Continuous Vs Single Shot Adductor Canal Block After ACL Reconstruction - A Randomized Study
Phase: EARLY_PHASE1
Conditions: ACL Injury
Sponsor: Northwell Health

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Official Title: Continuous Vs Single Shot Adductor Canal Block After ACL Reconstruction 
– A Randomized Study 
 
NCT: NCT04101682 
 
Document Date: August 11, 2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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RESEARCH PROTOCOL 
 
 
Protocol Title: 
Continuous Vs Single Shot Adductor Canal Block After ACL 
Reconstruction – A Randomized Study 
Principal Investigator: 
Randy Cohn 
Primary Contact Name: 
Nicholas Frane 
Primary Contact Phone: 
7634395741 
Primary Contact E-mail: 
nfrane@northwell.edu 
Date Revised: 
8/11/2020 
IRB Number: 
18-0811 
 
 
Guidelines for Preparing a Research Protocol 
 
Instructions: 
 
• You do not need to complete this document if you are submitting an Application for 
Exemption or Application for a Chart Review.   
• Do not use this template if: 
o  Your study involves an FDA regulated product.  In this case, use the Clinical 
Trial Protocol Template. 
o Your study has a protocol from a sponsor or cooperative group.  In this case, use 
the Protocol Plus.   
o Your study is a registry or repository for data and/or samples,  In this case, use 
Protocol Template – Registry Studies.  .   
• If a section of this protocol is not applicable, please indicate such. 
• Do not delete any of the text contained within this document. 
• Please make sure to keep an electronic copy of this document.  You will need to use it, if 
you make modifications in the future.   
• Start by entering study information into the table above, according to these rules: 
o Protocol Title:  Include the full protocol title as listed on the application. 
o Investigator:  include the principal investigator’s name as listed on the application 
form 
o Date Revised:  Indicate the date at which the protocol was last revised 
o IRB Number:  Indicate the assigned IRB number, when known.  At initial 
submission, this row will be left blank.   
• Once the table information in entered, proceed to page 2 and complete the rest of the 
form. 
 
 
 
 Continue to next page to begin entering information about this study  
 
 

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1.  PREVIOUS STUDY HISTORY 
 
Has this study ever been reviewed and rejected/disapproved by another IRB prior to 
submission to this IRB? 
 
No  
 Yes −  if yes, please explain:  
 
 
2. BRIEF SUMMARY OF RESEARCH 
• The summary should be written in language intelligible to a moderately educated, 
non-scientific layperson.  
• It should contain a clear statement of the rationale and hypothesis of your study, a 
concise description of the methodology, with an emphasis on what will happen to the 
subjects, and a discussion of the results.  
• This section should be ½ page 
 
 
We will be randomizing patients to either receive an adductor canal block in the 
operating room postoperatively as single shot of 20-30cc bupivacaine or to have a 
catheter inserted into the adductor canal which will be attached up to a continuous 
infusion pump of bupivacaine that will have a set flow rate over the next couple 
days. Our hypothesis is that patients will have better pain control, sleep, and 
decreased opioid consumption with the use of a continuous infusion pump 
 
 
3. INTRODUCTION/BACKGROUND MATERIAL/PRELIMINARY STUDIES AND 
SIGNIFICANCE 
• Describe and provide the results of previous work by yourself or others, including 
animal studies, laboratory studies, pilot studies, pre-clinical and/or clinical studies 
involving the compound or device to be studied.  
• Include information as to why you are conducting the study and how the study differs 
from what has been previously researched, including what the knowledge gaps are. 
• Describe the importance of the knowledge expected to result 
 
ACL reconstruction is a common procedure performed ranging an 
estimated 60,000 to 175,000 times a year in the United states (6). Many factors can 
contribute to clinical outcome with ACL reconstruction, most notably with pain 
and rehabilitation. Numerous tactics are employed to help alleviate postoperative 
pain, ranging from simple conservative management such as ice and elevation, to 
oral and IV narcotics. Current trends in management aim to reduce the use of 
narcotics and to investigate various alternative modalities for achieving analgesia 
without compromising clinical outcomes. One way of achieving this is with use of 
peripheral nerve blocks. Administered by an anesthesiologist or certified nurse 
anesthetist, analgesia is delivered to a peripheral nerve using ultrasound guidance 
and in some incidences a catheter is then placed overlying the nerve sheath. This 

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catheter is then connected to a device with a reservoir that administers local 
anesthetic at a set rate that can be locked or manipulated by the user, which gives 
the theoretical advantage of continuous analgesia of the operative site. 
Historically, other methods were used to combat post-operative pain. 
Buchko et al looked at intra-articular analgesia after arthroscopic ACL 
reconstruction and found an increased rate of chondrolysis, which was similar to 
other studies that looked at its use in the shoulder joint (11). Use of peripheral 
nerve blockade is not new practice and has been described throughout the 
literature. Manickam et al showed 100% success rate and full blockade after twenty 
minutes with use of the adductor canal block (12). The safety and efficacy of the 
Continuous Peripheral Nerve Block (CPNB) has been thoroughly investigated. 
Carvhalo et al found that the addition of a peripheral catheter added only 10 
minutes to procedural time versus single shot peripheral nerve block (14). In a 
group of 35 trauma patients it was found that despite continuous peripheral nerve 
infusion, serum levels of Ropivicaine were well below toxic levels (15). A review 
article by Nicolotti et al found that the incidence of positive cultures of placed 
catheters varied widely from 6%-57%, but the actual incidence of positive cultures 
resulting in clinical infection was 0%-3.2% (13). The large discrepancy between 
the two values was found to be likely due to inadequate skin preparation and 
improper technique with removal. 
 
Some studies have shown the efficacy of CPNB use and concluded with positive 
results. A multicenter prospective study of use of CPNBs found high quality 
postoperative pain reduction along with low rates of neurologic or infectious 
complications (1) and according to Enneking et al. CPNBs have been shown to 
improve patient satisfaction and improve rehabilitation compared to IV narcotics 
after orthopedic surgery for both upper and lower extremity (3). A more recent 
study prospectively looked at CPNB vs placebo (Normal Saline) performed in the 
upper extremity and found that there was a statistically significant reduction in 
pain, opioid use, sleep disturbances and increase in patient satisfaction scores (4). 
A large meta analysis by Richman et al looked at the efficacy of CPNBs and found 
statistically significant reduction in opioid use, pain up to 72 hours postoperative 
and decrease in episodes of nausea and vomiting (5) with use versus opioid 
analgesia. 
In the lower extremity two main methods of block are employed, femoral nerve 
block (FNB) or adductor canal block (ACB). The use of FNB in ACL 
reconstruction, as shown by Mulroy et al, was found to have superior efficacy in 
pain control and reduction in opioid consumption when testing single shot FNB vs 
sham (9). One complication of FNB is quadricep muscle weakness, which Jaeger et 
al. demonstrated as a 49% reduction from baseline while ACB reduced strength 8% 
from baseline (10). Kwofie at al found that with ACB vs FNB that there was a 
statistically significant preservation in balance and strength in ACB compared to 
FNB (8). These studies show the advantages of ACB to anesthetize surgical sites 
without compromising quadriceps strength and balance. Abdallah et al showed that 
using ACB versus FNB reduced quadriceps weakness with similar functional 
outcomes and pain reduction in ACL reconstruction (7). The superiority of 

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continuous catheter delivery over single injection in regards to pain and reduction 
and opioid use have not been shown in the literature. To our knowledge there are 
no randomized controlled trials that compare      single injection versus CPNB in 
the adductor canal following ACL reconstruction. In this study we look to compare 
these two methods of analgesia after ACL reconstruction examining the effects on 
pain control, opioid use, and satisfaction scores. 
 
 
4. OBJECTIVE(S)/SPECIFIC AIMS AND HYPOTHESES 
• A concise statement of the goal(s) of the current study.  
• The rationale for and specific objectives of the study.  
• The goals and the hypothesis to be tested should be stated. 
 
 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
 
 
To Compare the 
efficacy of two 
different modes of 
administration of 
peripheral nerve block 
for postoperative pain 
control after primary 
ACL reconstruction. 
 
Pain control as measured 
by a visual analogue 
scale (0-10) on post 
operative day 1,2,3,4,7, 
and at first follow up visit 
(Day 14).      
 
Our study seeks to better clarify 
the effectiveness of two 
postoperative pain control 
methods after ACL 
reconstruction. Visual analogue 
scale is commonly used to assess 
pain in postoperative patients. 
This is an easy way to assess 
patients pain in a quick and easy 
to understand method.  
Secondary 
 
 
To compare the daily 
opioid consumption in 
patients post 
operatively after ACL 
Reconstruction. 
 
This will be measured as 
daily consumption of 
oxycodone (morphine 
equivalents) on post 
operative day 1,2,3,4,7, 
and 14.      
 
A secondary objective of our 
study would be to examine pain 
control objectively by opioid 
consumption each day. This is a 
secondary measure of the 
efficacy of pain control. The 
hope is that with better pain 
control via peripheral nerve 
block patients would be less 
reliant on opioid pain 
medication. 
To determine the 
effectiveness of pain 
control and quality of 
sleep. 
 We will measure this by 
asking if they had a 
disturbance in their sleep 
or trouble getting to sleep 
through email surveys. 
 
Our study wants to look at how 
pain control and sleep quality 
are correlated and to analyze if 
better pain control also allowed 
patients to have better 
postoperative sleep habits. 

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General Well Being 
Short Form - 12 Survey 
given preoperatively and 
at 14 days post 
operatively. 
This assessment test is to 
classify changes in general 
health and wellbeing, 
physical, and mental health. 
 
Knee Assessment 
Score 
International Knee 
Documentation 
Committee Subjective 
Knee Form (IKDC) to be 
given preoperatively and 
at 14 days post 
operatively.  
Designed to assess patients 
with a variety of knee 
disorders. 
 
 
 
 
 
5.  RESOURCES AVAILABLE TO CONDUCT THE HUMAN RESEARCH 
• Explain the feasibility of meeting recruitment goals of this project and demonstrate a 
potential for recruiting the required number of suitable subjects within the agreed 
recruitment period 
o How many potential subjects do you have access to? 
• Describe your process to ensure that all persons assisting with the trial are 
adequately informed about the protocol and their trial related duties and functions 
 
We will be recruiting patients from multiple surgeons who perform ACL 
reconstructions in an attempt to get a higher number of patients. Our recruitment is 
estimated to last 9-12 months to get an adequate number of patients. In the event 
that we are still in need we can extend the trial a few months in order to capture the 
adequate number of participants. All the involved providers and staff will be given 
the same instructions which are standardized to ensure that each facility and staff 
follow the same protocol. In addition, there will be a resident investigator or co 
investigator at each site to oversee the project. 
 
 
6.  RECRUITMENT METHODS 
• Describe the source of potential subjects 
• Describe the methods that will be used to identify potential subjects 
• Describe any materials that will be used to recruit subjects.  A copy of any 
advertisements (flyers, radio scripts, etc.) should be submitted along with the 
protocol.  
• If monetary compensation is to be offered, this should be indicated in the protocol 
 
We will include multiple different sites to increase our enrolment participants. All 
patients will be recruited in the outpatient setting after being diagnosed with an 

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ACL tear and deciding to have operative reconstruction with one of the 
participating surgeons. At that point, the patients will be recruited for the study. 
There will be no active recruiting outside of the surgeon’s patient population that 
requires surgical reconstruction of their ACL. 
 
In regards to retention, the patients will agree to the time points to participate in the 
email surveys from REDCAP. The surveys have automatic reminders every 2 hours 
in addition the study co-investigators will receive notifications and can contact the 
patient’s if they do not complete the surveys at the agreed time. The patients will 
have a postoperative      visit 10-14 days after the indicated surgery with the 
attending physician. The patient will also be contacted via telephone on post-
operative day 1, 2, 3, 4 and 7 to assess for adverse events. 
 
 
7.  ELIGIBILITY CRITERIA 
• Describe the characteristics of the subject population, including their anticipated 
number, age, ranges, sex, ethnic background, and health status. Identify the criteria 
for inclusion or exclusion of any subpopulation.  
• Explain the rationale for the involvement of special classes of subjects, such as 
fetuses, pregnant women, children, prisoners or other institutionalized individuals, or 
others who are likely to be vulnerable.   You cannot include these populations in your 
research, unless you indicate such in the protocol 
• Similarly, detail exclusionary criteria: age limits, special populations (minors, 
pregnant women, decisionally impaired), use of concomitant medications, subjects 
with other diseases, severity of illness, etc. 
 
INCLUSION CRITERIA - In order to be eligible to participate in this study, an 
individual must meet all of the following criteria: 
1. Provision of signed and dated informed consent form 
2. Stated willingness to comply with all study procedures and availability for 
the duration of the study  
3. Male or female, aged >16 years old 
4. In good general health as evidenced by medical history and deemed 
medically healthy enough to tolerate surgery by the patient’s primary care 
physician 
5. MRI with evidence of ACL tear, and wanting to have an ACL 
reconstruction surgery 
6. Ability to take oral medication and be willing to adhere to the study 
intervention, including telephone calls and access to email. 
7. Have a working telephone and electronic device with  ability to access 
email that allows them for daily communication to complete the electronic 
correspondence.      
 
 
EXCLUSION CRITERIA - An individual who meets any of the following criteria 
will be excluded from participation in this study: 

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1. Current daily opioid requirement exceeding the equivalent of 15mg 
morphine 
2. Daily prescription of corticosteroid, tricyclic antidepressant, gabapentin, or 
tramadol 
3. Carrying the diagnosis of chronic pain syndrome, uncontrolled anxiety, 
history of schizophrenia or related psychiatric disorders 
4. History of alcohol or drug abuse/addiction 
5. History of      preexisting nerve damage in the surgical extremity 
6. Knee surgery (same knee) in the previous 12 weeks 
7. Anticipated knee surgery in the other knee planned in the ensuing 6 months 
8. Diabetic patients with blood sugar values exceeding 250 mg/dl in the 
previous month 
9. BMI >40Kg/m2 
10. Pregnancy, which will be determined by a serum or urine HCG test on the 
day of surgery. 
11. Incarceration 
12. Inability to communicate with staff, including being unreachable by 
telephone and/or e-mail. 
13. Revision ACL reconstruction 
14. Patient reconsideration after initial agreement. 
15. Non-English speaking subjects 
 
 
 
8.  NUMBER OF SUBJECTS 
• Indicate the total number of subjects to be accrued locally.  If applicable, distinguish 
between the number of subjects who are expected to be pre-screened, enrolled 
(consent obtained), randomized and complete the research procedures. 
• If your study includes different cohorts, include the total number of subjects in each 
cohort. 
• If this is multisite study, include total number of subjects across all sites.   
 
We will enroll 78 patients in the event that we lose some to follow up or if patients 
decide to unenroll in the study. We don’t foresee many patients being lost to follow 
up because all patients will be enrolled only until their first follow up visit. The 
historic rate of patient’s not following up with the surgeons after ACL 
reconstruction is almost 0. 
 
 
9. STUDY TIMELINES 
• Describe the duration of an individuals participation in the study 
• Describe the duration anticipated to enroll all study subjects 
• The estimated date of study completion 
 

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Study Duration - 1 Year 
Each Individual’s Participation –up to 14 days, depending on the date of initial 
follow up visit after the procedure. After that, the patients will follow up with their 
respective surgeons at time points determined by the surgeon for routine follow up. 
 
 
10.  ENDPOINTS 
• Describe the primary and secondary study endpoints 
• Describe any primary or secondary safety endpoints  
 
A participant is considered to have completed the study if he or she has completed 
all phases of the study including the last visit or the last scheduled procedure.  The 
end of the study is defined as completion of the last visit or procedure which we 
defined as the initial follow up visit in the office      and the final survey will be 
sent out 14 days after the indicated surgery. 
 
 
 
11.  RESEARCH PROCEDURES 
• Include a detailed description of all procedures to be performed on the research 
subject and the schedule for each procedure. 
• Include any screening procedures for eligibility and/or baseline diagnostic tests 
• Include procedures being performed to monitor subjects for safety or minimize risks 
• Include information about drug washout periods 
• If drugs or biologics are being administered provide information on dosing and route 
of administration 
• Clearly indicate which procedures are only being conducted for research purposes. 
• If any specimens will be used for this research, explain whether they are being 
collected specifically for research purposes.   
• Describe any source records that will be used to collect data about subjects 
• Indicate the data to be collected, including long term follow-up 
 
Screening evaluation will occur during the preoperative visit prior to surgery which 
generally occurs within 28 days prior to surgery. No separate screening is indicated 
in this study. 
 
Patients will be asked to participate in the study if they are having ACL 
Reconstruction surgery with one of the orthopedic surgeons who is participating in 
the study. They will be informed and consented in the office or in the preoperative 
holding area prior to surgery. 
Patients undergo ACL reconstruction at either Plainview, Franklin, Huntington, 
Long Island Jewish, or North Shore University Hospital. 
 
Any medical condition that is present at the time that the participant is screened 
will be considered as baseline and not reported as an adverse event (AE). However, 

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if the study participant’s condition deteriorates at any time during the study, it will 
be recorded as an AE.  
 
Changes in the severity of an AE will be documented to allow an assessment of the 
duration of the event at each level of severity to be performed. AEs characterized 
as intermittent require documentation of onset and duration of each episode. 
 
We will record all reportable events with start dates occurring any time after 
informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) 
after the last day of study participation.  At each study visit/call, we will inquire 
about the occurrence of AE/SAEs since the last visit/survey/call.  Events will be 
followed for outcome information until resolution or stabilization. 
 
 
Study procedures and evaluations 
● All patients who are enrolled in this study will have been evaluated and 
determined to be a candidate for ACL reconstruction surgery. The 
indications for surgery, determination of need for surgery and physical 
examination determining this need are independent from the interventions 
and outcomes being assessed by this study.  
● Efficacy Assessment plan- All patients will be sent surveys through 
REDCAP,      which is a secure patient secure electronic data capture 
software     on postoperative days 1,2,3,4, 7 and 14.  A     nd be assessed in 
person at the post-operative visit which usually falls between post op day 
10-14 depending on weekend and convenience. They will be surveyed for 
primary and secondary outcomes     . Primary outcome will be assessed 
using visual analog scale 0-10. Secondary outcomes; Opiate consumption, 
Sleep quality, disturbances in sleep, global health assessment through the 
SF-12, and knee function through IKDC pre operatively and POD 14.  The 
patient will also be contacted via telephone on post-operative day 1, 2, 3, 4 
and 7 to assess for adverse events. 
● Screening evaluation will occur during the preoperative visit prior to 
surgery which generally occurs within 28 days prior to surgery. No separate 
screening is indicated in this study.  
● Procedure for administering study intervention and follow-up procedures. 
The participant will be seen in the preoperative holding suite prior to 
surgery to ensure that the patient      is still willing to undergo 
randomization for the study. The patient will then undergo randomization 
by a computer-based software and the anesthesiologist will be informed of 
the plan. The participant will undergo anesthesia at the discretion of the 
anesthesiologist per routine given the participant’s clinical baseline. The 
participant will undergo ACL reconstruction based on the standard of care 
treatment. Following surgery but prior to leaving the operating room the 
anesthesiologist will place the adductor canal block and the catheter based 
on the participant’s randomization under ultrasound guidance to ensure 
proper placement of the block. The participant will then undergo routine 

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post-operative care in the recovery suite with routine recovery room vital 
checks. For participants who are randomized to the continuous pump group, 
the pump will be assembled and filled by pharmacy and attached to the 
previously placed catheter while the participant is in the recovery room. 
Once the participants are awake and alert in the recovery room, a study 
investigator will review the study specifics again, including the surveys 
with written information on the questions that will be asked. They will also 
be given written instructions on how to use the continuous pumps and how 
to remove it. If the patient is uncomfortable removing it themselves, they 
can come to the office to have it removed. For participants who received a 
continuous pump the investigator will go over the function of the pump, 
troubleshooting, and how to remove the pump at home. All participants will 
be discharged home from the recovery room after they have met the routine 
discharge criteria following existing standard of care recovery room 
protocols. The patient will also be contacted via telephone on post-operative 
day 1, 2, 3, 4 and 7 to assess for adverse events. 
● All data will be recorded in an encrypted database which is HIPPA and IRB 
compliant. All participant information will be labeled with a participant 
study identification number with no identifiable information documented.  
 
Procedures 
In Office visit/schedule  
Study Day 1, Day of 
Operation 
Study Day 2 (POD 1) 
Study Day 3 (POD 2) 
Study Day 4 (POD 3) 
   Study Day 5 (POD 4) 
Study Day 8 (POD 7) 
Final Study Day, in office 
visit 
 (POD 10-14) 
Informed consent 
X  
 
 
 
 
 
 
Demographics 
X  
 
 
 
 
 
 
Medical history 
X  
 
 
 
 
 
 
Randomization 
X  
 
 
 
 
 
 
Administer study intervention 
 
X 
 
 
 
 
 
 
Physical exam (including height and 
weight) 
X 
X 
 
 
 
 
 
X 
Preoperative Workup per standard 
protocol 
X 
 
 
 
 
 
 
 
Pregnancy test b 
 
X 
 
 
 
 
 
 
Adverse event review and 
evaluation 
X             X     X     X     X      X 
MRI/Imaging assessment 
X  
 
 
 
 
 
 
Online RedCAP Surveys 
(VAS, sleep disturbance, Opioid 
Consumption 
X 
X 
X 
X 
X 
X 
X 
X 

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Online REDCAP: 
SF-12, IKDC 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
Prior to  
Enrollment 
 
 
 
 
 
 
 
 
 
 
Visit 1 
Time Point  
 
 
 
 
 
 
 
Visit 2-8 
POD 1-4,7,14 
 
 
 
 
Visit 8 
Follow up Visit 
POD 10-14 
 
 
 
 
 
 
 
 
 
 
 
12.  STATISTICAL ANALYSIS 
• Describe how your data will be used to test the hypotheses.  
• State clearly what variables will be tested and what statistical tests will be used. 
Obtain informed consent. Screen potential participants by inclusion and exclusion 
criteria; obtain history, SF-12, IKDC, Pain and Sleep Scores, document. 
Randomize 
Single Shot Adductor 
Canal Block N=39 
Continuous Adductor Canal 
Block N =39 
ACL Reconstruction at Hospital 
Given either form of post-operative pain management 
Given instruction on study via patient forms and informed of survey and 
follow up times  
REDCAP Surveys: Pain Assessment, Sleep Assessment, Opioid 
Consumption, Phone Call on post-operative day 1, 2, 3, 4 and 7. 
Follow-up visit in office, physical exam per usual protocol, assessments of 
study endpoints and safety 
Analysis of Data (No Patient 
Visit Required) 

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• Include sample size calculations.  
• If this is a pilot study, state which variables will be examined for hypothesis 
generation in later studies.  
 
Blinding: 
Due to the nature of the intervention (bolus block, continuous infusion pump), it is 
not possible to blind the physicians or patients.  
 
Consent: 
Consent will be obtained during the preoperative visit, prior to surgery. 
 
Randomization: 
Subjects will be randomly assigned in a 1:1 ratio to either bolus block or 
continuous catheter.  The randomization will be stratified by hospital 
(Plainview, Franklin, Huntington, Long Island Jewish, or North Shore 
University Hospital.   
 
The Biostatistics Unit will develop a randomization procedure using a 
permuted block design within the Biostatistics Randomization Management 
System (BRMS).   
 
Additional details of the procedure, including required record keeping, will be 
further developed upon approval of this protocol.  The Biostatistics Unit has 
extensive experience in implementing and in producing detailed 
documentation for such procedures. 
 
Intention to Treat (ITT): 
All analyses will be carried out according to the ITT principle.  The ITT 
population will be all subjects randomized, regardless of what treatment they 
actually received.  All patients will be analyzed in the group to which they 
were randomized. 
 
Statistical Considerations: 
Specific Aims: 
To compare the efficacy of two postoperative pain control methods (bolus 
block, continuous catheter) in patients undergoing ACL reconstruction.   
 
Primary Outcome 
Outcomes measured on post-operative days 0, 1,2,3,4,7, and at the post-
operative follow-up visit.  (Outcomes for days 0, 1,2,3,4, and 7 will be obtained 
via email and electronic surveys     .  Outcomes for the post-operative follow-
up visit will be measured during the postoperative      visit which takes place 
between days 10 and 14.  This will be referred to as “Day 10”).   
● Pain Control 

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o Maximum pain will be measured on a scale of 0 to 10, where 0 represents no 
pain and 10 represents the worst possible pain.  Patients      will report the 
maximum pain felt in the 24 hours  
o Current pain will be measured on a scale of 0 to 10, where 0 represents no 
pain and 10 represents the worst possible pain.   
o Daily opioid consumption (expressed as morphine equivalents). 
 
Secondary Outcomes 
Outcomes measured on post-operative days 1,2,3,4,7, and at the post-
operative follow-up visit.   
● Quality of Sleep 
o Trouble falling asleep due to pain (yes,no)  
o Wake due to pain (yes,no) 
Outcomes measured at post-operative follow-up visit 
● Satisfaction with surgery, on a scale of 0 to 10, where 0 represents extremely 
dissatisfied and 10 extremely satisfied 
● Adverse events:  Adverse events will be assessed at each visit.  At the end of the 
study, each subject will be categorized as having had one or more adverse events, 
or not having had any adverse events. 
● Serious Adverse events:  Serious adverse events will be assessed at each visit and 
via telephone on post-operative day 1, 2, 3, 4 and 7.  At the end of the study each 
subject will be categorized as having had one or more serious adverse events, or 
not having had any serious adverse events.   
 
Statistical Methods: 
Primary Outcomes: 
For each outcome, repeated measures analysis of variance (RMANOVA), where 
post-operative pain control method (bolus block, continuous catheter) is the 
between subjects effect and post-operative day is the within subjects effect 
will be used to examine the association between pain control method and that 
outcome.  Site (stratification variable) will be included as a covariate in each 
model.  The interaction of post-operative control method and day will be 
included in the model.  If the interaction is significant, then pairwise 
comparisons of pain control method at each day will be carried out within the 
RMANOVA model.  If the usual assumptions required for the ANOVA model are 
not met, then a suitable transformation, or an appropriate non-parametric 
method will be used. 
 
Secondary Outcomes: 
For binary outcomes measured on days 1,2,3,4,7 and 10: 
For each outcome, a generalized linear mixed model (GLMM) for binary 
clustered (i.e., hierarchical) data will be used to examine the association between 
pain control method and that outcome.  GLMM will be used to account for the 
hierarchical structure of the data, (namely, multiple days within a subject). Site 
(stratification variable) will be included as a covariate in each model. 
 
For binary outcomes measured on day 10 only: 

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For each outcome, logistic regression will be used to examine the association 
between pain control method and that outcome.  Site (stratification variable) will 
be included as a covariate in each model. 
 
For satisfaction with surgery: 
Analysis of variance (ANOVA) will be used to examine the association between 
pain control method and satisfaction with surgery.  Site will be included as a 
covariate in the model.  If the usual assumptions required for the ANOVA 
model are not met, then a suitable transformation, or an appropriate non-
parametric method will be used. 
 
 
 
Sample Size Justification: 
In a published study of 85 patients undergoing arthroscopic shoulder surgery, 
patients were randomly assigned to catheter (43 patients) or single-shot block 
(42 patients) for postoperative analgesia.  Median pain with movement on day 
3, measured on a visual analog pain scale, 6 in the single-shot group and 4 in 
the catheter group.  As there is limited information available regarding 
postoperative pain levels following ACL reconstruction, we will assume that 
the difference in pain levels between bolus block and continuous catheter will 
be similar (i.e. continuous catheter will be 2 points lower than bolus block).  
The standard deviation will be estimated as 2.5.  This estimate was obtained 
by dividing the range (10-0) by 4. 
 
The proposed analysis will examine pain levels over multiple days during the 
postoperative period.  If a significant interaction between treatment and day is 
found, it will be of interest to determine which days differ.  Although this 
comparison will be carried out within the ANOVA model, the 2 sided two 
sample t-test will be used for purposes of calculating the required sample size.  
A sample size of 39 subjects per group will yield 80% power to detect a 2 
point difference between the two groups on any single day using a two sided 
two-sample t-test at the 0.01 significance level.  The reason for applying this 
“Bonferroni-type” adjustment is that pairwise comparisons will be carried out 
for 6 different days, and with this number of statistical tests, it is more likely to 
find a significant difference at the nominal 5% level when one does not 
actually exist.  Based on our experience, most, if not all patients return for the 
postoperative visit, and therefore, no adjustment for drop-out has been made.  
Therefore, the proposed sample size will be 78 subjects (39 for each treatment 
group). 
 
 
 
13. SPECIMEN BANKING 

Version Date:          8/11/2020           
 
Page 16 of 37 
• If specimens will be banked for future research, describe where the specimens will be 
stored, how long they will be stored, how they will be accessed and who will have 
access to the specimens 
• List the information that will be stored with each specimen, including how specimens 
are labeled/coded 
• Describe the procedures to release the specimens, including:  the process to request 
release, approvals required for release, who can obtain the specimens, and the 
information to be provided with the specimens. 
 
n/a 
 
 
14.  DATA MANAGEMENT AND CONFIDENTIALITY 
• Describe the data and specimens to be sent out or received.  As applicable, describe: 
o What information will be included in that data or associated with the 
specimens? 
o Where and how data and specimens will be stored? 
o How long the data will be stored? 
o Who will have access to the data? 
o Who is responsible for receipt or transmission of data and specimens? 
• Describe the steps that will be taken to secure the data during storage, use and 
transmission. 
 
There will be no data in regard to specimens in this study. 
All recorded data with respect to the questions listed above will be recorded onto a 
data sheet on the Northwell REDCap software to ensure patient confidentiality and 
encryption. Only investigators and co investigators will have access to the REDCap 
file which will be secured by password. Once the data has been analyzed the 
patient specific information will be deleted. 
 
 
15.  DATA AND SAFETY MONITORING PLAN 
 
A specific data and safety monitoring plan is only required for greater than minimal risk 
research.  For guidance on creating this plan, please see the Guidance Document on the 
HRPP website. 
 
Part I – this part should be completed for all studies that require a DSMP.   
Part II – This part should be completed when your study needs a Data and 
Safety Monitoring Board or Committee (DSMB/C) as part of your Data and 
Safety Monitoring Plan.   
 
Part I:  Elements of the Data and Safety Monitoring Plan 

Version Date:          8/11/2020           
 
Page 17 of 37 
•  Indicate who will perform the data and safety monitoring for this study.   
• Justify your choice of monitor, in terms of assessed risk to the research subject’s 
health and well being.  In studies where the monitor is independent of the study staff, 
indicate the individual’s credentials, relationship to the PI, and rationale for selection 
• List the specific items that will be monitored for safety (e.g. adverse events, protocol 
compliance, etc) 
• Indicate the frequency at which accumulated safety and data information (items listed 
in # above) will be reviewed by the monitor (s) or the DSMB/C.   
• Where applicable, describe rules which will guide interruption or alteration of the 
study design.   
• Where applicable, indicate dose selection procedures that will be used to minimize 
toxicity. 
• Should a temporary or permanent suspension of your study occur, in addition to the 
IRB, indicate to whom will you report the occurrence.   
 
DSMP form is attached 
 
 
Part II:  Data and Safety Monitoring Board or Committee 
 
 
•  When appropriate, attach a description of the DSMB.   
• Provide the number of members and area of professional expertise.   
• Provide confirmation that the members of the board are all independent of the study. 
 
n/a 
 
 
16. WITHDRAWAL OF SUBJECTS 
• Describe anticipated circumstances under which subjects will be withdrawn from the 
research without their consent 
• Describe procedures for orderly termination 
• Describe procedures that will be followed when subjects withdraw from the research, 
including partial withdrawal from procedures with continued data collection.   
 
Participants may withdraw voluntarily from the study at any given time with no 
reason as is outlined in the informed consent for participation in the study. Any 
participant who withdraws from a study arm will still be contacted for follow-up 
assessments as outlined within this protocol unless the participant elects to forgo 
follow-up contact with the study assessors. This will include the surveys for 
outcome assessment, phone calls made on the subsequent postoperative days and 
the office visit following surgery.   
Discontinuation from the continuous administration of local anesthetic prior to 
completion of the medications’ dosing will not be deemed a withdrawal from the 
study but rather a discontinuation of treatment and the participant will continue to 
be followed up with for assessment of study outcomes with notation of the 
discontinuation of treatment within the database and the reason for discontinuation 
documented.  

Version Date:          8/11/2020           
 
Page 18 of 37 
All participants who discontinue intervention will be followed in order to assess for 
potential adverse events, serious adverse events and any unanticipated problems 
pertaining to the use or administration of the study medications.  
Adverse events include but are not limited to block failure, allergy to local 
anesthetic, persistent pain at injection/catheter site, local skin irritation at catheter 
site, pump/device failure. 
Should a participant experience any of the serious adverse events listed in the next 
section, this participant will immediately be halted from their study intervention. 
These patients will be recommended to seek immediate care for assessment of their 
serious adverse event to best ensure patient safety. Should a patient experience an 
adverse event or unanticipated event, the study investigator who is contacted will 
determine if the participant’s event meets criteria for discontinuation of treatment. 
 
ADVERSE EFFECTS OF TREATMENT 
 
Risks associated with single shot adductor canal block 
1. Peripheral Nerve Injury 
a. This is a rare complication that is usually transient and goes away 
with time. The estimated incidence is .5% for any nerve irritation 
after the procedure. The risk of injury to the nerve that is permanent 
in 1/10,000. These are very rare in part due to the implementation 
and success of ultrasound use for guidance of the needle and/or 
catheter during nerve blockade. This allows the anesthesiologist 
direct visualization to differentiate between perineural, intraneural, 
and interfascicular. 
b. These injuries will be monitored with a physical examination after 
the procedure once the patient has woken from anesthesia. Any 
deficits beyond what is expected by the nerve blockade will be 
followed at post-operative visit in the office to evaluate for 
resolution of transient symptoms. In the event of a peripheral nerve 
injury there is no intervention that can change the outcome of the 
block that has been delivered. If symptoms fail to progressively 
improve, neurological consultation should be sought in 3-4 weeks. 
Incomplete lesions with evidence of moderate or severe deficit are 
an indication for early neurological consultation and consideration 
of neurophysiologic testing (nerve conduction studies and 
electromyography). 
2. Local Anesthetic System Toxicity 
a. Ranges from mild symptoms of metallic taste, agitation, and 
circumoral numbness to more severe findings such as seizure, 
respiratory arrest, cardiac arrhythmias. 
b. Manifestations of local anesthetic toxicity typically appear 1 to 5 
minutes after the injection, but onset may range from 30 seconds to 
as long as 60 minutes. These symptoms will be monitored for and 
usually happen because of accidental injection into the vascular 
system. This is exceedingly rare with the advent of ultrasound 

Version Date:          8/11/2020           
 
Page 19 of 37 
guidance and direct visualization of the injection. During the 
procedure the patients are attached to full monitors which will 
monitor blood pressure, cardiac rhythm, oxygen saturation. Any 
noticeable severe findings are treated with supportive care with 
propofol, lipid infusions which can reverse the effects from the local 
anesthesia. 
c. Lipid infusion protocol as recommended by the ASEA practice 
advisory on local anesthetic systemic toxicity is as follows: 
i.  1.5 ml kg21 bolus of 20% lipid emulsion Infusion at 0.25 ml 
kg21 per min for at least 10 min after return of circulatory 
stability Consider giving a second bolus and increasing 
infusion to 0.50 ml kg21 if circulatory stability not attained 
Upper limit of lipid emulsion recommended is 10 ml kg21 
over the ﬁrst 30 min. 
d. In addition, the patients will be on a monitor in the post anesthesia 
recovery unit until they are deemed stable and ready for discharge. 
Any abnormalities will be noted by the nurse taking care of the 
patient who would inform the anesthesiologist and surgeon. This is 
standard protocol at our institution when any regional blocks are 
given for post-operative patients. 
e. The patients will be given a hand out and instructed to watch for 
signs or symptoms such as chest pain, rapid heart beating, difficulty 
breathing, or seizure like activity. If any of these symptoms are 
present, they would normally be observed immediately after the 
block is performed or while the patient is still being monitored, 
however after discharge they will still be informed to watch for 
symptoms in the event of a delayed response. They will be 
instructed to call the study PI or safety officer and likely be sent to 
the emergency room for evaluation. 
3. Local Infection 
a. For single shot adductor canal blocks the risk of infection is very 
low. To minimize this risk the site is prepped in sterile fashion with 
either chlorhexidine or iodine scrub. The injecting physician washes 
hands and uses sterile gloves and instruments for the course of this 
procedure. 
b. Perioperative antibiotics will also be given which is standard 
protocol for ACL reconstruction regardless of catheter insertion or 
not. 
c. In the event that the patient notices any skin irritation, redness, foul 
smell, or drainage form the site of the injection, they will be advised 
to first call the safety officer, PI, or other co-investigator to describe 
their symptoms. The patients will also watch for fevers or chills. If 
infection is suspected they will be sent to the emergency room or 
surgeons office for evaluation and further testing. They may be 
started on a course of oral antibiotics if an infection is concerning 
after evaluation. 

Version Date:          8/11/2020           
 
Page 20 of 37 
 
Risks associated with continuous peripheral nerve catheter placement: 
1. Both anesthetists and surgeons recognize the beneﬁts of peripheral 
nerve catheters (PNCs). The continuous infusion of local anesthetic near 
a peripheral nerve or plexus produces fewer systemic side-effects than 
i.v. opioids, increases postoperative patient satisfaction, and can allow 
for faster functional recovery of the operated limb. 
2. Block Failure 
a. Occasionally, there are instances when the catheter is passed 
easily but the nerve block fails to provide adequate anesthesia or 
analgesia. 
b. This is rare with the use of ultrasound guidance and localization 
of the continuous catheter.  
c. In the event of a block failure or inadequate placement that is not 
providing the patient any relief, the catheter will be removed 
either by the patient or post operatively depending on when it is 
discovered. 
d. The practicing anesthesiologist will discuss with the patient the 
option of either trying a second time to place the catheter 
successfully in the post anesthesia recovery area or 
discontinuing the block altogether. 
3. Accidental Catheter Migration/Removal 
a. The incidence of accidental catheter removal is reported in the 
literature at about 1%. The use of sterile adhesive tagaderm 
dressing has been implemented to firmly secure the catheter to 
the skin to avoid migration or fall out. The dressing is checked 
to be secure after it has been applied. 
b. In the event that the catheter is accidently removed or dislodged 
during the course of the study, it should be removed and there 
will be no further intervention once the patient has been 
discharged home. The patient can place a Band-Aid over the 
catheter site and notify the coinvestigator or PI. 
4. Localized Infection 
a. Localized inﬂammation is infrequent (0–10%), and local 
infection (0–3%), abscess formation (0–0.9%), and sepsis occur 
even more rarely. 
b. Transparent dressings are used to reduce the number of dressing 
changes while appropriately monitoring the site for signs of 
inﬂammation 
c. Since the continuous catheter remains in for 48-72 hours, it does 
pose a theoretical increased risk of infection compared to a 
single shot adductor canal block although this has not been 
proven in the literature. To minimize this risk the site is prepped 
in sterile fashion with either chlorhexidine or iodine scrub. The 
injecting physician washes hands and uses sterile gloves and 
instruments for the course of this procedure. 

Version Date:          8/11/2020           
 
Page 21 of 37 
d. Perioperative antibiotics will also be given which is standard 
protocol for ACL reconstruction regardless of catheter insertion 
or not. 
e. In the event that the patient notices any skin irritation, redness, 
foul smell, or drainage form the site of the injection, they will be 
advised to first call the safety officer, PI, or other co-investigator 
to describe their symptoms. The patients will also watch for 
fevers or chills. If infection is suspected they will be sent to the 
emergency room or surgeons office for evaluation and further 
testing. They may be started on a course of oral antibiotics if an 
infection is concerning after evaluation 
5. Local Anesthetic System Toxicity 
a. The patients with a continuous catheter will be receiving a fixed 
rate of flow of local anesthetic to the nerve site for 48-72 hours. 
This does put them at a theoretical risk for toxicity while they 
are at home with the catheter in even though the dosage is well 
below the threshold for systemic toxicity. They will be educated 
on the following signs and symptoms similar to the single shot 
patients. 
b. Ranges from mild symptoms of metallic taste, agitation, and 
circumoral numbness to more severe findings such as seizure, 
respiratory arrest, cardiac arrhythmias. 
c. Manifestations of local anesthetic toxicity typically appear 1 to 5 
minutes after the injection, but onset may range from 30 seconds 
to as long as 60 minutes. These symptoms will be monitored for 
and usually happen because of accidental injection into the 
vascular system. This is exceedingly rare with the advent of 
ultrasound guidance and direct visualization of the injection. 
During the procedure the patients are attached to full monitors 
which will monitor blood pressure, cardiac rhythm, oxygen 
saturation. Any noticeable severe findings are treated with 
supportive care with propofol, lipid infusions which can reverse 
the effects from the local anesthesia. 
d. Lipid infusion protocol as recommended by the ASEA practice 
advisory on local anesthetic systemic toxicity is as follows: 
i.  1.5 ml kg21 bolus of 20% lipid emulsion Infusion at 
0.25 ml kg21 per min for at least 10 min after return of 
circulatory stability Consider giving a second bolus and 
increasing infusion to 0.50 ml kg21 if circulatory 
stability not attained Upper limit of lipid emulsion 
recommended is 10 ml kg21 over the ﬁrst 30 min. 
e. In addition, the patients will be on a monitor in the post 
anesthesia recovery unit until they are deemed stable and ready 
for discharge. Any abnormalities will be noted by the nurse 
taking care of the patient who would inform the anesthesiologist 

Version Date:          8/11/2020           
 
Page 22 of 37 
and surgeon. This is standard protocol at our institution when 
any regional blocks are given for post-operative patients. 
f. The patients will be given a hand out and instructed to watch for 
signs or symptoms such as chest pain, rapid heart beating, 
difficulty breathing, or seizure like activity. If any of these 
symptoms are present, they would normally be observed 
immediately after the block is performed or while the patient is 
still being monitored, however after discharge they will still be 
informed to watch for symptoms in the event of a delayed 
response. They will be instructed to call the study PI or safety 
officer and likely be sent to the emergency room for evaluation. 
 
Unanticipated events will be assessed on a case by case basis and the study 
investigators will determine if the patient should be halted/discontinued and 
whether or not they should seek immediate care. 
 
Any participant who is discontinued from treatment will continue to be assessed 
following the previously stated follow-up procedure.  
 
The data to be collected at the time of study intervention discontinuation will 
include the following: 
● All data pertaining to the patient’s enrollment in the study including which 
arm of the study they were randomized to, whether or not they received the 
treatment to which they were randomized, all outcome data that was 
recorded up to the time of discontinuation and any stated reason for 
discontinuation will be documented.  
● Should a participant experience a known complication of the medication 
this will be recorded as an adverse event, serious adverse event, or 
unanticipated event as noted above. 
● The participants will continue to be followed according the protocol and 
their outcome data will continue to be obtained as is possible given the 
situation. 
● A case report form page will be produced for any participant who 
discontinues treatment or withdraws, this will include the date and any 
specific reasons for discontinuation/withdrawal from the study. 
 
 
 
Participants are free to withdraw from participation in the study at any time upon 
request. 
An investigator may discontinue or withdraw a participant from the study for the 
following reasons: 
● Serious adverse event 
● Pregnancy 
● Significant study intervention non-compliance  

Version Date:          8/11/2020           
 
Page 23 of 37 
● If any clinical adverse event (AE), laboratory abnormality, or other medical 
condition or situation occurs such that continued participation in the study 
would not be in the best interest of the participant. Adverse events or 
unanticipated events will be assessed on a case by case basis and 
discontinued as noted in the section above. 
● If the participant meets an exclusion criterion (either newly developed or 
not previously recognized) that precludes further study participation.  
● An investigator will discontinue/withdraw a patient from study participation 
if they are not deemed contactable, this will be defined as inability to 
contact after 3 separate attempts are made at least 2 hours apart across two 
days.  
The reason for participant discontinuation or withdrawal from the study will be 
recorded on the Case Report Form (CRF) as noted in the section above. Subjects 
who sign the informed consent form and are randomized but do not receive the 
study intervention they are randomized to will be followed in the study as if they 
have obtained their intervention this deviation from protocol will be documented 
for post-hoc analysis reasons.  Subjects who sign the informed consent form, and 
are randomized and receive the study intervention, and subsequently withdraw, or 
are withdrawn or discontinued from the study, maintained in the group to which 
they are randomized for assessment documentation with notation made as to their 
withdrawal to assist in the post-hoc analysis.  
Study participants who are randomized to the continuous infusion cohort will be 
provided with information about the pumps themselves and troubleshooting advice. 
They will also be provided with contact information for the investigators should 
they run into issues. The troubleshooting of the device will be done as noted in the 
above section and need for discontinuation of the therapy will be assessed as noted 
above with safety concerns as the primary reason for discontinuation.  
 
A participant will be considered lost to follow-up if he or she fails to respond to  
study surveys followed for more than one day of follow up, misses the phone calls, 
or misses the post-operative office visit planned for postoperative day 10-14 and is 
unable to be contacted by the study site staff.  
 
The following actions must be taken if a participant fails to respond to study 
surveys or return to the clinic for a required study visit: 
● The investigators will attempt to contact the participant and reschedule the 
missed visit planned for Post-op days 10-14 and counsel the participant on 
the importance of maintaining the assigned visit schedule and ascertain if 
the participant wishes to and/or should continue in the study. 
● Before a participant is deemed lost to follow-up, the investigator or 
designee will make every effort to regain contact with the participant 

Version Date:          8/11/2020           
 
Page 24 of 37 
(where possible, 3 telephone calls and, if necessary, a certified letter to the 
participant’s last known mailing address or local equivalent methods). 
These contact attempts will be documented in the participant’s medical 
record or study file. After 3 attempted phone calls spanning two 
postoperative days the patient will be deemed lost to follow-up. 
● Should a participant be unreachable for one day of the study follow-up this 
will not be deemed a loss to follow-up, however this occurrence will be 
documented in the data and accounted for in the analysis phase of the study.   
Should the participant continue to be unreachable, he or she will be considered to 
have withdrawn from the study with a primary reason of lost to follow-up. 
 
 
17. RISKS TO SUBJECTS 
• Describe any potential risks and discomforts to the subject (physical, psychological, 
social, legal, or other) and assess their likelihood and seriousness and whether side 
effects are reversible. Where appropriate, describe alternative treatments and 
procedures that might be advantageous to the subjects.  
• Include risks to others , like sexual partners (if appropriate) 
• Discuss why the risks to subjects are reasonable in relation to the anticipated benefits 
and in relation to the importance of the knowledge that may reasonably be expected 
to results 
• Describe the procedures for protecting against or minimizing any potential risks, 
including risks to confidentiality, and assess their likely effectiveness.   
 
Risks associated with single shot adductor canal block 
4. Peripheral Nerve Injury 
a. This is a rare complication that is usually transient and goes away 
with time. The estimated incidence is .5% for any nerve irritation 
after the procedure. The risk of injury to the nerve that is permanent 
in 1/10,000. These are very rare in part due to the implementation 
and success of ultrasound use for guidance of the needle and/or 
catheter during nerve blockade. This allows the anesthesiologist 
direct visualization to differentiate between perineural, intraneural, 
and interfascicular. 
b. These injuries will be monitored with a physical examination after 
the procedure once the patient has woken from anesthesia. Any 
deficits beyond what is expected by the nerve blockade will be 
followed at post-operative visit in the office to evaluate for 
resolution of transient symptoms. In the event of a peripheral nerve 
injury there is no intervention that can change the outcome of the 
block that has been delivered. If symptoms fail to progressively 
improve, neurological consultation should be sought in 3-4 weeks. 
Incomplete lesions with evidence of moderate or severe deficit are 
an indication for early neurological consultation and consideration 
of neurophysiologic testing (nerve conduction studies and 
electromyography). 

Version Date:          8/11/2020           
 
Page 25 of 37 
5. Local Anesthetic System Toxicity 
a. Ranges from mild symptoms of metallic taste, agitation, and 
circumoral numbness to more severe findings such as seizure, 
respiratory arrest, cardiac arrhythmias. 
b. Manifestations of local anesthetic toxicity typically appear 1 to 5 
minutes after the injection, but onset may range from 30 seconds to 
as long as 60 minutes. These symptoms will be monitored for and 
usually happen because of accidental injection into the vascular 
system. This is exceedingly rare with the advent of ultrasound 
guidance and direct visualization of the injection. During the 
procedure the patients are attached to full monitors which will 
monitor blood pressure, cardiac rhythm, oxygen saturation. Any 
noticeable severe findings are treated with supportive care with 
propofol, lipid infusions which can reverse the effects from the local 
anesthesia. 
c. Lipid infusion protocol as recommended by the ASEA practice 
advisory on local anesthetic systemic toxicity is as follows: 
i.  1.5 ml kg21 bolus of 20% lipid emulsion Infusion at 0.25 ml 
kg21 per min for at least 10 min after return of circulatory 
stability Consider giving a second bolus and increasing 
infusion to 0.50 ml kg21 if circulatory stability not attained 
Upper limit of lipid emulsion recommended is 10 ml kg21 
over the ﬁrst 30 min. 
d. In addition, the patients will be on a monitor in the post anesthesia 
recovery unit until they are deemed stable and ready for discharge. 
Any abnormalities will be noted by the nurse taking care of the 
patient who would inform the anesthesiologist and surgeon. This is 
standard protocol at our institution when any regional blocks are 
given for post-operative patients. 
e. The patients will be given a hand out and instructed to watch for 
signs or symptoms such as chest pain, rapid heart beating, difficulty 
breathing, or seizure like activity. If any of these symptoms are 
present, they would normally be observed immediately after the 
block is performed or while the patient is still being monitored, 
however after discharge they will still be informed to watch for 
symptoms in the event of a delayed response. They will be 
instructed to call the study PI or safety officer and likely be sent to 
the emergency room for evaluation. 
6. Local Infection 
a. For single shot adductor canal blocks the risk of infection is very 
low. To minimize this risk the site is prepped in sterile fashion with 
either chlorhexidine or iodine scrub. The injecting physician washes 
hands and uses sterile gloves and instruments for the course of this 
procedure. 

Version Date:          8/11/2020           
 
Page 26 of 37 
b. Perioperative antibiotics will also be given which is standard 
protocol for ACL reconstruction regardless of catheter insertion or 
not. 
c. In the event that the patient notices any skin irritation, redness, foul 
smell, or drainage form the site of the injection, they will be advised 
to first call the safety officer, PI, or other co-investigator to describe 
their symptoms. The patients will also watch for fevers or chills. If 
infection is suspected they will be sent to the emergency room or 
surgeons office for evaluation and further testing. They may be 
started on a course of oral antibiotics if an infection is concerning 
after evaluation. 
 
Risks associated with continuous peripheral nerve catheter placement: 
6. Both anesthetists and surgeons recognize the beneﬁts of peripheral 
nerve catheters (PNCs). The continuous infusion of local anesthetic near 
a peripheral nerve or plexus produces fewer systemic side-effects than 
i.v. opioids, increases postoperative patient satisfaction, and can allow 
for faster functional recovery of the operated limb. 
7. Block Failure 
a. Occasionally, there are instances when the catheter is passed 
easily but the nerve block fails to provide adequate anesthesia or 
analgesia. 
b. This is rare with the use of ultrasound guidance and localization 
of the continuous catheter.  
c. In the event of a block failure or inadequate placement that is not 
providing the patient any relief, the catheter will be removed 
either by the patient or post operatively depending on when it is 
discovered. 
d. The practicing anesthesiologist will discuss with the patient the 
option of either trying a second time to place the catheter 
successfully in the post anesthesia recovery area or 
discontinuing the block altogether. 
8. Accidental Catheter Migration/Removal 
a. The incidence of accidental catheter removal is reported in the 
literature at about 1%. The use of sterile adhesive tagaderm 
dressing has been implemented to firmly secure the catheter to 
the skin to avoid migration or fall out. The dressing is checked 
to be secure after it has been applied. 
b. In the event that the catheter is accidently removed or dislodged 
during the course of the study, it should be removed and there 
will be no further intervention once the patient has been 
discharged home. The patient can place a Band-Aid over the 
catheter site and notify the coinvestigator or PI. 
9. Localized Infection 

Version Date:          8/11/2020           
 
Page 27 of 37 
a. Localized inﬂammation is infrequent (0–10%), and local 
infection (0–3%), abscess formation (0–0.9%), and sepsis occur 
even more rarely. 
b. Transparent dressings are used to reduce the number of dressing 
changes while appropriately monitoring the site for signs of 
inﬂammation 
c. Since the continuous catheter remains in for 48-72 hours, it does 
pose a theoretical increased risk of infection compared to a 
single shot adductor canal block although this has not been 
proven in the literature. To minimize this risk the site is prepped 
in sterile fashion with either chlorhexidine or iodine scrub. The 
injecting physician washes hands and uses sterile gloves and 
instruments for the course of this procedure. 
d. Perioperative antibiotics will also be given which is standard 
protocol for ACL reconstruction regardless of catheter insertion 
or not. 
e. In the event that the patient notices any skin irritation, redness, 
foul smell, or drainage form the site of the injection, they will be 
advised to first call the safety officer, PI, or other co-investigator 
to describe their symptoms. The patients will also watch for 
fevers or chills. If infection is suspected they will be sent to the 
emergency room or surgeons office for evaluation and further 
testing. They may be started on a course of oral antibiotics if an 
infection is concerning after evaluation 
10. Local Anesthetic System Toxicity 
a. The patients with a continuous catheter will be receiving a fixed 
rate of flow of local anesthetic to the nerve site for 48-72 hours. 
This does put them at a theoretical risk for toxicity while they 
are at home with the catheter in even though the dosage is well 
below the threshold for systemic toxicity. They will be educated 
on the following signs and symptoms similar to the single shot 
patients. 
b. Ranges from mild symptoms of metallic taste, agitation, and 
circumoral numbness to more severe findings such as seizure, 
respiratory arrest, cardiac arrhythmias. 
c. Manifestations of local anesthetic toxicity typically appear 1 to 5 
minutes after the injection, but onset may range from 30 seconds 
to as long as 60 minutes. These symptoms will be monitored for 
and usually happen because of accidental injection into the 
vascular system. This is exceedingly rare with the advent of 
ultrasound guidance and direct visualization of the injection. 
During the procedure the patients are attached to full monitors 
which will monitor blood pressure, cardiac rhythm, oxygen 
saturation. Any noticeable severe findings are treated with 
supportive care with propofol, lipid infusions which can reverse 
the effects from the local anesthesia. 

Version Date:          8/11/2020           
 
Page 28 of 37 
d. Lipid infusion protocol as recommended by the ASEA practice 
advisory on local anesthetic systemic toxicity is as follows: 
i.  1.5 ml kg21 bolus of 20% lipid emulsion Infusion at 
0.25 ml kg21 per min for at least 10 min after return of 
circulatory stability Consider giving a second bolus and 
increasing infusion to 0.50 ml kg21 if circulatory 
stability not attained Upper limit of lipid emulsion 
recommended is 10 ml kg21 over the ﬁrst 30 min. 
e. In addition, the patients will be on a monitor in the post 
anesthesia recovery unit until they are deemed stable and ready 
for discharge. Any abnormalities will be noted by the nurse 
taking care of the patient who would inform the anesthesiologist 
and surgeon. This is standard protocol at our institution when 
any regional blocks are given for post-operative patients. 
f. The patients will be given a hand out and instructed to watch for 
signs or symptoms such as chest pain, rapid heart beating, 
difficulty breathing, or seizure like activity. If any of these 
symptoms are present, they would normally be observed 
immediately after the block is performed or while the patient is 
still being monitored, however after discharge they will still be 
informed to watch for symptoms in the event of a delayed 
response. They will be instructed to call the study PI or safety 
officer and likely be sent to the emergency room for evaluation. 
 
Unanticipated events will be assessed on a case by case basis and the study investigators 
will determine if the patient should be halted/discontinued and whether or not they 
should seek immediate care. 
 
Since identifiers are being recorded, there is also risk of loss of confidentiality of the 
patients 
 
 
 
 
18. RESEARCH RELATED HARM/INJURY 
• Describe the availability of medical or psychological resources that subjects might 
need as a result of anticipated problems that may be known to be associated with the 
research. 
• If the research is greater than minimal risk, explain any medical treatments that are 
available if research-related injury occurs, who will provide it, what will be provided, 
and who will pay for it.   
 
Adverse events and planned interventions prior to discontinuation 
 
● Failure of catheter placement despite successful administration of single site 
injection- any participant who was randomized to receive a continuous 

Version Date:          8/11/2020           
 
Page 29 of 37 
pump, but the catheter was unable to be placed will be discontinued from 
the continuous pump protocol, however these patient’s will continue to be 
followed according to the above stated protocol and their outcomes assessed 
in an intent-to treat manner based on their initial randomization. 
● Continuous Block failure- if patient perceives no benefit from block but 
pump appears to be functioning patient will be requested to continue the 
pumps use until the medication dosing is completed, a perceived block 
failure will be documented. 
● Allergy to local anesthetic- if a patient reports a systemic allergic response 
including but not limited to shortness of breath, diffuse rash, or angioedema 
the patient will be recommended to discontinue the intervention and seek 
emergency care. If the patient reports a local confined rash or skin irritation 
around the catheter site with no systemic symptoms the patient will be 
recommended to take a dose of Benadryl and apply a warm compress, if 
symptoms resolve the patient will remain in the study if there is no 
resolution the patient will be told to discontinue the medication 
administration and seek care for further evaluation.  
● Persistent pain at catheter site- the patient will be advised to place a cold or 
warm compress at the catheter site and adjust the adhesive bandage if 
necessary if these interventions do not alleviate the participants pain within 
12 hours the patient will be advised to discontinue the intervention.  
Pump/device failure- if the participant reports that the pump does not appear to be 
functioning properly the investigator who was contacted will assist the participant 
with troubleshooting the pump over the phone. If the investigator deems that the 
pump does not appear to be functioning after two independent attempts at 
troubleshooting/restarting the participant will be advised to discontinue the 
intervention at that time. 
 
 
19. POTENTIAL BENEFIT TO SUBJECTS 
 
• Explain what benefits might be derived from participation in the study, noting in 
particular the benefit over standard treatment (e.g. a once-a-day administration 
instead of four times a day, an oral formulation over an IV administration).  
• Also state if there are no known benefits to subjects, but detail the value of knowledge 
to be gained 
 
The idea is to evaluate the differences between 2 standard methods  
1. To Compare the efficacy of two different modes of administration of peripheral 
nerve block for postoperative pain control after primary ACL reconstruction. 
2.  To compare the daily opioid consumption in patients, post operatively after ACL 
Reconstruction. 
3. To determine the effectiveness of pain control and quality of sleep. 
4. To compare patient satisfaction with their surgery based on method of pain 
control. 
 

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This will give us valuable information regarding our hypothesis that patients will have 
better pain control, satisfaction, sleep, and decreased opioid consumption with the use of 
a continuous infusion pump 
 
 
 
20. PROVISIONS TO PROTECT PRIVACY INTERESTS OF SUBJECTS 
 
• Describe the methods used to identify potential research subjects, obtain consent and 
gather information about subjects to ensure that their privacy is not invaded.  
• In addition consider privacy protections that may be needed due to communications 
with subjects (such as phone messages or mail).   
 
a. All of the patient’s information that will be collected for the study 
will be uploaded to Northwell’s secure REDCAP data collections 
system. Password access and encryption will help ensure that all 
patient information will be kept private. Strict recording processes 
and careful handling of data will be used to ensure there is no 
breach of data that has been recorded. After the study information 
has been recorded and the study is complete this information will be 
deleted. These measures will help maintain patient privacy. 
b. Information that will be gathered from the surveys will be done by 
one of the coinvestigators that has been listed. The data variables 
that are recorded will be directly entered to Northwell REDCAP 
which is protected by user name and password. All of the co 
investigators will be in direct contact with the subjects and there 
won’t be any intermediate passing off of the information to be 
recorded which decreases the handling of patient specific 
information and results. 
c. Regarding identifying potential research subjects: The senior 
orthopedic surgery attendings participating in the study have been 
informed to contact us when they have a potential subject who is 
planning to have an ACL reconstruction when they have been seen 
in the office. There will be no marketing or recruiting used outside 
of patients that are undergoing this procedure with the orthopedic 
surgeon.  
 
Informed consent will be obtained in a private area to ensure the subjects’ privacy 
is protected. 
We have informed consent as attached, we will use encrypted data collection, 
Northwell REDCap, including the answers to surveys and phone calls, to protect 
their information. 
 
 
 
21.  COSTS TO SUBJECTS 
 

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• Describe any foreseeable costs that subjects may incur through participation in the 
research 
• Indicate whether research procedures will be billed to insurance or paid for by the 
research study.   
 
No additional costs will be given to patients more than what they would be paying 
for their ACL reconstruction and perioperative pain management which are current 
routine procedures being done at all institutions. 
 
 
 
22. PAYMENT TO SUBJECTS  
 
• Describe the amount of payment to subjects, in what form payment will be received 
and the timing of the payments.   
 
n/a 
 
 
23.  CONSENT PROCESS 
 
If obtaining consent for this study, describe: 
• Who will be obtaining consent 
• Where consent will be obtained 
• Any waiting period available between informing the prospective participant and 
obtaining consent 
• Steps that will be taken to assure the participants’ understanding 
• Any tools that will be utilized during the consent process 
•   Information about how the consent will be documented in writing.  If using a  
standard consent form, indicate such.   
• Procedures for maintaining informed consent.   
 
The informed consent will be attached 
 
● Who will be obtaining consent 
o Consent will be obtained by the Principal Investigator or 
one of the individuals that have been approved by the 
IRB to obtain consent. 
● Where consent will be obtained 
o Consent will be obtained in the Ambulatory Surgery unit 
prior to surgery or at the preoperative visit in the office 
by one of the IRB approved consenting investigators. 
Patients will be given the information on the study and it 
will be reviewed with them prior to obtaining consent. 
● Any waiting period available between informing the prospective 
participant and obtaining consent: The orthopedic surgeon can 

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inform the patients of the study at the pre-operative office visit 
to give them time to think about it before obtaining consent in 
the ambulatory surgery unit. This will allow patients a period of 
time to think about the pros and cons of participating in this 
research study which will be determined on the day of surgery 
preoperatively. 
● Steps that will be taken to assure the participants’ understanding 
o We have attached patient handouts in our protocol and 
IRB form to give patients a full understanding of the 
study plans, interventions, risks and benefits of each. 
o In addition, we will go over this information with the 
patient in person to confirm that they understand the 
goals of the study and the potential benefit to the patient. 
● Any tools that will be utilized during the consent process 
o Informed consent documentation 
●   Information about how the consent will be documented in 
writing.  If using a standard consent form, indicate such.   
o We will be using a standard consent form which we have 
designed and included in our IRB submission. 
● Procedures for maintaining informed consent. 
Signed informed consent forms will be maintained in a secure office with 
limited access. 
 
 
In the state of NY, any participants under the age of 18 are considered children.  If your 
study involves children, additional information should be provided to describe: 
• How parental permission will be obtained 
• From how many parents will parental permission be obtained 
• Whether permission will be obtained from individuals other than parents, and if 
so, who will be allowed to provide permission.  The process used to determine 
these individual’s authority to consent for the child should be provided 
• Whether or not assent will be obtained from the child 
• How will assent be documented 
• Whether child subjects may be expected to attain legal age to consent to the 
procedures for research prior to the completion of their participation in the 
research.  If so, describe the process that will be used to obtain their legal 
consent to continue participation in the study.  Indicate what will occur if consent 
is not obtained from the now-adult subjects.   
 
-We will not be using subjects under the age of 16 
-For age groups 16-18, we will provide all the information to the patient and the 
parents regarding the study, and obtain additional minor assent from the patient, 
and permission from 1 parent. 
-Permission will not be obtained from individuals other than parents 
-Assent form attached, for ages 16-18; will be used for documentation 
 

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If the subject becomes 18 before completion of participation in the study, we 
will reconsent the subject with an adult consent form 
 
 
If the study involves cognitively impaired adults, additional information should be 
provided to describe: 
• The process to determine whether an individual is capable of consent 
• Indicate who will make this assessment 
• The plan should indicate that documentation of the determination  and 
assessment will be placed in the medical record, when applicable, in addition to 
the research record. 
• If permission of a legally authorized representative will be obtained, 
o  list the individuals from who permission will be obtained in order of priority 
o Describe the process for assent of subjects; indicate whether assent will be 
required of all, some or none of the subjects.  If some, which subjects will be 
required to assent and which will not. 
o If assent will not be obtained from some or all subjects, provide an 
explanation as to why not 
o Describe whether assent will be documented and the process to document 
assent 
o Indicate if the subject could regain capacity and at what point you would 
obtain their consent for continued participation in the study 
 
We will not be involving cognitively impaired adults in this study. 
 
 
If the study will enroll non-English speaking subjects: 
• Indicate what language(s) other than English are understood by prospective 
subjects or representatives 
• Indicate whether or not consent forms will be translated into a language other 
than English 
• Describe the process to ensure that the oral and written information provided 
to those subjects will be in that language 
• If non-English speaking subjects will be excluded, provide a justification for 
doing so 
 
Non-English-speaking subjects will be excluded due to lack of translated 
documentation, and the inability of each resident to translate the questions 
over the phone 
 
 
24.  WAIVER OR ALTERATION OF THE CONSENT PROCESS       
 N/A          
 
Complete this section if you are seeking an alteration or complete waiver of the consent   
process. 

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• Describe the possible risks of harm to the subjects involved in this study and 
explain why the study involves no more than minimal risk to the subject:   
• Explain why the waiver/ alteration will not adversely affect the rights and welfare 
of subjects 
• Explain why it is impracticable to conduct this research if informed consent is 
required   
• Explain why it is not possible to conduct this research without using the 
information or biospecimens in an identifiable form 
• If appropriate, explain how the subjects will be provided with additional pertinent 
information after participation.   If not appropriate to do so, explain why.  
 
n/a 
 
Complete this section if you are obtaining informed consent but you are requesting a 
waiver of the documentation of consent (i.e., verbal consent will be obtained). To 
proceed with a waiver based on these criteria, each subject must be asked whether they 
wish to have documentation linking them to this study.  Only complete subsection 1 OR 
subsection 2.  
 
  SUBSECTION 1 
 
• Explain how the only record linking the subject to the research would be the 
consent document. 
• Explain how the principal risk of this study would be the potential harm resulting 
from a breach in the confidentiality 
• Indicate whether or not subjects will be provided with a written statement 
regarding the research. 
 
n/a 
 
SUBSECTION 2 
•  Describe the possible risks of harm to the subjects involved in this study and 
explain why the study involves no more than minimal risk.   
• Confirm that the research only involves procedure for which consent is not 
normally required outside the research context.  
• Indicate whether or not subjects will be provided with a written statement 
regarding the research. 
 
n/a 
 
. 
 
25. WAIVER OF HIPAA AUTHORIZATION  
 
 
 
 N/A       
 
Complete this section if you seek to obtain a full waiver of HIPAA authorization to use 
and/or disclose protected health information.  

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• Describe the risks to privacy involved in this study and explain why the study 
involves no more than minimal risk to privacy:   
• Describe your plan to protect identifiers from improper use or disclosure and to 
destroy them at the earliest time. 
•  Indicate why it is not possible to seek subjects’ authorization for use or 
disclosure of PHI. 
• Indicate why it is not possible to conduct this research without use or disclosure 
of the PHI.   
• Indicate if PHI will be disclosed outside NSLIJ Health System, and if so, to whom.   
Note:  PHI disclosed outside NSLIJ Health System, without HIPAA authorization 
needs to be tracked. Please see guidance at www.nslij.com/irb for information 
about tracking disclosures. 
 
n/a 
 
Complete this section if you seek to obtain a partial waiver of the patient’s 
authorization for screening/recruitment purposes (i.e., the researcher does not have 
access to patient records as s/he is not part of the covered entity) 
Note: Information collected through a partial waiver for recruitment cannot be shared 
or disclosed to any other person or entity. 
• Describe how data will be collected and used:  
• Indicate why you need the PHI (e.g.PHI is required to determine eligibility, 
identifiers are necessary to contact the individual to discuss participation, other) 
• Indicate why  the research cannot practicably be conducted without the partial 
waiver (e.g. no access to medical records or contact information of the targeted 
population, no treating clinician to assist in recruitment of the study population, 
other) 
n/a 
 
 
26.  VULNERABLE POPULATIONS: 
 
Indicate whether you will include any of these vulnerable populations. If indicated, 
submit the appropriate appendix to the IRB for review: 
 
X  Children or viable neonate 
  Cognitively impaired 
  Pregnant Women, Fetuses or neonates of uncertain viability or nonviable  
  Prisoners 
  NSLIJ Employees, residents, fellows, etc 
  poor/uninsured 
  Students 
  Minorities 
  Elderly 
  Healthy Controls 

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If any of these populations are included in the study, describe additional safeguards that 
will be used to protect their rights and welfare. 
 
Vulnerable population - Children age 16-18 
We will obtain permission from  1 parent and assent from the patient after providing 
them all the necessary information to go forward with the study 
 
 
27.  MULTI-SITE HUMAN RESEARCH (COORDINATING CENTER) 
 
If this is a multi-site study where you are the lead investigator, describe the management 
of information (e.g. results, new information, unanticipated problems involving risks to 
subjects or others, or protocol modifications) among sites to protect subjects. 
n/a 
 
 
 
28.  REFERENCES/BIBIOGRAPHY 
 
Provide a reasonable list of references directly related to the study. Any diagrams for 
new medical devices or brief reprints from journals might also prove useful. 
 
 
1. Capdevila X, Pirat P, Bringuier S, et al. Continuous peripheral nerve blocks in 
hospital wards after orthopedic surgery: a multicenter prospective analysis of 
the quality of postoperative analgesia and complications in 1,416 patients. 
Anesthesiology. 2005;103(5):1035–45. 
2. Salviz EA, Xu D, Frulla A, Kwofie K, Shastri U, Chen J, Shariat AN, Littwin S, 
Lin E, Choi J, Hobeika P, Hadzic A; Continuous Interscalene Block in Patients 
Having Outpatient Rotator Cuff Repair Surgery: A Prospective Randomized 
Trial; Anesthesia & Analgesia; Vol 117(6), December 2013, p 1485–1492 
3. Enneking FK, Wedel, DJ; The art and science of peripheral nerve blocks; 
Anesth  Analg  2000;90:1–2. 
4. Mariano ER, Afra R, Loland VJ, Sandhu NS, Bellars, RH, Bishop ML, Cheng 
GS, Choy LP, Maldonado RC, IIfeld BM; Continuous Interscalene Brachial 
Plexus Block via an Ultrasound-Guided Posterior Approach: A Randomized, 
Triple-Masked,Placebo-Controlled Study; Anesth Analg. 2009 May ; 108(5): 
1688–1694. doi:10.1213/ane.0b013e318199dc86 
5. Richman JM, Liu SS, Courpas G, Wong R, Rowlingson AJ, Mcgready J, Cohen 
SR, Wu CL; Does Continuous Peripheral Nerve Block Provide Superior Pain 
Control to Opioids? A Meta-Analysis; Anesth Analg 2006;102:248–57. 

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6. Buller LT, Best MJ, Baraga MG, Kaplan LD; Trends in Anterior Cruciate 
Ligament Reconstruction in the United States; Orthop J Sports Med; 2014 Dec 
26;3(1):2325967114563664. doi: 10.1177/2325967114563664 
7. Abdallah, FW, Whelan DB, CHan VW, Prasad GA, Endersby RV; Adductor 
Canal Block Provides Noninferior Analgesia and Superior Quadriceps Strength 
Compared with Femoral Nerve Block in Anterior Cruciate Ligament 
Reconstruction; Anesthesiology 5 2016, Vol.124, 1053-1064. 
doi:10.1097/ALN.0000000000001045. 
8. Kwofie MK, Shastri UD, Gadsen JC, Sinha SK, Abrams JH, Xu D, Salviz EA; 
The effects of ultrasound-guided adductor canal block versus femoral nerve 
block on quadriceps strength and fall risk: a blinded, randomized trial of 
volunteers; Reg Anesth Pain Med 2013; 38:321-325. 
9. Mulroy MF, Larkin KL,  Batra MS, Hodgson PS, Owens BD; Femoral Nerve 
Block With 0.25% or 0.5% Bupivacaine Improves Postoperative Analgesia 
Following Outpatient Arthroscopic Anterior Cruciate Ligament Repair; 
Regional Anesthesia and Pain Medicine, Vol 26, No 1 (January–February), 
2001: pp 24–29. 
10. Jaeger P, Nielsen Z JK, Henningsen MH, Hilsted KL, Mathiesen O, Dahl, JB; 
Adductor Canal Block versus Femoral Nerve Block and Quadriceps Strength: 
A Randomized,