Clinical trial NCT02933671
Conditions: Hip Osteoarthritis Primary Total Hip Arthroplasty Pain
Keywords: suprainguinal fascia iliaca (SIFI) nerve block
Sponsor: Duke University
Start date: 2017-08-01; Completion date: 2020-03-17
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn if using a suprainguinal fascia iliaca (SIFI) injection technique (also called a "nerve block") that numbs the nerves going to the side and front of the upper leg will improve pain control after surgery. The SIFI technique uses a numbing solution (local anesthetics) that is injected next to nerves in the hip to reduce pain. This block may affect movement in the leg and make the legs weak. The amount of leg weakness is not known and assessment of this will be included in the study. Many institutions use the SIFI block for patients having total hip replacements, with the hope of providing good pain relief combined with improved mobility after surgery.

Detailed description:

Arms: arm 1: A nerve block technique using a numbing medication called ropivacaine. arm 2: The same nerve block technique as above, however using an inactive solution of salt water.
Interventions: intervention 1: Suprainguinal fascia iliaca (SIFI) block intervention 2: Sham block intervention 3: Ropivacaine intervention 4: Saline
Intervention descriptions: intervention 1: An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine. intervention 2: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. intervention 3: Local anesthetic (numbing drug) intervention 4: Salt water placebo

Protocol documents:
Prot_SAP_000.pdf: 
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Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip 
Arthroplasty 
 
Document Date: December 11, 2019 
 
NCT02933671


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1.  Protocol Title:  
 
Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip 
Arthroplasty. 
 
2.  Purpose of the Study:  
 
The goal of this prospective randomized double-blind study is to determine if an 
ultrasound guided suprainguinal fascia iliaca (SIFI) technique is efficacious as an 
analgesic for total hip arthroplasty. Efficacy will be determined by analyzing post-
intervention pain scores (NRS 11), opioid consumption, and functional status including 
ambulation and dynamometry for quadriceps function.  English speaking ASA 1-3 
patients ages 18-75 years old undergoing primary total hip arthroplasty will be assessed 
post-operatively after a general anesthetic.  Once pain scores are >5/10, patients will be 
blocked with either 0.2% ropivacaine or saline, and numerical pain scores and opioid 
consumption will be evaluated over the following 24 hours. Data will be analyzed on an 
intent to treat basis using a two-sided t-test (parametric) or Mann-Whitney-Wilcoxson 
(non-parametric) with a p-value of 0.05 as significant.  Patients will assume standard risk 
associated with nerve blocks, including theoretical risk of nerve damage and local 
anesthetic systemic toxicity. 
 
3.  Background & Significance:  
Several regional anesthesia techniques have been implemented to decrease 
postoperative pain following total hip arthroplasty (THA), with varying success1,2.  Of 
these, the fascia iliaca block is commonly utilized nerve block for hip surgery.  This block 
anesthetizes the lateral femoral cutaneous nerve (LFCN), but has a reported 10-37% 
failure rate3-5.  To reduce failure, the femoral nerve and the LFCN have been blocked 
individually utilizing ultrasound guidance. The LFCN, if blocked individually, has 
traditionally been approached below the inguinal ligament3-8 and has been shown to be 
useful in patients with chronic pain. In chronic pain, desired sensory block of the LFCN 
while avoiding motor block is important, leading to deposition of local anesthetic distal to 
the inguinal ligament.   
Anterior approaches for total hip arthroplasty have led to careful cadaveric 
examination of the course of the LFCN9-11 following reports of LFCN damage caused by 
the anterior approach8,9.  The LFCN has an unreliable course with variable branching 
below the inguinal ligament. The branching is variable such that one or more branches 
may course above, through, or below the inguinal ligament. The branches may cross 
sartorius laterally anywhere from 0-9 cm below the inguinal crease9-11. In contrast, the 
LFCN has a reliable course above the inguinal ligament and conserved course 
superficial to iliacus muscle and immediately below the fascia iliaca in the pelvis8. 
Swenson, et al.12, described injection of local anesthetic under the fascia iliaca at 
the level of the inguinal ligament with subsequent distal compression to advance the 
local anesthetic in a retrocaudal direction with MRI confirmation of distribution using dye.  
Sensory deficit in the distribution of the LFCN was demonstrated in all patients although 
local anesthetic was up to 2.2 cm laterally from the ASIS in 40% of their subjects.  This 
technique, however, causes a significant motor block since local anesthetic is injected 
near the femoral nerve. 
Hebbard, et al.13, described an infrainguinal approach for suprainguinal needle 
placement in cadavers and demonstrated dye surrounding LFCN in the pelvis by 
advancing the needle in a cephalad direction underneath the inguinal ligament13. Despite 
the potential advantages of the suprainguinal needle placement, the long needle entry 
path and difficulty imaging the correct fascial plane, particularly in obese patients, can 


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make this approach challenging. As such, this approach has not been widely studied in 
the several years since its description. 
 
Similarly, Kumar, et al.14, described a modified suprainguinal approach using a 
landmark based technique during which the needle was placed 1 cm above the inguinal 
ligament and 1/3 of the distance medially from the ASIS to the pubic tubercle.  With this 
technique, decreased VAS pain scores were seen, as was less morphine consumption 
and less post-operative nausea and vomiting than patients receiving traditional 
infrainguinal fascia iliaca blocks, showing a benefit for suprainguinal injection. 
Our recent case series comprised of 5 patients described the novel ultrasound 
guided out-of-plane suprainguinal fascia iliaca (SIFI) plane block15. The approach 
described requires new probe positioning and new sonographic landmarks for combined 
LFCN and femoral nerve analgesic block.  Pain scores were slightly lower in the block 
group, however, opioid consumption was decreased.  Gross motor function was 
preserved despite local anesthetic tracking down to femoral nerve, however no 
qualitative measures were taken.  Overall, the ultrasound guided SIFI approach to 
anesthetizing the LFCN showed promise, but has not been adequately evaluated for 
efficacy in a prospective study. 
 
       4.  Design & Procedures:  
 
Preoperatively, patients will be given standard of care premedications: 975mg 
acetaminophen and 300mg gabapentin by mouth prior to surgery.  These medications 
may be altered or not given depending on patient comorbidities or other extenuating 
factors such as allergy/intolerance.  Furthermore, a spinal anesthetic will be placed in 
the preoperative area.  
 
Patients will be taken to the operating room and sedated using IV propofol to a 
bispectral index (BIS) of 60-80, indicating adequate sedation.  Once sedated, patients 
will be given a 0.5mg/kg ketamine bolus (based on ideal body weight) and 10mg 
dexamethasone will be given prior to incision.  The orthopedic surgery attending will 
determine the degree of preoperative knee extension prior to the procedure and inform 
the anesthesia team.  At conclusion of the case sedation will be stopped and patient will 
be taken to the post-operative care unit (PACU). 
 
Post-operatively study interventions will begin. Patients will be assessed from 
arrival in PACU to determine their level of pain as well as nausea/vomiting.  Once the 
patient reported pain score in the recovery area is >5/10 on a 0-10 numerical pain scale 
study personnel will initiate intervention.  Patients will be given a one time IV bolus of 
15mg ketorolac. 
 
Patients will be randomized into either SIFI block or sham group with an online 
randomization program by the study PI (WMB) prior to any patient enrollment.  Patients 
will be given a number (1-40), and the randomized numbers will be given to key study 
personnel member that will be unblinded. The intervention drug, either 30mL 0.2% 
ropivacaine or sham block, consisting of 30mL saline, will be drawn up by this key 
personnel member of the study team who is unblinded and will not be involved in the 
SIFI block or post-operative analysis.  This person will supply the regional 
anesthesiologist with the intervention, however, both the regional anesthesiologist 
performing the block and the patient will be blind as to the contents of the syringe. 
 
At the completion of the intervention, verbally reported pain scores (NRS 11) and 
opioid consumption (IV morphine equivalents) will be measured by a blinded observer 
starting at time zero and monitored every 10 minutes for 1 hour (+/- 5 minutes). Verbal 
pain scores will then be recorded each hour for first 4 hours, 6 hours and 24 hours (+/- 
10 minutes). Patients will have post-operative orders for supplementary pain control that 


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include 25mcg IV fentanyl for pain scores 5-7 and 50mcg IV fentanyl for pain scores 8-
10. 
 
Subjects’ verbal pain scores and opioid consumption will be recorded hourly for 
the first four hours, at 6 hours, and at 24 hours.  Dynamometry will be utilized 2 hours 
post intervention on POD0 to determine the extent of quadriceps weakness achieved by 
SIFI injection as compared to unblocked leg.  Ambulation distance in feet will be 
measured POD0 and POD1 by physical therapy.  These results will be recorded as will 
hospital length of stay. 
 
5.  Selection of Subjects: 
ASA 1-3 patients aged 18-75 years old undergoing primary hip arthroplasty will 
be enrolled.  Patients will be identified preoperatively in either preoperative screening 
clinic or the night prior to surgery depending on method of preoperative screening.  
Patients in the study will be ASA 1-3 patients, many will be screened by phone instead 
of a clinic visit. Patients not seen in preoperative screening clinic will be contacted by 
telephone by primary investigator (WMB) to confirm eligibility and, if eligible and 
interested, the study will be explained. Patients will be given the opportunity to ask initial 
questions about the study over the phone. Patients interested in participating will be 
again have the protocol fully explained and written informed consent will be obtained on 
the day of surgery prior to receiving any sedation 
 
Inclusion 
 
Patients that will be included in the study are English speaking 18-75 year old 
ASA 1-3 patients undergoing primary total hip arthroplasty. 
 
Exclusion 
 
Patients will be excluded from the study if they meet one or more of the following 
Criteria: 
 
1) ASA 4 or 5 
 
2) Revision hip arthroplasty 
 
3) Diagnosis of chronic pain  
 
4) Daily chronic opioid use (over 3 months of continuous opioid use). 
 
5) Inability to communicate pain scores or need for analgesia. 
 
6) Acute hip fracture 
 
7) Infection at the site of block placement 
 
8) Age under 18 years old or greater than 75 years old 
 
9) Pregnant women (as determined by standard of care day-of surgery urine  
 
bHCG) 
 
10) Intolerance/allergy to local anesthetics 
11) Weight <50 kg 
12) Suspected or known addiction to or abuse of illicit drug(s), prescription 
medicine(s), or alcohol within the past 2 years. 
13) Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the 
opinion of the investigator, may interfere with study assessments or compliance. 
14) Current or historical evidence of any clinically significant disease or condition 
that, in the opinion of the investigator, may increase the risk of surgery or 
complicate the subject’s postoperative course. 
 
 
6.  Subject Recruitment & Compensation: 


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Only patients who are having total hip arthroplasty are eligible for this study. We 
will not bias any demographic groups in identifying patients eligible for this study. A total 
of 40 patients will be consented from Duke University Medical Center. An IRB approved 
phone script may be used to discuss the study with eligible patients missed at their Pre-
Op screening visit. Patients will not receive any additional compensation for enrollment 
in this study. 
 
7.  Consent Process 
 
A patient’s permission to be approached for research will be obtained by the 
primary care team involved with the patient.  The consent process will be conducted by 
the research personnel or one of the physicians involved in the study. The consent 
process will take place in the pre-operative screening or the surgical clinics. Throughout 
the consent process, measures will be taken to maintain privacy, such as by conducting 
face-to-face conversations in private rooms. As much time as necessary will be spent 
with each potential subject to sufficiently explain and answer all questions, and address 
all concerns they may have in regard to the study and/or consent process.  Under 
HIPAA waiver, the study team will identify potential subjects from clinic schedules, OR 
schedules and Maestro Care. 
 
8.  Subject’s Capacity to Give Legally Effective Consent: 
 
Patients who do not have the capacity to give legally effective consent will not be 
approached for participation in this study.  
 
9.  Study Interventions: 
 
See 4 above. 
 
10. Risk/Benefit Assessment: 
 
Patients will not incur any added risk to standard risks incurred with regional 
anesthesia.  These standards risks are: 
• 
Regional anesthesia - minor pain or discomfort, injury to arteries, veins or nerves 
affecting the arms or legs, residual numbness or weakness or paralysis, 
headache, muscle soreness, infection, allergy or adverse drug reaction, 
intravascular injection of local anesthetic causing seizure or cardiac arrest. 
Patients will be monitored in the post-operative care unit by nurses assigned to their 
care.  Once pain scores >5, the study team will be notified and the intervention will be 
performed. Patients will have post-operative analgesics available for pain control that 
include 25mcg IV fentanyl for pain scores 5-7 and 50mcg IV fentanyl for pain scores 8-
10.  Fentanyl will not be administered prior to intervention unless intervention cannot be 
performed within 5 minutes of notification by PACU nurse. 
 
Benefits include contributing to general knowledge base to improve future patient 
care.  This includes potential confirmation of analgesic benefit, decreased pain scores, 
and improved patient satisfaction.  Conversely, this study may show no benefit of the 
block, thereby invalidating the technique. 
 
11. Costs to the Subject: 
 
Subjects will not incur any additional costs to participate in the study.  A 
MaestroCare build will be created to ensure that any subjects are not charged for 
researched related procedures, equipment, or medications. 
 
12. Data Analysis & Statistical Considerations: 


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The primary hypothesis, that there is a difference in numeric pain score at 4 
hours postoperatively between the intervention groups, will be assessed with a two-
sided 2 group t-test or Mann-Whitney-Wilcoxson test as appropriate.  We will perform a 
secondary repeated measures ANOVA or non-parametric Friedman test to assess 
difference in numeric pain score over the full 24-hour period. If there is evidence of a 
difference in numeric pain score during the 24-hour period, we will perform post-hoc 
pair-wise multiple comparison corrected tests to identify the time-points where the 
intervention groups differ on pain score.  Additional secondary analyses will assess 
differences in cumulative opioid consumption in IV morphine equivalents and motor 
strength for both tibial and common peroneal nerves with parametric or non-parametric 
tests as appropriate. Statisticians employed by the Department of Anesthesiology will 
conduct these analyses. 
 
A total of 40 participants will be enrolled in the study, randomized equally 
between study (n=20) and placebo (n=20) groups based on sample size calculation for a 
non-parametric Mann-Whitney Test with α=0.05, β=0.8, difference in means=2, and 
effect size of 1.0. The sample size required for a non-parametric test will provide greater 
than 80% power if the data meet requirements for a parametric t-test.   
 
 
13. Data & Safety Monitoring:  
 
In accordance with federal regulations the PI will monitor for, review, and 
promptly report to the IRB, appropriate institutional officials, sponsor, coordinating center 
and the appropriate regulatory agency head all unanticipated problems involving risks to 
subjects or others that occur in the course of a subject’s participation in a research study 
(45 CFR 46.103(b)(5)(i) and 21 CFR 56.108(b)(1)), all AE reports will be reported per the 
DUHS IRB policies. PI will be monitoring all AEs and submitting reports to the IRB per 
DUHS IRB policy. 
 
14. Privacy, Data Storage & Confidentiality 
 
Potential subjects and their families will be approached private rooms. Any 
guests not involved in the consent process will be asked to leave the room during any 
such communications, unless the patient allows them to be present.  Efforts to maintain 
subject confidentiality will include following Federal Privacy Regulations which provide 
safeguards for privacy, security, and authorized access. Except when required by law, 
subjects will not be identified by name, social security number, address, telephone 
number, or any other direct personal identifier in study records disclosed outside of Duke 
University Health System (DUHS).  Subjects will not be revealed in any reports or 
publications resulting from this study.   For records disclosed outside of DUHS, subjects 
will be assigned a unique code number. The paper and electronic data will be stored as 
per the RDSP. 
 
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