Psoas Compartment Block Versus Periarticular Local Anesthetic Infiltration for Pain Management for Total Hip Arthroplasty: A Prospective, Randomized Study
Phase: PHASE4
Conditions: Osteoarthritis, Arthroplasty
Sponsor: Corewell Health East

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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 
 
 

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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 
 
 
 

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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 

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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 

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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. 

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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 

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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 

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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  

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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 

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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.   

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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 

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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’