JOURNAL OF 108 - CLINICAL MEDICINE A N D PHARMACY Vol.12 - N''8/2017
So sanh tac dung giam dau trong chuyen da de duong ngoai mang cung bang ropivacain 0,1% voi levobupivacain 0,1%
Epidural analgesia during labor, a comparison between ropivacaine 0.1% and levobupivacaine 0.1%
Nguyen Dire Lam*, Pham Hda Himg** *Trucmg Dgi hoc YHd Ngi
**Benh vien da khoa Bdi Chdy, Quang Ninh
Muc tiiu: So sanh tac dung g i l m dau trong ehuyen da de va cle t i e dung khong mong mudn tren me va con cua gay te ngoai mang cdng gida ropivacain 0,1 % vPl levobupivacain 0,1 %. Ddi tuang vd phdOng phdp: Thd nghiem lam sang co so sanh tren 100 san phu, d§ thudng tai Benh vien Phu San Ha Npi, dupc g i l m dau trong dd bang phuong p h i p gay te ngoai mang edng va dupe ehia ngau nhien thanh hai nhdm:
Nhdm R sddung ropivacain 0,1 %va fentanyl 2mcg/ml, nhom L sddung levobupivacain 0,1% va fentanyl 2mcg/ml. Lieu bolus ban dau d e l hai nhom la 10ml, li^u thudc te duy tri truyen hen tuc qua catheter ngoai mang cdng la 8ml/giP, khi benh nhan xuat hien dau, VAS > 4 thi tiem them 5ml thude te d moi nhdm qua catheter ngoai mang edng. Ap dung phuong phap truyen lien tuc thudc te bang bom tiem dien qua catheter ngoai mang edng va dupe dieu chinh tde dp truyen tuy theo dap dng cua sin phu. Kef qud: Oiem dau VAS cua eac benh nhan d tat e l eac thdi diem trong nghien cdu deu khong cd sU khae biet cd y nghTa thdng ke gida hai nhom, 100% sin phu sau d ^ deu hai long va rat hai Idng. Cae san phu d nhom ropivacain it bi dc che van dpng va it t i c dung khong mong mudn hon so vPi nhom levobupivacain: J)/ le de ehe van ddng Bromage dp 0 11: 100% so vpi 88%, Bromage dp 1 d nhdm ropivacain la 0% so vdi 12% d nhdm levobupivacain. Ty le run d nhdm ropivacain la 4% so vdi 16%. Kit lugn: Gay te ngoai mlng cdng de gilm dau trong chuyen da bang ropivacain 0,1% cd tac dung g i l m dau tUOng duong vdi levobupivacain 0,1%
nhung ft de che van dpng hon va ft tac dung khong mong muon hem.
Tdkhoa: Gay te ngoai mang cdng, g i l m dau trong chuyen da, ropivacain, levobupivacain.
Summary
Objective: The aim of the present study was to compare the effects and side effects of epidural analgesia during labor with 0.1% ropivacaine or 0.1% levobupivacaine. Subject and method: The study was conducted at Hanoi Obstetric and Gynecology Hospital. One hundred women in labor were randomly assigned to receive epidural analgesia with either 0.1% ropivacaine plus fentanyl 2meg/ml (group R) or 0.1 % levobupivacaine plus fentanyl 2mcg/ml (group L). Epidural analgesia was initiated with 10ml of anesthetic solutionand was maintained with 8ml/h continuous bolus doses through the epidural catheter. Anesthetic dose can be adjusted according to the response of the parturients. Result No significant difference was observed in VAS pain score between the two groups during the total labor time. 100%of postpartum women in both groups rated same satisfaction ofanalgesia (satisfied and very
Ngdy nh4n bdi: 11/9/2017. ngdy chdp nhdn ddng. 15/9/2017
Ngucriphdn hdi: Nguyen Dire Lam. Email [email protected] - Trudng Dai hoc YHd Ngi
TAP CHlY DUOC LAM SANG 1 Tapl2-S68/2017 satisfied). Patients in the group R experienced fewer motor inhibited and side effects than those in the group L: 100% of group R vs 88% of group L had Bromage 0 and 6% of group L had Bromage 1;4% of group R vs 16% of group L had trembling. Conclusion: Analgesia with ropivacaine 0.1% for labor pain relief is associated with lower incidence of motor blocks in comparison with analgesia with levobupivacaine 0.1 %. There is no difference of analgesic effect between the two groups.
Keywords: Epidural anesthesia, pain relief during labor, ropivacaine, levobupivacaine.
I . D a t v a n d e
Gay te ngoai mang cdng giam dau trong ehuyen da dd la phdong phap g i l m dau dupe da ehudng nhat tren the gidi cung nhu d Viet Nam vi:
Hieu q u i g i l m dau cao, khdng I n h hUdng tdi con co tCf eung - ddng ldc chfnh eCia chuyen da, ft anh hddng den tuan hoan, hd hap eua me, it anh hUdng den thai nhi vi thude it qua hang r i o rau thai. Tuy nhien, viec Ida chpn thudc te rat quan trpng vi ngoai hieu qua giam dau eon p h l i d i m bao an toan cho me, cho eon va it t i e dung khdng mong mudn.
Ropivacain va levobupivacain la nhdng thuoc te the hi mdi, an toan, ft ddc tfnh tren tim mach va than kinh hon bupivaeain. £>a ed nhdng nghien cdu so sanh t i c dung cda ropivacain vdi buplvacain va levobupivacain vdi bupivaeain cho thay hieu qua gilm dau cda ropivacain va levobupivacain tuong duong vdi buplvacain nhUng ft t i e dung dc che van dong hon buplvacain va it ddc tren tim maeh hon so vdi buplvacain. Nhdng chua ed nghien cdu so sanh tie dung g l i m dau trong ehuyen da cda ropivacain v l levobupivacain d ndng dp 0,1%. Vi v l y chung tdi tien h l n h nghidn cdu nay nham mue tidu: So sdnh hieu qud gidm dau, mdc do dc chi vdn dgng, cdc tdc dung khdng mong mudn vd mdc do hdi Idng cua sdn phu khi gidm dau ngodi mdng cdng trong chuyen dg di bdng ropivacain 0,1 % vdi levobupivacain 0,1 %.
2. Doi t d d n g va p h d d n g p h a p 2.1. Doi tdcfng
100 s i n phu eon so, chuyen da dd, tudi > 18, ASA dp I - II, ed t d cung m d 3cm cd ehi djnh de dudng dddi va ddng y g i l m dau bang phdong p h i p gay te ngoai mang cdng. Tieu ehuan loai t r d : Cle san phu cd chdng chi djnh gay te viJng, dien bien cupe di bat t h d d n g ' Sa day rau, suy thai...
2.2. Phdar^ i h d p ; Thd nghidm lam sang ngau nhien cd d d ' !•
2.3. Cdch thde tien hanh
Chuan bi benh n h i n : Benh n h i n ddpc kham lam sang va lam ele xet nghiem can lam sang, neu benh n h i n khdng cd chdng ehi djnh g l y td ngoai mang cdng thl tien hanh g i l i thich cho s i n phu va gia dmh ve ky t h u l t . Oat 1 dudng truyen tinh mach ngoai vi 20G va truyen 500ml dung dich Ringer laetat. Mae monitor theo doi nhip tim, huyet I p , dp bao hda oxy mao mach, tan sd t h d cda me v l mae monitor s i n khoa theo ddi tim thai, tan sd eOn co, eudng dp con CO. Bdc tham ngau nhien de ehia benh n h i n t h l n h 2 nhdm: Nhdm R sd dung ropivacain 0,1%, nhdm L sd dung levobupivacain 0,1%, c l hai nhdm deu phdi hpp vdi fentanyl 2mcg/ml.
Tien hanh gay te n g o l i mang cdng: Vj trf d khe L3-4 vdi t u the benh nhan nam nghieng trai cong lUng t d m , x l c djnh khoang ngoai m l n g edng bang ky thuat mat sdc can vdi bom tiem chda dung djch NaCI 0,9%. Ludn catheter len phfa dau s i n phu de cd djnh 4 - Sem trong khoang ngoai mang edng. Lieu test gdm 3ml lidocain 2%. Bat dau g l i m dau bang tiem lieu ban dau qua catheter ngoai mang cdng 10ml dung djch ropivacain 0 , 1 % phdi hop vdi 2mcg/ml fentanyl h o l e dung djch levobupivacain 0,1 % phdi hop vdi 2mcg/ml fentanyl. Sau dd duy tri bom tiem dien 8ml/gid eae dung djch thudc te. Neu s i n phu van dau diem VAS > 3 thi tiem them tdng lieu 5ml dung djch thudc td, each nhau 10 phut den khi VAS < 3 rdi duy tri lieu chay bom tiem dien 8ml/gid. Rut catheter ngoai mang cdng khi k h I u xong tang sinh mdn.
2.4. Cdc chi tieu ddnh gid
B l n h gia t i c dung giam dau theo thang diem VAS, d i n h g i l tac dung dc ehe van ddng theo thang diem Bromage, d i n h gia cae t i c dung khdng mong mudn hay gap: Budn ndn, run, ngda, b f t i e u . . .
JOURNAL OF 108 - CLINICAL MEDICINE AND PHARMACY VoL12-N''8/2017
3. Ket q u i
Bang 1 . Dac diem chung cua san phu va gSy te ngoai mang cdng
Thong so Tuoi (nam) Chieu cao (cm) Can nang (leg) Tuan tuoi thai (tuin)
Nhom R (ropivacain) (n = 50) 27,16 ±3,81 (21-38) 158,38±3,76(150-167)
63,62 ± 4,76 (52,5 - 73) 39,28 ±1,07 (33-42)
Nhom L (levobupivacain) (n = 50) 27,64 ±3,16 (20-34) 157,78 ±3,89 (150-167)
63,92 ± 5,7 (55 - 80) 39,22 ±1,09 (38-42)
P
>0,05
>0,05
>0,0S
>0,05 Nhdn xit Khdng cd su khac biet ve ele d i e diem chung cCia cac ddi tdpng nghien cdu. Ty le md lay thai cung khdng ed sd k h l c biet gida hai nhdm.
BSng 2. Hieu qua vo cdm va hieu qua phong be van dpng
Thong so Thdi gian tiem tang u:c che c^m giac dau (phut)
Diem dau VAS Trade gay te Giai doan lb Giai doan II Khi lam thCi thuat san CTc che van dong theo Bromage
B6 0 D o i D6 2 Do 3
Huyet ap trung binh thay doi < 10%
Huyetap trung binh thay doi 10-20%
Huyet ap trung binh thay doi > 20%
Luong thuoc sCfdung Thuoc te(mg) Fentanyl (meg)
Nhom R (ropivacain) (n = 50) 7,26 ±1,94
7,34 ±1,08 1,81 ±0,94 2,27 ±1,3 2,79 ±1,34
50(100%) 0 (0%) 0(0%) 0(0%) 45 (90%)
5(10%) 0
31,69 ±9,92 63,38 ±19,84
Nhom L (levobupivacain) (n = 50) 7,14 ±2,02
7,16 ±0,98 1,74 ±0,88 2,47 ±1,22 2,84±1,17
44 (88%) 6(12%)
0(0%) 0(0%) 43 (86%)
7(14%) 0
30,55 ± 8,83 60,86 ±17,51
P
>0,05
>0,05
>0,05
>0,05
>0,05
>0,0S
<0,05
>0,05
>0,05
>0,05
>0,05
>0,05 W/jpn xef; Nhdm levobupivacain c d t / le dc che van dpng d mdc Bromage dp I la 12% so vdi C ropivacain (p<0,05).
Bdng 3. Oanh gia cac tac dung khong mong muon
Thong so Buon non Run Ngufa
Nhom R (ropivacain) (n = 50)
3(6%) ' 2 (4%) 6(12%)
Nhom L (levobupivacain) (n = 50) 5 (10%) 8(16%) 5(10%)
P
>0,05
<0,05
>0,05 Nhdn xetTy le ret run d nhdm levobupivacain cao hon nhdm ropivacain {p<0,05).
fAP CHI Y DUOC LAM SANG 108 Tapl2-S6 8/2017
Bing 4. Oanh gia sU hai long cOa s i n phu
Thong so Rat hai long Hal long Khong hai long
Nhom R (ropivacain) (n = 50) 30 (62,5%) 18(37,5%) 0(0%)
Nhom L (levobupivacain) (n = 50) 25(58,14%) 18(41,86%) 0(0%)
P
>0,05
>0,05
Nhdn xet Khdng co sd k h l c biet ve sd h l l Idng eua c l e s i n phu d hai nhdm (p>0,05).
Cle san phu d hai nhom nghien cdu khdng cd su khlc biet ve cae dac diem chung nhU: Tudi cua san phu, tuoi thai, chieu cao, can nang. De so sanh hieu qui g i l m dau trong ehuyen da de bSng g l y te ngoai mang edng eua hai loai thudc te thi chi tieu can quan tam 11 thdi gian khdi phat tae dung giam dau [1].
Trong nghien cdu cda chdng tdi, thdi gian nay khdng cd sd khae biet ed y nghia thdng ke gida hai nhom (7,26 ± 1,94 phut d nhdm ropivacain va 7,14 ± 2,02 phut d nhdm levobupivacain). Ket qua eua ehdng tdi thIp hcffi ket q u i nghien cdu cua Lakesh K Anandkhl nghien edu g l y te ngoai mang edng eho 25 sin phu bang ropivacain 0,1% -i- fentanyl 2mcg/ml v l 25 san phu bang buplvacain 0,125% -i- fentanyl 2mcg/ml (thdi gian khdi phat tac dung giam dau cCia nhdm ropivacain la 9,14 ± 1,46 phut) [2]. Theo nghien edu cua Takako Hamada khi nghien cdu so s i n h 23 san phu bang levobupivacain 0,1 % + fentanyl 2meg/ml va 23 sin phu dung levobupivacain 0,06% + fentanyl 2mcg/ml {thc^ gian khc^ phat t i e dung g i l m dau cua nhdm levobupivacain 0,1% la 9,53 ± 2,37 phdt) [5]. Cd le la do chung tdi tien h l n h nghien cdu tren s i n phu CO ed t d cung da m d 3cm cdn cac tac gia khae nghien cdu tren sin phu cd ed t d cung < 6cm va di^m VAS trung binh cda cac san phu chung tdi nghien cdu (VAS
< 8) thap hon VAS trung binh ma cac tae g i l tren nghien edu (VAS > 8). Ket q u i nghien cdu cho thay:
Thdi gian thudc te ropivacain ndng dp 0,1% cd tae dung dc ehe cam gilc dau tdong ddOng vdi levobupivacain 0,1 %, hai thude nay cd thdi gian khdi te nhanh, dap dng ddOc nhu cau g i l m dau trong chuyen da de khi cd t d cung m d 3 - 4em d ngddi con so.
Hieu q u i g i ^ " ^ ^^^ '^'^dc the hi§n ro nhat khi 3 l n h qia d<^' ^^^ ^ ^^^ *'^^' ^ ' ^ " ^ trUdc va sau
khi gay te ngoai mang cdng cung nhd trong sudt c i c giai doan cua q u i trinh chuyen da. TrUde khi gay te, diem VAS trung binh cua hai nhdm deu rat cao (7,34 ± 1,08 d nhdm ropivacain va 7,16 + 0,98 d nhdm levobupivacain). Tuy nhien, diem VAS d cac thdi diem sau khi khdi phat tae dung giam dau den het giai doan lb, giai doan 11 cua cudc chuyen da va khi lam thd thuat san khoa nhu kiem s o l t t d cung khau tang sinh mdn deu dUdi 4 va khong cd sU khae biet gida hai nhdm nghien edu. Bieu nay eho thay hieu q u i giam dau cua ropivacain 0 , 1 % la tUOng duong vdi levobupivacain eung ndng dp. Ket qua eua ehiing tdi phu hpp vdi ket qua trong nghidn cdu cua Long J va Yue Y khi g l y te n g o l i mang edng san khoa b i n g ropivacain (diem VAS d cudi giai doan I la 3,3 ± 1,3; cudi giai doan 11 11 3,9 ± 2,2 va eudi giai doan III la 2,1 ±0,9) [3].
Trong gay te ngoai mang euffig sin khoa, ngoai hieu q u i g i l m dau ngudi ta cdn quan tam den mdc dp de che van ddng t d cung vi eon co t d cung la ddng luc chinh cua cupc de. Neu thudc te gay dc che van ddng nhieu thi se lam tang t^ le p h l i lay thai bang dung cu (foocxep, g i l c hut). Ket q u i nghien edu cua chung tdi cho thay: Nhdm ropivacain it bl dc che van ddng hon so vdi nhdm levobupivacain (ty Id Bromage dp 0 va dp 1 ia 100% va 0% so vdi 88% va 12%), sd khlc biet ed y nghia thdng ke vdi p<0,05 va khdng ed s i n phu nao dc che van ddng Bromage do 2,3.
N g o l i hieu q u i giam dau va de ehe van ddng thi t i c dung khdng mong mudn cua thudc te cung rat quan trpng vi nd g l y ra khd chju eho s i n phu va nd lien quan true tiep den mdc 66 hai Idng cua san phu.
Ket q u i nghien cdu cua ehung tdi eho thay c l e s i n phu chi gap cac tac dung khPng mong mudn nhe nhd ngda, budn ndn, run, cac t i e dung khdng mong
JOURNAL OF 108 - CLINICAL MEDICINE AND PHARMACY VoL12-N°8/2017
mudn n l y ehi d mde nhe, khdng phai dieu tri gi, va chiem ty le nhd tuong dng vdi nhdm ropivacain 0,1% va levobupivacain 0,1%: Ty le s i n phu bj budn ndn ehiem 6% va 10%, ngda chiem 12% va 10%.
Rieng tJ le run chlem 4% d nhdm ropivacain va 16%
d nhdm levobupivacain t$' le nay khac nhau ed y nghla thdng ke vdi p<0,05. Nhdng t i e dung phu nay thddng het rat nhanh v l khdng phai dieu trj gi, hieu q u i g i l m dau tdt ndn 100% cac san phu dupe g i l m dau trong chuyen da deu hai Idng, trong dd ty le rat hai long rat eao (62,5% ddi vdi nhdm ropivacain 0,1% v l 58,14% ddi vdi nhdm levobupivacain 0,1%).
£>ieu nay cho thay ca hai thude te ropivacain 0,1% v l levobupivacain 0,1% cd hieu q u i g i l m dau t d t d i p dng ddpc nhu cau g i l m dau cua eac s i n phu trong chuyen da de, nhung ropivacain it gap dc che van ddng hon va ft g l y run hon so vdi levobupivacain.
5. Ket luan
Gay te ngoai mang cdng de g i l m dau trong chuyen da de bang ropivacain 0 , 1 % phdi hop vdi fentanyl 2meg/ml cd tac dung g i l m dau tuong duong vdi levobupivacain 0 , 1 % phdi hpp vdi fentanyl 2meg/ml (diem VAS giai doan lb, 11 eua hai nhdm lan lupt la 1,81 + 0,94 va 2,27 ± 1,3 so vdi 1,74
± 0,88 va 2,47 ± 1,22) nhUng it gay de che van ddng hon (khdng ed bdnh nhan nao d nhdm ropivacain bi phong be van ddng do I theo Bromage so vdi 12%i
cua nhdm levobupivacain) nen ft anh hUdng den k h i nang ran de eda s i n phu va ft gay ret run hon (4% d nhdm ropivacain so vdi 16% d nhdm levobupivacain). Ngoai ra, cae t i c dung khdng mong mudn khac khdng cd su k h l c biet cd )? nghTa thdng kegida hai nhdm.
Tai lieu tham khio
1 Nguyen Ddc Lam, Nguyen The Lpe (2010) Ddnh gid tdc dung cda ropivacain 0,1% phdi hgp vdi fentanyl 2pg/ml gdy ti ngodi mdng cdng gidm dau trong di. Hpi nghj sin khoa Viet - Phap - H I Npi, tr.
205-209.
2. Lakesh KA (2016) A comparison of 0,1% ropivacain and 0,1% bupivaeain with patient - controlled epidural analgesia for labor: A double blind study.
3. Long J, Yue Y (2003) Patient controlled intra venous analgesia with tramadol for pain relief Chinese Medical Journal 116(11): 1572-1575.
4. Rosen M (2012) Onset of labor epidural analgesia with ropivacain and a varying dose of fentanyl.
International Journal of Obstetric Anesthesia 21(1) 45-50.
5. Takako H (2013) Comparison between 0.06% and 0.1% levobupivacaine combined with 2pg/ml of fentanyl for epidural labor analgesia.