Comparing Fascia Iliaca Compartment Block With Pericapsular Nerve Group Block for Hip Fracture Pain Control Before Operation
Phase: NA
Conditions: Hip Fractures, Analgesia, Nerve Blocks
Sponsor: Mackay Memorial Hospital

Comparing Fascia Iliaca Compartment Block with Pericapsular Nerve 
Group Block for Hip Fracture Pain Control before Operaton
Study Protocol with SAP (statstcal analysis plan)
Date: 12/04/2019

Background
Hip fracture is a global health care concern. It is estiatee that the nuiber of 
hip fractures globally was 1.6 iillion in 20001, ane will be increasee to 6.25 iillion 
by 20502. Tiiely surgery is the iainstay of treatient for hip fractures3. Before 
operaton, pain ianageient for hip fracture is a clinical challenge. The fracture-
ineucee pain is so intense that ieeical treatient with acetaiinophen, non-steroie 
ant-inflaiiatory erugs (NSAIIssa or opioies iay not proiiee aeeauate analgesia. 
Furtheriore, opioie analgesia is liiitee by siee efects such as nausea, ioiitng, 
eizziness, seeaton, ane respiratory eepression. On the contrary, peripheral nerie 
block proiiees beter pain control for hip fracture than opioies 4,5. Fascia iliaca 
coipartient block (FIC blocka, for exaiple, has been repeateely shown to be 
superior to opioies for pain control for hip fracture5,6. Recently, a noiel peripheral 
nerie block techniaue, the “pericapsular nerie group block (PENG blocka7”, has been 
eeielopee for hip fracture pain control. PENG block is consieeree to proiiee beter 
coierage of artcular branches froi the obturator nerie than FIC block, ane thus 
iight be superior to FIC block in hip fracture pain control. Howeier, there is no 
stuey coiparing the analgesic efect for hip fracture pain between the FIC block ane 
PENG block. 
Aim
The aii of this stuey is to coipare the analgesic efect of FIC block ane PENG 
block in hip fracture pain control.
Methods
This will be a raneoiizee, assessor ane partcipant-blineee stuey. Ieult 
patents (agee 20 years or oleera scheeulee for surgical treatient for hip fracture 
with Iierican SAociety of Inesthesiologists (ISAIa physical status I-III will be assessee 
for eligibility to partcipate the stuey. The exclusion criteria incluees: allergy to local 
anesthetcs, pregnancy, inability to uneerstane ane use the nuierical ratng scale 
(NRSA 0-10, 0: no pain, 10: worst pain iiaginablea afer instructon, chronic use of 
opioies, coagulopathy, neuropathy or seiere eiabetc iellitus. If the patents giie his 
/her inforiee consents, his/her baseline eeiographic eata (geneer, age, height, ane 
boey weighta ane types of hip fracture will be recoreee. Partcipants will be 
raneoily allocatee into either FIC block or PENG block by using the website 
RESAEIRCH RINsOMIZER (htps://www.raneoiizer.orga. One of the two 
anesthesiologists experiencee in perforiee the FIC ane PENG blocks will perfori 
the nerie blocks. Only the anesthesiologist perforiing the nerie block ane his 
assistant will be aware of which nerie block the partcipant receiiee iiieeiately 

before perforiing nerie block by opening a sealee enielope. The assessors, in-
charge anesthesiologists ane nurse anesthetsts, operaton rooi personnel, 
surgeons ane stuey partcipants will be all blineee to the raneoiizaton. The 
partcipants are unlikely to know which nerie block they receiie because the neeele 
inserton sites ane neeele trajectories of these two nerie blocks are auite close to 
each other.
On arriial of the operatng theater, all partcipants will be sent to the nerie 
block area, where contnuous electrocareiograi (ECGa, pulse oxiietry, ane non-
iniasiie interiitent blooe pressure ionitoring will be appliee ane an intraienous 
line will be establishee. Before any interienton, pain at rest ane euring the 
fracturee lower liib being passiiely internal rotatee in extension to neutral positon 
froi its usual externally rotatee eeforiity by assessors will assessee using NRSA. If 
the partcipant cannot tolerate passiie internal rotaton of his/her fracturee liib 
eue to pain, iipossibility to perfori the test will be recoreee as well as the worst 
NRSA score euring these ateipts. The saie assessient will be perforiee eiery 10 
iins for untl 30 iins afer coipleton of the nerie block. Then the patent will be 
sent to the operaton rooi, where spinal anesthesia will be perforiee for the 
surgery. 
Procedures of the nerve blocks
I supra-inguinal FIC block will be perforiee in the way as eescribee preiiously8, 
9. I linear ultrasoune transeucer (6-15 MHz, SAonoSAite, M-Turbo, USAIa is placee in a 
sagital plane to ieentfy the anterior superior iliac spine (ISAISAa. By slieing the 
transeucer ieeially, the fascia iliaca ane abeoiinal internal obliaue, satorius, ane 
iliopsoas iuscles are ieentiee. Ifer ieentfying the “bow-te sign”, a 23-gauge 
neeele (7ii, Nipro, Japana is insertee in plane froi caueal to cephalae untl the 
neeele tp penetrate the fascia iliaca. Ifer negatie aspiraton, 0.35% ropiiacaine 
30iL with 1:400,000 epinephrine will be injectee to separate the fascia iliaca ane 
the iliacus iuscle. 
The PENG block will be perforiee as preiiously eescribee7. I curiilinear 
ultrasoune transeucer (2-5 MHz, SAonoSAite, M-Turbo, USAIa is initally place on the 
anterior inferior iliac spine (IIISAa ane then alignee to the iliopubic eiinence by 
rotatng aroune 45 eegree. In this iiew, the iliopubic eiinence, iliapsoas iuscle ane 
teneon, pectneus iuscle, feioral artery ane iein will be ieentiee. I 23-gauge 
neeele (7ii, Nipro, Japana is insertee in plane froi lateral to ieeial untl the 
neeele tp in the iusculofascial plane between the psoas teneon anteriorly ane the 
pubic raius posteriorly. Ifer negatie aspiraton, 0.35% ropiiacaine 20iL with 
1:400,000 epinephrine will be injectee.

Outcome measurements
The priiary outcoie of this stuey is the pain ieasureient at rest ane euring 
the fracturee liib being passiiely internally rotatee 30 iins afer nerie block. The 
seconeary outcoies incluees the pain ieasureient euring positoning for spinal 
anesthesia (froi supine to lateral eecubitus with flexion of the healthy hipa, pain 
ieasureient at 6, 12, ane 24 hours afer operaton, the tie speneing for 
perforiing spinal anesthesia (eeinee as startng of positoning ianeuier to reioial 
of spinal neeelea, auality of positon for spinal anesthesia (characterizee as 
unsatsiee, satsiee, gooe, ane excellent by the anesthesiologists perforiing the 
spinal anesthesiaa, the tie interial between the ene of operaton ane pain irst 
perceiiee by the patent, the tie interial between the ene of operaton ane the 
irst reauest for rescue analgesics, total consuipton of rescue analgesics within 24 
hours afer the operaton, the tie interial between the ene of operaton ane the 
irst tie the patent can aibulate with assistance afer operaton, the tie 
speneing for nerie block (eeinee as froi contact of skin by the ultrasoune 
transeucer to reioial of the neeelea, ane satsfacton of the patent regareing 
preoperatie analgesia froi nerie block ( iery gooe, gooe, aeeauate, poor, iery 
poora inauiree on the 1st postoperatie eay.
Statstcs
Basee on a preiious stuey, the staneare eeiiaton of pain score afer FIC block 
was 2.410. Issuiing the iiniial clinically iiportant eiference in NRSA score is 1.5, 
44 patents in each group are reauiree to achieie a power of 80% ane a leiel of 
signiicance of 5% (two sieeea. One huneree eligible patents (50 patents in each 
groupa will be enrollee in the stuey afer inforiee consents are obtainee. The eata 
of norial eistributon will be analyzee with ineepeneent t-test, otherwise Mann-
Whiteny U test will be usee for analyses. Categorical eata will be analyzee using χ2 
test or Fisher’s exact test. P < 0.05 will be consieeree statstcally signiicant.
There is no conflict of interest.
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