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ORIGINAL ARTICLE
Year : 2023 | Volume
: 13
| Issue : 1 | Page : 45-50
Walking epidural in labor analgesia: A comparative study of ropivacaine with fentanyl and without fentanyl
Avni Thacker1, Divya Kheskani1, Divyesh Panchal2, Heena Chhanwal1
1 Department of Anaesthesia, GCS Medical College, Hospital and Research Centre, Ahmedabad, Gujarat, India
2 Department of Obstetrics and Gyanecology, GCS Medical College, Hospital and Research Centre, Ahmedabad, Gujarat, India
Correspondence Address:
Dr. Heena Chhanwal
B-103, First Floor, Shreedhar Nest, Opp. Sangath Banquet Hall, Nr. Chitvan Flat, Koteshwar Bhat Road, Motera, Ahmedabad - 380 005, Gujarat
India
Source of Support: None, Conflict of Interest: None
CheckDOI: 10.4103/JOACC.JOACC_32_22
Background: Labor pain and child birth entail a number of physiological consequences that may lead to deleterious effects on the mother and fetus. Implication of a neuraxial technique is being appreciated in labor. Fetal prognosis and maternal consent and its satisfaction are key to labor analgesia. Method: The primary objectives were to determine the visual analog scale (VAS), total duration of labor analgesia, patient-controlled analgesia demand, sensory and motor block, and hemodynamics. The secondary objectives were to determine obstetrics parameters such as maternal satisfaction, cervical dilation, membrane, APGAR score, and complications such as hypotension, bradycardia, and vomiting. A randomized prospective comparative, interventional study including 50 parturients was conducted, where they were divided into two equal groups of 25 each, and epidural analgesia was given by 0.2% ropivacaine with 2 mcg/ml fentanyl and 0.2% ropivacaine without fentanyl. Observation and Results: Analgesia was more in the RF group compared to the R group. The maternal satisfaction was more in the RF group than in the R group. Clinical hemodyamics, VAS score, Bromage score, and APGAR score were appreciable in the RF group as compared to the R group. Conclusion: We concluded that 0.2% ropivacine with fentanyl gives more analgesia and maternal satisfaction than ropivacine alone.
Keywords: Labor analgesia, maternal satisfaction, parturients, VAS
Women's perception and experience of labor are subjective, complex, and unique. The negative experience is associated with subsequent infertility, and hence, it is considered as a part of maternity care.[1]
Labor is a physiological process of delivery fetus characterized by regular, painful uterine contractions with progressive increasing frequency, cervical effacement, and dilation.
From 1847 methods of painless labor, there has been evolution from ether and chloroform to neuraxial methods today. A separate set of practices is developed as obstetric anesthesia to deliver safe services to the mother.[2]
The early first stage and the second stage of labor pain are visceral in origin. With successive uterine cramps, the cervix is straightened and bulged, and through this, excitatory nocioceptive afferents are activated. The endocervix and lower segment from T10 to L1 are supplied by these nocioceptive afferents.
During the later part of the first and second stages of labor addition to the visceral pain, another pain emerges from afferent supply of the vaginal surface of the cervix, perineum, and vagina. It is the end result of straightening, bulging, and ischemic injury (tearing or iatrogenic) of the perineum, vagina, and pelvic floor. This pain is felt at the time of subsiding of the fetus and at this active stage. The contractions of the uterus are more intense and in a rhythmic and regular manner.[3]
AimsThe aim is to compare the epidural injection Inj. Ropivacine 0.2% with Inj. Fentanyl and Inj. Ropivacaine 0.2%. The primary objectives were to study the analgesia [visual analog scale (VAS), total duration of labor analgesia, patient-controlled analgesia (PCA) demand], sensory and motor block, and hemodynamics.
The secondary objectives were to determine obstetrics parameters (such as maternal satisfaction, cervical dilation, membrane, and APGAR score) and complications (hypotension, bradycardia, vomiting).
ProcedureThis is a prospective comparative interventional single-center study carried out at a tertiary care hospital. After obtaining ethical approval and CTRI registration, we have included 50 parturients who gave written and informed consent in our study. Parturients included were full-term parturients (37–42 wks) in active labor enrolled for the study. Parturients excluded from our study were those with bleeding disorders, those with deformities of the spine, those taking anti-coagulants, those who have blood pressure (BP) <90/60 mmHg, those allergic to local anesthetics and opioid, and those who were not willing to opt for it. Parturients attending out-patient department for antenatal visits as well as those who were admitted directly were counseled for labor analgesia. Thorough assessment of patients including clinical systemic examination and laboratory investigation was performed. Among all, those who fulfilled criteria and active labor were enrolled for the study. All parturients were randomly divided by computerized randomization into two equal groups of 25 each, in which the first group (R + F) received epidural 0.2% ropivacaine 11 ml with 2 mcg of fentanyl/ml and the second group (R) received epidural 0.2% ropivacaine 11 ml.
Parturients were prepared for epidural block apart from routine preparation of delivery. Monitors (non-invasive blood pressure, pulse oximeter, electrocardiogram, and cardiotocography) were attached, and baseline vitals were recorded. Iv cannula of 18 G was taken on the non-dominant hand and pre-loaded with 10 ml/kg of Ringer lactate solution. The equipment needed for airway management and resuscitation of the mother and baby was kept ready before performing the block. The autoclaved epidural tray used for performing the block contained the following.
Disposable epidural set 18G Tuohy needles with a catheter; disposable syringes of 2 ml, 5 ml, and 10 ml; skin towels; sterile dressings; sponge-holding forceps; and the drugs lignocaine hydrochloride 2% vial, ropivacine 0.2% ampoule, fentanyl 50 μg/ml ampoule, and normal saline for dilution were used. Preparation of epidural ropivacine was performed according to group allocation. For group RF, 11 ml of 0.2% ropivacine mixed with 22 μg of Inj. Fentanyl was given. For group R, 11 ml of 0.2% ropivacine mixed with 0.4 ml of normal saline was given. The block was performed after shifting the patient to the operation theater in the sitting/left lateral position with monitors attached.
Under all strict aseptic precautions, the ideal space chosen was L3-L4/L4-L5. Local infiltration with 2cc of 2% lignocaine was given. With the bevel directed upward, a mid-line approach with a Tuohy needle was used, and epidural space was identified by the loss of resistance technique. Epidural catheter placement was performed in the absence of uterine contraction. A catheter was placed 3–5 cm in the epidural space. After negative aspiration, the epidural catheter was secured and 4 ml of the prepared solution of ropivacine was given as the test dose. After this, the bolus of 11 ml 0.2% ropivacine and 22 μg fentanyl in group RF or 11 ml of 0.2% ropivacine in group R was given epidurally, and then the patient was shifted back to the labor room. After 15 min, when the pain of the parturient was relieved, infusion of 0.125% ropivacine started at 6 ml/hr, and if there was pain and more demand, 5 ml of 0.125% was given at lockout intervals of 10 min.
Continuous fetal and maternal monitoring done and after episiotomy epidural catheter was removed.
We had observed parameters such as VAS, total duration of labor analgesia, PCA demand, sensory and motor block, and hemodynamics; obstetrics parameters such as maternal satisfaction, cervical dilation, membrane, and APGAR score; and complications such as hypotension, bradycardia, and vomiting.
Statistical analysis was performed using SPSS (Statistical Package for Social Sciences) version 20 for windows. The profile of the cases was compared with the treatment allocation in order to check if there was any significant difference. Descriptive statistics are presented as mean ± standard deviation (SD). Component bar and line diagrams were drawn as and when required. Two-sided independent Student's t tests to analyze continuous data and Chi-square test for association were used to compare categorical variables between treatment allocations. P <0.05 was considered as statistically significant.
Observation and ResultsTotal duration of labor analgesia in group RF with a mean of 217.2 and an SD of 98.97 min and in group R with a mean of 247.6 and an SD of 94.04. The P value of 0.2711 was statistically insignificant [Figure 1].
PCA demand group RF has a mean of 2.64 and an SD of 1.57. In group R, the mean was 4.04 and the SD was 1.20 milligam/hour. The P value of 0.0009 was statistically significant [Figure 2].
Pulse rate changes in both groups were not statistically significant at any stage (P > 0.05, NS). As compared to the baseline pulse rate, pulse rate changes in both groups remain statistically not significant at any stage (P > 0.05, NS). Mean BP changes in both groups were not statistically significant at any stage (P > 0.05, NS).
As compared to baseline mean BP, pulse diastolic BP in both groups remains statistically not significant at any stage (P > 0.05, NS). SPO2 changes in both groups were not statistically significant at any stage (P > 0.05, NS).
As compared to baseline SPO2, SPO2 values in both groups remain statistically not significant at any stage (P > 0.05, NS) [Figure 3].
VAS scores were reduced from 9.36 ± 0.7 to 1.00 ± 0.00 in group RF (statistically significant, P < 0.05), while in Group R, the scores were reduced from 9.44 ± 0.58 to 2.72 ± 2.24 (statistically significant, P < 0.05) after 10 minutes [Table 1].
Between the groups, VAS (pain score) was statistically not significant most of the time, except at 5 min (p value 0.0001), 10 min (P value 0.0004), 210 min (p value 0.0465), 240 min (p value 0.0004), 270 min (0.0036), and 310 min (0.0064).
The sensory level of the block in both the groups shows a p value of 0.6825, which was statistically insignificant. Bromage scores in both groups are provided, which show a p value of 1.000, which was statistically insignificant [Table 2].
Group RF had a mean of 4.56 and an SD of 0.50 and group R had a mean of 3.8 and an SD of 0.50 and a p value of 0.0001, which is statistically significant. Cervical dilation in group RF had a mean of 4.36 with an SD of 0.56. Group R had a mean of 4.32 with an SD of 0.62. The p value was 0.8181, which was statistically insignificant. The membrane in both the groups had a p value which was statistically insignificant. As shown, the APGAR score at birth was statistically insignificant with p value 0.6411, and the APGAR score at 5 and 10 min was statistically insignificant as the p value was 1.000.
As shown, the APGAR score at 10 min was statistically insignificant as the p value was 1.000 [Table 3].
Discussion"The delivery of the infant into the arms of a conscious and pain-free mother is one of the most exciting and rewarding moments in medicine", said Moir. There are so many myths associated with pain relief in labor. Therefore, giving secure analgesia during labor is a big dispute for us. A neuraxial analgesia technique is a novel approach for providing quality of analgesia to the mother. It does not compromise maternal and fetal safety. Ambulatory labor analgesia prevents delayed labor, painfull labor, abnormal presentation, and fetal distress; for this reason, it is gold standard approach.[4]
Ropivacaine is known to be associated with reduced systemic toxicity and motor blockade compared to bupivacaine, allowing the parturient to be ambulant. Hence, it is preferred for providing labor analgesia. The minimum concentration of 0.2% ropivacaine is required to produce adequate labor analgesia. However, the addition of opioids to local anesthetics allows a lower concentration of the local anesthetic to produce similar quality of analgesia.[5] Fentanyl is most commonly used as an analgesic adjuvant to epidural analgesia. Fentanyl acts on substantia gelatinosa on the dorsal horn of the spinal cord by blocking fibers carrying nociceptive impulses both pre- and post-synaptically.[6]
In my study, labor epidural analgesia was given to 50 patients. The patients were divided into two groups of 25 patients each. The labor analgesia epidurally was given in the RF group with 11 ml 0.2% ropivacine with fentanyl 2 μg/ml, and in the R group, epidural analgesia was given with 11ml 0.2% ropivacine given initially. After that, continuous infusion was given with 0.125% ropivacine at 6 ml/hr.
We compared quality of labor analgesia by VAS score during labor and maternal satisfaction score at the end of delivery.
In our study, demographic variables among both groups were comparable.
In our study, analgesia was considered adequate when the VAS score [Table 1] becomes <3. Group RF shows VAS <3 in 5 mins, 2.44 ± 1.80, compared with group R, which shows vas <3 in 10 mins, which was 2.72 ± 2.24 with a P value of < 0.001. Roopesh Kumar et al.[7] compared 40 parturients. Group R1 received initial epidural injection of 15 ml of ropivacaine 0.1% with fentanyl 2g/ml Ÿ. Group R2 received initial epidural injection of 15 ml of ropivacaine 0.2% with fentanyl 2g/ml. Onset of Analgesia was faster in group R2 (65% parturients in 0–5 min) as compared to group R1 (17.5% parturients in 0–5 min) with a p value of < 0.001.
Yogesh Kumar Chhetty et al.[8] compared a total of 80 parturients in active labor, who were divided into two groups of 40 each and received an epidural injection of 15 ml ropivacaine 0.125% with fentanyl (2 mcg/ml) in group R1 and 15 ml of ropivacaine 0.2% with fentanyl (2 mcg/ml) in group R2 as the initial bolus dose. After epidural injection, the majority of parturients (75%) achieved VAS <3 significantly earlier in group R2 (0–5 min) than in group R1 (5-15 min), signifying onset of analgesia to be significantly faster in group R2 as compared to group R1, P < 0.001. The results of both studies are consistent with our study result. In our study, the patient-controlled epidural analgesia (PCEA) demand [Figure 2] in the RF group was a mean of (2.64 ± 1.57), and in the R group, it was (4.04 ± 1.20) with a P value of 0.0009, which was significant. Patients of the plain ropivacine group alone needed more bolus for pain control than patients with ropivacine and fentanyl. Therefore, fentanyl has an adjuvant role in pain relief. Therefore, requirement of local anaestheics was also less. Arun Ahirwar et al.[9] studied 90 prime gravida in labor, who were divided into three groups (n = 30), and patient-controlled epidural labor analgesia was given to them: initial bolus of 10 ml of ropivacaine 0.125% in Group I, with fentanyl 2 μg/ml in Group II and with clonidine 1μg/kg in Group III. Subsequently, each group received ropivacaine 0.125% through PCEA as background infusion of 5 ml/hr with a lockout interval time of 10 min and subsequent bolus of 5 ml. The total analgesic dose and PCA bolus requirement were maximum in group I and minimum in group III, and the difference among groups was significant statistically, Miwako Saito et al.[10] After establishing effective epidural analgesia with 11 ml of 0.2% ropivacaine, all parturients were divided into one of two groups: the PCEA group (n = 29) or the CEI group (n = 29). In the PCEA group, the pump was initiated to deliver a basal infusion at 6 ml·h−1 and a demand dose of 5 ml; the lockout interval was 10 min, and there was a 31 ml·h−1 limit. The drugs used were 0.1% ropivacaine + fentanyl 2 μg·ml−1. In the CEI group, epidural analgesia was maintained with the same solution as the PCEA group at a constant rate of 10 ml·h−1. If the parturient requested additional analgesia in the CEI group, we added 8 ml of epidural 0.2% ropivacaine without fentanyl. The hourly requirement of ropivacaine was significantly less in the PCEA group than in the CEI group (9.3 ± 2.5 vs. 17.6 ± 7.6 mg·h − 1; P < 0.05). Parturient satisfaction assessed by the Visual Analogue Scale tended to be higher in the PCEA group than in the CEI group. The results of both studies are consistent with our study result.
The total duration of labor analgesia [Figure 1] in group RF was a mean of (217.2 ± 98.97), and in group R, it was a mean of (247.6 ± 94.04) with a P value of 0.2711, which was statistically insignificant. Yvonne Lim et al.[11] recruited 300 nulliparous parturients. Analgesia was initiated with intrathecal ropivacaine 2 mg and fentanyl 15 g and maintained with epidural ropivacaine 0.1% with fentanyl 2 g/mL. Group 0: demand-only PCEA, bolus of 5 mL, and a lockout interval of 15 min. Group 5: background infusion of 5 mL/h, bolus of 5 mL, and a lockout interval of 12 min. Group 10: background infusion of 10 mL/h, bolus of 5 mL, and a lockout interval of 10 min. The maximum dose of all groups was 20 mL/h. The mean duration of effective analgesia in Group 10 was significantly longer than that in Group 0 [mean duration of effective analgesia: 895 min, 95% confidence interval (CI) 823–966 vs 565 min, 95% CI 454–677 min, P 0.001] [Figure 1]. When analyzed with the intent-to-treat approach, the mean duration of effective analgesia in Group 10 was longer than that in Group 0, Şükrü Gündüz et al.[12]
Group R received 20 mL of ropivacaine 0.125% with fentanyl 50 μg, and group B received 20 mL of bupivacaine 0.125% with fentanyl 50 μg. The duration of analgesia (minute) of the R group was 123.56 ± 19.45, and in the B group, it was 130.30 ± 19.65 with a P value of 0.478. Our study result was concurrent with both studies.
Hemodynamics [Figure 3] were comparable in both the groups. In our study, we found that 0.2% ropivacine is adequate for analgesia and it also produces adequate sensory block but does not produce motor blockage at this dose. It has minimum effect in hemodynamics. Therefore, we used it as a sole agent and at a concentration of 0.2%. In a previous study of Yaakov Belin et al.,[13] Roopesh Kumar et al.,[7] and Yogesh Kumar Chhetty et al.,[8] we found similar findings of 0.2% ropivacine as per our study. The maximum sensory dermatome level [Table 2] in both groups achieved was T7. 24% in group RF and 12% in group R had T7 levels. 48% in group RF and 56% in group R had T8 levels. 24% in group RF and 24% in group R had T9 levels. 4% in group RF and 8% in group R had T10 levels. Our study result was in agreement with Priyanka Chuttani et al.[14] and Gaurav Tomar et al.[15] In our study, motor block [Table 2] was assessed by modified bromage score. 0 = no impairment; 1 = unable to raise the extended leg but able to move the knees and foot; 2 = unable to raise the extended leg as well as flex knees but able to move the foot; and 3 = not able to move the flex ankle, feet, or knees. In our study, in both groups, 22% have 0 bromage score. Only 3% of the patients developed bromage 1. This study result was similar to that of Yaakov Beilin et al.[13] We also compared parameters [Table 3] such as onset, degree and duration of analgesia, progress and outcome of labor, sensory blockade and motor blockade, outcome of newborn by APGAR score, and complications between both the groups. In our study, maternal satisfaction [Table 3] was given by 1 to 5 numbers according to maternal experience of labor analgesia and graded by mother very unsatisfied 1, not satisfied 2, somewhat satisfied 3, satisfied = 4, and very satisfied = 5. In our study, in the RF group, all mothers were satisfied and very satisfied, and in the R group, the mother's satisfaction score was between satisfied and somewhat satisfied. In our study, the group RF mean was (4.56 ± 0.50) and the group R mean was (3.8 ± 0.50) with a P value of 0.0001, which was statistically significant. Gaurav S. Tomar et al.[15] included 90 ASA grade I-II parturients in active labor to three different groups: group A: 10 ml bupivacaine 0.125% + fentanyl 10 μg (1 μg/ml), group B: 10 ml bupivacaine 0.125% + fentanyl 20 μg (2 μg/ml), and group C: 10 ml bupivacaine 0.125% (the control group). The maternal satisfaction level was significantly higher (90%) in group B; twenty parturients reported excellent analgesia, whereas seven reported a good score, when compared to 60% satisfaction level in group A and just 40% in the control group (P value < 0.0001). Priyanka Chuttani et al.[14] had taken 60 laboring parturients who were allocated two equal groups to receive either 0.1% ropivacaine with 2 μg/ml fentanyl or 0.1% levobupivacaine with 2 μg/ml fentanyl as an epidural solution via PCEA pump infusions (4 ml/h) after 15 ml loading dose of the respective solutions. The mean maternal satisfaction on a VAS of (0–100) mm, where 0 represents complete dissatisfaction and 100 represents complete satisfaction at 1 and 24 hours after delivery in group A, was observed as 77.67 ± 19.95 mm. The mean maternal satisfaction at 1 and 24 hours after delivery in group B was 80.00 ± 12.59 mm and 80.33 ± 12.99 mm, respectively. The results of both studies are consistent with our study result. In our study, the APGAR score [Table 3] shows at birth a P value of 0.6411. At 5 min, a P value of 1.000 is shown. At 10 min, the P value is 1.000. Our observation was in agreement with Yvonne Lim et al.[11] P.D.W. Fettes et al.[16] show similar APGAR scores. In our study, in group RF, 8% of the patients developed nausea, 4% developed vomiting, which was treated by ondensteron 4 mg, 4% of the patients developed mild headache, 4% of the patients developed hypotension, which was treated by bolus iv fluid and ephedrine 6 mg IV, and 4% of the patients developed pruritis, which was resolved after 1 hour. In group R, 8% of the patients developed nausea, 4% developed vomiting, which was treated by ondensteron 4 mg, 4% of the patients developed mild headache, and 4% developed drowsiness. Hence, in our study, we conclude that addition of fentanyl 2mcg/ml to ropivacine decreases the time of onset of analgesia and increases the duration of analgesia and the level of maternal satisfaction during labor, which was a similar finding in the previous study of Gaurav S Tomar et al.,[15] Yogesh Kumar et al.,[8] and Roopesh Kumar et al.[7]. Newer advances include introduction of newer techniques such as combined spinal epidurals; low-dose epidurals facilitating ambulation; pharmacological advances such as introduction of remifentanil for patient-controlled intravenous analgesia; introduction of newer local anaesthetics and adjuvants such as ropivacaine, levobupivacaine, sufentanil, clonidine, and neostigmine; and use of inhalational agents such as sevoflourane for patient-controlled inhalational analgesia using special vaporizers all have revolutionized the practice of pain management in laboring parturients.[2]
ConclusionWe conclude that in labor epidural analgesia, 0.2% ropivacaine with fentanyl is more effective for pain relief compared to 0.2% ropivacaine. Addition of fentanyl to repivacaine in epidural space will increase the duration and quality of analgesia with a similar safety profile. This study also concludes that adding of fentanyl reduces the requirement of PCEA demand. Addition of local analgesia with opioid did not hamper ambulation and bearing down of patients and had similar incidence of maternal and fetal outcomes, with good patient satisfaction. Hence, the effects of both local anesthetic agents with fentanyl epidurally are similar. Durations of action are also similar in both drugs, but ropivacaine has selective sensory fiber blockage compared to motor fiber blockage.
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The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
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Conflicts of interest
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References
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