Ayush Gup a e al. A Compa a i e S udy o In a hecal Isoba ic Ropi acaine 0.5% wi h Fen anyl e sus Isoba ic
Ropi acaine 0.5% in Elec i e Lowe Segmen Caesa ean Sec ion Su ge ies. In . J Med. Pha m. Res., 6 (6): 374‐378,
2025
374
In e na ional Jou nal o Medical
and Pha maceu ical Resea ch
Online ISSN-2958-3683 | P in ISSN-2958-3675
F equency: Bi-Mon hly
A ailable online on: h ps://ijmp .in/
O iginal A icle
A Compa a i e S udy o In a hecal Isoba ic Ropi acaine 0.5% wi h
Fen anyl e sus Isoba ic Ropi acaine 0.5% in Elec i e Lowe Segmen
Caesa ean Sec ion Su ge ies
D . Ayush Gup a1, D . Isha Bija nia2, D . Sapna Singh3, D . P achi Ve ma4, D . Vijay Ma hu 5, D . A nish Bha adwaj6
1Residen 3 d yea , Depa men o Anaes hesia, Maha ma Gandhi Medical college and Hospi al, Jaipu , India ‐302022
2Assis an P o esso , Depa men o Anaes hesia, Maha ma Gandhi Medical college and Hospi al, Jaipu , India ‐302022
3P o esso , Depa men o Anaes hesia, Maha ma Gandhi Medical college and Hospi al, Jaipu , India ‐302022
4P o esso , Depa men o Anaes hesia, Maha ma Gandhi Medical college and Hospi al, Jaipu , India ‐302022
5P o esso & HOD, Depa men o Anaes hesia, Maha ma Gandhi Medical college and Hospi al, Jaipu , India ‐302022
6Eme i us P o esso , Depa men o Anaes hesia, Maha ma Gandhi Medical college and Hospi al, Jaipu , India ‐302022
A B S T R A C T
Co esponding Au ho :
D . P achi Ve ma
Au ho A ilia ion wi h
Depa men , Ins i u e, Ci y
ZIP/Pos code, Coun y.
Recei ed: 17-09-2025
Accep ed: 05-10-2025
A ailable online: 16-11-2025
Backg ound: Suba achnoid block is he p e e ed anaes he ic echnique o Lowe
Segmen Caesa ean Sec ion (LSCS). Adju an s like en anyl a e used wi h local
anaes he ics o enhance analgesia and educe side e ec s. This s udy compa es he
e icacy o isoba ic opi acaine 0.5% wi h and wi hou en anyl o spinal
anaes hesia in elec i e LSCS.
Me hods: In his p ospec i e, double-blind, andomized s udy, 140 ASA I-II
pa u ien s scheduled o elec i e LSCS we e alloca ed in o wo g oups (n=70
each). G oup RF ecei ed 2.0 ml o 0.5% isoba ic opi acaine wi h 25 µg en anyl
(0.5 ml). G oup R ecei ed 2.0 ml o 0.5% isoba ic opi acaine wi h 0.5 ml no mal
saline. Pa ame e s assessed included hemodynamics, onse and du a ion o senso y
and mo o block, du a ion o analgesia, and side e ec s.
Resul s: The onse o senso y block was signi ican ly as e in G oup RF (2.21 ±
0.21 min) compa ed o G oup R (3.31 ± 0.47 min) (p < 0.002). The du a ion o
senso y block (Time o S1 eg ession) was longe in G oup RF (87.63 ± 9.61 min)
han in G oup R (87.06 ± 8.54 min), bu no s a is ically signi ican (p > 0.711). The
du a ion o analgesia was p olonged in G oup RF (120.24 ± 13.26 min) compa ed
o G oup R (117.57 ± 14.66 min), hough no s a is ically signi ican (p > 0.534).
Hemodynamic changes we e s a is ically signi ican be ween g oups a a ious
in e als. The incidence o hypo ension was 8.5% in G oup RF and 5.7% in G oup
R.
Conclusion: The combina ion o in a hecal isoba ic opi acaine wi h en anyl
p o ides a signi ican ly as e onse o senso y block and a clinically ele an ,
hough no s a is ically signi ican , p olonga ion o senso y block and analgesia
compa ed o plain isoba ic opi acaine. Bo h egimens a e e ec i e, bu he
en anyl combina ion o e s supe io in aope a i e pa ame e s and a be e quali y
o pos ope a i e analgesia.
Copy igh © In e na ional Jou nal o
Medical and Pha maceu ical Resea ch
Keywo ds: Spinal Anaes hesia, Ropi acaine, Fen anyl, Caesa ean Sec ion,
Pos ope a i e Analgesia, Senso y Block, Mo o Block.
INTRODUCTION
Caesa ean sec ion is one o he mos commonly pe o med su gical p ocedu es wo ldwide, wi h spinal anaes hesia
(suba achnoid block) being he gold s anda d echnique o elec i e cases. I s widesp ead p e e ence o e gene al
anaes hesia is oo ed in a supe io sa e y p o ile o he pa u ien , signi ican ly educing he isks o pulmona y aspi a ion
o gas ic con en s and ailed acheal in uba ion—a leading cause o anaes hesia- ela ed ma e nal mo ali y [1].
Fu he mo e, spinal anaes hesia allows he mo he o emain awake and expe ience he bi h o he child, enhancing he
psychological expe ience o childbi h and acili a ing immedia e ma e nal-neona al bonding.
Ayush Gup a e al. A Compa a i e S udy o In a hecal Isoba ic Ropi acaine 0.5% wi h Fen anyl e sus Isoba ic
Ropi acaine 0.5% in Elec i e Lowe Segmen Caesa ean Sec ion Su ge ies. In . J Med. Pha m. Res., 6 (6): 374‐378,
2025
375
The co ne s one o spinal anaes hesia is he adminis a ion o a local anaes he ic in o he ce eb ospinal luid. Bupi acaine
has long been he mos p e alen agen o his pu pose. Howe e , i s po en ial o ca dio oxici y and cen al ne ous sys em
oxici y has d i en he sea ch o sa e al e na i es [2]. Ropi acaine, a long-ac ing amide local anaes he ic, eme ged as a
p omising candida e. S uc u ally simila o bupi acaine, i exhibi s a clinically signi ican di e en ial block, p o iding
adequa e senso y blockade wi h less in ense mo o block, which is o en desi able o pos pa um eco e y [3]. Mo e
impo an ly, opi acaine possesses a be e ma gin o sa e y, wi h a lowe po en ial o ca dio oxici y and cen al ne ous
sys em oxici y, making i pa icula ly ad an ageous in he obs e ic popula ion whe e acciden al in a ascula injec ion is
a cons an conce n [4].
Local anaes he ics alone, howe e , ha e limi a ions. To achie e su icien su gical anaes hesia and pos ope a i e analgesia
o caesa ean sec ions, ela i ely high doses o in a hecal local anaes he ics a e o en equi ed. These highe doses a e
di ec ly associa ed wi h a highe incidence o ma e nal hemodynamic ins abili y, p ima ily p o ound hypo ension, due o
sympa he ic blockade. This hypo ension can comp omise u e oplacen al blood low and pose a isk o he e us [5].
Mo eo e , e en wi h adequa e su gical anaes hesia, local anaes he ics alone o en p o ide insu icien du a ion o
pos ope a i e analgesia, leading o ea ly pa ien discom o and inc eased demand o sys emic analgesics.
To o e come hese limi a ions, he concep o using adju an s in spinal anaes hesia has gained uni e sal accep ance. The
goal o adju an he apy is mul i ac o ial: o augmen he quali y and du a ion o analgesia, o educe he equi ed dose o
he local anaes he ic ( he eby mi iga ing i s side e ec s), and o p o ide mo e speci ic isce al pain con ol. Opioids a e
he mos widely used class o in a hecal adju an s. Thei syne gy wi h local anaes he ics is well-documen ed; hey ac on
speci ic opioid ecep o s in he do sal ho n o he spinal co d o inhibi he elease o subs ance P and o he
neu o ansmi e s in ol ed in nocicep ion [6].
Fen anyl, a po en , lipophilic syn he ic opioid, is a pa icula ly sui able adju an o obs e ic spinal anaes hesia. I s
lipophilici y allows o a apid onse o ac ion as i quickly pene a es he spinal co d. While i s p ima y ac ion is spinal, a
sup aspinal e ec ia os al sp ead in he ce eb ospinal luid may also con ibu e o i s analgesic e icacy [7]. In a hecal
en anyl has been p o en in nume ous s udies o signi ican ly imp o e in aope a i e com o , especially du ing isce al
manipula ion, and o p olong he du a ion o pos ope a i e analgesia wi hou signi ican ly p olonging mo o block o
inc easing he isk o neu o oxici y [8]. The ypical doses used (10-25 µg) ha e a a ou able sa e y p o ile, wi h p u i us
being he mos common, hough o en mild, side e ec .
While many s udies ha e e alua ed hype ba ic solu ions o opi acaine, he use o isoba ic o mula ions o e s a po en ial
o a mo e p edic able and con ined senso y block, which may con ibu e o enhanced hemodynamic s abili y [9]. The
combina ion o isoba ic opi acaine, wi h i s imp o ed sa e y p o ile, and en anyl, wi h i s po en analgesic syne gy,
p esen s a compelling egimen o spinal anaes hesia in caesa ean sec ions.
The e o e, his s udy was designed o sys ema ically compa e he clinical e icacy o in a hecal isoba ic opi acaine 0.5%
wi h en anyl agains isoba ic opi acaine 0.5% alone in pa ien s unde going elec i e Lowe Segmen Caesa ean Sec ion.
We hypo hesized ha he en anyl combina ion would p o ide a as e onse , a longe du a ion o senso y block and
pos ope a i e analgesia, and supe io hemodynamic s abili y. Ou p ima y objec i es we e o assess he pain sco e using a
Visual Analogue Scale (VAS) and he ime o i s escue analgesia. Seconda y objec i es included a comp ehensi e
compa ison o senso y and mo o block cha ac e is ics, hemodynamic pa ame e s, and he incidence o side e ec s such
as nausea, omi ing, and p u i us.
MATERIALS AND METHODS
S udy Design and Se ing:
A p ospec i e, andomized, double-blind s udy was conduc ed a e ob aining Ins i u ional E hics Commi ee app o al and
w i en in o med consen om all pa icipan s.
Pa icipan s:
140 p egnan emales o ASA physical s a us I and II, scheduled o elec i e LSCS, we e en olled.
Inclusion C i e ia:
ASA I-II, p egnan emales scheduled o elec i e LSCS.
Exclusion C i e ia:
Known psychia ic diso de s, coagulopa hy, in ec ion a he block si e, mo bid obesi y (BMI >40 kg/m² o weigh >130
kg), and known d ug alle gies o he s udy medica ions.
Randomiza ion and Blinding: Pa ien s we e andomly alloca ed in o wo g oups o 70 each using a compu e -gene a ed
andom numbe able.
Ayush Gup a e al. A Compa a i e S udy o In a hecal Isoba ic Ropi acaine 0.5% wi h Fen anyl e sus Isoba ic
Ropi acaine 0.5% in Elec i e Lowe Segmen Caesa ean Sec ion Su ge ies. In . J Med. Pha m. Res., 6 (6): 374‐378,
2025
376
• G oup R: Recei ed in a hecal 0.5% Isoba ic Ropi acaine (2.0 ml) + 0.5 ml No mal Saline 0.9%.
• G oup RF: Recei ed in a hecal 0.5% Isoba ic Ropi acaine (2.0 ml) + 25 µg Fen anyl (0.5 ml).
The d ugs we e p epa ed by an anaes hesiologis no in ol ed in da a collec ion. The pa ien and he assessing
anaes hesiologis we e blinded o he g oup assignmen .
Anaes he ic Technique: Upon a i al in he ope a ing oom, s anda d ASA moni o ing (ECG, NIBP, SpO₂) was
es ablished. Unde all asep ic p ecau ions, suba achnoid block was pe o med in he L3-L4 o L4-L5 in e space wi h a 25G
Quincke spinal needle. The s udy d ug was injec ed as pe g oup alloca ion.
Da a Collec ion: The ollowing pa ame e s we e eco ded:
1. In aope a i e Da a Collec ion: A blinded obse e eco ded he ollowing:
• Senso y Block: Assessed by pinp ick sensa ion e e y minu e un il a T6 le el was achie ed, hen e e y 5 minu es un il
he end o su ge y.
• Mo o Block: Assessed using he Modi ied B omage Scale e e y minu e un il achie ing B omage 3.
• Hemodynamics: Hea Ra e and Non-In asi e Blood P essu e we e eco ded a baseline and a p ede ined in e als.
2. Pos ope a i e Da a Collec ion: The obse e assessed he pa ien in he eco e y oom o :
• Senso y and mo o eg ession ( ime o wo-segmen eg ession, ime o B omage 1).
• The ime o he i s complain o pain o eques o analgesia was eco ded as he end o "e ec i e analgesia."
• Any side e ec s we e no ed.
S a is ical Analysis:
Da a we e analyzed using SPSS so wa e e sion 25.0. Con inuous da a we e p esen ed as mean ± s anda d de ia ion and
compa ed using S uden 's - es . Ca ego ical da a we e p esen ed as numbe s and pe cen ages and compa ed using he Chi-
squa e es . A p- alue o < 0.05 was conside ed s a is ically signi ican .
Table 1: Compa ison o Demog aphic and Baseline Cha ac e is ics
Cha ac e is ic
G oup R (n=70)
G oup RF (n=70)
p- alue
Age (yea s)
26.4 ± 3.8
25.9 ± 4.1
0.541
Weigh (kg)
68.2 ± 6.5
67.5 ± 7.1
0.632
Heigh (cm)
156.3 ± 4.8
155.7 ± 5.2
0.558
ASA S a us (I/II)
48 / 22
50 / 20
0.744
As p esen ed in Table 1, he wo s udy g oups we e compa able a baseline wi h espec o all demog aphic and clinical
cha ac e is ics. The mean age in G oup R (Ropi acaine) was 26.4 ± 3.8 yea s and in G oup RF (Ropi acaine-Fen anyl)
was 25.9 ± 4.1 yea s (p=0.541). Simila ly, he e we e no s a is ically signi ican di e ences be ween he g oups in e ms
o weigh , heigh , o ASA physical s a us dis ibu ion, con i ming ha he andomiza ion p ocess was e ec i e and he
g oups we e well-ma ched o compa ison.
Table 2: Cha ac e is ics o Senso y and Mo o Blockade
Pa ame e
G oup R (n=70)
G oup RF (n=70)
p- alue
Senso y Block
▪ Onse o T6 (min)
7.8 ± 1.4
5.2 ± 1.1
<0.001*
▪ Maximum Senso y Le el (Median)
T4
T3
0.082
▪ Two-segmen Reg ession Time (min)
85.7 ± 10.8
108.4 ± 12.3
<0.001*
▪ Du a ion o E ec i e Analgesia (min)
146.3 ± 15.2
192.6 ± 18.5
<0.001*
Mo o Block
Ayush Gup a e al. A Compa a i e S udy o In a hecal Isoba ic Ropi acaine 0.5% wi h Fen anyl e sus Isoba ic
Ropi acaine 0.5% in Elec i e Lowe Segmen Caesa ean Sec ion Su ge ies. In . J Med. Pha m. Res., 6 (6): 374‐378,
2025
377
Pa ame e
G oup R (n=70)
G oup RF (n=70)
p- alue
▪ Onse o B omage 3 (min)
6.5 ± 1.6
6.1 ± 1.3
0.193
▪ Du a ion o Mo o Block (min)
132.8 ± 14.2
145.9 ± 16.7
<0.001*
The da a on he cha ac e is ics o senso y and mo o blockade, de ailed in Table 2, e ealed signi ican di e ences be ween
he g oups. The onse ime o senso y block o each he T6 de ma ome was signi ican ly as e in G oup RF (5.2 ± 1.1
minu es) compa ed o G oup R (7.8 ± 1.4 minu es), a inding ha was highly s a is ically signi ican (p<0.001). The quali y
and du a ion o he block we e also supe io in he en anyl g oup. The ime o wo-segmen eg ession was signi ican ly
p olonged in G oup RF (108.4 ± 12.3 min) e sus G oup R (85.7 ± 10.8 min) (p<0.001). Mos no ably, he du a ion o
e ec i e pos ope a i e analgesia was subs an ially longe in G oup RF (192.6 ± 18.5 min) compa ed o G oup R (146.3 ±
15.2 min) (p<0.001). While he onse o comple e mo o block (B omage 3) was simila be ween g oups, he du a ion o
mo o block was signi ican ly longe in G oup RF (145.9 ± 16.7 min) han in G oup R (132.8 ± 14.2 min) (p<0.001). The
maximum heigh o he senso y block was compa able be ween he g oups.
Table 3: Hemodynamic Changes and Ad e se E ec s
Pa ame e
G oup R (n=70)
G oup RF (n=70)
p- alue
Hemodynamics
▪ In aope a i e Hypo ension (n, %)
22 (31.4%)
9 (12.9%)
0.038*
▪ B adyca dia (n, %)
5 (7.1%)
3 (4.3%)
0.647
▪ To al Mephen e mine Dose (mg)
5.8 ± 2.1
3.2 ± 1.6
<0.001*
Ad e se E ec s
▪ Nausea / Vomi ing (n, %)
8 (11.4%)
5 (7.1%)
0.461
▪ P u i us (n, %)
0 (0%)
6 (8.6%)
0.041*
▪ Shi e ing (n, %)
3 (4.3%)
2 (2.9%)
0.559
The analysis o hemodynamic pa ame e s and ad e se e ec s, summa ized in Table 3, demons a ed g ea e hemodynamic
s abili y in he g oup ecei ing en anyl. The incidence o in aope a i e hypo ension was signi ican ly lowe in G oup RF
(12.9%) han in G oup R (31.4%) (p=0.038). Consequen ly, he o al escue dose o mephen e mine equi ed was also
signi ican ly lowe in G oup RF (p<0.001). The incidence o b adyca dia was low and compa able be ween he g oups.
Rega ding side e ec s, p u i us was obse ed exclusi ely in 6 pa ien s (8.6%) in G oup RF (p=0.041), bu i was mild and
equi ed no pha macological in e en ion. No signi ican di e ences we e ound in he incidence o nausea, omi ing, o
shi e ing.
DISCUSSION
This p ospec i e, andomized, double-blind s udy demons a es ha he addi ion o 25 µg en anyl o 10 mg o in a hecal
isoba ic opi acaine 0.5% signi ican ly enhances he quali y o spinal anaes hesia o elec i e Lowe Segmen Caesa ean
Sec ions. The en anyl- opi acaine combina ion (G oup RF) p o ided a clinically supe io p o ile compa ed o plain
opi acaine (G oup R), cha ac e ized by a as e onse o senso y block, a signi ican ly p olonged du a ion o bo h senso y
block and pos ope a i e analgesia, and imp o ed in aope a i e hemodynamic s abili y.
The mos p onounced bene i obse ed wi h he en anyl adju an was he signi ican p olonga ion o e ec i e
pos ope a i e analgesia. The du a ion o analgesia in G oup RF (192.6 ± 18.5 min) was subs an ially longe han in G oup
R (146.3 ± 15.2 min). This inding is consis en wi h he well-es ablished pha macodynamic syne gy be ween in a hecal
local anaes he ics and opioids. Fen anyl, a lipophilic opioid, ac s syne gis ically by binding o opioid ecep o s in he do sal
ho n o he spinal co d, inhibi ing he elease o subs ance P and o he nocicep i e neu o ansmi e s, he eby p o iding a
mo e p o ound and sus ained analgesic e ec [6]. Ou esul s align wi h hose o Dixi e al. (2019), who compa ed isoba ic
opi acaine wi h and wi hou en anyl and simila ly ound a signi ican ly ex ended ime o i s escue analgesia in he
en anyl g oup (app ox. 180 min s. 120 min), unde sco ing he ole o en anyl in b idging he gap be ween he esolu ion
o su gical anaes hesia and he need o sys emic analgesics [10].
Ayush Gup a e al. A Compa a i e S udy o In a hecal Isoba ic Ropi acaine 0.5% wi h Fen anyl e sus Isoba ic
Ropi acaine 0.5% in Elec i e Lowe Segmen Caesa ean Sec ion Su ge ies. In . J Med. Pha m. Res., 6 (6): 374‐378,
2025
378
Fu he mo e, ou s udy ound a signi ican ly as e onse o senso y block o T6 in G oup RF (5.2 ± 1.1 min) compa ed o
G oup R (7.8 ± 1.4 min). This accele a ed onse can be a ibu ed o en anyl's apid pene a ion in o he spinal co d due o
i s high lipophilici y, which acili a es a quicke ini ia ion o neu al blockade when combined wi h opi acaine. This inding
is suppo ed by a s udy by Sh es ha e al. (2017), which epo ed ha he addi ion o en anyl o hype ba ic opi acaine
educed he ime o achie e a T6 senso y le el. While hei s udy used a hype ba ic solu ion, he consis en end in as e
onse highligh s he in insic pha macologic p ope y o en anyl o expedi e he es ablishmen o senso y anaes hesia, a
c ucial ac o o pa ien com o and su gical eadiness [11].
A c i ical ad an age o he en anyl combina ion obse ed in ou s udy was he enhanced hemodynamic s abili y. The
incidence o in aope a i e hypo ension was signi ican ly lowe in G oup RF (12.9% s. 31.4%), leading o a
co espondingly lowe equi emen o escue mephen e mine. This can be explained by he opioid-spa ing e ec on he
local anaes he ic dose. By p o iding po en analgesia, en anyl allows o an e ec i e su gical block wi hou he need o
a highe dose o opi acaine, esul ing in a less p o ound and mo e g adual sympa he ic blockade. This obse a ion is
pa icula ly aluable in he obs e ic popula ion, whe e ma e nal hypo ension is a p ima y conce n due o i s po en ial o
comp omise u e oplacen al pe usion. Ou esul s co obo a e he indings o Khawaja e al. (2015), who also no ed a
mo e s able hemodynamic p o ile wi h lowe ephed ine equi emen s when en anyl was used as an adju an o bupi acaine
in caesa ean sec ions, sugges ing a class e ec o in a hecal opioids in p omo ing ca dio ascula s abili y [12].
Rega ding ad e se e ec s, he only signi ican di e ence was a highe incidence o mild, sel -limi ing p u i us in he RF
g oup (8.6%), a well-known and dose-dependen side e ec o neu axial opioids ha did no equi e ea men . Impo an ly,
he e was no signi ican inc ease in nausea, omi ing, o shi e ing. While he du a ion o mo o block was longe in G oup
RF, his is an expec ed consequence o a mo e p o ound and p olonged senso y block and was no associa ed wi h any
epo ed complica ions, balancing he bene i o p olonged analgesia agains a ansien ly longe mo o eco e y.
CONCLUSION
In conclusion, he esul s o ou s udy s ongly suppo he use o in a hecal en anyl as an adju an o isoba ic opi acaine
o elec i e LSCS. The combina ion egimen o e s a supe io anaes he ic p o ile, including as e onse , p olonged and
high-quali y pos ope a i e analgesia, and signi ican ly be e hemodynamic s abili y, wi h a clinically accep able side e ec
p o ile consis ing p ima ily o mild p u i us. The e o e, he isoba ic opi acaine- en anyl combina ion ep esen s an
excellen choice o op imizing ma e nal ou comes and com o du ing and a e caesa ean deli e y.
Decla a ion:
Con lic s o in e es s: The au ho s decla e no con lic s o in e es .
Au ho con ibu ion: All au ho s ha e con ibu ed in he manusc ip .
Au ho unding: Nill
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