Conditions: Osteoarthritis Arthroplasty
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 100
Healthy volunteers: no

Brief summary:
The primary objective of this study is to examine whether there is a difference in the level of resting pain following total hip arthroplasty with an anterior approach with use of a psoas compartment block versus a local periarticular anesthetic infiltration

Detailed description:
A single-center, prospective, randomized clinical trial with a total of 100 patients. One orthopaedic adult reconstruction surgeon at Beaumont Hospital Royal Oak (JJV) will perform all surgeries. After the patient has consented they will be randomized to one of the following two groups:

1. Psoas compartment block (n=50)
2. Periarticular local anesthetic infiltration (n=50),

The patient will be blinded to the study group.

Arms:
arm 1: After exposure anesthetic (Ropivacaine with NaCl) is introduced directly into the iliopsoas muscle, where it then spreads to the lumbar plexus (the nerves responsible for sensation around the surgical site). arm 2: An anesthetic "cocktail" of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues.

Interventions: intervention 1: Ropivacaine with NaCl intervention 2: Epinephrine intervention 3: Morphine intervention 4: Ketorolac Tromethamine intervention 5: Ropivacaine
Intervention descriptions: intervention 1: 50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment intervention 2: 0.15 mg Epinephrine are injected as part of the drug "cocktail" intervention 3: 4 mg Morphine are injected as part of the drug "cocktail" intervention 4: 30 mg morphine are injected as part of the drug "cocktail" intervention 5: 30 mL 0.5% Ropivicaine are injected as part of the drug "cocktail"

Protocol document:
Prot_SAP_001.pdf: 
Protocol version 10.24.2016 
Page 1 of 12 
 
PSOAS COMPARTMENT BLOCK VERSUS PERIARTICULAR LOCAL 
ANESTHETIC INFILTRATION FOR PAIN MANAGEMENT FOR TOTAL 
HIP ARTHROPLASTY: A PROSPECTIVE, RANDOMIZED STUDY 
Orthopaedic Surgery 
Beaumont Health System 
October 24, 2016 
 
 


Protocol version 10.24.2016 
Page 2 of 12 
 
Table of Contents 
1.0 BACKGROUND AND SIGNIFICANCE ............................................................................................ 3 
2.0 OBJECTIVE .......................................................................................................................................... 3 
3.0 HYPOTHESIS ...................................................................................................................................... 3 
4.0 RESEARCH DESIGN AND METHODOLOGY ............................................................................... 4 
4.1 Inclusion Criteria .............................................................................................................................. 4 
4.2 Exclusion Criteria ............................................................................................................................. 4 
4.3 Enrollment and Consent ................................................................................................................. 4 
4.4 Randomization ................................................................................................................................. 5 
4.5 Study Procedures/Intervention ...................................................................................................... 5 
4.5.1 Psoas Compartment Block Administration ........................................................................... 5 
4.5.2 Local Anesthetic Infiltration Administration........................................................................... 5 
4.5.3 Postoperative Pain Management Protocol ........................................................................... 6 
4.6 Data Collection ................................................................................................................................. 6 
4.7 Statistical Analyses ......................................................................................................................... 7 
4.7.1 Sample Size .................................................................................................................................. 8 
5.0 RISKS AND BENEFITS ...................................................................................................................... 8 
5.1 Potential Benefits to Subjects ........................................................................................................ 8 
5.2 Potential Risks to Subjects ............................................................................................................. 8 
6.0 DATA SAFETY MONITORING AND ADVERSE EVENTS ........................................................... 9 
6.1 Plan for Monitoring and Safety Review ........................................................................................ 9 
6.2 Risk Monitoring and Adverse Event Reporting ......................................................................... 10 
7.0 REFERENCES ................................................................................................................................... 11 
8.0 APPENDIX I ....................................................................................................................................... 12 
 
 
 


Protocol version 10.24.2016 
Page 3 of 12 
 
1.0 BACKGROUND AND SIGNIFICANCE  
Total hip arthroplasty can be associated with significant pain in the immediate 
postoperative period. In order to mitigate pain and subsequently facilitate patient 
mobilization and recovery, surgeons can use various methods of analgesia. Two current 
techniques are a more novel, psoas compartment block, which is gaining popularity for 
use in total hip arthroplasty with an anterior approach, and a periarticular local anesthetic 
injection. For a psoas compartment block, anesthetic is introduced directly into the 
iliopsoas and spreads to the lumbar plexus. For a periarticular local anesthetic infiltration, 
an anesthetic “cocktail” is injected at multiple spots to the surrounding tissue at the 
surgical site. To date, it is unclear which of these methods provides the best pain relief 
during the immediate postoperative recovery period. 
It is theorized that the surgeon-delivered psoas compartment block can provide better 
and more complete pain relief than the “cocktail” injection since it is a consistent 
technique, and the injection specifically targets nerves that provide the operative area 
with sensation. Comparatively, the “cocktail” injection can be performed relatively 
consistently from one case to the next, but there is less knowledge of where the injectate 
will go and how effectively it will anesthetize the nerves – especially in the subcutaneous 
tissues. 
The proposed study is a prospective, randomized clinical trial comparing patient-reported 
pain following total hip arthroplasty with a psoas compartment block versus a periarticular 
local anesthetic infiltration. 
2.0 OBJECTIVE 
 The primary objective of this study is to examine whether there is a difference in 
the level of resting pain following total hip arthroplasty with use of a psoas 
compartment block versus a periarticular local anesthetic infiltration. 
 The secondary objective is to examine whether there is a difference in the amount 
of in-hospital opioid drug use postoperatively  
3.0 HYPOTHESIS 
 Our hypothesis is that the psoas compartment block will provide better pain relief 
(as measured by resting pain score) than the periarticular local anesthetic 
infiltration postoperatively at one or more of  six specified post-operative times  
 Additionally, we hypothesize less need for in-hospital opioids with a psoas 
compartment block within 24 and 24 to 48 hours postoperatively 


Protocol version 10.24.2016 
Page 4 of 12 
 
4.0 RESEARCH DESIGN AND METHODOLOGY  
We will perform a single-center, prospective, randomized clinical trial with a total of 100 
patients. One orthopaedic adult reconstruction surgeon at Beaumont Hospital Royal Oak 
(JJV) will perform all surgeries. After the patient has consented they will be randomized 
to one of the following two groups:  
 
1.) Psoas compartment block (n=50) 
2.) Periarticular local anesthetic infiltration (n=50), 
 
The patient will be blinded to the study group.  
4.1 Inclusion Criteria 
 Patients undergoing unilateral primary total hip arthroplasty by Dr. James Verner 
at Beaumont Hospital Royal Oak 
 Have a diagnosis of primary osteoarthritis (i.e. degenerative joint disease) 
 Surgical approach is anterior  
4.2 Exclusion Criteria  
 Minors (age less than 18 years) 
 Pregnant (surgically sterile, post-menopausal, or negative blood test)  
 Previous ipsilateral hip surgery  
 Lumbar instrumentation 
 Acute trauma 
 Rheumatoid arthritis  
 Avascular necrosis  
 Hip dysplasia  
 Known sensitivity, allergy, or contraindication to anesthetics being used in the 
study 
 Narcotic sensitivity 
 History of over 6 months of opioid dependency prior to surgery (excluding 
tramadol) 
 Peripheral neuropathy 
 Mental/cognitive impairment that would interfere with the patient’s self-
assessments of function, pain, or quality of life 
4.3 Enrollment and Consent 
Patients scheduled to undergo total hip arthroplasty with Dr. Verner will be screened 
preoperatively for eligibility. Patients will be identified by operative schedules. Patients 
that meet all criteria will be contacted by personnel on the delegation of authority as a 


Protocol version 10.24.2016 
Page 5 of 12 
 
consent provider at least one week in advance of their procedure.  After initial contact, if 
the patient is interested, the research coordinator will offer to email or mail a copy of the 
consent for the patient to review before consent. The patient will be consented prior to 
any study procedure or assessments take place. At the time of consent, the patient will 
have sufficient time to read the consent form and discuss any questions they may have 
with the consent provider. Patients will be allowed to drop out of the study at any time 
before their procedure.  
4.4 Randomization 
The 100 patients in the study will be randomized in a 1:1 ratio to have their procedure 
performed either with a psoas compartment block or with local anesthetic infiltrate. 
Randomization assignments will be contained in sequentially numbered, opaque, sealed 
envelopes, which will be prepared by a statistician in the Research Institute using blocked 
randomization from The SAS System for Windows version 9.3. After the patient is 
consented, the consenter will assign the patient to a group following the treatment listed 
in the envelope and inform the surgeon. Logs will be maintained by consenting personnel 
to ensure the list is being followed and each patient’s group is documented. 
4.5 Study Procedures/Intervention 
4.5.1 Psoas Compartment Block Administration  
Following exposure, the rectus femoris muscles are elevated with a two-prong retractor, 
thus exposing the iliopsoas muscle.  An 18G spinal needle is inserted to a depth of 0.5-
1.0 cm under the fascia at the level of the musculotendinous junction or more proximally, 
and 0.3% ropivicaine in 50 mL are administered into the psoas compartment. The local 
anesthetic travels proximally and anesthetizes a portion of the lumbar plexus specifically 
targeting the obturator, femoral, and lateral femoral cutaneous nerves to provide local 
pain control. 
4.5.2 Local Anesthetic Infiltration Administration 
A combination of medications including 30 mL 0.5% ropivicaine, 0.15 mg epinephrine, 4 
mg morphine, and 30 mg toradol (hereby referred to as “cocktail”) will be diluted with 19 
mL of 0.9% NaCl and will be injected into the tissues surrounding the hip joint in a 
systematic fashion ensuring uniform delivery to all tissues incised and instrumented.  
This cocktail is infiltrated into the periarticular tissues including muscle, joint capsule, 
and subcutaneous tissues at the surgeon’s discretion.  We will use the following 
technique, which will be standardized amongst all patients: joint capsule, rectus femoris 
direct and reflected head, tensor fascia lata, and subcutaneous tissues circumferentially 
every 25 mm. 


Protocol version 10.24.2016 
Page 6 of 12 
 
4.5.3 Postoperative Pain Management Protocol 
All patients will follow Dr. Verner’s standard of care pain management protocol. There 
may be slight differences in the amount of pain medication given to the patients’ intra- 
and postoperatively at the anesthesiologist’s and/or nurse anesthetist’s discretion.  
4.6 Data Collection 
 Primary outcome variable: VAS Pain scores measured at times in Appendix I: 
Table I 
 Secondary outcome variable: Total amount of opioid usage in-hospital  (and with 
24 hours and 24-48 hours postoperatively) 
Demographic and Operative Variables  
 Sex 
 Age 
 Race 
 BMI 
 ASA score 
 Comorbidities, as recorded by anesthesiology 
 Date of Surgery 
 Time of Surgery 
 Laterality (left/right) 
 Operative Time (skin incision to skin close, mins) 
 Estimated Blood Loss (mL) 
 Intraoperative Complications (fracture, bleeding events, etc.) 
 
Outcomes Variables 
 Narcotic Use  (expressed in oral morphine equivalent units)  
 Non-narcotic pain medication usage 
 Major Postoperative Complications (DVT, Falls, Infection, etc.) through first 
postoperative visit 
 Units of blood transfused  
 Complications related to block/anesthetic  
 VAS Resting Pain Scores  
 VAS Ambulating Pain Scores 
 Time of First Physical Therapy Session  
 Length of Hospital Stay (Days) 
 Readiness for discharge (days), requiring the following: 
o A pain score of <4 (numeric rating scale) without non-oral narcotics 


Protocol version 10.24.2016 
Page 7 of 12 
 
o Normal eating 
o Minimal nausea 
o Urination without a catheter 
o A dry surgical wound 
o No acute medical problems 
o The ability to independently transfer and walk 100 feet 
o Stable vitals 
 
Pain will be measured on a numeric Likert scale, rating the pain from 0 (none) to 10 
(maximal). Scores will be collected at 3 hours postoperatively, in the morning and 
afternoon on postoperative day one and two and at the post-operative clinic visit. The 
patient will record their pain on a data collection form that is given to them at each time 
point. Pain will be recorded for when the patient is at rest and when the patient is 
ambulating. On postoperative day one and postoperative day two the patient will be asked 
to fill out the Quality of Recovery Score [Myles] and Opioid-Related Symptom Distress 
Scale [Apfelbaum, Yadeau] (Appendix I: Table I). 
All pain medications will be prescribed per standard of care. Pain medication usage in-
hospital will be recorded from Epic. All opioid consumption will be converted to oral 
morphine equivalents in milligrams. All demographic and operative variables will also be 
collected for each patient from electronic medical records.   
Readiness for discharge will be assessed in both the morning and evening of each 
postoperative day.  
4.7 Statistical Analyses 
A table of descriptive summaries on demographic and operative variables by treatment 
group will be prepared (means and standard deviations if normally distributed, median 
and range if not normally distributed, counts and percentages for categorical variables); 
inference procedures which are consistent with the chosen variable summaries will be 
used to compare treatment groups.   
Before analyzing continuous variables, data sets will be assessed for normality using a 
Shapiro-Wilk Test and equal variance using the Levene-test. For normal data an 
independent Student’s t-test will be used to compare means, and a Mann-Whitney Rank 
Sum Test will be used for data that is not normally distributed. The two treatment groups 
will be compared on categorical variables using the Chi-Square test or a Fisher Exact test 
for low frequency occurrences.  
VAS Pain scores (resting, ambulating) will be compared between groups at each time 
point using a Mann-Whitney Rank Sum test. A Bonferroni correction will be used to 


Protocol version 10.24.2016 
Page 8 of 12 
 
account for repeated measures and control for a Type I error. A p-value below .05/6 = 
.0083 at each individual postoperative time point will be considered statistically significant. 
Opioid usage will be compared for total in-hospital as well as broken down by use a 24 
hours and use from 24-48 hours using the Mann-Whitney Rank Sum test. A p-value below 
.05/3 = .017 at each individual postoperative time point will be considered statistically 
significant. Composite scores and subscores of the Quality of Recovery-40 and Opioid-
related Symptom Distress Scale, as well as the time to readiness for discharge, will be 
compared between groups with the t-test or Mann-Whitney Rank Sum test as appropriate.  
For all other tests which do not include Bonferroni adjustment, a two-sided p-value < 0.05 
will be considered statistically significant. Missing data will be treated as such; there will 
be no imputation. An exploratory subgroup analysis will also be performed, excluding 
patients with longer than 3 day stay or patients that required additional surgical 
intervention. Confidence intervals for the difference in means/medians/odds ratios 
between the two groups will also be calculated where appropriate. Graduate-trained 
engineers will analyze data with SPSS statistical software (SPSS Version 20.0, IBM, Inc).  
4.7.1 Sample Size 
The sample size determination of 50 per group was based on a review of the literature 
and feasibility. Dr. Coffey has provided justification for a lack of sample size analysis 
(see Appendix I).  
5.0 RISKS AND BENEFITS 
5.1 Potential Benefits to Subjects  
Participants enrolled in the study may have better pain relief if they are randomized to the 
psoas compartment block group. However, this has not been proven and patients may 
receive no direct benefit from inclusion in this study. Knowledge gained in this study may 
provide benefit to future patients undergoing total hip arthroplasty with an anterior 
approach if benefits of one technique can be identified.   
5.2 Potential Risks to Subjects 
The risks of participating in this study include the same risks normally associated with hip 
surgery whether the patient is in the study or not. The risks directly related to the 
techniques being studied are as follows:  
 
 
 
Standard of Care Risks  


Protocol version 10.24.2016 
Page 9 of 12 
 
 
Less Frequent (occurring from 1% to 10% of the time): 
 
Low blood pressure 
 
Nausea 
 
Vomiting 
 
Low heart rate 
 
Anxiety 
 
Numbness of skin 
 
Pain 
 
Itching 
 
Fever 
 
Dizziness 
 
Chills 
 
Reduced sensation of your hip area (where the surgery will take place) 
 
Block failure (this is when the block does not work, thus causing pain after surgery) 
 
Rare (occurring less than 1% of the time): 
 
Runny nose  
 
Allergic reaction 
 
Temporary or permanent nerve damage 
 
Infection 
 
Perioperative injury secondary to numbness or weakness, such as falling if trying to    
walk before the block wears off   
 
With any procedure, unusual, unexpected or previously unreported side effects may 
occur.  Risks will be assessed throughout the course of the study.  
There is also a rare risk of breach of confidentiality. Every effort will be made to maintain 
patient privacy, however this cannot be guaranteed.  
6.0 DATA SAFETY MONITORING AND ADVERSE EVENTS 
6.1 Plan for Monitoring and Safety Review 
An internal safety monitoring committee will be assembled. Members of group will include 
a scientific reviewer, two clinicians, and a biostatistician for an independent review of 
adverse event data provided by the investigator. Members invited to participate in the 
group are independent of the study. The scientific reviewer is Tristan Maerz, PhD. The 
clinicians are Randy Fayne, MD, and attending anesthesiologist, and Kelly Pseres, NP 
who works at MOI with adult reconstruction patients. The group will meet twice throughout 
the course of the study to monitor safety, recruitment, subject eligibility, adherence to 
treatment plan, documentation of dropouts and adverse events. The first meeting will be 
after 30 patients have completed the study. The second meeting will be after 75 patients 


Protocol version 10.24.2016 
Page 10 of 12 
 
have completed the study. Enrollment will continue while these meetings are being 
planned and taking place. Members will receive a composite of the collected data 
including complications and adverse events broken down by study group from the study 
investigators to review before the meeting. One member will be responsible for taking 
minutes at the meeting. Reports from all meetings will be presented to the study 
investigators who will be responsible for reporting the data to the HIC. 
6.2 Risk Monitoring and Adverse Event Reporting  
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that 
may appear or worsen in a subject during the course of a study. A serious adverse 
event (SAE) is any AE which: 
o Results in death 
o Is life-threatening (i.e., in the opinion of the investigator the subject is at immediate 
risk of death from the AE) 
o Requires inpatient hospitalization or prolongation of existing hospitalization 
o Results in persistent or significant disability/incapacity (a substantial disruption of 
the subject’s ability to conduct normal life functions) 
o A medical event that may jeopardize the subject or require medical or surgical 
intervention 
 
The severity of adverse events (AEs) will be graded on a scale of 1 to 5 according to the 
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events   
([The NCI Common Terminology Criteria for Adverse Events, Version 4.0 [NCI 
CTCAE]). The PI will determine the relationship between the administration of the block 
and the occurrence of an AE/SAE as unrelated, probably not related, probably related, 
or definitely related. 
The participant will be monitored for risks and AEs in the hospital as standard of care. 
The PI and surgeon co-investigators will be responsible for tracking the occurrence of 
AEs while the patient is in-hospital. After discharge through the first follow-up 
appointment the patient will be monitored for hospital readmissions and asked to notify 
the PI of the occurrence of any AEs. A final assessment of complications and AEs will 
be made at a 3 week follow-up visit in the clinic (Michigan Orthopaedic Institute). 
AEs of grade 4 or 5 will be reported to the HIC within 7 days. They will also be reported 
to the chair of the internal safety monitoring committee within 7 days and he will make a 
recommendation as to whether the study should continue.   


Protocol version 10.24.2016 
Page 11 of 12 
 
7.0 REFERENCES  
 
Apfelbaum JL, Gan TJ, Zhao S, Hanna DB, Chen C. Reliability and validity of the 
perioperative opioid-related symptom distress scale. Anesth Analg. 2004 Sep;99 
(3):699-709, table of contents.  
Busch CA, Whitehouse MR, Shore BJ, McCalden RW, Bourne RB, "The Efficacy of 
Periarticular Multimodal Drug Infiltration in Total Hip Arthroplasty," Clinical Orthopaedics 
and Related Research, vol. 468, no. 8, pp. 2152-59, 2010.  
Green C, Byrne AM, O'Loughlin P, D. Molony D, D. Harmon D, Masterson E, "Surgeon 
Delivered Psoas Compartment Block in Total Hip Arthroplasty," Journal of Arthroplasty, 
vol. 29, pp. 393-6, 2014.  
Green C, Flannery O, Crotty J, Felle P, Masterson E, Harmon D. "A cadaveric study of 
injectate spread in the psoas compartment witha direct iliopsoas injection suggested for 
use during surgery," Clinical Anatomy, vol. 24, no. 6, pp. 763-7, 2011.  
Jiang J, Teng Y, Fan Z, Khan S, Cui Z, Xia Y, "The Efficacy of Periarticular Multimodal 
Drug Injection for Postoperative Pain Management in Total Knee or Hip Arthroplasty," 
Journal of Arthroplasty, vol. 28, no. 10, pp. 1882-7, 2013.  
Maheshwari AV, Blum YC, Shekhar L, Ranawat AS, Ranawat CS, "Multimodal Pain 
Management after Total Hip and Knee Arthroplasty at the Ranawat Orthpaedi Center," 
Journal of Arthroplasty, vol. 467, no. 6, pp. 1418-23, 2009.  
Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a 
postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84 (1):11-
5. 
Stevens M, Harrison G, McGrail M. "A modified fascia iliaca compartment block has 
significant morphine-sparing effect after total hip arthroplasty," Anaesthesia and 
Intensive Care, vol. 35, no. 6, pp. 949-52, 2007.  
Verner J, Fayne R, Soto R, "Surgeon Versus Anesthesiologist Administered Fascia 
Iliaca Block for Anterior Hip Replacement Surgery: a Randomized Prospective Trial," in 
Proceedings of the American Association of Hip and Knee Surgeons, Poster 193, 
Dallas, TX, 2014. 
Yadeau JT, Liu SS, Rade MC, Marcello D, Liguori GA. Performance characteristics and 
validation of the Opioid-Related Symptom Distress Scale for evaluation of analgesic 
side effects after orthopedic 


Protocol version 10.24.2016 
Page 12 of 12 
 
8.0 APPENDIX I 
 
Table I. Schedule of Events 
Study Procedures 
Screening  
 
Surgery 
3 hours 
postop  
POD1 
9 AM 
POD1 
5 PM 
POD2 
9 AM 
POD2 
5 PM 
3 weeks 
postop 
Visit Windows 
-21 to 0 
days 
N/A 
± 1 
hours 
± 2 
hours 
± 3 
hours 
± 2 
hours 
± 3 
hours 
± 1 
week 
Review inclusion and 
exclusion criteria 
X 
 
 
 
 
 
 
 
Informed consent 
review and signature 
 X* 
 
 
 
 
 
 
 
Study Group 
Determination 
(Randomization) 
 X* 
 
 
 
 
 
 
 
Intervention (psoas 
block or periarticular 
injection) 
 
X 
 
 
 
 
 
 
Collect resting pain 
score 
Xa 
 
X 
X 
X 
Xb 
Xb 
X 
Collect pain with 
ambulation 
Xa 
 
 
 Xc 
 Xc 
  Xb,c   Xb,c 
 Xc 
Quality of Recovery-40 
assessment 
 
 
 
X 
 
Xb 
 
 
Opioid-related 
symptom distress scale 
assessment 
 
 
 
X 
 
Xb 
 
 
Assess for adverse 
events 
 
 
X 
X 
X 
  X 
X 
X 
POD = postoperative day 
*Consent will happen before any study procedures or assessment are done and randomization will 
occur at that time 
a. Collected as standard of care in the clinic  
b. If patient has been discharged before this time point assessments will not be collected 
c. If patient is not ambulating they will have the option of selecting ‘N/A’ 
 

ICF_000.pdf: 
HIC # 2015-422 
 
                                        Page 1 of 7    
Version # 01.06.16      
 
 
 
                         
                                           
CONSENT FORM AND AUTHORIZATION FOR DISCLOSURE OF 
PROTECTED HEALTH INFORMATION 
  
STUDY TITLE: PSOAS COMPARTMENT BLOCK VERSUS PERIARTICULAR LOCAL 
ANESTHETIC 
INFILTRATION 
FOR 
PAIN 
MANAGEMENT 
FOR 
TOTAL 
HIP 
ARTHROPLASTY: A PROSPECTIVE, RANDOMIZED STUDY 
 
Principal Investigator:   James Verner, M.D. 
Address:                          
3601 West Thirteen Mile Road, 111 MOB-RO, 
Royal Oak, MI  48073 
Phone Number: 
(248) 663-1900 
 
Hospital:                         
 
William Beaumont Hospital – Royal Oak 
 
 
INTRODUCTION  
Why is this study being done? 
You are being asked to participate in a clinical research study.  The purpose of clinical research 
is to look at the nature of disease and try to develop improved methods to diagnose and treat 
disease. The doctor or clinician in charge of the study believes you meet the initial 
requirements to take part in the study.  Before agreeing to participate, it is important for you 
to read and understand the following explanation of the research procedures.  This Consent 
and Authorization form describes the purpose, procedures, benefits, risks and discomforts of 
the study.  It also describes the alternatives available to you, and your right to withdraw (quit) 
from the study at any time.   
 
Please read this information carefully and ask as many questions as you like before deciding 
whether or not you would like to take part in this research study. 
 
The goal of this study is to compare the effectiveness of pain relief after total hip replacement 
surgery via anterior approach with a psoas compartment block versus a periarticular local 
anesthetic injection. The anterior approach (via the front side of the body) for total hip 
replacement is a tissue-sparing alternative to traditional hip replacement surgery (which uses 
an approach on the back side of the body) that provides the potential for less pain, faster 
recovery and improved mobility. The technique allows the surgeon to work between muscles 
and tissues without detaching them from either the hip or thighbones - sparing the tissue from 
trauma. Despite these advantages, total hip replacement can still be associated with significant 
pain in the immediate postoperative period. Surgeons use various methods intraoperatively to 
alleviate postoperative pain. One technique that is possible with the anterior approach is called 
a psoas compartment block. The psoas is an anterior hip muscle that helps with flexion. With 
an anterior approach, an anesthetic drug can be injected directly into the psoas muscle, where 
it spreads to the nerves responsible for sensation around the surgical site, allowing for pain 
relief. Alternatively, the surgeon can use a periarticular local anesthetic injection. In this 
technique an anesthetic "cocktail" of four drugs is injected to the surrounding tissues at 
several locations at the surgical site. Either of these techniques can be used as standard of 


HIC # 2015-422 
 
                                        Page 2 of 7    
Version # 01.06.16      
 
 
 
                         
                                           
care and the local anesthetics being used are all approved by the United States Food and Drug 
Administration (FDA).  
 
A total of 100 of Dr. Verner’s patients will take part in the study at William Beaumont Hospital 
Royal Oak.  
 
How long will I be in the study? 
If you decide to take part in this study, your participation is expected to last approximately 3 
weeks. To take part you must be undergoing a primary total hip replacement with an anterior 
approach, and be able to comply with the study requirements.  You may not take part in this 
study if you are currently enrolled in another related research study which could alter or 
influence the study results.  
 
DESCRIPTION OF THE STUDY 
What will happen if I take part in the research study? 
You are being asked to take part in this research study because you are undergoing total hip 
arthroplasty with an anterior approach. The results of this study will compare the effectiveness 
of two different techniques for managing postoperative pain.  
 
If you agree to take part in this study you will be randomized (like the flip of a coin) to receive 
either: 
A. An intraoperative psoas compartment block  
B.  An intraoperative periarticular anesthetic injection 
 
You are being invited to participate because you are eligible for the study based on your 
information so far.  None of the information collected so far will be used for research unless 
you agree to participate in this study by signing this Consent and Authorization Form. 
 
If you agree to be in this study and sign and date this Consent and Authorization form, you 
will be asked to do the following things; below is a table describing what will occur during 
participation:  
 
Schedule of Events Table 
 
Preop 
Surgery 
3 hours 
postop 
POD 1 
9 am 
POD 1 
5 pm 
POD 2  
9 am 
POD 2 
5 pm 
3 weeks 
postop 
Window 
-21 to 
0 days 
N/A 
± 1 
hours 
± 2 
hours 
± 3 
hours 
± 2 
hours 
± 3 
hours 
± 1 
week 
Consent review and 
signature 
X 
 
 
 
 
 
 
 
Intervention (psoas 
block or 
periarticular 
injection) 
 
X 
 
 
 
 
 
 
Pain assessment 
X 
 
X 
X 
X 
Xa 
Xa 
X 


HIC # 2015-422 
 
                                        Page 3 of 7    
Version # 01.06.16      
 
 
 
                         
                                           
Quality of recovery 
questionnaire 
 
 
 
X 
 
Xa 
 
 
Opioid-related 
symptom distress 
questionnaire 
 
 
 
X 
 
Xa 
 
 
POD = postoperative day 
a. If you have been discharged before this time point questionnaires will not be collected 
 
After your surgery, you will be asked to report on a sheet of paper your pain scores both while 
resting and while you are up and moving. Additionally, you will be asked to fill out two 
questionnaires on postoperative days one and two to assess how you are reacting to your pain 
medications and how well you are recovering from your surgery.  
 
PARTICIPANT RESPONSIBILITIES  
You will be asked to note any side effects or medical problems you may experience while you 
are taking part in this study.  For any illnesses or injuries, you should contact the study doctor 
immediately at the number listed on this consent form or in an emergency situation call 911 
(or go to the nearest hospital emergency room).    
 
RISKS, SIDE EFFECTS AND DISCOMFORTS 
Ask your physician what the standard of care risks are as well as the study risks. 
What side effects or risks can I expect from being in the study? 
 
Standard of Care Risks: 
 
Less Frequent (occurring from 1% to 10% of the time) 
 Low blood pressure 
 Nausea 
 Vomiting 
 Low heart rate 
 Anxiety 
 Numbness of skin 
 Pain 
 Itching 
 Fever 
 Dizziness 
 Chills 
 Reduced sensation of your hip area (where the surgery will take place) 
 Block failure (this is when the block does not work, thus causing pain after surgery) 
 
Rare (occurring less than 1% of the time) 
 Runny nose  
 Allergic reaction 
 Temporary or permanent nerve damage 
 Infection 


HIC # 2015-422 
 
                                        Page 4 of 7    
Version # 01.06.16      
 
 
 
                         
                                           
 Perioperative injury secondary to numbness or weakness, such as falling if trying to    
walk before the block wears off   
 
There is a rare risk of breach of confidentiality (release of information which personally 
identifies you). Every research study involves some risk to your confidentiality. It is possible 
that other people could find out you are in the study or see your study information.  But we 
will take every step to keep this from happening. 
 
BENEFITS 
What are the benefits of taking part in this study? 
There may be no direct benefit to you from taking part in this study. However, you may have 
improved pain relief if one technique proves superior. It is hoped that the results of this study 
will help doctors learn which treatment is most effective for pain management. 
 
ALTERNATIVE OPTIONS 
What are my choices other than taking part in this study?   
You do not have to take part in this study to receive treatment for your condition. Your 
alternative is to not participate in this study and receive standard medical care as prescribed 
by your doctor (which may include one of the study treatments).  
 
ECONOMIC CONSIDERATIONS 
What are the costs of taking part in this study? 
There will be no additional cost to you for the study procedures (questionnaires, pain scores) 
described in this consent.  Routine procedures you would have had done even if you were not 
taking part in this study, such as your surgery, hospitalization, anesthesia, and pain 
medications will be billed to your health insurance company and/or group health plans as 
usual. If these routine care costs are not covered by your health insurance/group health plan, 
the cost will be your responsibility. The study will cover the cost of the questionnaires.  
 
COMPENSATION 
What happens if I am injured because I took part in this study? 
Your involvement in this study is voluntary. The possible risks and side effects which might 
occur during the course of the research study have been described in this Consent and 
Authorization form. A research injury is any physical injury or illness caused by your 
participation in this study.  
 
Should you experience a research injury, there are no designated funds provided for 
subsequent medical care or compensation by either the study doctor/clinician or William 
Beaumont Hospital.  
 
Every effort to prevent any injury resulting from this study will be taken by your study doctor 
and William Beaumont Hospital.  Immediate necessary care, emergency treatment, and 
professional services will be available to you, just as they are to the general community. You 
and/or your insurance company will be responsible for the costs. Compensation (such as for 
lost wages and/or pain and suffering) is not available.   


HIC # 2015-422 
 
                                        Page 5 of 7    
Version # 01.06.16      
 
 
 
                         
                                           
 
What are my rights if I take part in this study? 
You are not giving up any of your legal rights by signing this form. 
 
CONFIDENTIALITY, DISCLOSURE AND USE OF YOUR INFORMATION 
Will my medical information be kept private? 
In order for this research study to take place, you must also authorize the researchers to 
access and use some of your protected health information (PHI). PHI is information which 
could identify you as an individual such as name, address, date of birth, etc. By signing this 
Consent and Authorization Form, you give William Beaumont Hospital permission to use and/or 
disclose (release) your health information related to this research. Your medical and billing 
records collected for the purpose of the study will remain confidential, but may be disclosed 
(released) or used by the following and/or their representatives:  
 The investigators (study doctor/clinician, research staff) 
 William Beaumont Hospital  
 The Food and Drug Administration 
 Other governmental regulatory agencies (domestic and/or foreign)  
 Your health insurance company and/or group health plans and their intermediaries 
(companies contracted to process claims) may also have access to your medical and billing 
records of the study. 
 
The purpose for this disclosure (release) or use is, for example, to assure compliance with the 
study protocol, to evaluate the effectiveness of the study, and/or to provide protection to you 
as a research study participant. The disclosure and use of your information will continue after 
your involvement in the study has ended. There is no expiration date for the use of your 
medical and billing records from the study. Any information about you disclosed to the parties 
identified above may be re-disclosed by them; however, such re-disclosure is not under the 
protections of this Consent and Authorization.  
 
You will not be identified in any publication or other release of study results, data, and other 
information (such as in professional writings or at professional meetings).  
 
If you decide to withdraw your authorization for the researchers to access and use your 
personal health information before the end of the study, you will be withdrawn from the 
research study. However, where the study relied on your Consent and Authorization for the 
time you participated in the study, your Consent and Authorization cannot be withdrawn and 
the information already collected may still be used and disclosed as you previously authorized.  
 
STOPPING STUDY PARTICIPATION 
What if I decide to stop taking part in the study? 
Taking part in this research study is completely voluntary. You may choose not to take part or 
to stop being in the study (withdraw) at any time without penalty or loss of benefits to which 
you are otherwise entitled, or without jeopardizing your medical care by your physician at 
William Beaumont Hospital. However, if you do not agree to sign this Consent and 
Authorization Form, you will not be able to take part in this study.  


HIC # 2015-422 
 
                                        Page 6 of 7    
Version # 01.06.16      
 
 
 
                         
                                           
Your participation in this study may be stopped by the study doctor/clinician, without your 
consent, for any reason, which will be explained to you. Examples include: 
 The study procedures appear to be medically harmful to you.  
 You fail to follow directions for participating in the study.  
 It is discovered you do not meet the study requirements.  
 The study is canceled.  
 It is determined to be in your best interest (for example, your disease has progressed 
despite treatment). 
 
Any significant new findings developed during the course of this research that might affect 
your willingness to participate will be provided to you and your study doctor.  While 
participating in this study, you should not take part in any other study.  This is to protect you 
from possible injury that may arise. 
 
CONTACTS 
Who can answer my questions about the study? 
You may talk to the study doctor/clinicians about any questions or concerns regarding your 
study participation, or if you think you may have suffered a research-related injury. The doctor 
in charge of the study, Dr. James Verner, may be reached at (248) 663-1900 to answer your 
questions. Your contact person is Kelly Slade, RN. You may contact her at (248) 551-0194. 
 
If you have questions regarding your rights as a research participant, or have problems, 
concerns, complaints, want information or would like to offer input, you may contact the 
Institutional Review Board (Human Investigation Committee) Chairperson at (248) 551-0662.  
The Human Investigation Committee is charged with the oversight of all human participant 
research conducted at William Beaumont Hospital facilities. 
 
 
 
 
 


HIC # 2015-422 
 
                                        Page 7 of 7    
Version # 01.06.16      
 
 
 
                         
                                           
STATEMENT OF VOLUNTARY PARTICIPATION 
I have read the above, have asked questions and have received answers about this study to 
my satisfaction. I understand what I have read and willingly give my consent to participate in 
PSOAS COMPARTMENT BLOCK VERSUS PERIARTICULAR LOCAL ANESTHETIC 
INFILTRATION FOR PAIN MANAGEMENT FOR TOTAL HIP ARTHROPLASTY: A 
PROSPECTIVE, RANDOMIZED STUDY. I understand I will receive a signed copy of this 
document and will be promptly informed of any new findings regarding this study.  I further 
authorize the use or disclosure of my health and personal information contained in records as 
described above.  
 
______________________________________ 
RESEARCH PARTICIPANT NAME (PLEASE PRINT) 
 
       
 
______________________________________             _______________     ___________________ 
 RESEARCH PARTICIPANT SIGNATURE 
 
 
 
DATE 
 
 
TIME 
 
ALTERNATIVE SIGNATURE (IF RESEARCH PARTICIPANT UNABLE TO SIGN) 
AS THE PERSONAL/LEGAL REPRESENTATIVE OF THE STUDY PARTICIPANT, PLEASE PRINT PARTICIPANTS NAME ABOVE IN THE RESEARCH 
PARTICIPANT SECTION, AND CHECK ONE OF THE BOXES BELOW AS THE BASIS FOR YOUR AUTHORITY TO SIGN THIS CONSENT AND 
AUTHORIZATION: 
 
 COURT-APPOINTED GUARDIAN 
          
 DURABLE POWER OF ATTORNEY                 
 
 NEXT OF KIN                         
*COURT LETTER IS REQUIRED 
 
         *ATTORNEY LETTER MUST BE PRESENT & VERIFIED BY 2 PHYSICIANS 
 
__________________________________                       ________________________________ 
NAME (PLEASE PRINT) 
 
                                            RELATIONSHIP TO PARTICIPANT    
 
_____________________________________                     _____________           ____________ 
SIGNATURE          
 
 
 
 
      DATE                          TIME 
 
                   
 WITNESS TO SIGNATURE ON CONSENT       
  WITNESS TO CONSENT PROCESS AND SIGNATURE  
 
_____________________________________ 
WITNESS NAME (PLEASE PRINT) 
 
 
______________________  
     ________________ 
       ____________ 
 
WITNESS SIGNATURE               
 
 
  DATE  
 
 
TIME 
 
AUTHORIZED CONSENT PROVIDER STATEMENT: 
I have explained this study and have offered the study participant an opportunity for any further 
discussion or clarification. 
 
_________________________________               ____________                 ___________________ 
NAME (PLEASE PRINT) 
 
 
                     CREDENTIALS             
PHONE NUMBER 
 
________________________________                __________________          ____________ 
SIGNATURE 
                                                     DATE   
 
             TIME