Clinical trial NCT05261009
Conditions: Pain, Postoperative Hip Pain Chronic
Sponsor: Wake Forest University Health Sciences
Start date: 2022-06-13; Completion date: 2023-07-20
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this randomized, double blinded, prospective study is to compare the postoperative analgesia provided by the PENG block to that provided by the LPB for patients undergoing primary anterior approach THA.

Detailed description:
Regional anesthesia procedures represent a common modality for postoperative analgesia after total hip arthroplasty surgeries (THA). The standard practice many years has been the Lumbar Plexus block (LPB), which anesthetizes the L1-L5 lumbar nerve roots1. While the LPB offers analgesia from the associated sensory block, it also blocks motor fibers, leading to lower extremity weakness that could potentially delay the patient's ability to participate in early physical therapy and may thereby delay discharge. In the past several years, newer regional anesthesia block approaches have been described and investigated in an attempt to provide patients with postoperative analgesia while avoiding associated muscle weakness, facilitating earlier physical therapy participation and discharge. One such nerve block is the peri-capsular nerve group (PENG) block, which anesthetizes the articular branches of the femoral, obturator, and accessory obturator nerves providing sensory innervation to the hip joint capsule without consistently causing lower extremity weakness2. Some institutions are utilizing the PENG block to provide postoperative analgesia and facilitate early mobilization. There are currently no prospective studies that directly compare the efficacy of LPB to PENG block for providing postoperative analgesia after THA.

Arms: arm 1: Those subjects assigned to the PENG treatment arm will receive a PENG block using 20mL of 0.2% ropivacaine with 1:400,000 epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot. arm 2: Those subjects assigned to the LPB treatment arm will receive a stimulation-based LPB dosed with 20cc of 0.2% ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Interventions: intervention 1: Peri-capsular Nerve Group (PENG) intervention 2: Lumbar Plexus Block (LPB)
Intervention descriptions: intervention 1: PENG block for postoperative pain management intervention 2: LPB for postoperative pain management

Protocol documents:
Prot_SAP_001.pdf: 
Ver 11/17/2023 
 pg. 1 
Short Title 
PENG Block versus LP Block for Postoperative Analgesia after Anterior Total Hip Arthroplasty 
 
Full Title 
Peri-capsular Nerve Group Block versus Lumbar Plexus Block for Postoperative Analgesia after 
Primary Anterior Approach Total Hip Arthroplasty 
 
Principal Investigators 
Daryl S. Henshaw, MD, MBA 
 
Sponsor or Funding Source 
Departmental funding 
 
Summary/Purpose/Rationale 
Regional anesthesia procedures represent a common modality for postoperative analgesia after 
total hip arthroplasty surgeries (THA). The standard practice at our institution for many years has 
been the Lumbar Plexus block (LPB), which anesthetizes the L1-L5 lumbar nerve roots1. While 
the LPB offers analgesia from the associated sensory block, it also blocks motor fibers, leading 
to lower extremity weakness that could potentially delay the patient’s ability to participate in 
early physical therapy and may thereby delay discharge. In the past several years, newer regional 
anesthesia block approaches have been described and investigated in an attempt to provide 
patients with postoperative analgesia while avoiding associated muscle weakness, facilitating 
earlier physical therapy participation and discharge. One such nerve block is the peri-capsular 
nerve group (PENG) block, which anesthetizes the articular branches of the femoral, obturator, 
and accessory obturator nerves providing sensory innervation to the hip joint capsule without 
consistently causing lower extremity weakness2. While we continue to perform LPB for 
postoperative analgesia after THA at our institution, some institutions are utilizing the PENG 
block to provide postoperative analgesia and facilitate early mobilization. There are currently no 
prospective studies that directly compare the efficacy of LPB to PENG block for providing 
postoperative analgesia after THA. 
 
Objectives 
The purpose of this randomized, double blinded, prospective study is to compare the 
postoperative analgesia provided by the PENG block to that provided by the LPB for patients 
undergoing primary anterior approach THA. We hypothesize that the PENG block will provide 
equivalent analgesia to LPB after THA. The primary outcome will be a comparison of patient-
reported numeric rating scale (NRS) pain scores with movement at six hours following block 
placement. Equivalency will be defined as a difference of less than one point in either direction 
on the eleven-point NRS pain scale (0-10). Secondary outcomes will include NRS pain scores 
with movement at 12, 18, and 24 hours, NRS pain scores at rest at 6, 12, 18, and 24 hours, time 
to first opioid administration, cumulative dose of postoperative opioid administration within the 
first 24 hours, motor strength at six hours after block placement as assessed by straight leg raise 
on a six-point scale (0-5)3, and distance walked at first postoperative physical therapy session.  
The 18 hour assessment for pain at rest and with movement is allowed to be done retrospectively 
at the time of the 24 hour assessment, as this time point would end up interrupting the sleep of 
the study subject as would be occurring in the early morning hours.  If the subject reports asleep 


Ver 11/17/2023 
 pg. 2 
at the 18 hour scheduled time point, the no pain score will be obtained.  This will be considered a 
missing data point and not a deviation. If the subject reports they were awake at the 18 hour time 
point, then a pain score at rest will be obtained but if the subject reports no movement, this score 
will be a missing data point and not a deviation. 
 
 
Methods/Measurements 
 
Design 
This will be a randomized, double blinded, equivalency trial that will take place after approval 
from our Institutional Review Board. Written informed consent will be obtained from all study 
participants prior to randomization. The trial will be registered on clinicaltrials.gov before any 
enrollment begins. 
 
Selection Criteria 
Inclusion: Adults between 18 and 90 years of age undergoing elective primary total hip 
arthroplasty surgery by an anterior approach at Atrium Health Wake Forest Baptist Davie 
Medical Center, and who have consented to and lack any contraindications to either LPB or 
PENG block for postoperative analgesia will be recruited for participation in the study. 
 
Exclusion: Patients with any contraindications to regional anesthesia, such as history of allergy 
to amide local anesthetics, pre-existing coagulopathy or thrombocytopenia (less than 100,000 per 
microliter), refusal to either analgesic block, presence of a progressive lower extremity 
neurological deficit, localized or systemic infection, chronic use of high dose opioid analgesics 
(defined at daily use greater than 60mg oxycodone equivalents), as well as those who are 
pregnant, will be excluded from participation. A diagnosis of multiple sclerosis and Parkinson’s 
disease will also exclude potential study subjects.  Any patients who refuse enrollment or 
withdraw their consent will be excluded and any of their information already collected will be 
destroyed. 
 
Setting 
Patients between 18 and 90 years of age, scheduled to undergo elective, primary total hip 
arthroplasty surgery at Davie Medical Center performed by the two orthopedic surgeons who 
perform THA by an anterior approach at our institution, will be identified for eligibility. These 
patients will be seen in the preoperative assessment clinic per our standard protocol prior to their 
surgery date, at which time the study will be discussed with all eligible patients, and they will be 
offered the ability to enroll in the study. Written informed consent will either be obtained during 
this visit, or the patient will be allowed to take the consent form home with them to discuss with 
their family and consider participation, and written informed consent can be finalized on the day 
of surgery. 
 
 
Study Protocol 
 
Baseline data collection 


Ver 11/17/2023 
 pg. 3 
Upon arrival and check-in to the regional anesthesia area of surgical services at Davie Medical 
Center on the day of surgery, enrolled patients will be asked to rate their baseline verbal pain 
score both at rest and with movement on the eleven-point NRS pain scale (0-10, where 0 
represents no pain and 10 represents the worst imaginable pain). Patient characteristics will be 
recorded, including age, gender, height, weight, BMI, surgeon, and operative side, as well as 
preoperative opioid use and doses. Baseline motor function will be assessed by straight leg raise 
on the surgical side to resistance and measured on the six-point Medical Research Council 
(MRC) scale (0-5, where 0 represents no voluntary contraction possible, 1 represents muscle 
flicker without movement of limb, 2 represents active movement only with gravity eliminated, 3 
represents movement against gravity but without resistance, 4 represents movement possible 
against some resistance, and 5 represents normal motor strength against resistance)3. 
 
Two phone numbers will be obtained from the patient, if the patient consents, for contact after 
discharge. Each patient will also be provided with a pain journal with which to document pain 
scores for any remaining time points after discharge, in case they are not available by phone at 
the time points of interest. All patients will still be admitted at the six hour mark, for collection 
of the primary endpoint of NRS pain with movement, as well as motor strength at six hours after 
block placement. 
 
Randomization 
Prior to beginning any regional anesthesia procedures, each patient will be randomized to one of 
the aforementioned treatment arms consisting of LPB or PENG block by research personnel 
and/or the attending anesthesiologist in charge of the patient’s care. Randomization will occur in 
blocks of sequentially numbered opaque envelopes. Patients will be blinded to their treatment 
arm assignment, as will all research personnel who collect outcome data. Patient blinding will 
occur through the use of a sham block procedure as detailed below. 
 
Interventions 
Once randomization occurs, standard American Society of Anesthesiology (ASA) monitors and 
supplemental oxygen will be applied to the patient, and a timeout procedure will be conducted to 
verify all patient data and paperwork are correct. Unless the patient has a contraindication, each 
patient will also receive a weight-appropriate dose of acetaminophen and celecoxib, or 
meloxicam (if the patient has an allergy to sulfonamide medications or to celecoxib) at this time.  
 
All blocks will be performed by an experienced faculty anesthesiologist well versed in the 
performance of LPB and PENG blocks, or by a regional anesthesia fellow directly supervised by 
a regional anesthesia specialized faculty anesthesiologist. Sedation for block placement will be 
administered using midazolam and fentanyl titrated to patient comfort, at the discretion of the 
attending anesthesiologist performing or supervising the regional anesthesia procedures. All 
subjects will start in the supine position, and their relevant anatomy for PENG block will be 
imaged using an ultrasound as described previously2, after skin preparation with chlorhexidine 
solution. All subjects will then receive a skin wheal using 1mL of 1% lidocaine at the skin entry 
site for a typical PENG block. Those subjects assigned to the PENG treatment arm will 
subsequently receive a PENG block using 20mL of 0.2% ropivacaine with 1:400,000 
epinephrine dosed in 5mL increments with negative aspiration beforehand and between each 
aliquot. All subjects will then be transitioned to lateral decubitus positioning with the surgical 


Ver 11/17/2023 
 pg. 4 
side up (standard at our institution, as we use an isobaric spinal solution). Using a skin marker, 
midline will be marked on their lumbar spine at the level of the iliac crests, and a point two thirds 
the distance between midline and the posterior superior iliac spine on the surgical side will be 
marked1. Following this, their lower back areas will be prepared with antiseptic solution and 
draped in sterile fashion. All subjects will then receive a skin wheal with 1cc of 1% lidocaine at 
the standard LPB block site just marked as described above. Those subjects assigned to the LPB 
treatment arm will subsequently receive a stimulation-based LPB dosed with 20cc of 0.2% 
ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative 
aspiration beforehand and between each aliquot. The PENG block site skin wheal will behave as 
a sham block for subjects enrolled in the LPB arm, and the LPB block site skin wheal will 
behave as a sham block for those enrolled in the PENG arm. 
 
All patients will then receive a spinal block as the primary anesthetic using 3.5mL of 0.5% 
ropivacaine with 10mcg fentanyl. Following placement of the spinal block, the patients will be 
brought to the operating room and receive our standard intraoperative protocol of propofol 
infusion for sedation, along with dexamethasone 10mg IV, ondansetron 4mg IV, surgical 
antibiotic prophylaxis as appropriate, and IV tranexamic acid 1g at both capsule opening and 
capsule closure. Any patients whose spinal block are determined to have failed, as checked prior 
to initiation of propofol sedation and surgical skin preparation with a pinch test on the surgical 
lower extremity, will be induced under general anesthesia using propofol with placement of a 
laryngeal mask airway or endotracheal tube at the discretion of the attending anesthesiologist. 
 
Materials 
Ultrasound guidance for imaging the relevant anatomy for the PENG block will be obtained 
using curvilinear probe and a sterile probe cover. An insulated, stimulating block needle be used 
to perform the PENG blocks for subjects enrolled in the PENG treatment arm, as well as for the 
LPB for subjects enrolled in the LPB treatment arm. The entire lower back area will be prepped 
in sterile fashion prior to LPB and spinal block placement. All products and medications used are 
FDA approved for the abovementioned procedures. 
 
Measurements 
Following the completion of surgery, all subjects will be brought to the post-anesthesia care unit 
(PACU) for recovery, where they will recover until satisfactory resolution of spinal block as 
judged by an attending anesthesiologist is shown. Subjects will then be transported to an 
inpatient room, where nurses will monitor their vital signs and pain scores regularly. Subjects 
will receive standard of care pain medications for postoperative pain management as indicated.  
Subjects will continue to receive scheduled acetaminophen 1000mg every six hours (or 15mg/kg 
if their weight is below 65kg), and the NSAID administered preoperatively (either celecoxib 
200mg twice daily or meloxicam 15mg once daily) barring any contraindication such as renal 
impairment or vascular disease.  Oxycodone every four hours may also be administered as 
needed with dose ranges determined by the Davie Medical Center perioperative surgical home 
anesthesiologist consulted for postoperative care, or another narcotic at equipotent dosages if 
they have a contraindication to oxycodone.  Alternatively, they may receive combination 
products such as Percocet (oxycodone/acetaminophen) or Vicodin/Norco 
(hydrocodone/acetaminophen) instead, with the acetaminophen dosage adjusted accordingly.  All 


Ver 11/17/2023 
 pg. 5 
opioids will be converted to oxycodone equivalents to allow for appropriate comparison using a 
widely available dose conversion table4.  
 
Nurses will chart vital signs and medication administration in the electronic medical record 
(EMR) as per our standard protocol. Research personnel will measure patient-reported NRS pain 
scores at rest and with movement for each time by patient interaction, either face to face, or by 
calling the patient’s room or phone numbers. This will include the primary outcome of patient-
rated pain with movement of the surgical extremity on the NRS pain scale at six hours after 
block placement (roughly correlating to two hours after arrival to their room) as well as 
secondary outcomes that include but are not limited to pain at rest and with movement at 12, 18, 
and 24 hours following block placement, and strength to straight leg raise at six hours post-block 
placement. The cumulative 24 hour opioid consumption will be abstracted from the EMR for 
doses received while admitted, and documented by the patient in their pain journal and 
abstracted via phone call after their discharge, if this occurs prior to 24 hours after the block. 
Physical therapists will also document their encounters in the EMR, including but not limited to 
the secondary outcome of distance ambulated during their first session in feet. These metrics will 
be accessed, abstracted, de-identified, and analyzed by research personnel who are blinded to 
group allocation. 
 
 
Statistical Analysis 
 
Power Analysis 
We define an equivalent mean pain score to be a margin of one point in either direction on the 
eleven-point NRS scale. Based on retrospective quality improvement data at our institution, the 
patient-reported surgical site pain on the eleven point NRS scale following THA in patients who 
received a preoperative LPB at Davie Medical Center had a mean of 4.8 and standard deviation 
of 2.0. Using these values, and setting the significance level to 0.05 with a power of 80%, we 
calculated the minimum required sample size to be n=69 in the LPB group and n=69 in the 
PENG group to conclude equivalence of movement pain at six hours between the two groups. 
Power was calculated using the R package ‘TOSTER’5. We intend to recruit n=80 patients per 
arm to allow for attrition and dropout. 
 
Data Analysis 
Demographic information will be collected and compared between the groups to verify that 
randomization balanced out important baseline variables between LPB and PENG. For the 
primary outcome of patient-reported pain with movement at six hours after block placement, the 
equivalence hypothesis test of LPB versus PENG groups will be performed using two one-sided 
t-tests. We will also calculate a point and confidence interval estimate of the difference between 
LPB and PENG groups. Secondary outcomes will also be compared using t-tests and confidence 
intervals.  
 
Missing Data Points 
If we find that study participants are missing substantial parts of their sequence of longitudinal 
measurements (6, 12, 18, and 24 hours), we will employ a mixed effects modeling framework 
that allows us to use all available data to test hypotheses about differences between PENG and 


Ver 11/17/2023 
 pg. 6 
LRB at each time point. Models will be implemented using the ‘lme4’ package6 in R statistical 
software7.  
 
 
Human Subjects Protection 
 
Subject Recruitment Methods 
Potential candidates for the study will be identified based on the posting for the surgical 
procedure of elective primary anterior approach total hip arthroplasty. Patients will be 
approached during their preoperative assessment clinic visit for eligibility and told about the 
study in detail, including any known or possible risks, benefits, and alternatives. They will be 
advised there will be no financial incentive to participate   Potential subjects will also be 
recruited over the phone if they are not scheduled for a preoperative evaluation by anesthesia.  
They will be identified by the surgery schedule.  Upon phone discussion they demonstrate 
interest a copy of the IRB approved informed consent form will be mailed to them to allow for 
adequate review of the study prior to the morning of surgery.  . Written informed consent will be 
obtained and scanned into the EMR during that visit, if they consent, or on the day of surgery, if 
they need more time to deliberate on enrolling. Ample opportunity to ask questions will be given 
both during this preoperative visit and on day of surgery. All patients meeting the 
aforementioned eligibility criteria, regardless of gender, age, race, and ASA physical status, will 
be offered to participate.  
 
Informed Consent 
Written informed consent will be obtained from each subject who agrees to enroll, scanned, and 
uploaded into the patient’s EMR for permanent storage. Each patient will have the opportunity at 
any time to decline enrollment, withdraw informed consent, and have their data removed from 
the dataset and destroyed at any point in time. 
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only the requisite information required to assess 
the study outcomes, minimizing the collection of any information that could directly identify 
subjects. Each patient will be assigned a unique study identifier that will appear on the data 
collection form, and any protected health information that may directly identify the patient 
corresponding to the unique study identifier will be kept secure with access limited to designated 
study personnel. Following collection of all data, subject identifying information will be 
destroyed at the earliest opportunity, consistent with data validation and study design, producing 
an anonymous data set for analysis. All patient information collected will be kept confidential 
during recruitment as well as the remainder of the study. All identifying protected health 
information will be de-identified in the electronic database during data collection, which will be 
encrypted and secured in the Atrium Health Wake Forest Baptist private servers and only 
accessible by two-factor authenticated, password-protected computers. Only selected research 
personnel will have access to the dataset. No reference to any individual participant will appear 
in reports, presentations, or publications that may arise from the study. 
 
Data and Safety Monitoring 


Ver 11/17/2023 
 pg. 7 
The principal investigators will be responsible for overall monitoring of the data and safety of 
study participants and will be assisted by other members of the research personnel in the 
identification of any safety concerns.  
 
Reporting of Unanticipated Problems, Adverse Events, or Deviations 
Each participating attending anesthesiologist will report to the principal investigators about any 
protocol violations, unanticipated problems with the protocol, or adverse events, which will 
promptly be reported to the IRB and corresponding government agency, if appropriate. 
 
 
 


Ver 11/17/2023 
 pg. 8 
Resources/Citations 
 
1: Capdevila X, Macaire P, Dadure C, Choquet O, Biboulet P, Ryckwaert Y, D'Athis F. 
Continuous psoas compartment block for postoperative analgesia after total hip arthroplasty: new 
landmarks, technical guidelines, and clinical evaluation. Anesth Analg. 2002 Jun;94(6):1606-13. 
 
2: Girón-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) 
Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. 
 
3: Compston A. Aids to the investigation of peripheral nerve injuries. Medical Research Council: 
Nerve Injuries Research Committee. His Majesty's Stationery Office: 1942; pp. 48 (iii) and 74 
figures and 7 diagrams; with aids to the examination of the peripheral nervous system. By 
Michael O'Brien for the Guarantors of Brain. Saunders Elsevier: 2010; pp. [8] 64 and 94 Figures. 
Brain. 2010 Oct;133(10):2838-44. 
 
4: McPherson, ML. Demystifying Opioid Conversion Calculations: A Guide for Effective 
Dosing. American Society of Health-Systems Pharmacists, Bethesda, MD (2010). 
 
5: Lakens, D.  Equivalence tests: A practical primer for t-tests, correlations, and meta-analyses. 
Social Psychological and Personality Science. 2017;8(4):355-362. 
doi:10.1177/1948550617697177 
 
6: Douglas Bates, Martin Maechler, Ben Bolker, Steve Walker. Fitting linear mixed-effects 
models using lme4. Journal of Statistical Software. 2015;67(1),1-48. doi:10.18637/jss.v067.i01. 
 
7: R Core Team (2020). R: A language and environment for statistical computing. R Foundation 
for Statistical Computing.Vienna, Austria. URL https://www.R-project.org/ 

ICF_002.pdf: 
Page 1 of 11
Adult Consent Form
PENG versus LPB Total Hip Arthroplasty
Ver 11/21/2022
LUMBAR PLEXUS BLOCK VERSUS PERICAPSULAR NERVE GROUP BLOCK 
FOR PRIMARY ANTERIOR TOTAL HIP ARTHROPLASTY
Informed Consent Form to Participate in Research
Principal Investigator
Rawad Hamzi, MD, MS; Sean Dobson, MD, PhD; Daryl S. Henshaw, MD, MBA
INTRODUCTION
You are invited to be in a research study. The purpose of this study is to compare two different 
types of nerve blocks that help with pain after hip replacement surgery. A nerve block is an 
injection that uses numbing medicine to take away some of the pain from surgery. We perform 
nerve blocks on nearly every person who comes in for a joint replacement surgery. You have 
been invited to be in this study because you have expressed interest in having a nerve block 
placed to help with pain management after your procedure, which is standard practice for the 
surgery you are having. Your participation in this research will involve two assessments and one 
brief questionnaire, and it should last for approximately 24 hours.
Participation in this study will involve randomly being assigned to receive one of two possible 
nerve blocks. Both involve using numbing medications that help to take away some of the pain 
from the surgery for several hours. All research studies involve some risks. One risk of this study 
that you should be aware of is that one of the nerve blocks may not work quite as well as the 
other. However, from what we have seen so far, they both seem to help equally with pain after 
hip surgery. We are using this study to confirm if the two blocks are equivalent.
Your participation in this study is voluntary. You do not have to participate in this study if you 
do not want to. There may be other choices available to you, such as choosing not to get a nerve 
block, or having the standard nerve block we would usually do but choosing not to participate in 
the study. You will not lose any services, benefits, or rights you would normally have if you 
chose not to participate.
The remainder of this form contains a more complete description of this study. Please read this 
description carefully. You can ask any question(s) if you need help deciding whether to join the 
study. The person in charge of this study is Rawad Hamzi, MD. If you have questions, 
suggestions, or concerns regarding this study or you want to withdraw from the study, his contact 
information is:
Rawad Hamzi, MD, MS
Wake Forest Baptist Medical Center
Department of Anesthesiology
Medical Center Boulevard
Winston-Salem, NC 27157
Department/Section of Anesthesiology
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00078699
Meeting Date Approved 9/21/2023          
Version Valid Until: 1/10/2024


Page 2 of 11
Adult Consent Form
PENG versus LPB Total Hip Arthroplasty
Ver 11/21/2022
If you have any questions, suggestions or concerns about your rights as a volunteer in this 
research, contact the Institutional Review Board at 336-716-4542 or the Research Subject 
Advocate at Wake Forest at 336-716-8372.
WHY IS THIS STUDY BEING DONE?
The purpose of this research study is to compare two different nerve blocks, which are simply 
numbing shots that help reduce the amount of pain following surgery. These two different nerve 
blocks are called Lumbar Plexus Block (LPB) and Pericapsular Nerve Group Block (PENG). We 
believe that both nerve blocks help reduce pain following your type of surgery to the same 
extent, but we have never before compared them scientifically. The LPB is the type of nerve 
block we have used for years for patients getting their hip replaced, and we have demonstrated it 
is safe and effective for pain control. The PENG block is a newer block that has also been proven 
safe and effective, but we have not directly compared these two blocks for patients getting hip 
replacement surgery. The proposed benefit of the PENG block is that it may not make the hip 
muscles as weak for the duration of the numbness compared to the LPB, which does. The goal of 
this study is to find out of if the pain control from these two blocks is similar.
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
One hundred and sixty patients will be enrolled in the study, all of whom will be having surgery 
at Davie Medical Center.
WHAT IS INVOLVED IN THE STUDY?
We are interested in improving pain relief following total hip replacement surgeries. One method 
for decreasing pain that we typically do is perform a nerve block (numbing shot) that will 
provide some numbness and pain relief in the area of your surgery. We also use a variety of oral 
medications to reduce pain and make it hurt less to move after surgery, which is an important 
part of recovery.
During your preoperative assessment clinic visit, the types of anesthesia and pain control options 
will be explained to you and you will be asked to sign a consent form, as is done with all patients 
presenting for joint replacement surgery. Should you elect to receive a nerve block, you will be 
approached by one of the research members involved in this study to discuss your potential 
participation. On the day of your surgery, you will be taken to a private bay in the preoperative 
holding area where you will meet the nursing staff and physicians responsible for caring for you. 
The types of anesthesia and the plan for a peripheral nerve block that can help provide pain relief 
after surgery will again be discussed with you in case you have further questions. Should you 
agree to participate, you will be asked to sign a consent form if you have not already. At that 
time, you will be randomized to receive either an LPB nerve block (Group 1) or a PENG nerve 
block (Group 2). Randomization means that you will be put into a group by chance, like flipping 
a coin. You will have an equal chance of being placed in either group, and your treatment team 
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00078699
Meeting Date Approved 9/21/2023          
Version Valid Until: 1/10/2024


Page 3 of 11
Adult Consent Form
PENG versus LPB Total Hip Arthroplasty
Ver 11/21/2022
will not select the group. You will also be asked questions about your pain before surgery and 
have your leg strength briefly measured by having you lift the leg on which you are having 
surgery. 
This study is comparing two methods for treating pain from your surgery. It is possible that one 
treatment group may have a better response than the other. Therefore, there is a risk that you may 
be assigned to a group that does not perform as well as its comparison. Neither you nor the 
researchers you see you following surgery will know which treatment you are receiving. This is 
so a fair evaluation of results can be made. This information is available to the researchers if 
needed in an emergency, however. 
After your group has been determined, you will receive a typical regional anesthetic, which is 
described below.
WHAT WILL BE THE PROCESS FOR THE NERVE BLOCKS?
Once it has been determined that it is an appropriate time to proceed with your nerve block, 
monitors will be applied to watch your vital signs throughout the procedure. A safety check will 
be performed to confirm that you are scheduled for the appropriate surgery, on the correct side, 
that all paperwork confirms these details, and that all of your pertinent history has been reviewed 
and does not contain any reason you should not have your surgical procedure. You will then 
receive sedation medications through your IV to relax and make you comfortable for the 
procedure. These medications will likely make you drift into a nap, or they may just make you 
very relaxed for the duration of the nerve block procedures. The next steps depend on which 
group you are assigned, but are very similar:
Group 1 (Lumbar Plexus Block group)
Once you are comfortable and sedated, we will use an ultrasound machine to look at the location 
where we would normally perform the PENG block on the front of your hip, and you will receive 
a small injection of numbing medicine at this site just under the skin. This small numbing 
injection for the skin is what we normally do before nerve blocks, to decrease the discomfort of 
the nerve block needle. This will be a “sham” block, meaning a numbing injection to make it 
unclear if you had a nerve block at this site. We will then turn you onto your side and place a 
small numbing injection just under the skin on the back where we would normally perform the 
LP block. You will then receive an LP block, which would involve us injecting numbing 
medicine near the nerves going to the hip joint and leg from the back. 
Group 2 (Pericapsular Nerve Group Block group)
Once you are comfortable and sedated, we will use an ultrasound machine to look at the location 
where we would normally perform the PENG block on the front of your hip, and you will receive 
a small injection of numbing medicine at this site just under the skin. This small numbing 
injection for the skin is what we normally do before nerve blocks, to decrease the discomfort of 
the nerve block needle. You will then receive a PENG block, which would involve us injecting 
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00078699
Meeting Date Approved 9/21/2023          
Version Valid Until: 1/10/2024


Page 4 of 11
Adult Consent Form
PENG versus LPB Total Hip Arthroplasty
Ver 11/21/2022
numbing medicine near the nerves going to the hip joint from the front. We will then turn you 
onto your side and place a small numbing injection just under the skin on the back where we 
would normally perform the LP block. This will be a “sham” block, meaning a numbing 
injection to make it unclear if you had a nerve block at this site.
The reason for both groups getting the small numbing injections to numb the skin at both block 
sites, even though you will only receive one of the actual nerve blocks, is to “blind” you and the 
researchers. In other words, we keep you “blinded” to make it unclear which group you were 
randomized to, so that the knowledge of which group you are in does not affect your perception 
of pain or strength and does not affect the measurement of these outcomes by the research staff. 
Our experience has been that either of these blocks will provide you with improved pain relief 
after surgery as compared to doing nothing. 
After you receive the nerve block, if the plan was for you to receive a spinal block for the 
anesthesia, which is our typical plan for nearly all patients getting joint replacements, you will 
have a spinal placed by the anesthesiologist with you still sedated. Because of the sedation, you 
may not be fully aware of these procedures and will likely be napping during them. The goal is 
to keep you comfortable and safe throughout these procedures and the surgery.
After completion of your numbing injections, you will meet the members of the operating room 
(OR) team who will be responsible for caring for you during the surgical procedure itself. 
After the surgery, you will be taken to the post anesthesia care unit (PACU) for continued 
monitoring while you continue to recover from the effects of anesthesia. Once you are awake 
enough and comfortable, you will be discharged from the PACU to your hospital room. You will 
have a nursing team that will take care of you in your room and get medications for you as 
needed. Research staff will follow up with you six hours after the placement of the nerve block 
to ask specific questions about your pain and measure your strength. We will also obtain phone 
numbers where we can call you in case you are sent home on the day of surgery, which is a 
decision that will be made by your surgery team and you. We will call you 24 hours after your 
surgery to ask you specific questions regarding your pain and recovery.
We will save images from the ultrasound to your electronic medical record. This is done to 
document our use of Ultrasound and the images obtained for safety and billing. The images will 
show a portion of your hip joint bone from the inside. You can choose to withdraw your consent 
to use and disclose the ultrasound pictures. You should also understand that you will not be able 
to inspect, review, or approve the images (including articles containing them) before they are 
used in this study.
At any point during this study, including before the surgery and afterwards, you may decide to 
withdraw your consent and not be included in the study, and any information we have collected 
about you will be destroyed. Your decision to not participate in the study or changing your mind 
to no longer participate will not affect your care or the treatment options available to you. With 
this informed consent, you agree that we may use the ultrasound images collected during the 
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00078699
Meeting Date Approved 9/21/2023          
Version Valid Until: 1/10/2024


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Adult Consent Form
PENG versus LPB Total Hip Arthroplasty
Ver 11/21/2022
study to present results from this study, although they will not have any data that would identify 
you. 
You may also decide to allow these ultrasound images to be used in future studies as long as they 
are kept secure, but you will not be able to inspect, review, or approve their future use, if they are 
used. These images will be de-identified and not be able to be traced to you. You may instead 
decide to request these ultrasound images be destroyed at the end of the study, although this 
consent form allows us to use them for presentation of data and results from this study.
Please choose one of the following regarding the use and disclosure of the images/photograph 
used in this research study:
_____ I would like the ultrasound images of me to be destroyed once their use in this study is 
finished.
_____ The ultrasound images of me can be kept for use in future studies provided they are kept 
secure, and any future study will be reviewed by an IRB. I understand that I will not be able to 
inspect, review or approve their future use.
HOW LONG WILL I BE IN THE STUDY?
Your involvement in the study will last about 24 hours. If you experience any side effects from 
the numbing such as prolonged tingling or pain, which are very rare, follow up will be provided 
to you.
You can stop participating at any time. If you decide to stop participating in the study, we 
encourage you to talk to the investigators or study staff first to learn about any potential health or 
safety consequences.
WHAT ARE THE RISKS OF THE STUDY?
Being in this study involves some risk to you. You should discuss the risk of being in this study 
with the study staff. Risks and side effects related to performing nerve blocks like the LPB or 
PENG blocks used in this study include the following.
As with any procedure that requires placing a needle through the skin, there is a risk of bleeding, 
bruising, and infection. When we perform nerve blocks, we meticulously clean your skin with an 
antiseptic solution, wear sterile surgical gloves, utilize sterile ultrasound probe covers and 
diligently maintain sterility throughout the procedure. Infection would be considered a rare risk. 
Bleeding and bruising can occur, but usually are of no clinical significance unless you are 
currently taking a powerful blood thinning medication. You may note some tenderness at the 
injection site, but the discomfort should be minimal, especially when compared to the amount of 
pain you would have otherwise experienced at your surgical site without a nerve block
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00078699
Meeting Date Approved 9/21/2023          
Version Valid Until: 1/10/2024


Page 6 of 11
Adult Consent Form
PENG versus LPB Total Hip Arthroplasty
Ver 11/21/2022
There is also a very rare risk of nerve injury. Symptoms of this include numbness, tingling, and 
rarely weakness. When nerve injuries do occur, although extremely rare, the symptoms are 
generally short lived, and often spontaneously resolve over the course of days to weeks. Longer 
durations, measured in months to years, have been reported, but are exceptionally rare.
Both nerve blocks will be performed using the same anesthetic medication at equal doses. This 
medication is called Ropivacaine, and when used appropriately, is very safe. However, in all 
procedures involving this class of medication, which includes medicines like Lidocaine and 
Novocain, toxicity can occur should the medicine be inadvertently administered within a vein or 
artery. To decrease this risk, we use several techniques to determine if this is happening. We add 
a medication called epinephrine, which if administered into your bloodstream will cause an 
almost immediate rise in heart and blood pressure, which we can see on our monitors. We also 
utilize ultrasonography to visualize the location of our needle and the spread of the numbing 
medications. These techniques help to minimize the risks of toxicity. When toxicity does occur, 
it can lead to tingling in the lips or mouth, ringing in the ears, seizures, and in severe cases, 
death. However, the risks of any of these signs of toxicity are rare and we take special measures 
to avoid them. There also may be other side effects that we cannot predict. You should tell the 
research staff about all the medications, vitamins, and supplements you take and any medical 
conditions you have. This may help avoid side effects, interactions, and other risks.
An additional risk to the lumbar plexus block is the risk of the local anesthetic spreading 
inadvertently into the epidural space.  When that occurs, you may potentially notice numbness 
from the waist down (as if having an epidural for your anesthesia) and a very low blood pressure.  
Should this occur you will be treated with the normal medications for your decreased blood 
pressure.  The numbness below the waist will resolve to “normal” sensation within 1-2 hours as 
the numbing medicine wears off.  
With regards to performing nerve blocks, the risk that patients are most concerned about is 
failure. Despite optimal technique, it is possible that you could receive one of the study blocks 
and receive little to no pain relief from it. This would be a risk whether you are enrolled in the 
study or not. In any case of block performance, whether successful or considered a failure, all 
patients, regardless of which group they were randomized to, will have orders for as needed pain 
medications. You will not be left to be in more pain because you decide to participate in this 
study.
In addition, there is always a slight risk in research of a breach of confidentiality. We will do our 
absolute best to always protect your confidential information, and these breaches are extremely 
rare.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
If you agree to take part in this study, there may or may not be direct benefit to you. Specifically, 
there is a chance that the pain control will be better with the block you receive. We hope the 
information learned from this study will benefit other people in the future. The benefits of 
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00078699
Meeting Date Approved 9/21/2023          
Version Valid Until: 1/10/2024


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PENG versus LPB Total Hip Arthroplasty
Ver 11/21/2022
participating in this study may be: that future patients undergoing hip replacement will receive 
the best nerve block to ensure that their post-operative pain is optimally controlled.
It is possible that one type of nerve block is better than the other. However, currently we do not 
know that for sure. Because individuals respond differently to therapy, no one can know in 
advance if either nerve block will be more helpful in your particular case.
WHAT OTHER CHOICES ARE THERE?
You do not have to be in this study to receive treatment. You should talk to your doctor about all 
the choices you have. Instead of being in this study, you have these options:
1. You can elect to avoid a nerve block to help with pain after surgery
2. You can elect to have nerve blocks even if you do not take part in the study.
WHAT ARE THE COSTS?
All study costs, including any study medications and procedures related directly to the study, will 
be paid for by the study. Costs for your regular medical care, which are not related to this study, 
will be your own responsibility.
WILL YOUR RESEARCH RECORDS BE CONFIDENTIAL?
The results of this research study may be presented at scientific or medical meetings or published 
in scientific journals.  Your identity and/or your personal health information will not be disclosed 
unless it is specifically authorized by you, required by law, or necessary to protect the safety of 
yourself or others.  There is always some risk that even de-identified information might be re-
identified. 
Participant information may be provided to Federal and other regulatory agencies as required.  
The Food and Drug Administration (FDA), for example, may inspect research records and learn 
your identity if this study falls within its jurisdiction.
WILL YOU BE PAID FOR PARTICIPATING?
You will receive no payment or other compensation for taking part in this study.
WHAT HAPPENS IF YOU EXPERIENCE AN INJURY OR ILLNESS AS A 
RESULT OF PARTICIPATING IN THIS STUDY?
Should you experience a physical injury or illness as a direct result of your participation in this 
study, Wake Forest University School of Medicine maintains limited research insurance 
coverage for the usual and customary medical fees for reasonable and necessary treatment of 
such injuries or illnesses. To the extent research insurance coverage is available under this policy 
the reasonable costs of these necessary medical services will be paid, up to a maximum of 
$25,000. Wake Forest University Baptist Medical Center holds the insurance policy for this 
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00078699
Meeting Date Approved 9/21/2023          
Version Valid Until: 1/10/2024


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PENG versus LPB Total Hip Arthroplasty
Ver 11/21/2022
coverage. It provides a maximum of $25,000 coverage for each claim and is limited to a total of 
$250,000 for all claims in any one year. The Wake Forest University School of Medicine, and 
the North Carolina Baptist Hospitals, Incorporated do not assume responsibility to pay for these
medical services or to provide any other compensation for such injury or illness. Additional 
information may be obtained from the Medical Center’s Director of Risk and Insurance 
Management, at (336) 716-3467.
If you are injured, the insurer may require information such as your name, social security 
number, and date of birth in order to pay for your care. This is because the insurer is required by 
law to report any payments made to cover the care of any persons who are members of a 
government insurance plan to the Department of Health and Human Services.
You do not give up any legal rights as a research participant by signing this consent form. For 
more information on medical treatment for research related injuries or to report a study related 
illness, adverse event, or injury you should call Rawad Hamzi, M.D. at 336-716-4498 during 
normal business hours (7am until 4pm) or after hours call the hospital operator at 336-716-2011 
and ask for the acute pain management team.
WHAT ABOUT MY HEALTH INFORMATION?
In this research study, any information we collect from you or from your medical records about 
your health or behaviors is considered Protected Health Information. The information we will 
collect for this research study includes:
1. Block performed
2. Pain scores at rest and with activity at 6, 12, 18, and 24 hours.  You will not be contacted 
between the hours of midnight and 0700 if the 12 and 18 hour assessments fall within that time 
frame.  
3. Opioid pain medication use for the first 24 hours after placement of your block
4. Strength with raising your leg
5. Any reported opioid side effects (nausea, vomiting, itching)
6. Patient satisfaction questionnaire
7. Distance walked at first physical therapy session after surgery
8. Name
9. Weight
10. Height
11. Sex
12. Medical record number
13. Date of birth
14. Address
If this research study involves the diagnosis or treatment of a medical condition, then Protected 
Health Information collected from you during this study may be placed in your medical record, 
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00078699
Meeting Date Approved 9/21/2023          
Version Valid Until: 1/10/2024


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Adult Consent Form
PENG versus LPB Total Hip Arthroplasty
Ver 11/21/2022
and may be used to help treat you, arrange payment for your care, or assist with Medical Center 
operations.
We will make every effort to keep your Protected Health Information private. We will store 
records of your Protected Health Information in a cabinet in a locked office or on a password 
protected computer. 
Your personal health information and information that identifies you (“your health information”) 
may be given to research personnel during and after the study. This is for reasons such as to 
carry out the study, to determine the results of the study, to make sure the study is being done 
correctly, to provide required reports and to get approval for new products.
Some of the people, agencies, and businesses that may receive and use your health information 
are the research sponsor; representatives of the sponsor assisting with the research; investigators 
at other sites who are assisting with the research; central laboratories, reading centers or analysis 
centers; the Institutional Review Board (IRB); representatives of Wake Forest University Health 
Sciences and North Carolina Baptist Hospital; representatives from government agencies such as 
the Food and Drug Administration (FDA); the Department of Health and Human Services 
(DHHS); and similar agencies in other countries.
Monitors, auditors, and the IRB or other regulatory agencies will be granted direct access to the 
participant’s original medical record for verification of clinical trial procedures or data, without 
violating confidentiality of the participant and to the extent permitted by other applicable laws.
Additionally, the following people or organizations will be granted access to your Protected 
Health Information:
1. The study investigator and his/her staff, or others at Wake Forest University Health
Sciences who oversee research
2. Other people or laboratories providing services for the research project on behalf of
Wake Forest University Health Sciences and Wake Forest University Baptist Medical
Center
3. The Regional Anesthesia and Acute Pain Management service team that helps to
manage your pain should you stay in the hospital
If required by law or court order, we might also have to share your Protected Health Information 
with a judge, law enforcement officer, government agencies, or others. If your Protected Health 
Information is shared with any of these groups, it may no longer be protected by federal or state 
privacy rules.
Any Protected Health Information collected from you in this study will be maintained in the 
research records. Any research information entered into your medical record will be kept for as 
long as your medical record is kept by the Medical Center. You will not be able to obtain a copy 
of your Protected Health Information in the research records until all activities in the study are 
completely finished.
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00078699
Meeting Date Approved 9/21/2023          
Version Valid Until: 1/10/2024


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PENG versus LPB Total Hip Arthroplasty
Ver 11/21/2022
You can tell Rawad Hamzi, MD that you want to take away your permission to use and share 
your Protected Health Information at any time by sending a letter to this address:
Rawad Hamzi, MD, MS
Wake Forest Baptist Medical Center
Department of Anesthesiology
Medical Center Boulevard
Winston-Salem, NC 27157
However, if you take away permission to use your Protected Health Information you will not be 
able to be in the study any longer. We will stop collecting any more information about you, but 
any information we have already collected can still be used for the purposes of the research 
study.
By signing this form, you give us permission to use your Protected Health Information for this 
study.
If you choose to participate in this study, your medical record at Wake Forest University Baptist 
Medical Center will indicate that you are enrolled in a clinical trial. Information about the 
research and any medications or devices you are being given as a participant may also be 
included in your medical record. This part of the medical record will only be available to people 
who have authorized access to your medical record. If you are not a patient at this Medical 
Center, a medical record will be created for you anyway to ensure that this important information 
is available to doctors in case of an emergency.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This website will not include information that can identify you. At most, the 
website will include a summary of the results. You can search this Web site at any time.
WHAT ARE MY RIGHTS AS A RESEARCH STUDY PARTICIPANT?
Taking part in this study is voluntary. You may choose not to take part or you may leave the 
study at any time. Refusing to participate or leaving the study will not result in any penalty or 
loss of benefits to which you are entitled. If you decide to stop participating in the study, we 
encourage you to talk to the investigators or study staff first to learn about any potential health or 
safety consequences. The investigators also have the right to stop your participation in the study 
at any time. This could be because new information became available, the entire study has been 
stopped, or you have an unexpected reaction.
You will be given any new information we become aware of that would affect your willingness 
to continue to participate in the study.
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00078699
Meeting Date Approved 9/21/2023          
Version Valid Until: 1/10/2024


Page 11 of 11
Adult Consent Form
PENG versus LPB Total Hip Arthroplasty
Ver 11/21/2022
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
For questions about the study or in the event of a research-related injury, contact the study 
investigator, Rawad Hamzi, MD at 336-716-4498 during normal business hours (7am until 4pm) 
or after hours call hospital operator at 336-716-2011 and ask for the acute pain management 
team. 
The Institutional Review Board (IRB) is a group of people who review the research to protect 
your rights. If you have a question about your rights as a research participant, or you would like 
to discuss problems or concerns, have questions or want to offer input, or you want to obtain 
additional information, you should contact the Chairman of the IRB at (336) 716-4542 or the 
Research Subject Advocate at (336) 716-8372.
You will be given a copy of this signed consent form. 
SIGNATURES
I agree to take part in this study. I authorize the use and disclosure of my health information as 
described in this consent and authorization form.  If I have not already received a copy of the 
Privacy Notice, I may request one or one will be made available to me.  I have had a chance to 
ask questions about being in this study and have those questions answered.   By signing this 
consent and authorization form, I am not releasing or agreeing to release the investigator, the 
sponsor, the institution or its agents from liability for negligence.
Subject Name (Printed):_____________________________
Subject Signature: _________________________________ Date: ________Time:_______ am pm 
Person Obtaining Consent (Printed):_____________________________
Person Obtaining Consent:___________________________ Date:_________ Time:________ am pm
WFU School of Medicine 
Institutional Review Board 
IRB Number: IRB00078699
Meeting Date Approved 9/21/2023          
Version Valid Until: 1/10/2024