Clinical trial NCT03746951
Conditions: Orthopedic Disorder
Sponsor: Nationwide Children's Hospital
Start date: 2019-04-24; Completion date: 2020-01-31
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators aim to compare the use of a suprainguinal fascia iliaca compartment block vs lumbar plexus block as an adjunct to general anesthesia in pediatric patients undergoing orthopedic procedures involving the hip or upper femur. This study will help determine the efficacy of the two techniques and their advantages when compared to each other including time to perform the block, opioid consumption reduction, effects on postoperative pain, and the length of stay.

Detailed description:

Arms: arm 1: FICB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the groin. arm 2: LPB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the back.
Interventions: intervention 1: Ropivacaine Hcl 0.5% Inj Vil 20Ml
Intervention descriptions: intervention 1: Anesthetic agent used in peripheral nerve block

Protocol documents:
Prot_SAP_000.pdf: 
 
 
Comparative evaluation of lumbar plexus and suprainguinal fascia iliaca 
compartment block for pain management after orthopedic surgical 
procedures involving hip and femur in pediatrics 
 
 
 
NCT03746951 
 
 
May 6, 2019 
 
 


PROTOCOL TITLE: LPB vs FICB 
 
Page 2 of 12 
HRP-503  v.12.10.18 
PROTOCOL TITLE: 
Comparative evaluation of lumbar plexus and suprainguinal fascia iliaca 
compartment block for pain management after orthopedic surgical procedures 
involving hip and femur in pediatrics. 
PRINCIPAL INVESTIGATOR: 
Name: Senthil Krishna, MD 
Department/Center: Anesthesiology & Pain Medicine 
Telephone Number: 614-722-4200 
Email Address: Senthil Krishna@nationwidechildrens.org 
VERSION NUMBER/DATE: 
Version 3/ 06May2019 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
2 
13Mar2019 
Adding coinvestigators, adding exclusion 
criteria, minor changes to methods. 
No 
3 
06May2019 
Changing the procedures regarding the 
neuromuscular blocking agents and the 
postoperative analgesia. 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


PROTOCOL TITLE: LPB vs FICB 
 
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HRP-503  v.12.10.18 
1.0 
Study Summary 
 
Study Title 
Comparative evaluation of lumbar plexus and suprainguinal 
fascia iliaca compartment block for pain management after 
orthopedic surgical procedures involving hip and femur in 
pediatrics. 
Study Design 
Prospective study 
Primary Objective 
The primary objective will be to measure total time to 
perform the regional anesthesia technique. 
Secondary 
Objective(s) 
The secondary objectives are opioid consumption during the 
first 24 and 48 postoperative hours, pain scores during the 
first 24 and 48 hours, and hospital length of stay. 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Lumbar plexus block or fascia iliaca compartment block 
with ropivacaine 0.5% with 1:200,000 epinephrine. 
IND/IDE #  
N/A 
Study Population 
Patients undergoing elective orthopedic surgical procedures 
involving the hip and upper thigh. 
Sample Size 
70 
Study Duration for 
individual 
participants 
Time of surgery to discharge home - ~ 48 hours 
Study Specific 
Abbreviations/ 
Definitions  
LPB – lumbar plexus block 
FICB – fascia iliaca compartment block 
 
2.0 
Objectives 
2.1 The primary objective will be to measure total time to perform the 
regional anesthesia technique.  The secondary objectives are opioid 
consumption during the first 24 and 48 postoperative hours, pain 
scores during the first 24 and 48 hours, and hospital length of stay. 
2.2 The hypothesis is that the two techniques will be equally effective in 
providing analgesia following hip and femur surgery in the pediatric 
population; however, the time to perform the FICB will be shorter 
than the lumbar plexus block. 
3.0 
Background 
3.1 Regional anesthesia techniques including peripheral nerve blockade 
in children undergoing orthopedic procedures provide effective 
postoperative analgesia, reduce opioid consumption, decrease the 
time to discharge, and minimize the exposure to general anesthetic 
agents.1-3 Increased use of regional anesthesia in infants, children, and 
adolescents has significantly improved the scope of pediatric pain 
management. Epidural analgesia was formerly the gold standard for 


PROTOCOL TITLE: LPB vs FICB 
 
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HRP-503  v.12.10.18 
pain treatment following orthopedic procedures involving the lower 
extremities despite the potential for adverse effects including 
hypotension and urinary retention.  Additionally, epidural analgesia 
provides bilateral sensory blockade for what may be a unilateral 
procedure. Lumbar plexus blockade (LPB) has recently seen 
increased use as an adjunct to decrease opioid consumption for 
procedures involving the hip and thigh.3,4  However, the technique is 
complex, time-consuming, and is associated with potential 
complications including needle advancement into the peritoneum or 
retroperitoneum, which may result in a renal hematoma, vascular 
puncture (retroperitoneal hematoma), or even bowel puncture.  
Alternatively, fascia iliaca compartment block (FICB) provides an 
easy and safe technique to anesthetize the femoral, lateral femoral 
cutaneous, and obturator nerves in a superficial fascial plane avoiding 
the potential risks of lumbar plexus block.5  FICB reduces opioid 
consumption in adult patients after total hip arthroplasty.  Desmet et 
al. demonstrated that a supra-inguinal FICB reduced opioid 
consumption by 46% in the first 24 hours and 45% over 48 hours in 
adult patients following total hip arthroplasty thus offering another 
regional anesthetic technique to provide postoperative pain 
management following procedures on the hip and upper thigh.6  To 
our knowledge, there are no studies comparing lumbar plexus block 
to fascia iliaca block for pain management after orthopedic 
procedures involving the hip and femur in the pediatric population.   
3.2 We aim to compare the use of a suprainguinal FICB vs lumbar plexus 
block as an adjunct to general anesthesia in pediatric patients 
undergoing orthopedic procedures involving the hip or upper femur. 
This study will help determine the efficacy of the two techniques and 
their advantages when compared to each other including time to 
perform the block, opioid consumption reduction, effects on 
postoperative pain, and the length of stay. If the FICB technique is 
equally effective, it would offer a safer alternative to lumbar plexus 
block, which may be accomplished in a more expeditious manner.  
4.0 
Study Endpoints 
4.1 Time to perform each block. 
4.2 Pain scores and opioid consumption during the first 24 and 48 hours 
post-op. 
5.0 
Study Intervention/Investigational Agent 
5.1 Study subjects will receive either a LPB or a suprainguinal FICB 
under ultrasound guidance. Either block will be achieved with 3 
mg/kg (0.6 mL/kg) of ropivacaine 0.5% with 1:200,000 epinephrine. 
5.2 Both of these blocks are considered standard of care and patients 
could receive either one without participating in this study. 


PROTOCOL TITLE: LPB vs FICB 
 
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HRP-503  v.12.10.18 
6.0 
Procedures Involved* 
6.1 This will be a double-blinded, randomized, prospective study 
involving patients, ranging in age between 2 and 18 years of age, 
ASA grade I-III, undergoing elective orthopedic surgical procedures 
involving the hip and upper thigh. Patients will be randomly divided 
into 2 groups: Group LP and Group FICB.  The block (LP or FICB) 
will be performed by one of the study investigators. The team 
providing intraoperative care will step out of the room during the 
regional block and care will be provided by the research team 
including an attending anesthesiologist. Once the primary anesthesia 
team finishes the induction phase, the study team will perform the 
regional anesthesia  time-out.  Measurement of the time to complete 
the block will start when the time-out is completed and end when the 
need is withdrawn and the patient is positioned in the surgical 
positioning.  The perioperative care teams will be blinded to the type 
of the block by using two dressings in all the patients.  The first 
dressing will be placed at the actual site of needle insertion and the 
second dressing at the site where needle would have been inserted if 
the patient were to receive the other type of block (in the back for the 
LP block and groin for the FICB). 
6.2 Anesthetic care will be standardized in all patients except for type of 
the regional nerve block. Patients requiring anxiolysis will receive 
oral midazolam 0.3-0.5 mg/kg (maximum 20 mg) 30 minutes prior 
surgery or intravenous midazolam (0.05 mg/kg up to 2 mg) prior to 
transport to the operating room. Once in the operating room, all 
patients will be monitored as per standard ASA guidelines. 
Anesthetic induction will be achieved with 70% nitrous oxide in 
oxygen and sevoflurane or with intravenous propofol. If preoperative 
midazolam was not administered, intravenous midazolam will be 
administered (0.05 mg/kg to a maximum of 2 mg). Following loss of 
consciousness, fentanyl (2 µg/kg) will be administered and the 
trachea intubated. Administration of neuromuscular blocking agents 
(NMBA) will be deferred until after regional anesthesia technique 
has been performed. Rocuronium (0.6-1 mg/kg) will be used 
according to surgeons request. In case NMBA are needed for 
tracheal intubation then succinylcholine (1-2mg/kg) will be used.    
Anesthesia will be maintained with 1-2 MAC of sevoflurane in 50% 
oxygen/air.   Following endotracheal intubation, patients will receive 
either a LPB or a suprainguinal FICB under ultrasound guidance. 
Either block will be achieved with 3 mg/kg (0.6 mL/kg) of 
ropivacaine 0.5% with 1:200,000 epinephrine.  Maximum block 
volume will be 30 mL for both blocks.  The time from the initiation 
of the time-out for the block until the patient has been returned to the 
surgical position will be noted.  Additional intraoperative analgesia 
will be achieved with bolus doses of fentanyl 1 µg/kg to maintain the 


PROTOCOL TITLE: LPB vs FICB 
 
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HRP-503  v.12.10.18 
heart rate and blood pressure within 20% of baseline. Prophylaxis for 
postoperative nausea and vomiting will include dexamethasone (0.1-
0.15 mg/kg up to 8 mg) and ondansetron (0.1-0.15 mg/kg up to 4 
mg). At the conclusion of surgery, residual neuromuscular blockade 
will be reversed and the patient’s trachea extubated. 
6.3 Postoperative analgesia will be achieved with IV hydromorphone as 
needed (PRN) with a dose regimen of 0.02 mg/kg per dose. 
Depending on patient’s use if there is need to escalate treatment a 
PCA, NCA or CCA will be started. Patients will also receive IV 
acetaminophen 15 mg/kg every 6 hours and IV ketorolac 0.5 mg/kg 
every 6 hours (unless contraindicated) during the 48 hour study 
period.  The first dose of these two agents will be administered in the 
operating room at the completion of the surgical procedure.  If the 
patient is ready to transition from IV to oral pain medications, 
oxycodone (0.1 mg/kg every 4 hours) will be started and the 
hydromorphone discontinued.  At that time, acetaminophen will be 
switched to oral and ketorolac switched to oral ibuprofen. 
6.4 The following data will be collected: 
• Block procedure time (in minutes and seconds) 
• Opioid administration intraoperatively. 
• Postoperative opioid consumption in the PACU. 
• Postoperative opioid consumption for the first 48 hours 
after surgery (PACU discharge to inpatient ward 
admission).  
• Pain assessment scores (VAS in older children, FACES 
scales in children between 2-4 and FLACC for non-
verbal children) in the PACU (first pain score) and for the 
first 48 hours (standard pain assessments) on the inpatient 
ward. 
• The duration of the need for intravenous opioid therapy.  
• Use of rescue pain medications in the PACU, on the 
floor, including non-opioids, will also be recorded and 
analyzed.  
• Hospital length of stay.  
The following demographic and surgical parameters will also be 
collected and recorded: patient age, gender, race/ethnicity, 
height, weight, ASA status, primary diagnosis, list of 
comorbidities, procedure, date, duration, admission status 
intraoperative medications, PACU arrival and discharge times, 
discharge destination, pain scores (including recorded time), 


PROTOCOL TITLE: LPB vs FICB 
 
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HRP-503  v.12.10.18 
regional anesthetic time and dose, and time of hospital admission 
and discharge.  
   
7.0 
Data and Specimen Banking* 
N/A 
 
8.0 
Sharing of Results with Subjects* 
8.1 Results will not be shared. 
9.0 
Study Timelines* 
• 
An individual study subject’s participation in the study should last 
approximately 48 hours total.  
• 
All study subjects should be enrolled within 2 years of study start. 
• 
The study should be completed within 3 years of study start.  
10.0 Inclusion and Exclusion Criteria* 
10.1 Potential subjects will be identified by reviewing the surgery 
schedule in Epic and will be recruited from the Surgery Unit pre-op 
area prior to their surgery. 
10.2 Inclusion criteria:  Aged 2-18 years, ASA grade 1-3, undergoing 
elective orthopedic surgical procedures involving the hip and upper 
thigh.   
Exclusion criteria:  Local anesthetic allergy, skin or localized infection at 
the site of catheter insertion opioid use within 3 months prior to surgery, 
history of opioid abuse or dependence, pre-existing motor or sensory 
deficits, patient or parent refusal. 
10.3 We are including children, and will not include: 
• 
Adults unable to consent 
• 
Pregnant women 
• 
Prisoners 
11.0 Vulnerable Populations* 
11.1 This study presents no more than minimal risk as it involves regional 
nerve blocks which are used routinely as standard of care by the 
anesthesiologists at this institution.  
12.0 Local Number of Subjects 
12.1 70 
12.2 Sample size will be determined according to a previous study 
investigating the time taken to perform 2 variations on the lumbar 
plexus block, with the slower technique taking 334 ± 156 seconds 
and the faster technique taking 238 ± 74 seconds. We hypothesize 
that the time difference between the 2 techniques in our study will be 


PROTOCOL TITLE: LPB vs FICB 
 
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HRP-503  v.12.10.18 
at least as large as the difference between the 2 block types 
investigated in this prior study. Specifically, assuming that the FICB 
will be at least 96 seconds faster than the LP block while the pooled 
standard deviation is 128 seconds, the proposed t-test would have 
80% power to confirm a statistically significant difference at a 95% 
confidence level when at least 29 subjects are enrolled in each group. 
Therefore, we propose enrolling a total of 70 patients to account for 
dropout or missing data.  
13.0 Recruitment Methods 
13.1 Subjects will be recruited from the surgery unit pre-op area.  They 
will be identified by reviewing OR schedules in Epic. 
14.0 Withdrawal of Subjects* 
N/A 
 
15.0 Risks to Subjects* 
15.1 The common side effects of ropivacaine (the numbing medication 
used in the nerve blocks) are injection site burning or pain and 
prickly feeling as the block wears off.  Occasional side effects of 
ropivacaine are ear ringing, metallic taste, and drowsiness. Rare side 
effects of ropivacaine are seizures, unconsciousness, respiratory 
arrest, low blood pressure, irregular heartbeat, cardiac arrest, and 
allergic reactions including anaphylaxis. There is also potential risk 
for loss of confidentiality. 
15.2 Subject information will not be given to any other investigators. 
Subjects and their information will be closely monitored and guarded 
by study staff; there will be limited access to patients and their 
information by trained study staff; and subject information will only 
be shared and discussed between study staff specific to this study. 
Subject PHI will be stored in a locked cabinet, and will be stored and 
maintained in password protected computer files. 
16.0 Potential Benefits to Subjects* 
16.1 No direct benefit to the subject. 
17.0 Data Management* and Confidentiality 
17.1 Continuous outcomes will be compared between groups using 2-
sample t-test or rank-sum tests according to the normality of the 
distribution (checked by the Shapiro-Wilk test). Categorical 
outcomes will be compared between groups using Chi-square or 
Fisher’s exact tests, according to cell size.  
17.2 Research records will be stored in a locked cabinet and password 
protected computer.  Only certified research personnel will be given 
access to identifiable subject information 


PROTOCOL TITLE: LPB vs FICB 
 
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HRP-503  v.12.10.18 
17.3 Following publication of study results, research records will be 
stored for a period of 3-5 years and then will be destroyed by placing 
in a secure shredding bin.  
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
18.1 The study will only be monitored by the study investigators. 
19.0 Provisions to Protect the Privacy Interests of Subjects 
19.1 Subject information will not be given to any other investigators. 
Subjects and their information will be closely monitored and guarded 
by study staff; there will be limited access to patients and their 
information by trained study staff; and subject information will only 
be shared and discussed between study staff specific to this study. 
20.0 Compensation for Research-Related Injury 
20.1 None 
21.0 Economic Burden to Subjects 
21.1 None 
22.0 Consent Process 
22.1 The consent process will begin in the preoperative surgery unit on 
the day of surgery, by PI, Sub-Investigators, Study Coordinators, 
and/or trained research staff. 
22.2 The study will be thoroughly explained to the patient and their 
family. There will be ample time allotted for questions and answers. 
An explanation of voluntary participation will take place, and the 
family will be asked if they are interested in participating in the 
study. If the patient and their parent(s), or legal guardian agrees to 
participate they will be asked to sign consent and assent forms. The 
patient will then be enrolled in the study with the understanding that 
they can elect to stop the study and be withdrawn from the study at 
any time.  
23.0 Process to Document Consent in Writing 
23.1 We will be following SOP: Written Documentation of Consent 
(HRP-091).  
24.0 Setting 
24.1 Subjects will be recruited from Surgery Unit and all study 
procedures will take place in the OR after the subject has been 
anesthetized.  
25.0 Resources Available 
25.1 The department of Anesthesiology and Pain Medicine has 2 research 
coordinators and 2 research associates that will be enrolling subjects 


PROTOCOL TITLE: LPB vs FICB 
 
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HRP-503  v.12.10.18 
for this study.  All study staff will be trained on the study 
procedures. 
26.0 Multi-Site Research* 
N/A 
 
27.0  Protected Health Information Recording 
 
1.0 
Indicate which subject identifiers will be recorded for this research. 
☒  Name 
☐  Complete Address 
☐  Telephone or Fax Number 
☐  Social Security Number (do not check if only used for ClinCard) 
☒  Dates (treatment dates, birth date, date of death) 
☐  Email address , IP address or url 
☒  Medical Record Number or other account number 
☐  Health Plan Beneficiary Identification Number 
☐  Full face photographic images and/or any comparable images (x-rays) 
☐  Account Numbers 
☐  Certificate/License Numbers 
☐  Vehicle Identifiers and Serial Numbers (e.g. VINs, License Plate Numbers) 
☐  Device Identifiers and Serial Numbers 
☐  Biometric identifiers, including finger and voice prints 
☐  Other number, characteristic or code that could be used to identify an 
individual 
☐  None (Complete De-identification Certification Form) 
 
2.0   
Check the appropriate category and attach the required form* on the Local 
Site Documents, #3. Other Documents, page of the application.  (Choose one.) 
☒  Patient Authorization will be obtained. (Include the appropriate HIPAA 
language (see Section 14 of consent template) in the consent form OR attach 
the HRP-900, HIPAA AUTHORIZATION form.) 
☐  Protocol meets the criteria for waiver of authorization. (Attach the HRP-901, 
WAIVER OF HIPAA AUTHORIZATION REQUEST form.) 
☐  Protocol is using de-identified information. (Attach the HRP-902, DE-
IDENTIFICATION CERTIFICATION form.) (Checked "None" in 1.0 above) 
☐  Protocol involves research on decedents. (Attach the HRP-903, RESEARCH 
ON DECEDENTS REQUEST form.) 
☐  Protocol is using a limited data set and data use agreement. (Contact the 
Office of Technology Commercialization to initiate a Limited Data Use 
Agreement. 
 
*Find the HIPAA forms in the IRB Website Library, Templates. 
 


PROTOCOL TITLE: LPB vs FICB 
 
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HRP-503  v.12.10.18 
Attach the appropriate HIPAA form on the “Local Site Documents, #3. 
Other Documents”, page of the application. 
 
3.0    How long will identifying information on each participant be maintained? 
Following publication of study results, research records will be stored for a period 
of 3-5 years and then will be destroyed by placing in a secure shredding bin. 
 
4.0 
Describe any plans to code identifiable information collected about each 
participant. None 
 
5.0 
Check each box that describes steps that will be taken to safeguard the 
confidentiality of information collected for this research: 
☒ Research records will be stored in a locked cabinet in a secure location 
☒ Research records will be stored in a password-protected computer file 
☐ The list linking the assigned code number to the individual subject will be 
maintained separately from the other research data 
☒ Only certified research personnel will be given access to identifiable 
subject information 
 
6.0 
Describe the provisions included in the protocol to protect the privacy 
interests of subjects, where "privacy interests" refer to the interest of 
individuals in being left alone, limiting access to them, and limiting access to 
their information. (This is not the same provision to maintain the 
confidentiality of data.) 
 
Subject information will not be given to any other investigators. Subjects and 
their information will be closely monitored and guarded by study staff; there will 
be limited access to patients and their information by trained study staff; and 
subject information will only be shared and discussed between study staff specific 
to this study. 
 
Confidential Health Information 
 
1.0 
Please mark all categories that reflect the nature of health information to be 
accessed and used as part of this research. 
 
☒  Demographics (age, gender, educational level) 
☒  Diagnosis 
☐  Laboratory reports 
☐  Radiology reports 
☐  Discharge summaries 
☒  Procedures/Treatments received 
☒  Dates related to course of treatment (admission, surgery, discharge) 
☐  Billing information 
☒  Names of drugs and/or devices used as part of treatment 
☐  Location of treatment 


PROTOCOL TITLE: LPB vs FICB 
 
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HRP-503  v.12.10.18 
☐  Name of treatment provider 
☐  Surgical reports 
☒  Other information related to course of treatment 
☐  None 
 
2.0 
Please discuss why it is necessary to access and review the health information 
noted in your response above. 
It is necessary to meet the objectives of the study and to analyze the data. 
 
3.0 
Is the health information to be accessed and reviewed the minimal necessary to 
achieve the goals of this research?  ☒ Yes    ☐ No 
 
4.0 
Will it be necessary to record information of a sensitive nature?  ☐ Yes   ☒ No 
 
5.0 
Do you plan to obtain a federally-issued Certificate of Confidentiality as a means 
of protecting the confidentiality of the information collected?  ☐ Yes   ☒ No 
 
References:  
1. Wong J, Marshall S, Chung F, Sinclair D, Song D, Tong D. Spinal anesthesia 
improves the early recovery profile of patients undergoing ambulatory knee 
arthroscopy. Can J Anaesth 2001;48:369-74. 
2. Rappaport B, Mellon RD, Simone A, Woodcock J. Defining safe use of anesthesia 
in children. N Engl J Med 2011;364:1387-90. 
3. Ross AK, Eck JB, Tobias JD. Pediatric regional anesthesia: Beyond the caudal. 
Anesth Analg 2000;91:16-26.  
4. Dadure C, Raux O, Gaudard P, Sagintaah M, Troncin R, Rochette A, Capdevila 
X. Continuous psoas compartment blocks after major orthopedic surgery in 
children: A prospective computed tomographic scan and clinical studies. Anesth 
Analg 2004;98:623-628. 
5. Eastburn E, Hernandez M, Boretsky K, Technical success of the ultrasound-guided 
supra-inguinal fascia iliaca compartment block in older children and adolescents 
for hip arthroscopy. Pediatr Anesth 2017;27:1120-1124. 
6. Desmet M, Vermeylen K, Van Herreweghe I, et al, A longitudinal supra-inguinal 
fascia iliaca compartment  block reduces morphine consumption after total hip 
arthroplasty. Reg Anesth Pain Med 2017;42:327-333.