identifiers; and (iii) limiting access to information stored to 
HSS investigators.”] 
2.0 * Is any physical testing being done other than surveys, 
questionnaires, etc?: 
No 
2.1 If yes, please list the testing being done and describe any 
potential risks: 
Help 
ID: 2014-018 Section: PART III - IRB Application - Assessment Procedures 
Help 
Informed Consent 
1.0 Indicate the types of consent that will be involved in this study 
(check any or all that apply): 
Informed Consent Category 
Written/signed consent by subject 
2.0 Waivers: If you are applying for any waivers of consent (check 
any or all that apply): 
Name 
Waiver of Consent 
Waiver of Assent 
Waiver of Parental Permission 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 25 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART III - IRB Application - Assessment Procedures 
Name 
Waiver of Written or Signed Consent (i.e. information sheets, telephone 
consent, verbal script) 
3.0 * Will this study include non-english speaking participants? 


No 
4.0 If the study does not include non-english speaking 
participants, please justify: 
This study utilizes questionnaires that are validated in english. Therefore only 
english speaking patients will be recruited for study participation. 
5.0 
Please provide assurance by checking the box below that the 
study will make all possible efforts to collect Federally 
mandated gender, race and ethnicity data for all subjects 
included in the study. 
 Agree 
This will not be possible for the following reasons: 
6.0 Will this study be posted at ClinicalTrials.gov? 
Yes No 
If yes, please post at the site upon approval of the study by the IRB. 
ClinicalTrials.gov requires that listings be updated every 12 months as well 
as 30 days after Major Amendment approvals of a protocol. For more 
information about what studies should be posted at the site and when to 
update a posted study at the site, please visit the following website: 
http://www.icmje.org/faq_clinical.html 
Help 
Consent Forms & Process of Consent 
1.0 
Good News! We've prepared several different types of 
consent form templates with some of the information you have 
already provided. Please follow the instructions below to 
complete the process. 
Instructions: 
1.1) Download the applicable consent form(s) to your machine 
and modify as appropriate. Save the modified documents and 
upload them in the following question. 
Assent Form For Adolescent Participation In Research Study 
Lay term 
Glossary 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 26 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART III - IRB Application - Assessment Procedures 
Informed Consent To Participate In A Genetic Research Study 
Informed Consent To Participate In Research 
Informed Consent To Participate In Research Registry 
1.2) Please upload all informed consents, waivers, translated 
documents, phone recruitment scripts, recruitment ads, 
brochures, etc to be used in this study. 
Name Modified Version 
Updated Consent form 7/12/2016 1:44 PM 0.01 
Help 
Data Privacy & Confidentiality 
1.0 How will the data for this study be collected and recorded? 


Data will be collected by an investigator or research assistant. Sources 
of data include medical records and patient physical 
assessments/interviews conducted by study personnel. Data will be 
recorded and managed using REDCap electronic data capture tools 
hosted at the Clinical and Translational Science Center (CTSC) at 
Weill Cornell Medical College. REDCap (Research Electronic Data 
Capture) is a secure, web-based application designed to support data 
capture for research studies, providing: 1) an intuitive interface for 
validated data entry; 2) audit trails for tracking data manipulation and 
export procedures; 3) automated export procedures for seamless data 
downloads to common statistical packages; and 4) procedures for 
importing data from external sources. Connection to REDCap occurs 
via the hospital’s encrypted cable and wireless networks, and data will 
be entered through a password-protected computer terminal or iPad. 
2.0 Select Data Recording Identifiers used on this study: 
Name 
De-identified 
Coded (Data will be linked to subjects via encrypted codes) 
Identifiable 
2.1 If Other is selected, please specify: 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 27 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART III - IRB Application - Assessment Procedures 
N/A 
3.0 Where will the research data be stored? Please specify the 
physical location and how it will be secured to protect 
confidentiality: 
Any information collected electronically will be stored on the 
REDCap server. The REDCap server and data are hosted by Weill 
Cornell Medical College CTSC, with the servers physically located in 
the Payson building of Weill Cornell New York Presbyterian 
Hospital. Access to this space is limited to members of the Hospital’s 
informatics department. Electronically, several intrusion protection 
mechanisms, including firewalls and encryption, are in place to protect 
the server and its data. 
Any paper-based data sheets utilized for the study will be stripped of 
all personal identifiers whenever possible and stored the department’s 
locked office. 
4.0 Who, other than the specified study team, will have access to 
the study records or data? Specify their name, role, and 
affiliation. 
Informatics staff in the Weill Cornell Medical College CTSC will have 
access to the REDCap server as needed for administrative purposes. 
HSS IRB members, upon request, may also review study records 
and/or data. 
Do not list study 


personnel 
already listed in 
Section 1: 
5.0 If coded or identified data will be released, specify the 
persons/agencies to whom the information will be released. 
Please also indicate the provisions that will be taken to assure 
that the transmission of the data will maintain confidentiality: 
Data will be released to the project’s statistician, at designated 
intervals, including interim analysis (if appropriate) and at end of 
study. Any identifiers not essential for data analysis will be removed 
from the data set, which will be sent to the statistician as a password 
protected, encrypted file. 
6.0 Describe what will happen to the data or data set when the 
study is completed. Please indicate your plans for the 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 28 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART III - IRB Application - Assessment Procedures 
destruction of identifiers at the earliest opportunity consistent 
with the conduct of the research and/or clinical needs, if 
applicable: 
After data analysis, the study data set will be stored as an Excel or 
SPSS file. A unique feature of REDCap is that data fields marked as 
protected health information (PHI) can be automatically de-identified 
when data is exported. We will utilize this option when closing out the 
study after data analysis, so that no identifiers remain in the stored 
Excel or SPSS data set. In the REDCap program, the study will be 
changed from production mode to archive mode. This means the data 
and study forms will no longer be accessible to REDCap users. Only 
the research assistant and research manager will have rights to unarchive 
the study. The study will be maintained in REDCap for the 
period of time required by hospital/federal regulations, at which point 
it will be deleted. 
7.0 
If audio/video recordings or photographs will be used, specify 
your plans for deidentifying or anonymizing the material and 
when it will be destroyed: 
No audio/video recordings, photographs or medical imaging will be 
used in this study. 
8.0 Describe the data management software that will be 
used. Identify who will enter the data, and what data 
quality control measures will be used, such as dual 
entry, validation checks and locked fields. Insure that 
your plans are consistent with HIPAA regulations. 
Contact Ms. Andrea Ansorge with any questions 
related to HIPAA regulations and research. 


Data will be collected, managed, and stored using REDCap. 
Information will be entered directly into REDCap by a research 
assistant or other study personnel. Data quality assurance will include 
systematic training for study staff about patient assessment, 
administration of standardized surveys/questionnaires, and abstracting 
data from patient charts and medical systems. REDCap also features 
auto-validation in designated fields, the ability to create calculated 
fields, and provides audit trails for tracking data manipulation and user 
activity. 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 29 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART III - IRB Application - Assessment Procedures 
9.0 
Describe the measures that will be used to preserve 
confidentiality and rights of subjects. 
Below is Hospital for Special Surgery standard accepted practice. 
By completing this information, you attest that you will follow this 
procedure for preserving the confidentiality and rights of the 
subject. You can use the following standard, approved statement. 
9.1 If the HSS statement does not apply, please revise it 
accordingly. 
Access to the REDCap program is password-protected, and access to a 
specific study’s information within the program is limited to the 
research assistant and other IRB-approved study personnel who have 
been given permission to view and/or enter study data. REDCap 
program access is authorized by the CTSC; particular study access is 
granted by the research assistant. For data exports, fields marked as 
protected health information (PHI) in REDCap will be de-identified, if 
feasible. All transmission of data will occur via encrypted networks 
and in password-protected files. Any paper-based data sheets utilized 
for the study will have personal identifiers removed whenever possible 
and will be stored in the department’s locked office. Each subject will 
be assigned a unique study number for identification, and that number 
will not be derived from or related to information about the individual. 
Presentations and publications that result from this study will not 
contain any individual identifiers other than unique study numbers. 
Help 
Certificate of Confidentiality 
Certificates of Confidentiality constitute an important tool to protect the privacy of research study 
participants. They are issued by the National Institutes of Health (NIH) to protect identifiable research 
information from forced disclosure. They allow the investigator and others who have access to research 
records to refuse to disclose identifying information on research participants in any civil, criminal, 
administrative, legislative or other proceeding, whether at the federal, state or local level. 
Certificates of Confidentiality may be granted for studies collecting information that, if disclosed, could 
have adverse consequences for subjects or damage their financial standing, employability, insurability, 
or reputation. By protecting researchers and institutions from being compelled to disclose information 


that would identify research subjects, Certificates of Confidentiality help achieve the research objectives 
and promote participation in studies by assuring confidentiality and privacy to participants. 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 30 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART III - IRB Application - Assessment Procedures 
For more information, go to the following website: 
http://grants.nih.gov/grants/policy/coc/index.htm 
1.0 * Will a Certificate of Confidentiality be obtained for this study? 
No 
Help 
Help 
HIPAA 
The Healthcare Insurance Portability and Accountability Act (HIPAA) prohibits the use of 
a 
person's Protected Health Information without a valid authorization. 
1.0 * Will this study record any information which can identify the 
participants of this study? 
Yes 
2.0 * Will this study record information that if released, could 
reasonably place participants at risk of criminal or civil law 
suits? 
No 
3.0 * Will this study obtain or review information related to the 
respondent's medical records or health? 
Yes 
4.0 
Select the option(s) which fits this study: 
Name 
Self reported medical information 
Direct authorization through consent form 
Waiver of authorization requested (Full / Partial / Alteration) 
HIPAA Waiver 
Flow Chart 
Help 
Waiver of HIPAA Authorization 
Pursuant to the Privacy Regulations of HIPAA, an IRB is only permitted to approve a 
waiver of individual subjects' authorization if it finds and documents specific criteria 
relevant to the protection of subject privacy. 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 31 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART III - IRB Application - Assessment Procedures 
1.0 I am seeking: 
A full waiver of subject authorization to use and disclose health 
information during the course of the research study. 
 A partial waiver of subject authorization to use and disclose 
health information only for the purpose of: 


Reviewing the operating room schedule to identify potential 
patients. Coinvestigators other than the treating physician may 
approach patients to be in the research study. 
The following alteration to the authorization requirements: 
2.0 * Who will have access to the health information needed for the 
study? Please identify each person by name or category. 
Example include: the investigator, the research staff, coinvestigators 
and their research staffs, and all research 
monitors. 
Principal Investigator: Dr. Enrique Goytizolo 
And all IRB approved Co-Investigators 
3.0 * Please describe the risks to privacy presented by the 
research and whether the research presents more than 
minimal risk of harm to subjects' privacy. Include a description 
of what identifiers will be reviewed, collected, and stored; who 
will have access to identified information; how access to study 
data is controlled; who will monitor access to study data; and 
where data will be stored: 
All patients will be identified by a specific study number. Any patient information 
taken from medical records will be kept strictly confidential. Only the previously 
mentioned investigators will have access to this information. Thus our research 
presents a minimal risk of harm to subjects’ privacy. 
4.0 
* Can the research be practicably carried out without the 
waiver? Yes No 
If it is impracticable to obtain individual authorization, please 
describe why: 
We need to know the patients’ demographics to analyze the data collected. 
5.0 
* Can the research be practicably carried out without access to 
and use of identified health information? Yes No 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 32 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART III - IRB Application - Assessment Procedures 
If it is impracticable to conduct this research without access to 
identified health information, please describe why: 
We need to know the patients’ demographics to analyze the data collected. 
6.0 * What is your plan to protect identifiers from improper use and 
disclosure? 
Any information obtained during the course of this study will be solely for 
research purposes. Hence only the listed investigators shall have access to this 
information. Any patient information will be kept locked and secure. 
7.0 
* Will the patient identifiers be destroyed at the earliest 
opportunity? Yes No 
If yes, describe the plan for destroying identifiers (e.g. how, by 
whom, and when identifiers will be destroyed): 


After data analysis, the study data set will be stored as an Excel or SPSS file. A 
unique feature of REDCap is that data fields marked as protected health 
information (PHI) can be automatically de-identified when data is exported. We 
will utilize this option when closing out the study after data analysis, so that no 
identifiers remain in the stored Excel or SPSS data set. In the REDCap program, 
the study will be changed from production mode to archive mode. This means 
the data and study forms will no longer be accessible to REDCap users. Only the 
research assistant and research manager will have rights to un-archive the study. 
The study will be maintained in REDCap for the period of time required by 
hospital/federal regulations, at which point it will be deleted by the research 
assistant or research manager. 
If no, indicate the health or research justification for retaining the 
identifiers: 
8.0 * Explain how PHI will be acquired and used: 
Data will be collected by an investigator or research assistant. Sources of data 
include medical records and patient physical assessments/interviews conducted 
by study personnel. Data will be recorded and managed using REDCap 
electronic data capture tools hosted at the Clinical and Translational Science 
Center (CTSC) at Weill Cornell Medical College. REDCap (Research Electronic 
Data Capture) is a secure, web-based application designed to support data 
capture for research studies, providing: 1) an intuitive interface for validated data 
entry; 2) audit trails for tracking data manipulation and export procedures; 3) 
automated export procedures for seamless data downloads to common statistical 
packages; and 4) procedures for importing data from external sources. 
Connection to REDCap occurs via the hospital's encrypted cable and wireless 
networks, and data will be entered through a password-protected computer 
terminal or iPad. 
9.0 
Explain how PHI will be protected during this study: 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 33 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART III - IRB Application - Assessment Procedures 
Subject privacy and confidentiality will be maintained through 
the storage of study data in a password-protected computer 
database maintained by the PI and accessible only to the principal 
investigator, in addition to other IRB approved study personnel. 
Each subject will be assigned a unique study number for 
identification in the study database. This unique study number will 
not be derived from or related to information about the individual. 
The key linking this unique study number to patient identifiers (i.e. 
name, medical record number, date of birth, registry number, 
etc…) will be maintained in a different password protected 
database maintained by to which only will have access. 
 
10.0 * Justify your need to collect PHI on this study: 
PHI will be needed to screen for potential study participants, verify patient 
identity, and to coordinate patient information across multiple data sources, 
including CliniCIS, MMF, PS Reporter, REDCap, and paper charts. Some PHI 
including age, date of surgery, date of discharge and other unique identifying 
characteristics are essential data points for creating a demographic profile of 


study participants. 
Help 
Help 
PHI Identifiers 
1.0 
Identify the types of PHI collected: 
Name 
 Questionnaires or Interviews 
Billing Information or Databases 
Mental Health Records 
Data Registry 
 Hospital or Medical Records 
Biological Samples 
DNA Samples 
Other 
1.1 If Other, please specify the type of PHI collected: 
2.0 
Select all the PHI Identifiers that apply: 
Identifiers 
Names 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 34 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART III - IRB Application - Assessment Procedures 
Identifiers 
Medical Record numbers 
All elements of dates (except year) for dates related to an individual: 
Help 
Data Safety Monitoring Plan 
1.0 * Check the one box below that most accurately reflects the 
plan for data and safety monitoring for this study. 
The study will be monitored only by the study investigators and/or sponsor. 
1.1 If Other, Please specify your plan for data safety and 
monitoring for the study. If no DSMB required, Please specify 
why: 
2.0 Describe the clinical criteria for withdrawing an individual 
subject from the study due to safety or toxicity concerns: 
If a patient experiences complications, they will be kept at HSS for observation and 
withdrawn from the study. Such complications that would cause safety and toxicity 
concerns include local anesthetic toxicity, cardiac toxicity, and central nervous toxicity. 
3.0 Summarize any pre-specified criteria for stopping or changing 
the study protocol due to safety concerns. 
We do not have pre-specified criteria for stopping the study. 
4.0 * Are there any plans to perform an interim efficacy analysis: 
No 
4.1 If you answered Yes, please describe the plans to conduct 
an interim analysis. 
N/A 
Help 
Final Page 


You have completed your application! 
Please hit "Continue" to finish the HSS Clinical Trial Form. 
Please note that a submission may only be forwarded to the IRB by the Principal 
Investigator. To do this, the Principal Investigator must press the "SUBMIT 
STUDY" button in My Activities for this Study ID:2014-018. 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 35 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: PART III - IRB Application - Assessment Procedures 
You can track the ongoing status of your submission by logging into the study 
workspace. 
Please feel free to contact the IRB with any questions or concerns. 
ID: 2014-018 Section: HSS Clinical Trial Registry 
Help 
HSS Clinical Trial 
The Clinical Trial Registry is posted on the HSS main page to highlight research 
(including retrospective studies) being conducted at HSS. This same language, once 
approved by the IRB, can then be used on flyers if you so choose, to post in an effort to 
recruit subjects. 
1.0 Title: The Combination of Adductor Canal Block and Periarticular Injection with 
an Accelerated Rehabilitation Protocol. A novel technique for Patients 
Undergoing Total Knee Replacement (ACB PAI) 
2.0 PI: Enrique Goytizolo, M.D. 
3.0 Co-Investigators: 
First Name Middle Name Last Name Title 
Jacques YaDeau, MD, PhD IRB Vice Chair 
Angie Zhang Research Assistant 
Edwin Su, MD 
Amar Ranawat, MD 
Kara Fields Volunteer 
Douglas Padgett, MD 
Rupali Joshi Physical Therapist 
Isabel Armendi 
David Kim, MD 
Michael M Alexiades, M.D. MD 
Thuyvan Luu 
David Mayman, MD 
Jodie Curren, RN 
Denesy Mancenido Assistant Director, Research 
Yi Lin, MD 
Matthew Titmuss Physical Therapist 
Jennifer Cheng Research Associate 
Valeria Buschiazzo 
Geoffrey Westrich, MD 
Phuong Dinh Mac 
Katherine Lee 
Iyabo Muse Regional Anesthesia fellow 
4.0 
Posting date: 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 36 of 37 


https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 
ID: 2014-018 Section: HSS Clinical Trial Registry 
Name 
Upon IRB approval 
Post on this date: 
5.0 
Condition: 
Arthroplasty 
Other: 
6.0 State the summary including number of patients, enrollment 
period and duration of follow-up (use lay terms): 
We plan to enroll up to 114 patients undergoing knee replacement in order to get 
96 patients with usable data. All patients will receive peri articular injections as an 
anesthetic regimen. Half will additionally receive an adductor canal block. 
Patients will also have an accelerated physical therapy protocol to aid the 
achievement of rehab milestones. The primary outcome is time when patient is 
able to meet physical therapy discharge criteria, indicated by the ability to 
independently negotiate stairs- non-reciprocal (one leg at a time), with or without 
rails, and with or without assistive device (walker or cane). 
7.0 State the inclusion and exclusion criteria (use lay terms): 
8.0 State the contact information for the study: 
Help 
Print: 2014-018 - The Combination of Adductor Canal Block and Periarticular Injectio... 
Page 37 of 37 
https://ecap.hss.edu/eCAP/ResourceAdministration/Project/PrintSmartForms?Project=c
om.w... 8/22/16 

ICF_000.pdf: 
 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 1 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
7/14/2016 Thru 3/24/2017 
HOSPITAL FOR SPECIAL SURGERY 
535 East 70th Street  
New York, NY 10021 
 
 
INFORMED CONSENT TO PARTICIPATE IN RESEARCH 
 
 
TITLE: The Combination of Adductor Canal Block and Peri-Articular Injection with an 
Accelerated Rehabilitation Protocol. A Novel Technique for Patients Undergoing Total Knee 
Replacement 
 
PROTOCOL NO.: 2014-018 
 
SPONSOR: HSS Department of Anesthesiology, HSS Department of Rehabilitation, Adult 
Reconstruction and Joint Replacement Division 
 
INVESTIGATOR: Enrique Goytizolo, MD 
 
SITE(S): Hospital for Special Surgery 
 
STUDY-RELATED PHONE NUMBER(S): 
 
(212) 797-8676: Enrique Goytizolo, MD Principal Investigator 
 
(212) 774-7022: Katie (Phuong Dinh) Mac, BA Research Assistant 
(212) 774-7377: Jennifer Cheng, PhD Research Associate 
 
IRB #: 2014-018 
 
You are being asked to take part in a research study conducted by Hospital for Special Surgery 
(HSS).  You are being asked to participate in this study because you are to undergo total knee 
replacement surgery by Dr. Alexiades, Dr. Mayman, Dr. Padgett, Dr. Amar Ranawat, Dr. Su, or 
Dr. Westrich. 
 
You will still be responsible for the cost of your medical care just as you would be if you 
were not part of this study.  For example, any co-pays, deductibles, and co-insurance 
associated with your medical care. 
 
This document provides you with information about this study.  After reading this document, any 
questions you may have will be answered.  You may take home a copy of this document to 
consider or discuss with family and friends before making your decision.  
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site 
will include a summary of the results. You can search this Web site at any time. 
  


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 2 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
7/14/2016 Thru 3/24/2017 
 
1.  WHY IS THIS STUDY BEING DONE? 
Relieving post-operative pain is extremely important to orthopedic surgeons and 
anesthesiologists at HSS. The purpose of this study is to compare the effectiveness of two 
methods of pain control along with an accelerated physical therapy protocol in aiding the 
achievement of rehabilitation milestones. The two pain control methods include: (1) peri-
articular injections during the surgery and (2) peri-articular injections during the surgery and a 
peripheral nerve block. The peri-articular injections are performed by your surgeon and are 
injections of pain medicine around the knee. The nerve block (injection of local anesthetic, 
numbing medicine, near a nerve leading to the knee) being investigated in this study is the 
adductor canal block. The adductor canal block has been shown to decrease pain and morphine 
use and preserve quadriceps strength post total knee replacement. Your overall participation will 
continue over the course of your hospital stay at the Hospital for Special Surgery.  
 
2.  WHAT WILL YOUR PARTICIPATION REQUIRE?   
If you decide to be in this study, the following routine and/or experimental procedures will be 
performed:  
 
Study 
Visit # 
Surveys / 
Questionnaires 
Randomization 
Surgery 
Physical 
Therapist 
Visit #1 
Physical 
Therapist 
Visit #2 
Physical 
Therapist 
Visit #3 
Holding 
Area 
X 
X 
SOC 
 
 
 
PACU 
X 
 
 
SOC 
 
 
POD 1 
X 
 
 
SOC 
X (until 
Rehab 
goals are 
met) 
X (until 
Rehab 
goals are 
met) 
POD 2 
X 
 
 
SOC 
X (until 
Rehab 
goals are 
met) 
X (until 
Rehab 
goals are 
met) 
 
X=  Research procedures 
SOC= Standard of care (care you would receive if you were not participating in this study) 
 
This study will select your treatment by chance.  You will be assigned at random to one or more 
study groups: 
 
Group 1 - Peri-articular Injection group  
A spinal anesthetic with 0.5% bupivacaine (10 or 12.5mL) will be performed. The surgeon will 
perform the periarticular injections. The deep injection will consist of bupivacaine 0.5% with 
epinephrine, 30cc; morphine, 8 mg/ml, 1 cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 
mg in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine. 
Patients will also be given 2 mg of intravenous decadron  


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 3 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
7/14/2016 Thru 3/24/2017 
 
Group 2 – Peri-articular + Adductor Canal Block group 
 
In addition to the above peri-articular injection protocol, patients will receive an adductor canal 
block: 15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone.  
 
The randomization process is comparable to (or similar to) the flip of a coin.  It is not known if 
any treatment you receive will benefit you.  It is hoped the knowledge gained will benefit others 
in the future. You, as well as the research, nursing, physical therapist, and acute pain staff will be 
blinded as to which study group you are in. However, your anesthesiologist will not be blinded. 
 
You and/or your insurance will be responsible for any costs of all procedures performed that are 
standard of care, that is, care that you would receive even if you were not in this study. 
 
A total of 114 subjects will participate in this study at HSS.   
 
Your participation will involve a total of 6 study visits.  Most visits are expected to last 5-10 
minutes.  
 
3.  WHAT ADVERSE (BAD) EFFECTS CAN HAPPEN FROM BEING IN THE STUDY?  
WHAT RISKS ARE KNOWN ABOUT THE STUDY DRUG/STUDY DEVICE? 
The known effects, discomforts and foreseeable risks of physical, psychological, sociological, or 
other harm which you may reasonably expect to occur from being in this study are:  
 Adductor Canal Block: One group will receive the adductor canal block. This will be an 
injection of local anesthetic near the saphenous nerve with ultrasound guidance. It is a 
possibility that the nerve may become irritated or injured during the injection. Your 
anesthesiologist will talk with you more about this procedure. 
 Peri-articular Injection: Both groups will receive the peri-articular injection. This is an 
injection performed near the knee joint by your surgeon. The injection is a combination 
of local anesthetic and other medications hoped to reduce pain and side effects. It is 
possible that the tissue near the knee may become irritated or injured with the injection. 
 Opioids: Opioids are given to both groups pre operatively and are used for pain control 
after total knee replacement. Sometimes nausea, vomiting, itching, sedation and 
confusion, and constipation can occur.  
 Other Medications: Meloxicam (an oral non-steroidal anti-inflammatory drug) is used in 
both groups. It is standard of care at HSS for total joint replacements and is thought to 
reduce pain and improve mobility. Meloxicam is rarely associated with kidney problems. 
Steroids are given in both groups. Usually significant side effects do not occur with a 
single dose, but a short term rise in blood sugar is possible. 
 
Participation in this research involves the potential risk of a breach of confidentiality to your 
stored health information.  HSS tries to minimize those risks by (i) removing some direct 
identifiers from stored information [(i.e., names, social security numbers, medical record 
numbers); (ii) securing, in a separate location, and limiting access to information that would 
identify you; and (iii) limiting access to information stored to HSS investigators. 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 4 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
7/14/2016 Thru 3/24/2017 
 
There may be risks or side effects that are unknown at this time. If we learn about new risks that 
may affect your willingness to continue your participation, we will make you aware of them and 
you will be asked to re-consent to continue your participate in the study. 
 
Your condition may not get better from being in this study. Your condition may or may not get 
worse from being in this study.   
 
4.  WHAT BENEFIT CAN YOU EXPECT?  
All patients participating in the study will receive an accelerated physical therapy program 
postoperatively, at no cost to you.  
 
If you are in the group receiving peri-articular injections (50% chance) you may or may not 
receive any additional benefit. If you are in the group receiving peri-articular injections and the 
adductor canal block (50% chance) you may or may not experience less pain. If you experience 
less pain then you may reduce your opioid consumption. Reduced opioid consumption could lead 
to fewer opioid related side effects. Such side effects include constipation, nausea, vomiting, 
sedation, sleepiness, difficulty concentrating, difficulty urinating, and dry mouth.  
 
5.  COST  
Those research procedures listed in Section 2 will be covered by the study and will not be your 
financial responsibility.   
 
As indicated in Section 2, those costs which are considered Standard of Care for your treatment 
here at Hospital for Special Surgery will be your/or your insurance’s responsibility.  You will be 
responsible for any co-pays, deductibles, and co-insurance associated with your medical care, 
just as you would be for any costs billed to your health insurance outside of this study.  You will 
also be financially responsible for any medical care costs not covered by your health insurance. 
 
HSS is committed to providing financial assistance when financially warranted and consistent 
with its resources, regardless of age, gender, religion, race or sexual orientation.  So if you do not 
have health insurance, or if your health insurance does not pay for your medical care, you may 
seek financial assistance from HSS.  Eligibility determinations are made on a case-by-case basis 
in accordance with HSS’s financial assistance policy.  You will be responsible for any costs not 
covered by financial assistance, which could be all of the costs (if HSS determines that you are 
not eligible for financial assistance) or some of the costs (if financial assistance awarded by HSS 
does not cover all of the costs). For more information about the Financial Assistance 
Program or to request a Financial Assistance Application call (212) 606-1505 to speak with a 
Financial Assistance Counselor or you can visit the following site:  
http://www.hss.edu/patient-financial-assistance-notice.asp. 
 
6.  PREGNANCY  
Due to inherent risks, HSS policy prevents women who are pregnant or nursing a child from 
receiving the type of surgery or procedure needed to qualify for this research study.  So if you 
are currently pregnant or nursing a child, you may not participate in this study.   


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 5 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
7/14/2016 Thru 3/24/2017 
 
7.  PAYMENT FOR PARTICIPATION 
You will not be paid for your participation in this study.   
 
8.  COMMERCIAL ISSUES:  YOUR RIGHTS IN THE RESULTS OF THE STUDY 
There are no plans to compensate you for the use of the findings of this study, or any of the 
information or biologic materials (such as blood or tissue) collected from you during the study, 
even if they are used to develop or make a commercial product (such as a drug, device, biologic 
substance, or test).   
 
9.  ALTERNATIVES:  WHAT OTHER TREATMENT IS AVAILABLE IF YOU DON’T 
WANT TO BE IN THE STUDY?  
You do not have to participate in this study to receive treatment for your condition. 
 
10.  WHO WILL BE ABLE TO SEE YOUR RECORDS AND PERSONAL 
INFORMATION AND KNOW THAT YOU ARE IN THE STUDY? 
Federal regulations give you certain rights related to your health information.  These include the 
right to know who will be able to see your information and why they will be able to see it.  The 
study doctor must obtain your authorization (permission) to use or give out any health 
information that might identify you.  
 
What information may be used or given to others?   
 
If you choose to be in the study, the study doctor will get personal information about you.  The 
information might identify you.  The study doctor may also get information about your health 
including:  
 
 Medical and research records 
 Records about phone calls 
 Records about your study visits  
 Records of physical exams 
 Laboratory, x-ray, and other test results 
 Questionnaires 
 Records about any study device you received 
 
Who may use, disclose, or receive my information? 
  
The following person(s) class(es) of persons, and/or organization(s) may use, disclose, or receive 
my information: 
 The Principal Investigator and other Investigators for this study, including your study 
doctor. 
 The research coordinator, research nurses, and other members of the HSS research team 
working on this study. 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 6 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
7/14/2016 Thru 3/24/2017 
 Every research site for this study, including Hospital for Special Surgery and its affiliates, 
New York-Presbyterian Hospital, and Memorial Sloan-Kettering Cancer Center. This 
includes the research staff and medical staff at each institution. 
 The Patient Advocate or Research Ombudsman at these institutions. 
 Staff members of HSS responsible for administering clinical trials and other research 
activities 
 Any laboratories and other individuals and organizations that analyze your health 
information for this study. 
 Any health care provider that you have used in the past or may use up to the time this study 
ends. 
 The United States Food and Drug Administration (FDA), the federal Office for Human 
Research Protections (OHRP), any federal agency that provides support for this study, and 
any federal, state, or local agency responsible for overseeing HSS, the study doctor, or any 
other member of the HSS research team involved in this study. 
 The members and staff of the affiliated Institutional Review Boards (IRBs) at HSS, New 
York-Presbyterian Hospital, and Memorial Sloan-Kettering Cancer Center.  An IRB is a 
committee of health care providers, community representatives, and others that initially 
approves and periodically reviews biomedical and behavioral research that involves human 
subjects in order to protect the rights, safety and welfare of study participants. 
 Data Safety Monitoring Boards and others authorized to monitor the conduct of this study 
for safety or quality assurance, for example a Clinical Events Committee. 
 
Why will this information be used and/or given to others?   
 
Your health information may be given to others to carry out this study.  The research staff will 
analyze and evaluate the results of this study.   
 
Your health information may be given to the FDA.  It may also be given to governmental 
agencies in other countries. Your information may also be used to meet the reporting 
requirements of governmental agencies.  
 
The results of this study may be published in scientific journals or presented at medical meetings, 
but your identity will not be disclosed.   
 
What if I decide not to give permission to use and give out my health information?   
 
By signing this informed consent form, you are giving permission to use and give out your health 
information as described above.  If you refuse to give permission, you cannot be in this study.  
 
May I review or copy the information obtained from me or created about me? 
   
You have the right, in accordance with Hospital policy and applicable law, to review and copy 
your health information that is created or obtained in the course of this study.  However, if you 
decide to be in this study and sign this informed consent form, you will not be able to look at or 
copy your information until after the study is completed if doing so would impact the validity of 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 7 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
7/14/2016 Thru 3/24/2017 
the study (for example, if the study is “blinded” so that during the study you will not know what 
treatment or other intervention you are receiving). 
 
May I revoke (take back) my permission?  
 
Yes. Your permission will never expire unless you revoke it.  To revoke your permission, you 
must write to the study doctor at Hospital for Special Surgery, 535 East 70th Street, New York, 
NY 10021. 
 
You may revoke your permission to use and disclose your health information at any time.  If you 
revoke your permission, you cannot continue to participate in this study.   
 
After you revoke your permission, no new health information that might identify you will be 
gathered. Information that has already been gathered may still be used and given to others. This 
would be done if the information is needed for this study to be reliable.   
 
Is my health information protected after it has been given to others?  
 
Some persons who receive your health information may not be required to protect it, and they 
may share your information with others without your permission, if permitted by laws governing 
them.  Therefore, there is a risk that your information will be released to others without your 
permission. 
 
11.  CONFLICT OF INTEREST NOTIFICATION 
HSS is concerned about possible conflicts of interest in research, and has policies that require all 
investigators and senior research staff to report to HSS significant financial interests (such as 
stock ownership, royalty payments, and consulting agreements) and relationships (such as 
membership on a scientific advisory board) that are related to their research studies.  When an 
investigator reports a significant financial interest or relationship that relates to one of his/her 
studies, HSS’s Conflict of Interest Committee for Research reviews the information to evaluate 
the risk that the interest or relationship might influence how the investigator conducts the study 
or interprets the results of the study.  HSS may also take steps to minimize that risk.   
 
 
The Conflict of Interest Committee for Research has determined that there are no 
conflicts of interest associated with this study. 
 
 
The Conflict of Interest Committee for Research has determined that there is a 
potential conflict of interest associated with this study.  Please read the information 
below carefully. 
 
12.  VOLUNTARY PARTICIPATION/WITHDRAWAL 
Your decision to take part in this study is completely voluntary.  You are free to choose not to 
take part in the study and may change your mind and withdraw at any time.  Your relationship 
with physicians at HSS and your medical care at HSS, now or in the future, will not be affected 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 8 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
7/14/2016 Thru 3/24/2017 
in any way if you withdraw or refuse to participate.  You will not lose any benefits to which you 
are otherwise entitled. 
 
The study doctor and/or the sponsor may terminate your participation in this study at any time 
without your consent if, in their judgment, it is inadvisable for you to continue.   
 
13.  COMPENSATION FOR INJURY 
If you are injured as a result of participating in this study, the study doctor, other members of the 
research team, or other HSS professional medical staff will provide you with emergency medical 
treatment (or arrange to have such treatment provided to you), and will assist you in obtaining 
appropriate follow-up medical treatment. However, there is no plan to routinely provide 
compensation for additional medical care or other costs. 
 
Your health insurance may or may not pay for treatment of injuries as a result of your 
participation in this study.  
 
14.   SOURCE OF FUNDING  
Funding for this study will be provided by the HSS Department of Anesthesiology, HSS 
Department of Rehabilitation, and the Adult Reconstruction and Joint Replacement division. 
 
15.  QUESTIONS   
If you have any additional questions later on, or if you wish to report a medical problem that may 
be related to this study, Dr. Enrique Goytizolo can be reached at 212-797-8676 during office 
hours.  
 
If you have any questions about your rights as a participant in this study or any questions about 
your participation that you would like to ask an institutional representative who is not part of this 
study, you can call the Manager of the HSS Institutional Review Board at (212) 774-7154.  
 
If you would like to have more information about the Hospital’s financial disclosure review 
process in general, or in regard to this study, you may contact the Hospital’s Office of Legal 
Affairs at (212) 606-1592.   You may also ask the Hospital’s patient advocate at (212) 774-2403, 
to arrange for you to have this information. 
 
Do not sign this consent form unless you have had a chance to ask questions and have received 
satisfactory answers to all of your questions.  


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 9 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
7/14/2016 Thru 3/24/2017 
Agreement to Participate: Witnessing and Signature 
 
To be in this study, you or your legal representative must sign the next page of this informed 
consent form. By signing the next page, you are voluntarily agreeing to be in this study at HSS. 
 
Before signing, you should be sure of the following: 
 
 You have read all of the information in this “Informed Consent to Participate in Research” 
form (or had it read to you).  
 You have discussed the implications of your being in this study with your doctor, your 
study doctor and/or the study coordinator.  
 You have had the chance to ask questions about this study. 
 You received answers to your questions. 
 If you did not understand any of the answers, you asked the study doctor or the study 
coordinator to explain them to you. 
 The information given to you is based on what is now known about the study drug(s), 
device(s), or procedure(s).  There may be other risks or complications that are not known at 
this time. 
 You have had time to think about the information and decide whether or not to be in the 
study. 
 
Please check one of the following: 
 
   I AM NOT in another research study at this time. 
 
   I AM in another research study at this time. 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 10 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
7/14/2016 Thru 3/24/2017 
If you decide to be in this study: 
 
 You are expected to follow the study procedures. 
 You are expected to provide the information needed by the study doctor, the study 
coordinator, nurses, or other staff members for the study. 
 You will be told in a timely manner of any significant new information that may affect 
your willingness to stay in the study. 
 You may freely choose to stop being in the study at any time. 
 
By signing below, you are voluntarily agreeing to be in this study. 
 
You must be given a signed copy of this informed consent form to keep for yourself. 
 
 
 
______________________________________ 
_______________________________________ 
Print Name of Participant  
 
 
Signature of Participant 
 
            Date 
 
______________________________________           ______________________________________ 
Print Name of Parent/Legal Guardian (if applicable)1 
Signature of Parent/Legal Guardian  
Date 
 
____________________________________ 
_______________________________________ 
Print Name of Person Obtaining Consent 
 
Signature of Person Obtaining Consent       Date 
 
 
 
_____________________________________  
As an HSS representative, please sign here to indicate that you have given a signed copy of this informed consent 
form to the participant 
 
 
NOTE TO INVESTIGATORS: 
 
THE ORIGINAL OF THIS INFORMED CONSENT FORM MUST BE PLACED IN THE 
PARTICIPANT’S STUDY FILE. 
 
A SIGNED COPY OF THIS INFORMED CONSENT FORM MUST BE GIVEN TO THE 
PARTICIPANT. 
 
A COPY OF THE INFORMED CONSENT FORM MUST BE PLACED IN THE 
PARTICIPANT’S HOSPITAL MEDICAL RECORD IF THE PARTICIPANT IS (OR WILL 
BE) HOSPITALIZED AT ANY TIME DURING THE STUDY. 
 
 
                                                 
1 The parent or legal guardian of a child participant should sign this form on behalf of the child.  The signature of 
one parent is sufficient when the research is of minimal risk to the child, or when the research presents the prospect 
of direct benefit to the child.  The signature of both parents is required when the research involves greater than 
minimal risk with no prospect of direct benefit to the child.  The requirements for signature of both parents may be 
waived if one parent is deceased, unknown, incompetent, or not reasonably available, or when one parent has sole 
legal responsibility for the care and custody of the child.  If the participant is a child who is capable of giving assent, 
the child should also sign the attached Assent Form.