Expanding the Peri-operative Surgical Home Model: ERAS TKR With a Transitional Pain Service (TeleTPS) - Continuous Adductor Canal Catheter Versus Adductor Canal Block for Total Knee Arthroplasty, a Randomized Double-blinded Controlled Trial.
Phase: NA
Conditions: Chronic Pain, Opioid Use, Adductor Canal Block, Total Knee Arthroplasty
Sponsor: Hospital for Special Surgery, New York

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Expanding the peri-operative surgical home model: ERAS TKR with a 
transitional pain service (TeleTPS)- Continuous adductor canal catheter 
versus adductor canal block for total knee arthroplasty, a randomized double-
blinded controlled trial 
FUNDER: Anesthesiology Research Department 
PROTOCOL NO.: 2017-1858 
VERSION & DATE: Version 1, 06/09/2023 
 
 
 
 
 
 
 
 
 
 
 
 
This document contains the confidential information of the Hospital for Special Surgery.  It is provided 
to you and your company’s personnel for review.  Your acceptance of this document constitutes an 
agreement that you will not disclose the information contained herein to others without the prior written 
consent of the Hospital for Special Surgery.  No other use or reproduction is authorized by Hospital for 

 
Protocol Number: 2017-1858  
Version Date: 06/09/2023  
 
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Special Surgery, nor does the Hospital for Special Surgery assume any responsibility for unauthorized 
use of this protocol. 
TABLE OF CONTENTS 
TABLE OF CONTENTS ............................................. 2 
PROTOCOL SYNOPSIS ........................................... 3 
1.0 
INTRODUCTION ............................................. 5 
2.0 
OBJECTIVE OF CLINICAL STUDY ............... 6 
STUDY HYPOTHESES ............................................. 6 
2.1 
Study Duration .............................................................................................................. 6 
2.2 
Endpoints ...................................................................................................................... 6 
2.2.1 
Primary Endpoint .................................................................................................... 6 
2.2.2 
Secondary Endpoints ............................................................................................. 6 
2.3 
Study Sites .................................................................................................................... 7 
3.0 
STUDY POPULATION .................................... 7 
3.1 
Number of Subjects ..................................................................................................... 7 
3.2 
Inclusion Criteria .......................................................................................................... 7 
3.3 
Exclusion Criteria ......................................................................................................... 7 
3.4 
Randomization .............................................................................................................. 8 
4.0 
PROCEDURES ............................................... 8 
4.1 
Surgical Procedure ...................................................................................................... 8 
4.2 
Medical Record Requirements .................................................................................... 8 
4.3 
Data Collection ............................................................................................................. 8 
4.4 
Schedule of Assessments ......................................................................................... 10 
5.0 
STATISTICAL ANALYSIS ............................. 11 
6.0 
ADVERSE EVENT ASSESSMENT .............. 11 
6.1 
Adverse Event (AE) .................................................................................................... 11 
6.2 
Serious Adverse Events (SAE) ................................................................................. 11 
6.3 
Adverse Event Relationship ...................................................................................... 11 
7.0 
INVESTIGATOR RESPONSIBILITIES, RECORD 
AND REPORTS ....................................................... 11 
7.1 
Subject Consent and Information............................................................................. 11 
7.2 
Subject Data Protection ............................................................................................. 12 
7.3 
Staff Information......................................................................................................... 12 
7.4 
Protocol Reviews ....................................................................................................... 12 
8.0 
REFERENCES.............................................. 12 

 
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PROTOCOL SYNOPSIS 
Protocol Title: 
Expanding the peri-operative surgical home model: ERAS TKR with a 
transitional pain service (TeleTPS)- Continuous adductor canal 
catheter versus adductor canal block for total knee arthroplasty, a 
randomized double-blinded controlled trial 
Protocol Number: 
2017-1858 
Protocol Date: 
06/09/2023 
Sponsor: 
Anesthesiology Department 
Principal 
Investigator: 
David Kim, MD 
Products: 
AmbIT Pump and MediBag – Summit (Manufacturer) 
Arrow, FlexBlock CPNB Kit – Teleflex (Manufacturer) 
Objective: 
The purpose of this study is to conduct a randomized controlled trial on 
patients undergoing unilateral total knee arthroplasty to compare the 
benefits of receiving an adductor canal catheter versus a single-shot 
adductor canal block with and additive (dexamethasone). 
Study Design: 
Randomized Clinical Trial 
Enrollment: 
60 
Subject Criteria: 
Inclusion: 
• 
Patients with osteoarthritis scheduled for a primary total knee 
arthroplasty with a participating surgeon 
• 
Age 18 to 75 years 
• 
Planned use of regional anesthesia 
• 
Ability to follow study protocol 
• 
English speaking (secondary outcomes include questionnaires 
validated in English only) 
• 
Patients of participating surgeons: Drs. Mayman, Jerabek, 
Della Valle, Alexiades, Blevins, Chalmers, Ast, Carli, Ranawat 
• 
Lives within two hours of the hospital 
• 
Has a smartphone 
Exclusion: 
• 
Hepatic or renal  insufficiency 
• 
Younger than 18 years old and older than 75 
• 
Patients undergoing general anesthesia 
• 
Allergy or intolerance to one of the study medications 
• 
BMI > 40 
• 
Diabetes 
• 
ASA of III,IV 
• 
Chronic gabapentin/pregabalin use (regular use for longer than 
3 months) 
• 
Patients with chronic pain (from a referral to chronic pain 
service) or a pain catastrophizing scale (PCS)  > 30 

 
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• 
Chronic opioid use (taking opioids for longer than 3 months, or 
daily oral morphine equivalent of >5mg/day for one month) 
• 
Patients with severe valgus deformity or flexion contracture 
• 
Patients unable to follow home catheter instructions and 
unwilling to go home with an infusing catheter 
• 
Patients who have no home caregivers in the event if a 
catheter is to be sent home with the patient 
• 
Patients with planned stay at rehab facility (to avoid medical 
device being tampered with at the rehab facility) 
• 
Non English speakers (secondary outcomes include 
questionnaires validated in English only) 
Study Duration: 
• 
1 year 
Data Collection: 
Sources: EPIC, Medical Records, and Patient Reported. 
 
Variables: Name, DOB, Race, Gender, BMI, NRS (at rest and with 
movement), Opioid consumption, Time to reach discharge, Physical 
Therapy, Nerve Block success, Patient satisfaction, Knee Injury and 
Osteoarthritis Outcome Score (KOOS) Junior, Blinding assessment, 
ORSDS, LANSS, PCS, COMM, PDI 
Statistical Analysis: Proposed analysis: 
Two-sample t-test or Wilcoxon rank-sum test    
Interim analysis planned? No 
Alpha level: .05 
Beta or power level: .80 
Number of groups being compared: 2 
Resulting number per group: 30 
Total sample size: 60 
 
 
 
 

 
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1.0 INTRODUCTION 
Adductor canal blocks (ACB) have been shown to effectively provide adequate analgesia without 
compromising the quadriceps strength. IPACK (interspace between the popliteal artery and capsule 
of the posterior knee) has been shown to optimize the pain relief by providing analgesia to the 
posterior compartment of the knee without compromising foot strength. The IPACK is also known as 
the SPANK block (sensory posterior articular nerves of the knee) and is shown to involve blocking the 
superior medial and lateral genicular nerves, providing analgesia to the capsule of the knee joint as 
well as the intraarticular and extra-articular ligaments.  Typically, PAI’s (peri-articular injections) are 
used for anterior and posterior pain control while the ACB/IPACK block also manages 
anterior/posterior pain, respectively.   By incorporating these new techniques, it is possible to optimize 
pain relief without compromising motor strength. This has shown to facilitate ambulation and reduce 
opioid consumption (with its associated adverse effects), leading to earlier discharges. However, what 
happens when the blocks/infiltrations wear off when the patient is at home or rehab? 
A study done by the group in Virginia Mason, used an ambulatory continuous infusion at the rate of 8 
ml/hr with a 400 ml reservoir. They placed adductor canal catheters as part of their TKR pathway and 
allowed continuation of the catheter at home, if the patient reaches discharge criteria prior to 
completion of the infusion. 
With technological advancements in communication via hipaa-compliant text messaging 
services and video conferencing with smartphones and the exponential rise of telemedicine use in 
primary care services, we are able to expand the perioperative surgical home model by offering 
education forms, videos, and even video-visits to patients preoperatively via telemedicine.  With this 
new form of communication, we will be able to inform and educate the patients not only the pain 
management plan but also set the expectations. 
It has been shown that femoral nerve blocks accelerate the functional recovery of the patient 
and prolonging the optimization of pain control beyond the 24 hour period with femoral nerve 
catheters have reduced opioid consumption and pain scores.  However, falls and quadriceps 
weakness from the femoral nerve catheters precludes the patients from early participation in physical 
therapy and being sent home.  Recent studies examining the use of adductor canal catheters have 
not only demonstrated its motor sparing properties but also have shown analgesia that is equivalent 
to femoral nerve catheters. 
The purpose of the study is to see if a continuous infusion of local anesthetics using an adductor 
canal catheter prevents rebound pain during the first 7 days after surgery and especially its impact on 
the development of chronic postsurgical pain. 
 
By continuously infusing the catheter for 50 hours (up to POD 3), the patient should have 
better pain control, mobility, and have less rebound pain, often seen after POD 1. By infusing the 
catheter with a disposable single use ambIT system (Summit Medical Products), all patients enrolled 
in the ACC group will have the same amount running continuously and will lead to the possibility of 
discharging the patient with the catheter in place prior to the completion of the 50 hour infusion. The 
patients will be instructed prior to discharge on how to remove the catheter and also will download the 
Smartphone app “Diagnotes” in the hospital. The Diagnotes app (a HIPPA compliant text messaging 
service) will be the patients main form of communication with the anesthesiologist at home while the 
catheter is in place. 

 
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2.0 
OBJECTIVE OF CLINICAL STUDY 
The reason to do this study is to investigate whether the addition of a continuous ACB 
catheter will prolong analgesia beyond the 24-48 hour period and prevents the development of 
rebound pain and chronic postsurgical pain. Rebound pain is a known phenomenon where patients 
experience severe pain immediately after the resolution of the nerve block. It is also known that by 
prolonging the duration of analgesia, you diminish or prevent rebound pain from occurring.  Motor 
sparing compartment blocks have revolutionized the ability of patients to participate in rehabilitation 
earlier than before, even ambulating on POD 0.  Thus, by prolonging analgesia and promoting early 
ambulation, it is likely adductor canal catheters will not only lead to less opioid consumption but also 
allow earlier discharge.  The two “hot” themes in recent TKR analgesia pathways are not only 
providing an effective ERAS (Enhanced recovery after surgery) protocol, but also using regional 
anesthesia and non-opioid multimodal pathways to combat against the opioid epidemic. This study 
will help answer which modality is better (single shot blocks with additive versus catheter) and 
introduce a novel method of following patients at home via a transitional pain service (telemedicine).    
STUDY HYPOTHESES 
Hypothesis 1: There will be at least a difference of 2 points on the Pain Numeric Rating Scale (NRS) 
3 and 6 months post block administration.  
 
STUDY DESIGN 
2.1 Study Duration 
1 year 
2.2 Endpoints 
2.2.1 Primary Endpoint 
Our primary outcome will be pain perception in rest and with movement at 3 and 6 months 
post block administration. It will be measured in points on the Pain Numeric Rating Scale. 
2.2.2 Secondary Endpoints 
1. Opioid consumption at PACU, 24 hours on POD 1, 72 hours on POD 3, 96 hours on POD 4, 
1 week, 3 and 6 months after surgery 
2. NRS at rest and with movement on DOS (PACU after spinal resolution, 3-4 hours post-block), 
POD 1, POD 2, POD 3, POD 4, and POD7 
3. Physical therapy milestones – time of ambulation (including distance traveled), stairs, time of 
ambulating > 30 m, reaching discharge criteria, POD 0-4 
4. Patient satisfaction with pain control on POD 1,2, 4 
5. Hospital length of stay (time of meeting discharge criteria of adequate analgesia (NRS <4 at 
rest), independence from IV PCA, PT discharge) 
6. Opioid Related Symptom Distress Scale (PACU, POD 1,4) 
7. Buckling/Falls/Quadricep weakness as determined by PT precluding ambulation (POD 
0,1,2,3,4) 
8. Intraoperative measurements (induction times) (time out to induction end), tourniquet time, 
blood loss) 

 
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9. Block resolution (patient will be asked beginning on am of POD 1, when they felt the block 
has worn off, and on pm of POD 3 after catheter been discontinued) 
10. Distance of ambulation (POD 0, 1, 2, 3, 4), from PT notes in EPIC while inpatient 
11. Catheter related complications (delayed weakness, unintentional dislodgment, leakage, 
catheter infection, dysesthesias, falls, LAST) 
12. Readmission for pain control   
13. Block complications (neuropraxia (saphenous), transient palsies: peroneal, tibial nerve) 
14. Koos Jr at 6 weeks follow up 
15. Orthopedic Outcome Flexion/ Knee Society Score (Surgeon’s office) 
16. SF-36 questionnaire (phone interview 12-16 weeks post-op) 
17. Leeds Assessment of Neuropathic Symptoms and Signs (LANSS, if patient reports surgery-
related pain greater than 3 on the NRS at the 3 months postoperative visit, patient will fill out 
the form) 
18. Current opioid misuse measure (COMM, at the 3 months postoperative visit, if patients are 
still being prescribed opioids, patient will be asked to fill out the questionnaire) 
19. Incidence of patient contact via text messaging/video calls 
20. Number of unused opioids after 1 week. 
21. Pain catastrophizing scale (PCS) (Preop, POD 4, 3 months, 6 months) 
22. CPSP questionnaires: Pain Disability index Questionnaire  (3 months and 6 months): 
23. Blinding Assessement (POD 2):  Patient, RA, TeleTPS MD 
24. Block Complications- Quadriceps weakness and Foot Drops 
25. Non Opioid Pain medications consumption (lyrica, robaxin, tyelnol, etc), which may be given 
at the discretion of the APS service. (PACU, 24 hours on POD 1, 72 hours on POD 3, 96 
hours on POD 4, 1 week) 
26. IV PCA Usage (Time in hospital) 
2.3 Study Sites 
Hospital for Special Surgery – Main Campus 
3.0 STUDY POPULATION 
3.1 Number of Subjects 
A total of 60 subjects will be enrolled. 
 
3.2 Inclusion Criteria 
Subjects of either gender will be included if: 
• 
Patients with osteoarthritis scheduled for a primary total knee arthroplasty with a participating 
surgeon 
• 
Age 18 to 75 years 
• 
Planned use of regional anesthesia 
• 
Ability to follow study protocol 
• 
English speaking (secondary outcomes include questionnaires validated in English only) 
• 
Patients of participating surgeons: Drs. Mayman, Jerabek, Della Valle, Alexiades, Blevins, 
Chalmers, Ast, Carli, Ranawat  
• 
Lives within two hours of the hospital 
• 
Has a smartphone 
3.3 Exclusion Criteria 
Subjects will be excluded from the study if: 

 
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• 
Hepatic or renal  insufficiency 
• 
Younger than 18 years old and older than 75 
• 
Patients undergoing general anesthesia 
• 
Allergy or intolerance to one of the study medications 
• 
BMI > 40 
• 
Diabetes 
• 
ASA of III,IV 
• 
Chronic gabapentin/pregabalin use (regular use for longer than 3 months) 
• 
Patients with chronic pain (from a referral to chronic pain service) or a pain catastrophizing 
scale (PCS)  > 30 
• 
Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent 
of >5mg/day for one month) 
• 
Patients with severe valgus deformity or flexion contracture 
• 
Patients unable to follow home catheter instructions and unwilling to go home with an infusing 
catheter 
• 
Patients who have no home caregivers in the event if a catheter is to be sent home with the 
patient 
• 
Patients with planned stay at rehab facility (to avoid medical device being tampered with at 
the rehab facility) 
• 
Non English speakers (secondary outcomes include questionnaires validated in English only) 
3.4 Randomization 
Patients will be randomized into one of the two following groups: Adductor Canal Block + 
Sham Catheter and Adductor Canal Catheter. The randomization schedule will be created 
using SAS software by a member of the Healthcare Research Institute not otherwise involved 
in the trial. 
4.0 PROCEDURES 
4.1 Surgical Procedure 
Total Knee Arthroplasty/Replacement 
4.2  Medical Record Requirements 
EPIC 
4.3 Data Collection 
The following data will be collected: 
 
Day before surgery/Baseline 
• 
KOOS Jr 
• 
ACC 
• 
Pain Questionnaires 
• 
Pain Catastrophizing Scale 
• 
Diagnotes App 
 
Surgical procedure 
• 
date of surgery 
• 
type of surgery 
• 
surgery details 
• 
anesthesia details 

 
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Follow-up visits (PACU, POD1, POD2, POD3, POD4, POD7, 3 and 6 months post op) 
• 
Diagnotes App 
• 
Medication intake 
• 
Numerical Rating Scale (NRS) Pain Score 
• 
ORSDS 
• 
Physical Therapy 
• 
Blinding Assessment 
• 
Patient Satisfaction 
• 
KOOS Jr 
• 
ACC 
• 
OOFKSS 
• 
COMM 
• 
LANSS 
• 
Pain Questionnaires 
• 
Pain Catastrophizing Scale 
 

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4.4 Schedule of Assessments 
Study-Specific 
Procedures 
Who?/    (If RA, 
estimate overall 
hours) 
Day before 
DOS 
Pre-op 
(Holding 
Area) 
POD 0 ( 4-6 
hours post 
block) 
POD 1 
POD 2-4 
3 months 
6 
months 
Surgeon’
s Office 
Visit 
Identify eligible 
patients on 
schedule day 
before surgery 
RA 
X 
  
  
  
 
 
 
  
NRS Pain 
RA 
 
X 
X 
X 
X 
X 
X 
  
Diagnotes App 
RA/MD 
X 
X 
X 
X 
X 
 
 
  
ORSDS 
RA 
 
  
X 
X 
X 
X 
X 
 
Physical therapy 
RA 
 
  
X (SOC) 
X SOC) 
X (SOC) 
 
 
 
Blinding 
Assessment 
RA 
 
  
  
  
X (POD2) 
 
 
 
Patient Satisfaction 
RA 
 
  
X 
X 
X 
 
 
 
Opioid 
consumption 
RA/EPIC 
 
  
X 
X 
X 
X 
X 
 
KOOS Jr 
Surgeon 
X 
  
  
  
 
 
 
X (3 and 6 
months) 
ACC 
Anes 
X 
 
 
X 
X 
 
 
 
OOFKSS 
Surgeon 
 
 
 
 
 
 
 
X (3 and 6 
months) 
COMM 
RA 
 
 
 
 
 
 
 
3 and 6 
months 
LANSS 
RA 
 
 
 
 
 
 
 
3-4 
months 
Pain 
Questionnaires 
RA 
X 
 
 
 
 
 
 
3 and 6 
months 
Pain 
catastrophizing 
Scale 
RA 
X 
 
 
 
X (POD 4) 
X 
X 
 

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5.0 STATISTICAL ANALYSIS 
Proposed analysis: 
Two-sample t-test or Wilcoxon rank-sum test    
Interim analysis planned? No 
Alpha level: .05 
Beta or power level: .80 
Number of groups being compared: 2 
Resulting number per group: 30 
Total sample size: 60 
 
6.0 ADVERSE EVENT ASSESSMENT 
All Adverse Events (AEs) will be reported in the final study report. Definitions for Adverse Event (AE) 
used in this study are listed below and are based on FDA and international guidelines: 
 
6.1 Adverse Event (AE) 
Any untoward medical occurrence in a patient or clinical investigation subject administered a 
pharmaceutical product which does not necessarily have to have a causal relationship with 
this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign 
(including an abnormal laboratory finding, for example), symptom, or disease temporally 
associated with the use of a medicinal (investigational) product, whether or not considered 
related to the medicinal (investigational) product. 
 
6.2 Serious Adverse Events (SAE) 
The event is serious and should be reported to FDA when the patient outcome is: 
Death, Life-threatening, Hospitalization (initial or prolonged), Disability or Permanent 
Damage, Congenital Anomaly/Birth Defect, Required Intervention to Prevent Permanent 
Impairment or Damage (Devices), Other Serious (Important Medical Events). 
 
6.3 Adverse Event Relationship 
Relationship to study: definitely, probably, possibly, not related. 
7.0 INVESTIGATOR RESPONSIBILITIES, RECORD AND REPORTS 
 
7.1 Subject Consent and Information 
Research assistants will screen the co-investigating surgeons' patients undergoing ambulatory 
total knee arthroplasty surgery. Screening will involve reviewing the patient's EPIC chart to 
ensure that they meet the inclusion criteria and are not excluded due to any of the exclusion 
criteria listed. Patients who meet the inclusion criteria will be identified as potential study 
participants. After the investigating anesthesiologists have confirmed the eligibility of all 

 
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potential participants, one of the investigating anesthesiologists will approach the potential 
patients in the pre-operative holding area, explain the rationale for the study, and ask if the 
patient is interested in participating. 
7.2 Subject Data Protection 
Subject privacy and confidentiality will be maintained through the storage of study data in a 
password-protected computer database maintained by the Research Director 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) will be maintained in a different password-protected database 
maintained by Research Director, to which only the primary investigator will have access. 
7.3 Staff Information 
Primary Investigator: David Kim, MD 
Research Coordinator: Lisa Reisinger, MD, 646-714-6315; Pa Thor, PhD, 646-797-8535,  
 
7.4 Protocol Reviews 
Study protocol reviewed and approved by: 
• 
Anesthesiology CRP 
• 
Hospital for Special Surgery Institutional Review Board 
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