Clinical trial NCT05294640
Conditions: Eyelid Tumor Eyelid Bump Eyelid Deformity Eyelid Abscess Eyelid Boil Eyelid Papilloma Anesthesia, Local Ophthalmology
Keywords: Oculoplastics Local Anesthesia Eyelid Anesthesia Periocular Anesthesia
Sponsor: University of California, San Francisco
Start date: 2022-05-17; Completion date: 2023-02-21
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators aim to assess whether bacteriostatic saline provides the same level of anesthesia as traditional local anesthesia while reducing pain associated with medication infusion in minor eyelid procedures

Detailed description:
Benzoyl alcohol is an aromatic alcohol that has been used in healthcare primarily as an antibacterial preservative agent in bacteriostatic saline. It has also been shown to have anesthetic properties, and has been demonstrated to cause less pain with infusion compared to lidocaine, while maintaining adequate pain relief. The use of bacteriostatic saline alone as an anesthetic for incisional procedures in the periocular area has not yet been studied. The purpose of this study was to determine whether bacteriostatic saline provides an adequate level of anesthesia for minor in-office eyelid procedures while allowing for reducing pain associated with medication infusion compared with traditional local anesthetic agents. To assess this, the investigators will recruit 150 patients aged 18 or older undergoing minor eyelid procedures including eyelid biopsies, chalazion removal from outpatient oculoplastics clinics at University of California, San Francisco. Patients will be randomized in a 1:1 fashion to undergo local anesthetic with either 1% lidocaine with 1:100,000 epinephrine or 0.9% bacteriostatic saline. Primary outcome measure will be pain level on a scale of 1-10 with regards to injection and procedure itself. These will be compared between the two groups. The investigators hypothesize that bacteriostatic saline is superior to lidocaine with epinephrine in terms of pain with injection, but will result in a similar pain level during the procedure.

Arms: arm 1: Patients receiving bacteriostatic saline as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department arm 2: Patients receiving lidocaine with epinephrine as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department
Interventions: intervention 1: 0.9% Bacteriostatic Local Anesthetic Injection intervention 2: 1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection intervention 3: Eyelid Lesion Removal
Intervention descriptions: intervention 1: Following research and procedural consent, local anesthetic injection will be carried out using a standard 1 cc of local anesthetic corresponding to the study arm (0.9% bacteriostatic saline or 1% lidocaine with 1:100,000 epinephrine). Prior to anesthetic administration, the procedure site will be cleaned using standard measures. A 30 gauge needle on a 3 centimeter cubed volume syringe will be utilized. Five minutes will be given for local anesthetic to take effect. intervention 2: Following research and procedural consent, local anesthetic injection will be carried out using a standard 1 cc of local anesthetic consisting of a commercially available mixture of 1% lidocaine with 1:100,000 epinephrine. Prior to anesthetic administration, the procedure site will be cleaned using standard measures. A 30 gauge needle on a 3 centimeter cubed volume syringe will be utilized. Five minutes will be given for local anesthetic to take effect. intervention 3: Following anesthesia administration, patient will proceed with recommended eyelid lesion removal. The procedure site will be cleaned according to standard protocol, and standard technique for lesion removal will be performed, which will vary according to type of lesion but may involve use of Westcott scissors, forceps, #15 or #11 blades or other oculoplastics administration. The exact procedural details will be at the discretion of the surgeon.

Protocol documents:
ICF_001.pdf: 
[ B acteri ost atic S ali ne as a L oc al A nest hetic C o nse nt] [ 2 0 2 2] 
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U NI V E R SI T Y O F C A LI F O R NI A, S A N F R A N CI S C O & S A N F R A N CI S C O V A
C O N S E N T T O P A R TI CI P A T E I N A R E S E A R C H S T U D Y
St u d y Titl e: B a ct eri o st ati c S ali n e a s a L o c al A n e st h eti c i n Mi n or E y eli d Pr o c e d ur e s
R e s e ar c h Pr oj e ct 
Dir e ct or:
R o b ert K er st e n, M D, Pr of e s s or of O p ht h al m ol o g y.  
U C S W a n d a n d Gl a d y s C e nt er f or Vi si o n, 4 9 0 Illi n oi s Str e et, S a n 
Fr a n ci s c o, C A.  P h o n e:  4 1 5- 3 5 3- 2 8 0 0; e- m ail:  
R o b ert. K er st e n @ u c sf. e d u 
St u d y C o or di n at or:
M el e h a A h m a d, M D.  4 1 5- 3 5 3- 2 8 0 0. 
M el e h a. A h m a d @ u c sf. e d u
T hi s i s a cli ni c al r e s e ar c h st u d y a b o ut p ai n d uri n g l o c al a n e st h e si a f or mi n or pr o c e d ur e s of t h e 
e y eli d s a n d ar o u n d t h e e y e. W e ai m t o s e e if b a ct eri o st ati c s ali n e, w hi c h i s alr e a d y c o m m o nl y 
u s e d i n t h e m e di c al fi el d, i s l e s s p ai nf ul t o i nj e ct b ut pr o vi d e s t h e s a m e l e v el of a n e st h e si a 
d uri n g t h e pr o c e d ur e. At l e a st o n e of t h e st u d y r e s e ar c h er s i n t h e d e p art m e nt of O pt h al m ol o g y, 
R o b ert K er st e n, M D; R e z a V a g efi, M D; Br y a n Wi n n, M D; S e a n n a Gr o b, M D; M el e h a A h m a d, 
M D; or t h eir a s s o ci at e s, will e x pl ai n t hi s st u d y t o y o u.
R e s e ar c h st u di e s i n cl u d e o nl y p e o pl e w h o c h o o s e t o t a k e p art. Pl e a s e t a k e y o ur ti m e t o m a k e 
y o ur d e ci si o n a b o ut p arti ci p ati n g, a n d di s c u s s y o ur d e ci si o n wit h y o ur f a mil y or fri e n d s if y o u 
wi s h. If y o u h a v e a n y q u e sti o n s, y o u ar e w el c o m e t o a s k t h e r e s e ar c h er s.
Y o u ar e b ei n g a s k e d t o t a k e p art i n t hi s st u d y b e c a u s e y o u h a v e t h e c o n diti o n li st e d a b o v e a n d 
c o ul d h el p u s l e ar n m or e a b o ut h o w t o r e d u c e p ai n d uri n g mi n or e y eli d pr o c e d ur e s i n f ut ur e 
p ati e nt s li k e y o u.
W h y i s t hi s st u d y b ei n g d o n e ?
T h e p ur p o s e of t hi s st u d y i s t o tr y t o r e d u c e p ai n i n c urr e d d uri n g offi c e- b a s e d pr o c e d ur e s o n 
a n d ar o u n d t h e e y eli d s. 
T hi s st u d y i s n ot f u n d e d. T h e i n v e sti g at or s d o n ot h a v e a n y fi n a n ci al i nt er e st s t o di s cl o s e.
H o w m a n y p e o pl e will t a k e p art i n t hi s st u d y ?
A b o ut 1 5 0 p e o pl e will t a k e p art i n t hi s st u d y. P arti ci p a nt s will b e r e cr uit e d fr o m U C S F a n d will 
i n cl u d e p ati e nt s u n d er g oi n g a n i n- offi c e pr o c e d ur e at U C S F O c ul o pl a sti c s cli ni c. 
W h at will h a p p e n if I t a k e p art i n t hi s r e s e ar c h st u d y ?
If y o u a gr e e, t h e f oll o wi n g pr o c e d ur e s will o c c ur:

Y o u will b e “r a n d o mi z e d” t o r e c ei v e o n e of t w o l o c al a n e st h eti c a g e nt s pri or t o y o ur offi c e-
b a s e d e y eli d pr o c e d ur e. B ot h a g e nt s ar e f e d er al dr u g a g e n c y ( F D A)- a p pr o v e d, h o w e v er o n e
a g e nt i s t h e “ st a n d ar d of c ar e” ( w h at i s m o st oft e n u s e d), w h er e a s t h e ot h er a g e nt i s
e x p eri m e nt al. T h e e x p eri m e nt al a g e nt h a s b e e n utili z e d i n ot h er p art s of t h e b o d y f or m a n y
y e ar s a n d h a s b e e n u s e d ar o u n d t h e e y e i n c o m bi n ati o n wit h ot h er m e di c ati o n s. B ut, it h a s
I R B N U M B E R: 2 2- 3 6 2 7 6
I R B A P P R O V A L D A T E: 0 5/ 0 6/ 2 0 2 2
I R B E X PI R A TI O N D A T E: 0 5/ 0 5/ 2 0 2 3
N C T 0 5 2 9 4 6 4 0


[ B acteri ost atic S ali ne as a L oc al A nest hetic C o nse nt] [ 2 0 2 2] 
P A G E 2 O F 4
n ot b e e n u s e d o n it s o w n f or l o c al a n e st h e si a ar o u n d t h e e y e. R a n d o mi z ati o n m e a n s t h at 
y o u ar e p ut i nt o a gr o u p b y c h a n c e. A c o m p ut er pr o gr a m will pl a c e y o u i n o n e of t h e gr o u p s. 
N eit h er y o u n or y o ur d o ct or c a n c h o o s e t h e gr o u p y o u will b e i n. Y o u will h a v e a n e q u al 
c h a n c e of b ei n g pl a c e d i n a n y gr o u p. 

Y o u will u n d er g o y o ur e y eli d pr o c e d ur e i n t h e s a m e f a s hi o n a s if y o u h a d n ot p arti ci p at e d i n 
t h e st u d y

Y o u will b e a s k e d a b o ut p ai n l e v el o n a 0 t o 1 0 s c al e d uri n g a n e st h eti c i nj e cti o n a n d d uri n g 
y o ur e y eli d pr o c e d ur e 
St u d y l o c ati o n:  T h e s e pr o c e d ur e s will b e d o n e at U C S F’ s O c ul o pl a sti c s cli ni c 
H o w l o n g will I b e i n t h e st u d y ?
P arti ci p ati o n i n t h e st u d y will a d d a n a d diti o n al 5- 1 0 mi n ut e s t o y o ur st u d y vi sit. Y o u will n e e d t o 
a n s w er q u e sti o n s r e g ar di n g y o ur p ai n l e v el d uri n g a n e st h eti c i nj e cti o n a n d pr o c e d ur e it s elf. N o 
a d diti o n al vi sit s will b e r e q uir e d b y y o ur p arti ci p ati o n i n t hi s st u d y. 
C a n I st o p b ei n g i n t h e st u d y ?
Y e s. Y o u c a n d e ci d e t o st o p at a n y ti m e. J u st t ell t h e st u d y r e s e ar c h er or st aff p er s o n ri g ht a w a y 
if y o u wi s h t o st o p p arti ci p ati n g i n t h e st u d y. W e will r e v ert t o a d mi ni str ati o n t h e s ur g e o n s 
st a n d ar d- of- c ar e l o c al a n e st h eti c at y o ur r e q u e st. 
Al s o, t h e st u d y r e s e ar c h er m a y st o p y o u fr o m t a ki n g p art i n t hi s st u d y at a n y ti m e if h e or s h e 
b eli e v e s it i s i n y o ur b e st i nt er e st, if y o u d o n ot f oll o w t h e st u d y r ul e s, or if t h e st u d y i s st o p p e d.
W h at si d e eff e ct s or ri s k s c a n I e x p e ct fr o m b ei n g i n t h e st u d y ?

Y o u m a y h a v e si d e eff e ct s w hil e i n t h e st u d y. E v er y o n e t a ki n g p art i n t h e st u d y will b e 
w at c h e d c ar ef ull y f or a n y si d e eff e ct s. H o w e v er, d o ct or s d o n’t k n o w all t h e si d e eff e ct s t h at 
m a y h a p p e n. Si d e eff e ct s m a y b e mil d or s eri o u s, i n cl u di n g l o c al all er gi c r e a cti o n, f a st h e art 
r at e or p ai n. Y o ur h e alt h c ar e t e a m m a y gi v e y o u m e di ci n e s t o h el p l e s s e n t h e si d e eff e ct s. 

Y o u will b e a s si g n e d t o a n a n e st h eti c t y p e b y c h a n c e, a n d t h e tr e at m e nt y o u r e c ei v e m a y 
pr o v e t o b e l e s s eff e cti v e or t o h a v e m or e si d e eff e ct s t h a n t h e ot h er st u d y tr e at m e nt or 
ot h er a v ail a bl e tr e at m e nt s.

Y o u m a y e x p eri e n c e all er gi c r e a cti o n, m or e or l e s s p ai n or bl e e di n g wit h l o c al a n e st h eti c or 
d uri n g t h e pr o c e d ur e d e p e n di n g o n w hi c h l o c al a n e st h eti c y o u ar e r a n d o mi z e d t o. 

F or m or e i nf or m ati o n a b o ut ri s k s a n d si d e eff e ct s, a s k o n e of t h e r e s e ar c h er s.
Ar e t h er e b e n efit s t o t a ki n g p art i n t h e st u d y ?
T h er e will b e n o dir e ct b e n efit t o y o u fr o m p arti ci p ati n g i n t hi s st u d y a n d b e n efit s c a n n ot b e 
g u ar a nt e e d. H o w e v er, t h e i nf or m ati o n t h at y o u pr o vi d e m a y h el p h e alt h pr of e s si o n al s b ett er 
u n d er st a n d/l e ar n m or e a b o ut w h at l o c al a n e st h eti c s ar e m o st c o mf ort a bl e f or p ati e nt s 
u n d er g oi n g e y eli d pr o c e d ur e s li k e y o ur s.  
W h at ot h er c h oi c e s d o I h a v e if I d o n ot t a k e p art i n t hi s st u d y ?
Y o u ar e fr e e t o c h o o s e n ot t o p arti ci p at e i n t h e st u d y. If y o u d e ci d e n ot t o t a k e p art i n t hi s st u d y, 
t h er e will b e n o p e n alt y t o y o u. Y o u will still u n d er g o y o ur e y eli d pr o c e d ur e a s pl a n n e d, a n d y o u 
c a n still g et y o ur c ar e fr o m o ur i n stit uti o n t h e w a y y o u u s u all y d o.
I R B N U M B E R: 2 2- 3 6 2 7 6
I R B A P P R O V A L D A T E: 0 5/ 0 6/ 2 0 2 2
I R B E X PI R A TI O N D A T E: 0 5/ 0 5/ 2 0 2 3


[ B acteri ost atic S ali ne as a L oc al A nest hetic C o nse nt] [ 2 0 2 2] 
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Will i nf or m ati o n a b o ut m e b e k e pt c o nfi d e nti al ?
P arti ci p ati o n i n r e s e ar c h i n v ol v e s s o m e l o s s of pri v a c y.  W e will d o o ur b e st t o m a k e s ur e t h at 
i nf or m ati o n a b o ut y o u i s k e pt c o nfi d e nti al, b ut w e c a n n ot g u ar a nt e e t ot al pri v a c y.  S o m e 
i nf or m ati o n fr o m y o ur m e di c al r e c or d s will b e c oll e ct e d a n d u s e d f or t hi s st u d y.  If y o u d o n ot 
h a v e a U C S F m e di c al r e c or d, o n e will b e cr e at e d f or y o u.  Y o ur si g n e d c o n s e nt f or m a n d s o m e 
of y o ur r e s e ar c h t e st s will b e a d d e d t o y o ur U C S F m e di c al r e c or d.  T h er ef or e, p e o pl e i n v ol v e d 
wit h y o ur f ut ur e c ar e a n d i n s ur a n c e m a y b e c o m e a w ar e of y o ur p arti ci p ati o n a n d of a n y 
i nf or m ati o n a d d e d t o y o ur m e di c al r e c or d a s a r e s ult of y o ur p arti ci p ati o n.  St u d y t e st s t h at ar e 
p erf or m e d b y r e s e ar c h l a b s, a n d i nf or m ati o n g at h er e d dir e ctl y fr o m y o u b y t h e r e s e ar c h er s will 
b e p art of y o ur r e s e ar c h r e c or d s a n d m a y b e a d d e d t o y o ur m e di c al r e c or d.  Y o ur p er s o n al 
i nf or m ati o n m a y b e gi v e n o ut if r e q uir e d b y l a w.  If i nf or m ati o n fr o m t hi s st u d y i s p u bli s h e d or 
pr e s e nt e d at s ci e ntifi c m e eti n g s, y o ur n a m e a n d ot h er p er s o n al i nf or m ati o n will n ot b e u s e d.
Ar e t h er e a n y c o st s t o m e f or t a ki n g p art i n t hi s st u d y ?
T w o t y p e s of pr o c e d ur e s will b e d o n e d uri n g t hi s st u d y. S o m e ar e p art of y o ur st a n d ar d m e di c al 
c ar e a n d ot h er s ar e o nl y f or r e s e ar c h. Y o u or y o ur i n s ur er will b e bill e d f or t h e st a n d ar d m e di c al 
c ar e. Y o u will b e r e s p o n si bl e f or y o ur c o- p a y s, d e d u cti bl e s, a n d a n y ot h er c h ar g e s t h at y o ur 
i n s ur er will n ot p a y. T h er e i s a p o s si bilit y t h at y o ur i n s ur er m a y n ot c o v er all st a n d ar d m e di c al 
c ar e c o st s if y o u ar e r e c ei vi n g m e di c al s er vi c e s o ut of n et w or k. A n y pr o c e d ur e s d o n e o nl y f or 
r e s e ar c h will n ot b e c h ar g e d t o y o u or y o ur i n s ur er.
If y o u h a v e q u e sti o n s a b o ut w h at c o st s y o u will b e r e s p o n si bl e f or, pl e a s e t al k wit h t h e st u d y 
i n v e sti g at or b ef or e d e ci di n g t o e nr oll i n t h e st u d y. D e p e n di n g o n t h e t y p e of st u d y, s o m e of y o ur 
c o st s c o ul d b e s u b st a nti al.
Will I b e p ai d f or t a ki n g p art i n t hi s st u d y ?
Y o u will n ot b e p ai d f or t a ki n g p art i n t hi s st u d y.
W h at h a p p e n s if I a m i nj ur e d b e c a u s e I t o o k p art i n t hi s st u d y ? 
It i s i m p ort a nt t h at y o u t ell y o ur st u d y d o ct or, Dr. R o b ert K er st e n, if y o u f e el t h at y o u h a v e b e e n 
i nj ur e d b e c a u s e of t a ki n g p art i n t h e st u d y. Y o u c a n t ell t h e d o ct or i n p er s o n or c all hi m at 4 1 5-
3 5 3- 2 8 0 0.
W h at ar e m y ri g ht s if I t a k e p art i n t hi s st u d y ?
T a ki n g p art i n t hi s st u d y i s y o ur c h oi c e. Y o u m a y c h o o s e eit h er t o t a k e p art or n ot t o t a k e p art i n 
t h e st u d y. If y o u d e ci d e t o t a k e p art i n t hi s st u d y, y o u m a y l e a v e t h e st u d y at a n y ti m e. N o 
m att er w h at d e ci si o n y o u m a k e, t h er e will b e n o p e n alt y t o y o u i n a n y w a y. Y o u will n ot l o s e a n y 
of y o ur r e g ul ar b e n efit s, a n d y o u c a n still g et y o ur c ar e fr o m o ur i n stit uti o n t h e w a y y o u u s u all y 
d o.
W h o c a n a n s w er m y q u e sti o n s a b o ut t h e st u d y ?
Y o u c a n t al k t o t h e r e s e ar c h er( s) a b o ut a n y q u e sti o n s, c o n c er n s, or c o m pl ai nt s y o u h a v e a b o ut 
t hi s st u d y.  C o nt a ct t h e r e s e ar c h er( s) M el e h a A h m a d, M D a n d R o b ert K er st e n, M D at 4 1 5- 3 5 3-
2 1 4 2.
I R B N U M B E R: 2 2- 3 6 2 7 6
I R B A P P R O V A L D A T E: 0 5/ 0 6/ 2 0 2 2
I R B E X PI R A TI O N D A T E: 0 5/ 0 5/ 2 0 2 3


[ B acteri ost atic S ali ne as a L oc al A nest hetic C o nse nt] [ 2 0 2 2] 
P A G E 4 O F 4
If y o u wi s h t o a s k q u e sti o n s a b o ut t h e st u d y or y o ur ri g ht s a s a r e s e ar c h p arti ci p a nt t o s o m e o n e 
ot h er t h a n t h e r e s e ar c h er s or if y o u wi s h t o v oi c e a n y pr o bl e m s or c o n c er n s y o u m a y h a v e 
a b o ut t h e st u d y, pl e a s e c all t h e I n stit uti o n al R e vi e w B o ar d at 4 1 5- 4 7 6- 1 8 1 4.
C O N S E N T
Y o u h a v e b e e n gi v e n a c o pi e s of t hi s c o n s e nt f or m a n d t h e E x p eri m e nt al S u bj e ct’ s Bill of Ri g ht s 
t o k e e p.  
Y o u will b e a s k e d t o si g n a s e p ar at e f or m a ut h ori zi n g a c c e s s, u s e, cr e ati o n, or di s cl o s ur e of 
h e alt h i nf or m ati o n a b o ut y o u.
P A R TI CI P A TI O N I N R E S E A R C H I S V O L U N T A R Y.  Y o u h a v e t h e ri g ht t o d e cli n e t o b e i n t hi s 
st u d y, or t o wit h dr a w fr o m it at a n y p oi nt wit h o ut p e n alt y or l o s s of b e n efit s t o w hi c h y o u ar e 
ot h er wi s e e ntitl e d.
If y o u wi s h t o p arti ci p at e i n t hi s st u d y, y o u s h o ul d si g n b el o w.
D at e
P arti ci p a nt' s Si g n at ur e f or C o n s e nt
D at e
P er s o n O bt ai ni n g C o n s e nt
I R B N U M B E R: 2 2- 3 6 2 7 6
I R B A P P R O V A L D A T E: 0 5/ 0 6/ 2 0 2 2
I R B E X PI R A TI O N D A T E: 0 5/ 0 5/ 2 0 2 3

Prot_SAP_002.pdf: 
NCT05294640  
2/3/2024 
 
1 
Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures  
 
Introduction  
Benzoyl alcohol is an aromatic alcohol that has been used in healthcare primarily as an 
antibacterial preservative agent in bacteriostatic saline. It has also been shown to have 
anesthetic properties, and has been demonstrated to cause less pain with infusion 
compared to lidocaine1, while maintaining adequate pain relief for certain procedures 
such as IV insertion2,3, cervical anesthesia4 and hip injections5. It has also been 
demonstrated to provide pain relief when used to reconstitute botulinum toxin and to 
have greater cost effectiveness compared to lidocaine10,6.  
 
The use of bacteriostatic saline alone as an anesthetic for incisional procedures in the 
periocular area has not yet been studied.7 In a prospective, randomized, double-blinded 
randomized control trial comparing lidocaine buffered with either bacteriostatic saline or 
sodium bicarbonate in incisional eyelid surgery, lidocaine buffered with bacteriostatic 
saline showed greater comfort on injection with bacteriostatic saline buffer while 
providing a similar level of anesthesia,8 bacteriostatic saline with epinephrine was 
significantly less painful on infiltration. In a dermatologic randomized controlled trial, 
compared to lidocaine buffered with sodium bicarbonate for superficial procedures such 
as shave excision, scissor excision, superficial curettage but not deep punch biopsy or 
flap closures.9 
 
Clinical question  
 
Does bacteriostatic saline an adequate level of anesthesia compared to lidocaine with 
epinephrine while reducing pain associated with medication infusion in minor eyelid 
procedures.  
 
Participants  
 
Patients >= 18 years old undergoing clinic-based “minor” eyelid procedures in clinic with 
at least one lesion.  
 
Inclusion criteria:  
1. Age >=18 years old  
2. Any eyelid lesion presenting to clinic setting  
Exclusion criteria  
1. Any other topical, PO or IV sedating medications given alongside procedure  
2. Allergy to lidocaine or epinephrine  
 
Intervention 
  
1. 0.9% Bacteriostatic Saline  
2. 2% Lidocaine + 1/100,000 Epinephrine  
 
Outcome Measures  


NCT05294640  
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Primary 
1. Pain during injection (1-10) 
2. Pain during procedure (1-10)  
 
Secondary 
1. Bleeding requiring >5 minutes of firm pressure or cautery  
2. Need for additional anesthesia  
 
Study Protocol  
 
Prior to clinic day, patient list will be reviewed to identify potentially eligible patients. On 
the procedure day, eligible patients will be approached for participation following initial 
evaluation by attending physician. If patient amenable, patient will be consented for 
study. Photograph will be taken of the lesion directly in electronic medical record, and 
lesion circled using annotate function. Each lesion will be randomized separately using 
iPhone-based randomization application to either bacteriostatic saline or lidocaine with 
epinephrine. Fellow will be unblinded, attending physician blinded. Medication will be 
drawn up by fellow and handed to attending physician who will inject the medication. 
Immediately following injection, patient will be asked pain level on 0 to 10 scale, which 
was noted. Five minutes will be allowed to pass and then procedure will be 
commenced. If patient has more pain than acceptable to them, additional study agent 
will be injected and procedure re-started. If continued presence of pain, one more 
additional trial of the study agent will be allowed. If patient continues to have pain, 
medication will be defaulted to standard of care (lidocaine with epinephrine). 
Alternatively, if patient requests standard of care at any point, medication will be 
switched to this. Immediately following procedure, patient will be asked pain level on 0 
to 10 scale, which was noted. Number of reinjections or need to default to standard of 
care will be noted. Bleeding level (Mild, moderate, or severe) will be noted. Mild is 
defined as not needing pressure to stop. Moderate is defined as needing five minutes or 
pressure to stop. Severe is defined as needing cautery or a pressure patch. 
Immediately following injection, patient will be asked pain level on 0 to 10 scale.  
 
Statistical Plan  
 
Pain of injection and pain of procedure are recorded on a categorical scale and 
compared using Student T-Tests. Percent of lesions requiring reinjection and 
percentage of lesions with “severe” bleeding were compared using Chi-square tests. To 
see if lesions size had any effect on these metrics, the lesions will be divided into < 1 
mm, 1-5 mm, and > 5 mm, and analysis will be repeated on these groups.  
 
References  
 
1. Wilson L, Martin S. Benzyl alcohol as an alternative local anesthetic. Ann Emerg 
Med. 1999;33(5):495-499. doi:10.1016/s0196-0644(99)70335-5  


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2/3/2024 
 
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2. Minogue SC, Sun DA. Bacteriostatic saline containing benzyl alcohol decreases the 
pain associated with the injection of propofol. Anesth Analg. 2005;100(3):683-686. 
doi:10.1213/01.ANE.0000148617.98716.EB  
 
3. Patterson P, Hussa AA, Fedele KA, Vegh GL, Hackman CM. Comparison of 4 
analgesic agents for venipuncture. AANA J. 2000;68(1):43-51.  
 
4. Miller L, Jensen MP, Stenchever MA. A double-blind randomized comparison of 
lidocaine and saline for cervical anesthesia. Obstet Gynecol. 1996;87(4):600-604. 
doi:10.1016/0029-7844(95)00463-7  
 
5. Kruse RC, Kindle BJ, Wisniewski S, Presley J, Smith J, Sellon JL. Local Anesthesia 
Prior to Ultrasound-Guided Hip Joint Injections: A Double-Blind Randomized Controlled 
Trial of Bacteriostatic Saline versus Buffered Lidocaine. PM R. 2021;13(8):811-818. 
doi:10.1002/pmrj.12489  
 
6. Kwiat DM, Bersani TA, Bersani A. Increased patient comfort utilizing botulinum toxin 
type a reconstituted with preserved versus nonpreserved saline. Ophthal Plast Reconstr 
Surg. 2004;20(3):186-189. doi:10.1097/01.iop.0000129012.09632.49  
 
7. Hunt SV, Malhotra R. Bacteriostatic preserved saline for pain-free periocular 
injections: review. Eye Lond Engl. Published online January 11, 2022. 
doi:10.1038/s41433-021-01925-z  
 
8. Yuen VH, Dolman PJ. Comparison of three modified lidocaine solutions for use in 
eyelid anesthesia. Ophthal Plast Reconstr Surg. 1999;15(2):143-147. 
doi:10.1097/00002341-199903000-00017  
 
9. Lugo-Janer G, Padial M, Sánchez JL. Less painful alternatives for local anesthesia. J 
Dermatol Surg Oncol. 1993;19(3):237-240. doi:10.1111/j.1524-4725.1993.tb00342.x  
 
10. OmanKS,FinkR,KleinerC,etal.IntradermalLidocaineorBacteriostaticNormal Saline to 
Decrease Pain Before Intravenous Catheter Insertion: A Meta-Analysis. J Perianesth 
Nurs. 2014;29(5):367-376. doi:10.1016/j.jopan.2013.12.008