|Year : 2019 | Volume
| Issue : 3 | Page : 241-244
Comparison of the effect of bupivacaine–fentanyl compared bupivacaine–sufentanil in spinal anaesthetics in pregnant women in Zanjan, Iran
Zohreh Pishgahi1, Behnaz Molaei1, Vahideh Rashtchi2, Farzaneh Karami Tanha3
1 Department of OB and GYN, Fellowship of Perinatology, Zanjan University of Medical Sciences, Zanjan, Iran
2 Department of Nursing and Midwifery, Zanjan University of Medical Sciences, Zanjan, Iran
3 Department of Community Medicine, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran
|Date of Web Publication||6-Sep-2019|
Department of OB and GYN, Fellowship of Perinatology, Zanjan University of Medical Science, Zanjan
Source of Support: None, Conflict of Interest: None
Background: Labour pain is the most severe pain experienced by a mother during her lifetime. This study aims to encourage normal delivery, reduce caesarean section, and morbidity by comparing two fentanyl–bupivacaine and sufentanil–bupivacaine combination as spinal anaesthetics of the mothers who referred to Ayatollah Mousavi Hospital in Zanjan in the active phase of delivery. Materials and Methods: This study was performed on 90 pregnant women with active phase of labour who were divided into three groups. The first group received 50 μg fentanyl and 2.5 mg bupivacaine and the second group received 5 μg sufentanil and 2.5 μg bupivacaine by spinal injection and the third group received no intervention. The severity of analgesia and maternal and neonatal outcomes were recorded. To compare the data, ANOVA, t-test and Chi-square test were used. Results: Our study showed that the duration, the first and second stage of labour, did not show significant difference between three groups (P > 0.05). Sufentanil has a faster return pain duration (P = 0.37). Patients in Group A had more severe pain (3.93 vs. 4.73,P = 0.001). Return the sense was significantly longer for fentanyl (P = 0.001). In sufentanil group, 40% were in T8–T10 level, while in fentanyl use group, 20% were categorized in this range. Conclusion: The present study reported that the use of fentanyl or sufentanil in combination with bupivacaine for spinal analgesia as a low-risk method for controlling labour pain, although it seems that the combination of sufentanil–bupivacaine is more effective.
Keywords: Bupivacaine, fentanyl, normal vaginal delivery, spinal analgesia, sufentanil
|How to cite this article:|
Pishgahi Z, Molaei B, Rashtchi V, Tanha FK. Comparison of the effect of bupivacaine–fentanyl compared bupivacaine–sufentanil in spinal anaesthetics in pregnant women in Zanjan, Iran. Adv Hum Biol 2019;9:241-4
|How to cite this URL:|
Pishgahi Z, Molaei B, Rashtchi V, Tanha FK. Comparison of the effect of bupivacaine–fentanyl compared bupivacaine–sufentanil in spinal anaesthetics in pregnant women in Zanjan, Iran. Adv Hum Biol [serial online] 2019 [cited 2020 May 29];9:241-4. Available from: http://www.aihbonline.com/text.asp?2019/9/3/241/262893
| Introduction|| |
Labour pain is the most severe pain experienced by the mother during her lifetime., The regional analgesia during labour is favourable for normal vaginal delivery. Painful labour by inducing stress can be led to negative effects on the maternal and faetal outcomes.
The labour analgesia provides adequate pain relief without any the maternal and the faetal risk. Various non-pharmacological methods and pharmacological methods have been used for labour analgesia. The regional analgesia is widely used for labour anaesthesia. Regional analgesia have the most flexible, effective, and least depressant options when compared with parenteral and inhalation techniques. The spinal anaesthesia is one of regional analgesia. Simple technique, fast efficacy and uniform sensory and motor blocks are the advantages of spinal anaesthesia. It has been proposed that spinal opioids provide effective analgesia during labour, no adverse impact on the incidence of maternal and neonatal complications. The lipophilic drugs such as fentanyl and sufentanil among opioids have appropriate pharmacological effects for spinal anaesthesia. These drugs have rapid onset, the moderate duration of action and low desire to spread to the fourth vertebrae. Therefore, they are related to a low risk of respiratory depression.
Kuberan et al. in 2018 reported a higher incidence of increased baseline uterine tone and abnormal faetal heart rate (FHR) after spinal was observed when bupivacaine–fentanyl was used rather than bupivacaine alone of combined spinal–epidural in the spinal component. The abnormal FHR was low or rapidly resolved. Furthermore, the incidence of hypotension was similar in two the groups. Cheng et al. presented that fentanyl 25 μg is a good alternative for sufentanil 5 μg when added to bupivacaine 1.25 mg as the initial component of the combined spinal–epidural for early labour analgesia. The duration of labour analgesia for two group was similar.
The study of Farzi in Iran in 2017 showed that the use of fentanyl or sufentanil to intrathecal bupivacaine in spinal analgesia increased the duration of analgesia without major complication in caesarean section delivery.
There is a relevance of carrying out a study on individual population and genetic differences have any role to play in induction of the labour by using the combination treatment as the study is already reported in other population. So far, the study about the comparison of the effect of fentanyl–bupivacaine and sufentanil–bupivacaine combination as spinal anaesthetics for labour pain relief in Iran has been not conducted. Therefore, the present study compared the effects of fentanyl–bupivacaine and sufentanil–bupivacaine as spinal anaesthetics in pregnant women.
| Materials and Methods|| |
This study is a double-blind randomized clinical trial was conducted on 90 pregnant women with active phase of labour who were referred to the Ayatollah Musavi Hospital (Zanjan, Iran), in 2017.
Patients were randomized to 1 of 3 treatment groups: Group A – 50 μg fentanyl and 2.5 mg bupivacaine; Group B – 5 μg sufentanil and 2.5 mg bupivacaine; and Group C – control group without any intervention. Balanced block randomizations were used to allocate patients to mentioned groups, and finally, 30 patients were assigned to each group.
We included patients with the following criteria: (1) the first or second parity; (2) in women of second parity, having previous delivery of normal vaginal delivery; (3) being 38 weeks pregnant or higher with vertex presentation; (4) singleton pregnancy; and (5) lack of underlying diseases. Exclusion criteria included pregnant women with infection in the needle injection site, increased intracranial pressure, history of allergy to narcotic drugs or local anaesthetics and non-compensated liver failure, severe renal failure, heart failure, any kind of heart blockage, heart arrhythmia and confirmed hypertension.
All participants gave written consent and accepted in time attending for receiving routine prenatal care and delivery in our centres.
We used a researcher-made checklist including: mother's age, mother's education, labour history, type of intervention, duration of analgesia, the onset of pain relief, level of the sensory and motor block, Apgar score, type of delivery, newborn's sex, newborn weight and patient's satisfaction from analgesia and mean time of the first and second stage of labour.
Each patient also completed a baseline assessment using a 10-mm Visual Analogue Scale for pain and satisfactions, with 0 representing no pain and 10 representing the worst possible pain. In this study, the duration of analgesia was defined as the time interval from intrathecal injection to time of the first request for more analgesia. The vaginal examination was recorded by the trained resident for each hour and the level of the sensory and motor block was evaluated. Newborn weight, gender and Apgar score after birth were registered by the trained midwife.
Qualitative data were presented with frequency and percentage and quantitative variables were presented with mean ± standard deviation. Normality of data was assessed with Kolmogorov–Smirnov test. Continuous variables between two and three groups were compared using Student's t-test and ANOVA test, respectively. Categorical variables were, on the other hand, compared using Chi-square test or Fisher's exact test when >20% of cells with expected count of <5 were observed.
All the analyses were done using SPSS (version 22) (SPSS Inc., Illinois, USA). P < 0.05 was considered as statistically significant.
Ethical approval for the study was obtained from the Institutional Review Board of Zanjan University of Medical Sciences according to the Helsinki Declaration (Registration Number: A-11-230-10).
IRCT ID: IRCT20160818029414N4.
| Results|| |
In the present study, 90 women were assessed in three groups. In [Table 1], the demographic and clinical characteristics of individuals have been presented.
|Table 1: Demographic and clinical characteristics of participation (n=30)|
Click here to view
The age mean of participations was 25.8 ± 0.58 years (age range: 17–40 years). There were no significant differences between the three groups with respect to age (P = 0.25). In regard of previous delivery history, there was a significant difference between the three groups. So that, 80%, 60% and 46.7% of participations in Group A, B and C, respectively, had no history of previous delivery (P = 0.02). 78 (86.67%) were chosen vaginal delivery as delivery method. Delivery method in all of participations in Group C was vaginal in comparison 23.3% in Group A. This difference between the three groups was statistically significant (P = 0.024).
The duration of the first and second stage of labour did not show significant difference between three groups (P > 0.05). Neonatal Apgar score in Group A was 9.9 ± 0.4, in Group B was 9.83 ± 0.59 and in Group C was 9.88 ± 0.44. However, the difference was not statistically significant between three groups (P = 0.68) [Table 1].
The duration of analgesia between the intervention groups were not different (125 ± 61.96 vs. 126.23 ± 42.54, P = 0.97). Sufentanil has a faster return pain duration (P = 0.37). Patients in Group A had more severe pain (3.93 vs. 4.73, P = 0.001). Return the sense was significantly longer for fentanyl (P = 0.001) [Table 2].
|Table 2: Comparison of anaesthetic outcomes between the two groups (n=30)|
Click here to view
Maximum upper level of sensory block in both groups was in the range of >T10 (Thoracic 10) (80% vs. 53.33% in Group A compared Group B). In Group B, 40% were in T8–T10 level, while in Group A, 20% were categorized in this range [Table 3].
|Table 3: Number of patients with maximum upper level of sensory block (n=30)|
Click here to view
| Discussion|| |
The findings of the present study showed that the use of fentanyl or sufentanil in combination with bupivacaine for spinal analgesia is a low-risk method for controlling labour pain, although sufentanil has more effective and anaesthesia awareness in patients with fentanyl is much longer.
Cheng et al. showed that the duration of labour analgesia in the group with fentanyl 25 μg was similar to that obtained in the group with sufentanil 5 μg when these opioids were added to intrathecal bupivacaine 1.25 mg. Furthermore, both regimens produced satisfactory analgesia in 95% of the mothers. This study approves the findings of our study. Farzi et al. in Iran in 2017 showed that adding 25 μg fentanyl or 2.5 μg sufentanil to intrathecal bupivacaine in spinal analgesia raised the duration of analgesia and provided haemodynamic stability without major complication in caesarean section delivery. The result of this study was in line with the present study.
A meta-analysis by Li et al. was conducted in 2015. In this study, a ratio of approximately 6 fentanyl and 1 sufentanil in combination with bupivacaine was used to provide comparable analgesic properties via the epidural or intrathecal routes for labour pain relief. Duration of analgesia was approximately similar between bupivacaine–sufentanil and bupivacaine–fentanyl in treated women, but the number of neonates with Apgar scores of <7 was significantly more in bupivacaine–sufentanil-treated women. Therefore, this meta-analysis suggested that both fentanyl and sufentanil in combination with bupivacaine have similar analgesic properties for labour pain relief. Although some studies proposed that intrathecal administration of opioids, in general, is associated with increased risk of faetal heart abnormalities;, however, there was not significant association between abnormal FHR and fentanyl analgesia in this meta-analysis.
Palmer et al. reported a slower onset of block in mothers received intrathecal sufentanil compared with fentanyl, while the relatively higher doses of sufentanil injected. This study was in contrast with the results of others.
The present study has some the limitations: (a) the safety of drugs for mothers was confirmed, but some women were not willing to participate, and it prolonged the time duration for sampling and (b) the sample size was small in per group. This limitation may decrease the power of generalizing results. However, the results this study suggested that the use of fentanyl–bupivacaine or sufentanil–bupivacaine by spinal anaesthetics in labour can encourage mothers for performing of normal vaginal delivery and reduce caesarean section without any maternal and faetal complications.
| Conclusion|| |
The present study reported that the use of fentanyl or sufentanil in combination with bupivacaine for spinal analgesia as a low-risk method for controlling labour pain, although it seems that the combination of sufentanil–bupivacaine is more effective.
This study was supported by the Zanjan University of Medical Sciences. We gratefully acknowledge the kind support of the participants for their precious collaboration in this study as well as staffs of Mousavi Hospital.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Foji S, Yousefi Moghadam M, TabasiAsl H, Nazarzadeh M, Salehiniya H. A comparison of the effects of ENTONOX inhalation and spinal anesthesia on labor pain reduction and apgar score in vaginal delivery: A clinical trial study. Biomedicine (Taipei) 2018;8:17.
Layera S, Bravo D, Aliste J, De Q T. A systematic review of DURAL puncture epidural analgesia for labor. J Clin Anesth 2019;53:5-10.
Li B, Wang H, Gao C. Bupivacaine in combination with fentanyl or sufentanil in epidural/intrathecal analgesia for labor: A meta-analysis. J Clin Pharmacol 2015;55:584-91.
Kalra S, Saraswat N, Agnihotri GS. Comparison of efficacy of bupivacaine and fentanyl with bupivacaine and sufentanil for epidural labor analgesia. Saudi J Anaesth 2010;4:178-81.
Braga AA, Frias JA, Braga FS, Potério GB, Hirata ES, Torres NA. Spinal anesthesia for cesarean section. Use of hyperbaric bupivacaine (10mg) combined with different adjuvants. Rev Bras Anestesiol 2012;62:775-87.
American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Practice guidelines for obstetric anesthesia: An updated report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Anesthesiology 2007;106:843-63.
Braga Ade F, Braga FS, Hirata ES, Pereira RI, Frias JA, Antunes IF. Association of lipophilic opioids and hyperbaric bupivacaine in spinal anesthesia for elective cesarean section. Randomized controlled study. Acta Cir Bras 2014;29:752-8.
Kuberan A, Jain K, Bagga R, Makkar JK. The effect of spinal hyperbaric bupivacaine-fentanyl or hyperbaric bupivacaine on uterine tone and fetal heart rate in labouring women: A randomised controlled study. Anaesthesia 2018;73:832-8.
Cheng CJ, Sia AT, Lim EH, Loke GP, Tan HM. Either sufentanil or fentanyl, in addition to intrathecal bupivacaine, provide satisfactory early labour analgesia. Can J Anaesth 2001;48:570-4.
Farzi F, Mirmansouri A, Naderi Nabi B, Atrkar Roushan Z, Ghazanfar Tehran S, Nematollahi Sani M, et al.
Comparing the effect of adding fentanyl, sufentanil, and placebo with intrathecal bupivacaine on duration of analgesia and complications of spinal anesthesia in patients undergoing cesarean section. Anesth Pain Med 2017;7:e12738.
Abrão KC, Francisco RP, Miyadahira S, Cicarelli DD, Zugaib M. Elevation of uterine basal tone and fetal heart rate abnormalities after labor analgesia: A randomized controlled trial. Obstet Gynecol 2009;113:41-7.
Mardirosoff C, Dumont L, Boulvain M, Tramèr MR. Fetal bradycardia due to intrathecal opioids for labour analgesia: A systematic review. BJOG 2002;109:274-81.
Palmer CM, Cork RC, Hays R, Van Maren G, Alves D. The dose-response relation of intrathecal fentanyl for labor analgesia. Anesthesiology 1998;88:355-61.
[Table 1], [Table 2], [Table 3]