A Comparison of Analgesic Efficacy of Ultrasound-Guided Genicular Nerve Block Versus Saline Injection for Total Knee Replacement: a Prospective, Randomized Controlled Trial
Phase: PHASE4
Conditions: Postoperative Pain, Total Knee Arthroplasty, Nerve Block
Sponsor: Northwestern University

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PROTOCOL TITLE:  A Comparison of Analgesic Efficacy of Ultrasound-Guided 
Genicular Nerve Block versus Saline Injection for Total Knee Replacement: a 
Prospective, Randomized Controlled Trial 
 
 
 
PRINCIPAL INVESTIGATOR: 
Antoun Nader, MD  
Institution: Northwestern University, Feinberg School of Medicine  
Department: Anesthesiology 
Address: 251 East Huron Street, Feinberg Pavilion 5-704, Chicago, IL 60611 
Email Address: anader2@northwestern.edu  
Phone: (312) 695-3045  
Fax: (312) 695-5876 
 
 
 
 
 
 
 
VERSION NUMBER: 1.0 
 
 
 
 
 
 
VERSION DATE: 09/12/2017 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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OBJECTIVES: 
Research Questions:     
Do ultrasound-guided genicular nerve blocks with 0.5% bupivacaine provide improved 
knee analgesia for patients recovering from total knee replacement surgery compared 
to saline injection? 
 
Hypotheses:    
We hypothesize that the combination of ultrasound-guided adductor canal block (ACB) 
and genicular nerve block will achieve lower opioid consumption and therefore lead to 
decreased systemic side effects and improved overall satisfaction compared to 
ultrasound-guided saline injection for patients undergoing minimally invasive elective 
total knee arthroplasty (TKA). 
 
BACKGROUND: 
Total knee arthroplasty is associated with intense early postoperative pain. A sizeable 
proportion (25–40%) of patients experience severe pain postoperatively despite a 
comprehensive multimodal analgesic regimen.1 Enhanced recovery protocols that 
emphasize early mobilization and hospital discharge remain varied among hospitals. 
Regional anesthetic techniques have evolved to preserve motor function in an effort to 
promote early ambulation and hospital discharge, while optimizing sensory blockade for 
adequate analgesia. The (ACB) of the saphenous nerve has demonstrated reduced 
opioid consumption and preservation of quadriceps muscle strength when compared to 
placebo and to femoral nerve blockade 2 however, several studies have shown that 
despite ACB, many patients may still have at least moderate, movement-related pain. 
This may be partly because the ACB does not provide analgesia to the posterior aspect 
of the knee, in which pain is commonly moderate to severe after surgery. 
 
It has been proposed in the literature that complete blockade of the knee joint for 
adequate analgesia requires blockade of the genicular nerves.3 The genicular nerves 
provide sensory innervation to the joint capsule and internal and external ligaments of 
the knee joint. The superior and inferior medial genicular nerves arise in the posterior 
popliteal fossa and are sensory branches of the tibial nerve. The superior and inferior 
lateral genicular nerves are sensory branches of the common peroneal nerve and 
course anteriorly to the lateral knee. The identification of the genicular nerves using 
ultrasound has been described in the literature.4 
 
At our institution, all patients scheduled to undergo total knee replacement receive 
periarticular injections as part of their pain management, as this practice demonstrates 
effectively reduced narcotic consumption and improved patient satisfaction compared to 
IVPCA.5    
 
We hypothesize that the combination of ultrasound-guided ACB and genicular nerve 
block will further decrease opioid consumption and therefore lead to decreased 
systemic side effects and improved overall satisfaction compared to ultrasound-guided 
adductor canal block alone in patients undergoing elective minimally invasive TKA 
surgery.   

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INCLUSION AND EXCLUSION CRITERIA: 
Patient inclusion criteria:  
Participants 40 to 85 years old who are presenting for minimally invasive total knee 
arthroplasty under spinal anesthesia and are candidates for peripheral nerve blocks. 
Minimally invasive is defined as custom modified instrumentation, a quadriceps sparing 
arthrotomy that does not extend beyond 1cm proximal to the patella and surgical 
techniques that focus on soft tissue protection.  
 
Patient exclusion criteria:  
Patient refusal 
American Society of Anesthesiologists physical status classification of 4 or higher 
Pre-existing neuropathy in the femoral or sciatic distribution 
Coagulopathy 
Infection at the site 
Chronic opioid use (greater than 3 months) 
Pregnancy 
Medical conditions limiting physical therapy participation 
Any other contra-indication to regional anesthesia  
 
- Adults unable to consent N/A  
- Individuals who are not yet adults (infants, children, teenagers)N/A 
- Pregnant women N/A 
- Prisoners N/A 
 
STUDY-WIDE NUMBER OF PARTICIPANTS: N/A 
(If this is a multi-center study for which you are the lead investigator, indicate the total 
number of participants to be accrued across all sites.) 
 
STUDY-WIDE RECRUITMENT METHODS: N/A 
 
MULTI-SITE RESEARCH: N/A 
 
STUDY TIMELINES: 
Subject’s participation in the study will last 1 year 
Approximately 5 TKA surgeries are performed each week at the Feinberg Pavilion. If we 
are able to enroll 5 subjects per month it should take about 24 months to complete. 
 
STUDY ENDPOINTS: 
Primary Outcome: 
-Post-operative opioid consumption during the hospital stay. 
 
Secondary Outcome: 
-Pain scores (Visual Analog Scale pain score; 0 = no pain, 10 = excruciating pain) in the 
knee at rest and during activity recorded every 6 hours up to discharge.  
 

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-Overall global pain score (VAS pain scores; 0 = no pain, 10 = excruciating pain) 
recorded every 6 hours up to discharge.  
 
-Overall pain burden for the first 36 hours. 
 
-Opioid related side effects 
 
-Time to physical therapy milestones (active straight leg raise, time until patient first gets 
out of bed, ambulation about the hospital room with or without assistance, ambulating 
100 feet and ability to climb stairs) 
 
-Length of hospitalization  
 
-Readmission to the hospital or emergency room visit for evaluation during study period. 
 
PROCEDURES INVOLVED: 
All ASA 1-3, 40-85 year old patients who are scheduled for total knee reconstruction 
surgery and are scheduled to receive a nerve block as part of their postoperative 
analgesic care will be approached to participate in this study. Patients will be introduced 
to the study in the Lavin Pavilion12th floor pre- operative clinic by one of the study team 
members. On the day of surgery in the Feinberg pavilion 5th Floor. The subject will be 
approached by one of the study team members to answer any questions they have 
regarding the study. If they had not signed the consent document in the pre-operative 
clinic they will be asked again if they had reviewed the consent document and whether 
they would like to participate. Patient participation will last for 12 months.   
 
Sealed opaque envelopes will be pre-randomized into two study medication groups 
using a computerized random number generator.  
 
The study medication and protocol will consist of Group 1 (Active) – ultrasound-guided 
adductor canal blockade with 10 ml of 0.25% bupivacaine and ultrasound-guided 
genicular nerve blocks with 6 ml of 0.5% bupivacaine, and Group 2 (Control) – 
ultrasound-guided adductor canal block with 10 ml of 0.25% bupivacaine and 
ultrasound-guided genicular nerve blocks with 6 ml of normal saline. The surgeon will 
be blinded to the subjects study arm assignment. 
 
An ultrasound-guided ACB will be performed at the level of the mid-thigh of the leg 
halfway between the superior anterior iliac spine and the patella. The femoral artery, 
femoral vein, saphenous nerve will be visualized by ultrasonography and the expansion 
of the adductor canal will be recorded.  Sensory assessment of the saphenous 
distribution will be performed at 30 minutes.  The ultrasound-guided genicular nerve 
block will be performed at the site of the superior lateral, the superior medial, and the 
inferior medial genicular nerves. The superior lateral genicular nerve is located at the 
confluence of the lateral femoral shaft and the lateral femoral condyle (in the 
anteroposterior plane) and at the midpoint of the femur (in the lateral plane). The 
superior medial genicular nerve site is located at the confluence of the medial femoral 

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shaft and the medial femoral condyle (in the anteroposterior plane) and at the midpoint 
of the femur (in the lateral plane). The inferior medial genicular nerve site is located at 
the confluence of the medial tibial shaft and the tibial flare (in the anteroposterior plane) 
and the midpoint of the tibia (in the lateral plane). Color Doppler will be used to identify 
the arterial structures which serve as landmarks for the corresponding nerves. All nerve 
blocks will be performed by a study team physician.  
 
Postoperative follow-up will be done by study team member blinded to the group 
allocation.  The dosing of oxycodone/hydrocodone-acetaminophen will be as needed 
with management goal of a Visual Analog Scale (VAS) score of ≤ 4. Patients with pain 
not managed by oral agents will receive IV medication.  Patients will be visited during 
their hospital stay every six to eight hours until discharge to record pain scores, opioid 
consumption, and patient satisfaction.  In addition, patients will be given a pain diary to 
record (VAS) pain scores every six hours until hospital discharge.   
 
A study team member will follow up patients by telephone (if discharged prior to) at 48 
hours, 72 hours and at 3 weeks and will ask questions pertaining to the patient’s pain, 
narcotic side effects, and satisfaction with pain control.  Patients are scheduled to have 
a follow-up visit with their orthopedic surgeon at approximately 3 weeks and 1 year 
following surgery.  The range of motion, current pain medication use, pain scores and 
untoward events will be re-recorded during each surgical follow-up visit.  Patient’s 
medical record will be reviewed to verify or obtain correct opioid consumption and 
physical/occupational therapy participation during hospital stay. 
 
DATA AND SPECIMEN BANKING: N/A 
 
DATA AND SPECIMEN MANAGEMENT: 
Study members will have an active Collaborative Institutional Training Initiative (CITI) 
training certification. Their names and roles will be added to the IRB application.  
 
Each study subject will be assigned a study code number. The code will be used to link 
study data to patient identification (name) in a separate database that only the 
investigator has access.  
 
Strict measures will be in place to ensure that no loss of confidentiality occurs. Only 
study team members will have access to the data. The principal investigator will be 
responsible for handling and management of the data. 
 
Subject data will be stored on password protected secure computer at Northwestern 
University 10th floor Arkes (Department of Anesthesiology administrative office).  Data 
access will be password protected and only available to study team members. Access 
will be controlled by the Principal Investigator. Local data will be stored on Northwestern 
University, NM servers which are password protected and backed up nightly. 
Information regarding the perioperative course will be included in the data collection.   
Data will also be validated by the PI prior to data analysis.  
 

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Data will be stored on NM Servers and Department of Anesthesiology computers which 
are password protected.  Paper data will be stored in Arkes Pavilion 10th floor 
Department of Anesthesiology office research closet which is accessible by key card 
entry and then key for the closet.  Each study subject will be assigned a study code 
number. The code will be used to link study data to patient identification (name) in a 
separate database. 
 
The data both electronic and paper will be stored for five (5) years after manuscript 
preparation. Data both electronic and paper will be destroyed using departmental 
standards and approved vendors. 
 
PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF 
PARTICIPANTS: 
At the start of the study, a Data and Safety Monitoring Board (DSMB) will be appointed 
and will consist of the PI, a regional anesthesiologist, a statistician (Dr. McCarthy) all 
with expertise in the area of regional anesthesia complications after blocks for 
orthopedic surgery. The DSMB members must attest to not having any conflicts of 
interest with the study. A study team member (TBD) will participate in the DSMB 
meetings as non-voting member. The DSMB will be charged with oversight of the 
study’s safety and integrity and assessing the risk versus benefits of continuing the 
study if such questions arise. The DSMB will meet annually in person or by conference 
call or more often, if necessary, based on the progression of the study.  The DSMB will 
continue to meet until the completion of the study. 
 
The DSMB will review patient recruitment and patient follow-up, compliance with the 
protocol including protocol violations, timeliness and completeness of data entry, 
compliance with patient confidentiality and HIPPA regulations, and communications of 
adverse events to the IRB. The DSMB members should immediately review the data in 
order to make any requests for additional information or analysis in a time frame that 
can allow for such requests to be completed before the scheduled DSMB meeting. 
Members of the DSMB must maintain confidentiality of the study data until otherwise 
instructed. An interim analysis of the data looking at safety will be conducted by the 
DSMB when results from the first 50 subjects are available.  
 
WITHDRAWAL OF PARTICIPANTS: 
If the subject decides to discontinue their participation in the study, no further exams will 
be completed. The existent data sheet will be preserved and the removal of a partially 
completed subject from the data set will be noted in the study manuscript. A research 
team member will contact the PI by secured-email to inform him about the event that led 
to early study termination. 
 
RISKS TO PARTICIPANTS: 
ACB is a widely practiced technique performed to provide postoperative analgesia for 
patients undergoing total knee arthroscopy. The major risk of genicular nerve block is 
infection, which is exceedingly rare given the use of aseptic technique.  

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Subject’s involvement may make them feel emotionally uncomfortable because study 
team members will ask them questions regarding their pain and satisfaction throughout 
the study period. 
 
The risks of the study medication include unintentional intravascular injection of the 
local anesthetic solution. This may cause cardiovascular effects such as hypotension, 
bradycardia, ventricular arrhythmias or cardiac arrest. Allergic response which can be 
mild or as severe as anaphylaxis. Rare risks include restlessness, anxiety, dizziness or 
tremors.   
 
There is the risk of loss of confidentiality even though there are strict measures in place 
to prevent occurrence. 
 
POTENTIAL BENEFITS TO PARTICIPANTS: 
The potential benefit of participating in the study is that patients receiving the both the 
ACB and genicular nerve block may take less pain medication resulting in fewer side 
effects and achieve physical therapy milestones sooner than those who do not receive 
an genicular nerve block. 
 
VULNERABLE POPULATIONS: N/A 
 
COMMUNITY-BASED PARTICIPATORY RESEARCH: N/A 
 
SHARING OF RESULTS WITH PARTICIPANTS: N/A 
 
SETTING: 
Study participants will be identified and recruited from the Anesthesiology pre-operative 
clinic on the 17 Floor of Lavin Pavilion at Northwestern Memorial Hospital. The research 
will be performed in the pre and post-operative area at Feinberg Pavilion 5th Floor. Post-
surgery evaluations will occur on the orthopedics floors on the Feinberg Pavilion.  The 3 
week and 1 year follow up will occur in the orthopedic surgeon’s office within 
Northwestern Medicine. 
 
RESOURCES AVAILABLE: 
The Section of Regional Anesthesiology actively provides care to admitted patients at 
Feinberg Pavilion. As a Regional Anesthesiologist and member of the Anesthesiology 
Service I regularly supervise and provide care to patients on this unit. We have a 
dedicated group of study team members that assist with daily recruitment and follow-up 
of patients in clinical anesthesiology trials. Study team members all have CITI training. 
 
The primary investigator has expertise using the ultra-sonographic probe for needle 
guidance for nerve blocks. The study team members will set up the ultrasound machine 
for each study participant. 
 
 

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-The ability to recruit the number of study participants should be fairly easy 
given the number of TKA performed yearly.  
-The investigator will be present for all scheduled study related nerve blocks. 
-The study will be conducted in one of pre and post-operative rooms in the 
PACU on the 5th floor Feinberg Pavilion. 
-Participants will have the immediate availability of the supervising 
anesthesiologist and attending anesthesiologist of record.  
-Participating anesthesiologists and operating room staff and study team 
members will be briefed on the study prior to the subjects block. 
 
PRIOR APPROVALS:  
Department of Anesthesiology Research Committee 
 
RECRUITMENT METHODS: 
Subjects will be approached and recruited by a member of the anesthesia research 
team during the pre-operative clinic visit on the 17th floor Lavin Pavilion of Northwestern 
Memorial Hospital. Study team members will use Powerchart and Epic from NW to 
screen potential participants 
 
Describe materials that will be used to recruit subjects. N/A 
 
NUMBER OF LOCAL PARTICIPANTS: 
On the basis of the literature 6 we assumed that patients in Group B (Control group) will 
have an average opioid consumption at 36 hours following surgery of 48 mg IV 
morphine equivalents (morEq) while patients who receive genicular nerve blocks would 
experience a decrease of 20% in opioid consumption to an average of 39 mg IV morEq. 
Standard deviation was estimated to be 15. The effect size is 0.60. Comparison of 
means of two independent groups (Wilcoxon-Mann-Whitney Test) demonstrated a 
required total sample size of 94, 47 participants in each group. 80% power, 0.05 alpha 
level. Six patients will be added to account for lost to follow up or cancelled surgical 
cases.  
  
Pain burden defined as the area under the numeric rating score for pain for the first 36 
hours will be calculated using the trapezoidal method. Time to report first pain and 
overall patient satisfaction between groups will be compared using the Kruskal-Wallis H 
test. 
 
CONFIDENTIALITY: 
Data is collected on paper by study team members and then entered onto the 
Department of Anesthesiology password controlled computers located on the 10th floor 
Arkes Pavilion. Data are stored in a department (NM) server which is also password 
protected and backed up nightly.  Each study subject will be assigned a study code 
number. The code will be used to link study data to patient identification (name) in a 
separate database.   
 

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The paper folders will be stored in Arkes Pavilion 10th floor Department of 
Anesthesiology administrative office via key card controlled front door and key 
controlled closet.  Data access will be password protected and only available to study 
investigators and study team members. Access to the data is controlled by the principal 
investigator. Data both electronic and paper will be destroyed 5 years after manuscript 
preparation using current procedures and approved vendors. 
 
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS: 
The subject will have multiple interactions with the study team. The first interaction will 
be to discuss and obtain written informed consent; then multiple times during the 
perioperative period. The brief interactions will limit the amount of intrusion into the 
subject’s recovery process.  
 
The research study team is only to be allowed to view the data sheets, Powerchart and 
EPIC for selected data within the parameters of the study. 
 
COMPENSATION FOR RESEARCH-RELATED INJURY: N/A 
 
ECONOMIC BURDEN TO PARTICIPANTS:  
There is no additional cost to participate. The extra block will be paid for by the 
Department of Anesthesiology.  
 
CONSENT PROCESS: 
The consent process will take place on the 17th Floor Lavin Pavilion, at Northwestern 
Memorial Hospital. Subjects who have reviewed the document but have not signed prior 
to the surgical date will be approached again on the day of surgery on the 5th Floor 
Feinberg Pavilion. The research study team will spent greater than 10 minutes 
discussing the study. Ample time will be allowed for patient to answer questions 
regarding the study and the consent document. The subject will also be informed that 
there is no conflict of interest between the PI and the protocol. The PI will not receive 
financial remuneration nor will the study participation affect the subject’s financial 
charges for their care. 
 
Waiver or Alteration of Consent Process: N/A 
 
Participants who are not yet adults (infants, children, teenagers):N/A 
 
PROCESS TO DOCUMENT CONSENT IN WRITING: 
We will be following HRP-091. Consent attached to EIRB+ application 
 
DRUGS OR DEVICES: 
The FDA approved  Sonosite M-Turbo Ultrasound Machine will be stored on the 5th floor 
Feinberg Pavilion at Northwestern Memorial Hospital in the anesthesiology store room 
behind a locked door. The ultrasound machine is owned by the Department of the 
hospital and is stickered by biomedical engineering. 

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Appendix A 
DATA COLLECTION FORM 
Ultrasound-guided genicular nerve block  
Investigator: Antoun Nader, M.D. 
 
Subject: ____ ▪    Date of procedure:___/___/__ TKA 
description:____________________________ 
Surgical Procedure:  □ L  □ R                                  Baseline (24hr) pain score:_____     Sex:  
□M   □F Weight: ___lbs/kg  ▪ Height: ___in   Age: ____ 
Subject Demographics: Caucasian: ___ African American: __ Asian:___Hispanic: __ 
Middle Eastern: __Other: _________ 
                    
Time to complete block (needle in–needle out):____  
Time of block placement:___  Sensory Assessment at 30 minutes:  □Yes    □No 
Pain Score (VAS 0-10) after the performance of the block: _______   
  Immediate Complications:  □ None   □Yes    If yes, explain:                                                                      
  Delayed Complications:      □ None   □Yes    If yes, explain:  
 
Follow-up: Time to 1st pain:_____________   Location: 
Anterior______Posterior____Other_____ 
 
Physical Therapy Milestones  
Time  
Active straight leg raise 
 
Time until patient first gets out of bed 
 
Ambulation about the hospital room with or without assistance 
 
Ambulating 100 feet 
 
Ability to climb stairs 
 
 
6hr 
12hr 
18hr 
24hr 
30hr 
36hr 
42hr 
48hr 
Time:  
 
 
 
 
 
 
 
 
NRS (0-10) 
  At rest  
  During Activity 
 
 
 
 
 
 
 
 
Pain medication:  
  Norco ____mg 
  Oxycodone  
  Dilaudid  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Side effects (0-3) 
 1=mild, 2=mod, 3=severe     
                                Nausea   
                                  Vomit  
                                   Dizzy  
 
 
 
 
 
 
 
 
 
 
Patient Satisfaction 
(0-10) Pain Control 
 
 
 
 
 
 
 
 

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Time of Discharge:__________ Date:___/___/_____      Length of hospitalization: ______________ 
 
 
Follow up:  
 
 
Pain Scores (0-10)  
  At Rest: @ 3wk ________ and @ 1year_______ 
  During Activity: @ 3wk ________ and @ 
1year_______ 
 
Block Satisfaction @ 3wk (0-10):    
  □VS     □S     □Not Sat nor US    □US     □VUS 
 
Range of motion: @ 3wk ______and @ 1year 
__________. 
                                                                                
Readmission to the hospital or emergency room visit:    
□Yes    □No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
72hr 
3wks 
Time:  
 
 
NRS (0-10) 
  At rest  
  During Activity 
 
 
Pain medication:  
  Norco ____mg 
  Oxycodone  
  Dilaudid  
  Tramodol 
 
 
 
 
 
 
 
 
Side effects (0-3) 
 1=mild, 2=mod, 
3=severe                        
                                
Nausea   
                                  
Vomit  
                                   
Dizzy  
 
 
 
Patient 
Satisfaction 
(0-10) Pain 
Control 
 
 

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Appendix B: Code Identifier List 
 
A comparison of analgesic efficacy of ultrasound-guided genicular nerve block versus 
saline injection for total knee replacement: a prospective, randomized controlled trial. 
 
 
Subject ID #    Subject Name       MRN      Telephone Number        Age/Gender        
DOS   
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
19 
20 
….100. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix C: Pain Journal 
 
Subject #  __________ 
 
 Post Operative    Pain Score 0 (Low) 10 (High) 
6 Hours Post 
Operative 
 
12 Hours Post 
Operative 
 
18 Hours Post 
Operative 
 
24 Hours Post 
Operative 
 
30 Hours Post 
Operative 
 
36 Hours Post 
Operative 
 
42 Hours Post 
Operative 
 
48 Hours Post 
Operative