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| ORIGINAL ARTICLE |
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| Year : 2022 | Volume
: 9
| Issue : 2 | Page : 130-134 |
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A randomized controlled trial of lidocaine versus ropivacaine for pain relief after episiotomy
Asis Adhikary1, Papiya Biswas2, Tanushree Mondal3, Subir Kumar Bhattacharyya4
1 Consultant, JR Dhar Subdivision Hospital, Bongaon, Dist North 24 PGS, Darjeeling, West Bengal, India
2 Department of Microbiology, North Bengal Medical College and Hospital, Darjeeling, West Bengal, India
3 Department of Community Medicine, Medical College, Kolkata, West Bengal, India
4 Department of Obstetrics and Gynaecology, NRS Medical College, Kolkata, West Bengal, India
| Date of Submission | 06-Jul-2020 |
| Date of Decision | 23-Jun-2021 |
| Date of Acceptance | 17-Aug-2021 |
| Date of Web Publication | 20-Dec-2022 |
Correspondence Address:
Subir Kumar Bhattacharyya
FD 65/7, FD Block, Sector III, Salt Lake, Kolkata – 700 106, West Bengal
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/cjhr.cjhr_88_20
Introduction: Episiotomy is the most common surgical procedure for parturient. Analgesia after episiotomy has received less attention, though the postepisiotomy pain may hamper the day-to-day activities such as sitting, sleeping, urinating, and walking of the parturient. It is desirable to reduce the postepisiotomy pain as early as possible. Therefore, we planned to carry out a randomized controlled trial to compare the safety and efficacy of lidocaine versus ropivacaine perineal infiltration for pain relief after episiotomy. Materials and Methods: The prospective randomized controlled trial was conducted in the Department of Obstetrics and Gynaecology of R. G. Kar Medical College and Hospital, Kolkata. One hundred women were enrolled and randomized into the two groups: Lidocaine infiltration group and ropivacaine infiltration group. Primary objective was to evaluate the efficacy of postepisiotomy pain control by the visual analog scale (VAS) score at 24 h after the episiotomy. Secondary objectives were to evaluate the efficacy of postepisiotomy pain control by VAS score during suturing, at 2 h and 48 h or any adverse effects and maternal satisfaction at 48 h. Results: The postepisiotomy pain relief at 2 h and 24 h was significantly lower in ropivacaine in comparison to lidocaine infiltration. Mean VAS Score 24 h after suturing in lidocaine group was 6.38, and in ropivacaine group, it was 5.64. Maternal pain perception at the time of suturing and at 48 h was also less in ropivacaine than in lidocaine infiltration. Mothers were more satisfied with ropivacaine drug. Conclusion: The present study showed that there was definite improvement of postepisiotomy pain relief at 2 h and 24 h in ropivacaine local infiltration of the episiotomy wound in comparison to lidocaine infiltration and mothers were more satisfied with ropivacaine use.
Keywords: Lidocaine infiltration, maternal satisfaction, postepisiotomy pain, ropivacaine infiltration
How to cite this article:
Adhikary A, Biswas P, Mondal T, Bhattacharyya SK. A randomized controlled trial of lidocaine versus ropivacaine for pain relief after episiotomy. CHRISMED J Health Res 2022;9:130-4 |
How to cite this URL:
Adhikary A, Biswas P, Mondal T, Bhattacharyya SK. A randomized controlled trial of lidocaine versus ropivacaine for pain relief after episiotomy. CHRISMED J Health Res [serial online] 2022 [cited 2023 Jan 30];9:130-4. Available from: https://www.cjhr.org/text.asp?2022/9/2/130/364539 |
| Introduction | |  |
Globally, approximately 140 million births occur every year.[1] As highlighted in the World Health Organization framework for improving quality of care for pregnant women during childbirth, experience of care is as important as clinical care provision in achieving the desired person-centered outcomes.[2] Episiotomy is the most common surgical procedure for parturient.[3] In the selective episiotomy groups, episiotomy rates ranged from 8% to 59% (median 32%), and in the routine or liberal episiotomy groups they ranged from 51% to 100% (median 83%).[4] Obstetric analgesia has focused on pain during labor or after a caesarean delivery, whereas analgesia after a vaginal delivery has received less attention though the postepisiotomy pain may hamper the day-to-day activities such as sitting, sleeping, urinating, and walking of the parturient.[5] During delivery, the perineal pain following lacerations or episiotomy is transmitted through the pudendal nerves.[6] Most of the women with an episiotomy complain of pain on day 7 after the delivery and some of them have at least 1 functional complaint (difficulty in sitting, urinating, walking, or sleeping).[7] It is desirable to reduce the postepisiotomy pain as early as possible.
The standard analgesia with a nonsteroidal anti-inflammatory drug and oral paracetamol was not effective in 33% of women with postepisiotomy pain.[8] In addition, a prospective study showed that analgesics prescribed postoperatively are insufficiently administered (on the 1st day, 70% of patients received the exact analgesic prescription; however, on the 2nd day this percentage was reduced to 43%).[9] Hence, infiltration of local anesthetic drug like lidocaine and ropivacaine is better than oral preparations. The infiltration of lidocaine before suturing is routinely performed at our institution. However, ropivacaine might be an interesting alternative owing to its pharmacokinetic properties and the findings found in some study.[10] The efficacy of postepisiotomy pudendal nerve block with ropivacaine was assessed with a significant reduction in the visual analog scale (VAS) score was found at rest and while moving.[11] However, the procedure requires an anesthetist. Although this block seems theoretically convincing, it remains difficult to implement in daily practice. Pudendal nerve block requires a long training period and only a skilled physician can perform it. Moreover, there is a risk of intravascular progression with a greater toxic reaction than in infiltrations. Maternal satisfaction was not investigated in this study. A prospective longitudinal study comparing local infiltration of lidocaine versus ropivacaine showed a reduction in pain when ropivacaine was used for postepisiotomy analgesia instead of lidocaine.[12] This finding was consistent at 2, 24, and 48 h after infiltration of the episiotomy edges. Accordingly, maternal satisfaction was improved in the ropivacaine group. Its chief drawback was the nonrandomized design, which limited the extent of the conclusions that could be drawn. Therefore, we planned to carry out a randomized controlled trial to compare the safety and efficacy of lidocaine versus ropivacaine perineal infiltration for pain relief after episiotomy.
| Materials and Methods | | |
This prospective randomized controlled trial was conducted in the Department of Obstetrics and Gynaecology of R. G. Kar Medical College and Hospital, Kolkata (approximately 20,000 deliveries per year) from July 2014 to June 2015. This study was approved by the Ethical Committee and written informed consent was obtained from each participant admitted to the labor and delivery Unit. Patients admitted in the labor room meeting the following inclusion and exclusion criteria are to be included in the study. Inclusion criteria were parturient who underwent vaginal delivery without epidural analgesia and who had an episiotomy with infiltration anesthesia before suturing. Women were included regardless of their previous vaginal delivery history. Exclusion criteria were refusal to complete the pain and satisfaction assessments, chronic analgesic use for another disease and prescription of analgesics other than paracetamol for another reason during the study.
During the study, 100 women fulfilling the inclusion criteria consented for the study. Once informed consent is obtained, subjects were enrolled and randomized into the two study intervention groups: Lidocaine infiltration group (Group A) received 20 ml of lidocaine infiltration (10 mg/ml) and Ropivacaine infiltration group (Group B) received 20 ml of ropivacaine infiltration (7.5 mg/ml). Both the groups received the infiltration of the local anesthetic along both sides of the episiotomy 5 min before suturing. Randomization was done by computer-generated table of random numbers [Figure 1]. The randomization assignments were placed into consecutively numbered opaque, sealed envelopes. Before infiltration of drug into episiotomy wound, the envelope given to woman was opened by the patient's obstetrician to determine the treatment allocation. The parturient were blinded to the drug used. Blinding of the Obstetrician could not be done from knowledge of which intervention a participant received.
We administered the infiltration of the local anesthetic along both sides of the episiotomy 5 min before suturing. Group A of the mothers received 20 mL of lidocaine (10 mg/mL) and Group B received 20 mL of ropivacaine (7.5 mg/ml). Interrupted sutures (chromic catgut) were used subcutaneously; for the top skin layer, interrupted (chromic catgut) or continuous sutures were used. Incidents related to the injection of local anesthesia were recorded. The patients were blinded to the drug used. Second dose of infiltration not given to any mother. In addition, they routinely received 1 g of paracetamol orally 3 times per day. Then we asked the parturient to rank their pain on a VAS from “no pain” (corresponding to 0) to “pain as bad as it can possibly be” (corresponding to 10) during suturing and at 2, 24, and 48 h thereafter [Figure 2]. Maternal satisfaction for episiotomy pain relief at 48 h also investigated and was rated as very poor, poor, good, or very good. In addition, information about the women's clinical characteristics and the duration of hospitalization was also collected. Outcome parameters were assessed. Primary parameters was to evaluate the efficacy of postepisiotomy pain control by the VAS score [Figure 2] at 24 h after the episiotomy. Secondary parameters were to evaluate the efficacy of postepisiotomy pain control by VAS score during suturing, at 2 h and 48 h or any adverse effects of lidocaine and ropivacaine and maternal satisfaction at 48 h.
The sample size was calculated from preliminary study. At 24 h after delivery, the percentage of women with a VAS pain score of more than 4 was found to have decreased by 28%. We determined that to detect a reduction of 28% from 71% in the lidocaine group to 43% in the ropivacaine group, a study group size of 92 women (46 in each 2 arm) was needed to achieve a power of 80% with an alpha error of 5%. To allow for dropouts we planned to include 100 women (50 women in each group). The statistical analyses were performed using SPSS (Free trial version, IBM, Chicago, USA) version 22 using different code for different variable. Quantitative data were reported as mean ± SD if the data was normally distributed; otherwise, the values were given as median and interquartile range. For qualitative or binary data, percentages were also reported. The mean values were compared with the Mann–Whitney U test and percentages with the Fisher's exact test. Analysis of variance for qualitative or binary data, percentages was also reported. P value 0.05 was considered to be statistically significant.
| Results | | |
A total of 100 women who met the inclusion criteria were enrolled and randomized into the two study groups: Fifty (50%) to lidocaine group and 50 (50%) to ropivacaine group [Figure 1]. Outcome data were available for analysis. The baseline characteristics for the two groups are compared in [Table 1]. The two groups were comparable with respect to maternal age, maternal body weight, parity, and type of delivery. The mean age of the lidocaine group (group A) and ropivacaine group (group B) was 24.86 years and 25.14 years respectively (P = 0.896). Hence, age in this study was not statistically significant. Similarly, mean weight of the lidocaine group and ropivacaine group were 55.32 kgs and 56.42 kgs, respectively (P = 0.737). Out of 100 mothers most of the mothers were primipara, 68% in lidocaine group and 74% in ropivacaine group (P = 0.718). Operative instrumental deliveries occurred in 6 (12%) deliveries in lidocaine group and 8 (16%) in ropivacaine group (P = 1.000). Therefore, maternal weight, parity, and type of delivery in this study were also not statistically significant.{Figure 1}
Mean VAS score at 24 h was significantly lower in ropivacaine group (5.64 ± 1.425) in comparison with lidocaine group (6.38 ± 1.048; P = 0.003) [Figure 3]. Mean VAS score at 2 h was also significantly lower in ropivacaine group (3.24 ± 0.822) than in lidocaine group (3.66 ± 0.717; P = 0.047). Maternal pain perception in terms of VAS score at the time of suturing and at 48 h were also less in ropivacaine group than in lidocaine group (at the time of suturing; 1.30 ± 0.814 versus 2.06 ± 1.096 respectively, P = 0.115; at 48 h; 5.32 ± 0.891 vs. 5.86 ± 0.857 respectively; P = 0.093), though values were not statistically significant [Table 2]. The mean hospital stay in lidocaine group was more than in ropivacaine group (49.20 h vs. 48.8 h; P = 0.018). Only two mothers had complained of headache in lidocaine group. | Figure 3: Mean visual analog scale score at different time after suturing
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Regarding maternal satisfaction, women in ropivacaine group (B) were more satisfied than the lidocaine group (A), although it was not statistically significant (P = 0.669). Forty-three (86%) women in ropivacaine group reported “very good” or “good” satisfaction compared to 39 (78%) in lidocaine group [Table 3].
| Discussion | | |
A randomized controlled trial of lidocaine versus ropivacaine for pain relief after episiotomy was undertaken in this institution during the study period to know which drug is more effective regarding pain relief and maternal satisfaction after 48 h as well as to know any adverse drug reaction. The study was conducted among 100 pregnant mothers who met the inclusion and exclusion criteria admitted in the labor room in the Department of Obstetrics and Gynaecology of R. G. Kar Medical College and Hospital from July 2014 to June 2015. In this study, there was no drop out because of as per departmental protocol, mother should be observed for at least 48 h postpartum. Mothers who admitted to day time are enrolled in this study because of convenience to record VAS Score and maternal satisfaction at day time. The present study showed postepisiotomy pain relief at 2 h and 24 h were significantly lower in ropivacaine local infiltration of the episiotomy wound in comparison to lidocaine infiltration. Maternal pain perception at the time of suturing and at 48 h was also less in ropivacaine than in lidocaine infiltration. Mothers were more satisfied with ropivacaine drug.
Many analgesia techniques in obstetrics have been published. A randomized study assessed the efficacy of postepisiotomy pudendal nerve block with ropivacaine 7.5 mg/ml. A significant reduction in the VAS score was found at rest (for up to 48 h) and while moving (walking, sitting).[11] The application of pudendal nerve block requires a long training period and only a skilled physician can perform it. Moreover, as with all blocks, there is a risk of intravascular progression with a greater toxic reaction than in infiltrations. In a preliminary randomized study, the use of lidocaine (10 mg/mL) and ropivacaine (2 mg/mL and 7.5 mg/mL) has been compared.[13] The use of ropivacaine was associated with a reduction in pain, and the drug delayed the time until the first analgesia request after the postepisiotomy infiltration by approximately 10 h. Maternal satisfaction was not investigated in this prior study. The authors recommended, on a purely theoretical basis, the preferential use of the 2-mg/mL ropivacaine regimen.[13] By contrast, another randomized study did not demonstrate any improvement with ropivacaine use, nor with the use of lidocaine or saline serum.[14] However, the participants in that study received epidural analgesia and the evaluation period comprised 24 h only. Another study showed a reduction in pain when ropivacaine was used for postepisiotomy analgesia instead of lidocaine. This finding was consistent at 2, 24, and 48 h after infiltration of the episiotomy edges. Accordingly, maternal satisfaction was improved in the ropivacaine group.[12] However, the study was nonrandomized in design and the participants in the study were received epidural analgesia.
Like all local anesthetics, ropivacaine produces a bi-phasic vasomotor response with initial vasoconstriction followed by vasodilatation once a given drug concentration has been reached. Because the ropivacaine concentration at which its vasomotor effect is converted into a dilatation exceeds 7.5 mg/mL, local activity is prolonged.[15] Its slow resorption is associated with less toxicity. The difference in perceived pain lasted for up to 48 h, which is longer than the mean duration of ropivacaine action. It may be due to the prevention of peripheral hyperalgesia, especially because of the early anti-inflammatory activity of ropivacaine and because of ropivacaine provides early and prolonged pain relief for a procedure that otherwise causes substantial pain but for a short period of time only.[12],[16] The mean hospital stay in Lidocaine group was more in the lidocaine group than in ropivacaine group (49.20 h vs. 48.8 h; P = 0.018). Only two mothers had complained of headache in lidocaine group. In another study, authors did not find any adverse drug reaction between these two drugs.[12]
Regarding maternal satisfaction, women in ropivacaine group was more satisfied than the lidocaine group, although it was not statistically significant (P = 0.669). Forty-three (86%) women in ropivacaine group reported “very good” or “good” satisfaction compared to 39 (78%) in lidocaine group. Similar result was found in other study regarding maternal satisfaction. They showed that 43 (84.3%) parturient in the ropivacaine group reported good or very good satisfaction compared with 23 (45.1%) in the lidocaine group (P < 0.001).[12]
There are certain limitations in our study. Firstly, the study population was small and nonmulticentric. Second, the pain decrease with ropivacaine was observed despite short interval infiltration and suturing. Third, the information regarding specific characteristics of pain and its functional consequences are not included. Finally, mothers whose baby was in neonatal intensive care unit did not give proper VAS score due to disappointment.
| Conclusion | | |
The present study showed that there was definite improvement of postepisiotomy pain relief at 2 h and 24 h in ropivacaine local infiltration of the episiotomy wound in comparison to lidocaine infiltration and mothers were more satisfied with ropivacaine use.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3]
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