Clinical trial NCT04114058
Conditions: Femoro Acetabular Impingement
Keywords: hip arthroscopy
Sponsor: Cedars-Sinai Medical Center
Start date: 2019-10-29; Completion date: 2020-03-17
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness of fascia iliaca blockade vs local field infiltration with liposomal bupivicaine in controlling pain, narcotic utilization and falls in the postoperative period following hip arthroscopy

Detailed description:
The purpose the research is to help determine optimal means of post-operative analgesia following hip arthroscopic procedures. Post-operative pain is a significant contributor to patient satisfaction and the side effects of narcotic pain medication are well described. The ideal intervention for achieving appropriate analgesia following hip arthroscopy has not yet been defined. Determining means of achieving acceptable post-operative pain relief while minimizing narcotic usage will help yield maximal patient outcomes.The primary research procedures entailed in this study include fascia iliaca nerve blockade with Marcaine and local field infiltration with liposomal bupivicane (Exparel). The patients in this study will include those who have both a clinical and radiographic diagnosis of femoracetabular impingement (FAI), have failed non operative treatment, and are indicated for hip arthroscopy with labral repair and femoroplasty/acetabuloplasty. The study includes the surgical procedure and the first post-operative follow up visit. The total study duration is approximately 1.5 weeks for each patient. The study will be carried out until the patients first post-operative visit which typically occurs 7-10 days after the procedure. We are to include approximately 40 patients in total for this study over a period of 4 months.

Arms: arm 1: Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control arm 2: Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control
Interventions: intervention 1: liposomal bupivicaine intervention 2: Fascia iliaca blockade
Intervention descriptions: intervention 1: local field infiltration intervention 2: fascia iliaca compartment blockade

Protocol documents:
Prot_SAP_002.pdf: 
Page 1 of 2 
 
 
Pain Outcomes Following Hip Arthroscopy: A prospective randomized control study comparing 
fascia iliaca blockade with marcaine vs extracapsular local field infiltration with liposomal 
bupivacaine 
 
Version 1 12/27/2018 
 
Michael Banffy MD 
 
Kerlan Jobe Institute 
 
 
 


Page 2 of 3 
 
TABLE OF CONTENTS  
 
 
PROTOCOL SUMMARY  
 
 
 
 
 
 
 
3 
GENERAL INFORMATION 
 
 
 
 
 
 
 
3 
1.0 BACKGROUND, RATIONALE  
 
 
 
 
 
 
3 
2.0 STUDY OBJECTIVES  
 
 
 
 
 
 
 
4 
 
 
3.0 STUDY POPULATION 
 
 
 
 
 
 
 
4 
 
3.1 SELECTION OF THE STUDY POPULATION 
 
 
 
 
4 
 
3.2 INCLUSION CRITERIA 
 
 
 
 
 
 
4 
 
3.3 EXCLUSION CRITERIA 
 
 
 
 
 
 
5 
 
3.4 SUBJECT SCREENING AND ENROLLMENT 
 
 
 
 
5 
 
3.5 SUBJECT RECRUITMENT 
 
 
 
 
 
 
5 
4.0 STUDY DESIGN AND METHODS 
 
 
 
 
 
 
5 
5.0 DATA COLLECTION AND MANAGEMENT 
 
 
 
 
 
8 
 
5.1 DATA PROCUREMENT 
 
 
 
 
 
 
8 
 
5.2 TIME PERIOD OF DATA UNDER REVIEW 
 
 
 
 
8 
 
5.3 VARIABLES COLLECTED 
 
 
 
 
 
 
9 
 
5.4 SOURCE DOCUMENTS 
 
 
 
 
 
 
9 
 
5.5 DATA COLLECTION AND STORAGE  
 
 
 
 
9 
 
5.6 CONFIDENTIALITY AND SECURITY OF DATA  
 
 
 
9 
6.0 DATA AND SAFETY MONITORING 
 
 
 
 
 
 
9 
 
6.1 DATA AND SAFETY MONITORING PLAN 
 
 
 
 
9 
 
6.2 QUALITY CONTROL AND QUALITY ASSURANCE 
 
 
 
9 
7.0 STATISTICAL CONSIDERATIONS 
 
 
 
 
 
 
10 
 
7.1 STUDY OUTCOME MEASURES 
 
 
 
 
 
10 
 
7.2 SAMPLE SIZE CONSIDERATIONS 
 
 
 
 
 
10 
8.0 REFERENCES 
 
 
 
 
 
 
 
 
10 
 
 


Page 3 of 4 
 
PROTOCOL SUMMARY  
 
Purpose and Knowledge to be 
Gained 
 
• The purpose the research is to help determine optimal 
means of post operative analgesia following hip 
arthroscopic procedures.    
• Post operative pain is a significant contributor to patient 
satisfaction and the side effects of narcotic pain medication 
are well described. The ideal intervention for achieving 
appropriate analgesia following hip arthroscopy has not yet 
been defined. Determining means of achieving acceptable 
post operative pain relief while minimizing narcotic usage 
will help yield maximal patient outcomes.   
Research Procedures 
 
• The primary research procedures entailed in this study 
include fascia iliaca nerve blockade with Marcaine and 
local field infiltration with liposomal bupivicane (Exparel). 
Subject Population 
• The patients in this study will include those who have both 
a clinical and radiographic diagnosis of femoracetabular 
impingement (FAI), have failed non operative treatment, 
and are indicated for hip arthroscopy with labral repair and 
femoroplasty/acetabuloplasty. 
Duration 
• The study includes the surgical procedure and the first post 
operative follow up visit.  
• The total study duration is approximately 1.5 weeks for 
each patient. The study will be carried out until the patients 
first post operative visit which typically occurs 7-10 days 
after the procedure. We are to include approximately 40 
patients in total for this study over a period of 4 months. 
 
GENERAL INFORMATION  
CSMC Co-Investigators  
Zach Mcvicker MD, Adam Cady PA-C 
Sponsor/Funder 
Kerlan-Jobe Institute 
Collaborating Institutions 
Involved in the Research 
NA 
 
1.0 BACKGROUND, RATIONALE  
The number of hip arthroscopies performed in the US has risen dramatically in recent 
years with expanding indications, advances in surgical techniques, and better understanding of 
hip pathology. With this rise, there is a growing interest in improving postoperative pain control 
as pain following arthroscopic hip procedures can be considerable, with up to 90% of patients 
reporting severe pain in the immediate post operative period in some series1. 
 


Page 4 of 5 
 
Peripheral nerve blockade has been used for a multitude of orthopedic procedures as an 
adjunct to oral or IV pain medication administration. While femoral nerve blockade has been 
successfully used in total knee and hip arthroplasty2, the results of femoral nerve block following 
hip arthroscopy have been mixed. A decrease in opioid usage has been demonstrated in some 
studies2, but falls secondary to muscle weakness in blocked patients remains a worrisome 
complication3. Fascia iliaca blockade has been proposed as a means to achieve analgesia without 
frank motor deficit4,5; however recent studies have shown quadriceps weakness still occurs with 
fascia iliaca blocks6. At our institution, we have anecdotally corroborated this result with several 
patients undergoing hip arthroscopy with fascia iliaca blockade having fallen in the early 
postoperative period. 
Liposomal bupivacaine is a novel medication formulation encapsulating bupivacaine in a 
phospholipid bilayer inducing a protracted steady state release resulting in a prolonged duration 
of medication action. Local wound infiltration with liposomal bupivacaine has been successfully 
utilized for postoperative analgesia in a number of different orthopedic procedures7,8. 
We plan to compare the efficacy of extracapsular liposomal bupivacaine field infiltration 
for postoperative analgesia in hip arthroscopy patients in comparison to the fascia iliaca 
blockade.  
 
2.0 STUDY OBJECTIVES  
 
The purpose of this study is to compare two utilized methods of analgesia for hip 
arthroscopy. Patients will be randomized into two groups: fascia iliaca blockade and local 
field infiltration with liposomal bupivacaine. Pain numeric rating scale (NRS) scores, 
narcotic usage, and any self reported falls in the immediate post operative period will be 
compared between groups. 
 
3.0 STUDY POPULATION  
 
3.1 SELECTION OF THE STUDY POPULATION 
Patients will be selected for the study from the principal investigator’s practice 
(Michael Banffy MD). Patients seen in the outpatient office at the Kerlan Jobe Institute 
with a clinical and radiographic diagnosis of FAI that are indicated for hip arthroscopy 
and subsequently undergo surgery will be eligible for participation.   
 
3.2 INCLUSION CRITERIA 
Inclusion criteria for this study will be adult patients (>18 years old) with diagnosed 
FAI that are indicated for hip arthroscopic labral repair and 
femoroplasty/acetabuloplasty. 
3.3 EXCLUSION CRITERIA  
Exclusion criteria include patients undergoing revision procedures, bilateral 
procedures, those with advanced osteoarthritis (<2mm joint space on plain 
radiographs), frank dysplasia (anterior and/or lateral center edge angles <20 degrees 


Page 5 of 6 
 
and/or Tonnis angle >15 degrees), or diagnoses other than FAI (Legg Calve Perthes, 
femoral head avascular necrosis, septic arthritis, or post traumatic deformity). 
3.4 SUBJECT SCREENING AND ENROLLMENT 
  Data will be procured for this study in a prospective manner. Immediately following 
surgery, the post anesthesia care unit staff will record NRS pain scores and document 
narcotic usage in the immediate post operative period. Upon discharge, enrolled 
patients will maintain an NRS pain score log and record the amount of narcotics 
required at home prior to their first post operative visit. No further interrogation of the 
patients medical record will be required 
 
3.5 SUBJECT RECRUITMENT 
Subjects recruited for this study will come solely from the principal investigator’s 
practice. Patients will be approached at their preoperative visit by either Michael 
Banffy MD or Adam Cady PA-C. No advertising will be used. 
 
4.0 STUDY DESIGN AND METHODS 
 
Hypothesis: Patients treated with local field infiltration of liposomal bupivacaine will report less 
pain in the immediate post operative period and will utilize less narcotic pain medications than 
those who undergo a fascia iliaca block. Fewer post operative falls will be seen in patients 
without fascia iliaca block. 
Variable: NRS pain scores will be recorded in the PACU at 15 min and 1 hr post op in the 
PACU immediately following surgery. Enrolled patients will then record their NRS pain scores 
at home from POD 0 to 4. Total narcotic utilization and any reported falls will be recorded. 
Study Design/Methods: After consenting to participate, subjects will be randomized into one of 
two groups, using a random number generator. http://stattrek.com/statistics/random-number-
generator.aspx. 60 consecutive patients will be enrolled into their appropriate study arm.  
Group 1 patients will undergo a standard preoperative fascia iliaca blockade performed by 
anesthesia per with 0.5% Marcaine according to standard protocol. Group 2 patients will receive 
no regional anesthesia prior the procedure 
Both groups will then be placed under general anesthesia and undergo arthroscopic treatment of 
FAI. At the conclusion of the procedure, patients in the experimental group will undergo 
extracapsular local field blockade in the operative hip using a standardized mixture of 20ccs 
liposomal bupivacaine, 20ccs 1/4percent Marcaine and 80ccs of normal saline. This injection is 
performed in a standardized fashion through the preexisting arthroscopic portals into the 
pericapsular tissue according to FDA labeling/guidelines. This confers no increased risk to the 
patient beyond that of a standard hip therapeutic injection. Patients in the control group will not 
undergo any injection following the procedure. 


Page 6 of 7 
 
Perioperative nursing staff will administer the NRS pain scale surveys at 15 min and 1 hour post 
procedure in the recovery room. The nurses will provide pain medication and make patient 
assessments per their standard patient care responsibilities in the post anesthesia care unit and are 
not administering medication or performing procedures specifically for research purposes. 
All patients will be discharged home on the same day of the procedure. Patients in both groups 
will adhere to the same post operative protocol. A hip brace to be worn at all times will be 
applied to prevent excessive internal/external rotation of the operative extremity. Patients will be 
made 50% partial weightbearing on the operative extremity and will use crutches for ambulation. 
A standard prescription of Percocet 5-325 mg will be given to each patient with instructions to 
take 1 tab every 6 hours as needed for pain. A log of pain levels and amount of pain medication 
taken from POD 0-4 will be recorded by each patient. Patients will return to the office for the 
first post op visit in 7-10 days where the pain logs will be collected for analysis and any reported 
falls at home will be documented 
 
 
 
For Studies that Include Surveys  
The questionnaire to be used for this study is attached below. Numerical Rating Scale (NRS) 
Pain scores have previously been established as a validated metric for tracking pain intensity. 
Patients will be asked to rate their pain at 2 time points each day until POD 4. Additionally, 
patients will asked to document the number of narcotic pain medication pills taken each day until 
POD 4. Lastly, any self reported falls will be captured with this questionnaire. Any literacy or 
language concerns will be addressed at the preoperative visit using the teach back method as well 
as language interpreter services as needed. 
 
ANALOG PAIN SCALE FOR HOME 
Please indicate your pain level FIRST THING in the morning after waking before taking pain medication 
and at night before sleep BEFORE taking pills by selecting the appropriate number on the scale. Perform 
this every day after surgery until the 4th day. 
 
Day 
Pain Score (0-10) 0=no pain 10=worst pain 


Page 7 of 8 
 
1 (AM) 
 
1 (PM) 
 
2 (AM) 
 
2 (PM) 
 
3 (AM) 
 
3 (PM) 
 
4 (AM) 
 
4 (PM) 
 
 
NARCOTIC USAGE HOME LOG 
Please indicate the total amount of narcotic pain pills taken per day 
Day 
Total number of pills taken 
1 
 
2 
 
3 
 
4 
 
 
FALL AT HOME LOG 
If you fell down at home after surgery, please indicate how many times this happened. If no falls 
occurred, indicate N/A (not applicable) 
Number of falls 
 
 
 
 
 
 
 
 
 
*Schedule of Procedures 
 


Page 8 of 9 
 
Procedures  
Preop  Visit 
Surgery 
Post-op 
day 1 to 4 
First post 
operative 
visit (within 
7-10 days 
after 
procedure) 
Informed consent 
R 
 
 
 
Randomization 
R 
 
 
 
Fascia Iliaca Blockade with 0.5% 
Marcaine (Group I only) 
S 
 
 
Hip arthroscopy under general 
anesthesia (Group I and II) 
 
S 
 
 
Exparel extracapsular local field 
injection (right after surgical 
procedure- Group II only) 
 
S 
 
 
Hip brace with 50% partial 
weightbearing on the operative 
extremity prior to hospital discharge 
 
S 
S 
S 
Percocet 5-325 mg every 6 hours as 
needed 
 
S 
S 
S 
Numeric pain scale  
 
 
R 
 
Narcotic Usage home log (Number 
of narcotic pain medication taken 
each day) 
 
 
R 
 
Self reported occurrence of falls 
questionnaire 
 
 
R 
 
 
5.0 DATA COLLECTION AND MANAGEMENT 
 
5.1 DATA PROCUREMENT 
• Data procurement will be driven by the patient. NRS pain scores and the amount 
of narcotic utilization will be documented in the PACU by the PACU staff. Upon 
discharge from the surgery center, patients will be responsible for filling out the 
above questionnaire at home and will bring the completed form to their first 
postoperative visit 
 
 
5.2 TIME PERIOD OF DATA UNDER REVIEW  
• Data will be reviewed from the date of surgery POD 0 and up until POD 4. 
Data will be collected from the following timepoints: morning and evening 
NRS pain scales and daily narcotic utilization. Data will be collected 
prospectively and will be maintained until final data analysis has been 
completed at which point all documentation related to the study with PHI will 
be discarded in a HIPAA compliant manner. 


Page 9 of 10 
 
5.3 VARIABLES COLLECTED  
• The following data points/variables will be collected: Bidaily NRS pain scores, 
daily narcotic pain medication utilization, and self reported falls. 
5.4 SOURCE DOCUMENTS 
• Source documents (patient questionnaires) will be collected at the first 
postoperative visit. At this time point, the patient data will be de identified and 
placed into an excel sheet on a secure flash drive. The linking information will 
be maintained on a separate secure flash drive. 
5.5 DATA COLLECTION AND STORAGE  
• Upon collection of the paper patient survey at the first postoperative visit, 
information will be transferred to an electronic Excel sheet on a secure 
password protected flashdrive. The paper survey will be destroyed. Only the 
study authors will have access to the deidentified patient data and only the 
primary author will have access to the linking information.  
 
                5.6 Confidentiality and Security of Data 
• Confidentiality will be maintained according to the CSMC Office of Research 
Compliance and Quality Improvement Requirements for Safeguarding and 
Maintaining Confidentiality of Subject Information Collected for Research. 
See previous section for details. 
6.0 
DATA AND SAFETY MONITORING  
6.1 DATA AND SAFETY MONITORING PLAN 
Patients are routinely called by the attending anesthesiologist as well as the 
attending surgeons office on POD 1 for postoperative evaluation. During this 
contact, both the anesthesia team and surgeon can assess for any complication 
or untoward effect of the liposomal bupivacaine injection. Management of any 
complication will be directed by the anesthesia staff or surgeon. Patients will 
be seen for their first follow up visit at 7-10 days following surgery. Any 
protocol deviations will be recorded at this time point. The principal author 
(Nicholas Ramos MD) will review data records at 4 week time points during 
data collection to ensure appropriate capture of NRS pain score, narcotic 
utilization, and patient reported falls.  
6.2 QUALITY CONTROL AND QUALITY ASSURANCE 
• Patients are routinely contacted on POD 1 by both the attending 
anesthesiologist as well as the attending surgeon. During this contact, patients will 
be reminded to fill out their paper questionnaires in the appropriate manner 
according to study protocol. 


Page 10 of 11 
 
7.0 STATISTICAL CONSIDERATIONS  
 
7.1 STUDY OUTCOME MEASURES 
• Baseline demographics will be compared between groups using the chi 
square test for categorical data (sex) and ANOVA for continuous variables 
(age). Non parametric Kruskal Wallis testing will be used to compare 
average NRS pain scores and analgesia utilization between groups. The 
incidence of post operative falls will be compared between groups using the 
chi square test. 
7.2 SAMPLE SIZE CONSIDERATIONS  
• 
Power estimates were determined before patient enrollment to determine the 
enrollment size. The sample size was estimated with a basis on the numerical 
rating scale of pain as main variable. Alpha error accepted = 0.05 (type I error 
probability for a 2-sided independent t test) and a beta error = 0.2 (power = 80%).  
Effect size was estimated to be 1 (mean difference between groups =2 and SD both 
groups =2) It was calculated that it would be necessary to enroll 17 patients in each 
group. We will plan to enroll 40 patients total to account for any patient 
loss/dropout (20 pts each group) 
 
8.0 REFERENCES 
 
1. Ward JP, Albert DB, Altman R, Goldstein RY, Cuff G, Youm T. Are femoral nerve  blocks effective for 
early postoperative pain management after hip arthroscopy? Arthroscopy. 2012 Aug;28(8):1064-9. doi: 
10.1016/j.arthro.2012.01.003. Epub 2012 Apr 11. PubMed PMID: 22498045 
2. Paul JE, Arya A, Hurlburt L, Cheng J, Thabane L, Tidy A, Murthy Y. Femoral nerve block improves 
analgesia outcomes after total knee arthroplasty: a meta-analysis of randomized controlled trials. 
Anesthesiology. 2010 Nov;113(5):1144-62. doi: 10.1097/ALN.0b013e3181f4b18. Review. PubMed PMID: 
20966667 
3. Xing JG, Abdallah FW, Brull R, Oldfield S, Dold A, Murnaghan ML, Whelan DB. Preoperative Femoral 
Nerve Block for Hip Arthroscopy: A Randomized, Triple-Masked Controlled Trial. Am J Sports Med. 
2015 Nov;43(11):2680-7. doi: 10.1177/0363546515602468. Epub 2015 Sep 24. PubMed PMID: 26403206 
4. Krych AJ, Baran S, Kuzma SA, Smith HM, Johnson RL, Levy BA. Utility of multimodal analgesia with 
fascia iliaca blockade for acute pain management following hip arthroscopy. Knee Surg Sports Traumatol 
Arthrosc. 2014 Apr;22(4):843-7. doi: 10.1007/s00167-013-2665-y. Epub 2013 Sep 24. PubMed PMID: 
24061718 
5. Kay J, de Sa D, Memon M, Simunovic N, Paul J, Ayeni OR. Examining the Role of  Perioperative Nerve 
Blocks in Hip Arthroscopy: A Systematic Review. Arthroscopy.  2016 Apr;32(4):704-15.e1. doi: 
10.1016/j.arthro.2015.12.022. Epub 2016 Feb 20. Review. PubMed PMID: 26907370 
6. Behrends M, Yap EN, Zhang AL, Kolodzie K, Kinjo S, Harbell MW, Aleshi P. Preoperative Fascia Iliaca 
Block Does Not Improve Analgesia after Arthroscopic Hip Surgery, but Causes Quadriceps Muscles 
Weakness: A Randomized, Double-blind Trial. Anesthesiology. 2018 Sep;129(3):536-543. doi: 
10.1097/ALN.0000000000002321. PubMed PMID: 2997520 


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7. VanWagner MJ, Krebs NM, Corser W, Johnson CN. Liposomal bupivacaine reduces opioid consumption 
and length of stay in patients undergoing primary total hip arthroplasty. Hip Int. 2018 May 
1:1120700018778240. doi: 10.1177/1120700018778240. [Epub ahead of print] PubMed PMID: 29808726 
8.   Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With 
Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: 
Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 
10.1016/j.arth.2017.07.024. Epub 2017 Jul 25. Erratum in: J Arthroplasty. 2018 Oct 30;:. PubMed PMID: 
28802777