<b>BACKGROUND: </b>Epidural analgesia and remifentanil patient-controlled analgesia are two popular techniques for the treatment of labour pain, each with its own efficacy and toxicity.<b>METHODS: </b>Parturients requesting analgesia were randomly assigned to either patient-controlled intravenous remifentanil or epidural analgesia. Control patients consisted of parturients not requesting pain medication. The primary objective was to compare the incidence of maternal fever (temperature ⩾ 38°C); secondary outcomes included the incidence of low oxygen saturation, pain scores, nausea and vomiting, sedation scores, pruritus and neonatal outcome.<b>RESULTS: </b>Data from 140 parturients were analysed: 49 received remifentanil analgesia, 49 epidural analgesia and 42 no analgesia (controls). Fever (temperature ⩾ 38°C) developed in 10% of remifentanil patients compared to 37% of epidural patients and 7% of control patients (P<0.001). One or more hypoxaemic events (oxygen saturation <90% for at least 1 min) occurred in 48% of patients on remifentanil versus 15% of patients on epidural analgesia and 20% of control patients (P=0.003). Although pain intensity scores differed significantly between the two groups in favour of the epidural, mean satisfaction scores were similar in both analgesia groups (remifentanil 8.1 ± 1.2 vs. epidural 8.4 ± 1.2). Remifentanil analgesia was associated with a higher incidence of nausea and deeper levels of sedation. The differences in haemodynamic parameters between groups were small and clinically insignificant.<b>CONCLUSIONS: </b>During treatment of labour pain, epidural analgesia is associated with a higher incidence of maternal fever, while remifentanil analgesia results in more frequent and deeper hypoxaemic events.
In this study we aimed to explore the effects of epidural analgesia achieved by a combination of low-dose bupivacaine and fentanyl infused through an epidural catheter on mother, foetus and labour process in nulliparous at-term pregnant women during vaginal delivery. This study was designed in a prospective, randomised controlled manner. Epidural analgesia was achieved in 50 nulliparous women. Fifty nulliparous women did not undergo epidural analgesia procedure. The duration of the first stage of labour was significantly shortened, while the second stage was significantly lengthened in pregnant women who underwent epidural analgesia (p < 0.05). In conclusion, starting epidural analgesia application during the active phase of the first stage of labour may shorten the duration of the first stage compared with the group of nulliparous women not undergoing epidural analgesia. The factor that has an impact on this may be the addition of fentanyl to bupivacaine used for epidural analgesia.
OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour.
DESIGN: Multicentre randomised controlled equivalence trial.
SETTING: 15 hospitals in the Netherlands.
PARTICIPANTS: Women with an intermediate to high obstetric risk with an intention to deliver vaginally. To exclude a clinically relevant difference in satisfaction with pain relief of more than 10%, we needed to include 1136 women. Because of missing values for satisfaction this number was increased to 1400 before any analysis. We used multiple imputation to correct for missing data.
INTERVENTION: Before the onset of active labour consenting women were randomised to a pain relief strategy with patient controlled remifentanil or epidural analgesia if they requested pain relief during labour.
MAIN OUTCOME MEASURES: Primary outcome was satisfaction with pain relief, measured hourly on a visual analogue scale and expressed as area under the curve (AUC), thus providing a time weighted measure of total satisfaction with pain relief. A higher AUC represents higher satisfaction with pain relief. Secondary outcomes were pain intensity scores, mode of delivery, and maternal and neonatal outcomes. Analysis was done by intention to treat. The study was defined as an equivalence study for the primary outcome.
RESULTS: 1414 women were randomised, of whom 709 were allocated to patient controlled remifentanil and 705 to epidural analgesia. Baseline characteristics were comparable. Pain relief was ultimately used in 65% (447/687) in the remifentanil group and 52% (347/671) in the epidural analgesia group (relative risk 1.32, 95% confidence interval 1.18 to 1.48). Cross over occurred in 7% (45/687) and 8% (51/671) of women, respectively. Of women primarily treated with remifentanil, 13% (53/402) converted to epidural analgesia, while in women primarily treated with epidural analgesia 1% (3/296) converted to remifentanil. The area under the curve for total satisfaction with pain relief was 30.9 in the remifentanil group versus 33.7 in the epidural analgesia group (mean difference -2.8, 95% confidence interval -6.9 to 1.3). For who actually received pain relief the area under the curve for satisfaction with pain relief after the start of pain relief was 25.6 in the remifentanil group versus 36.1 in the epidural analgesia group (mean difference -10.4, -13.9 to -7.0). The rate of caesarean section was 15% in both groups. Oxygen saturation was significantly lower (SpO2 <92%) in women who used remifentanil (relative risk 1.5, 1.4 to 1.7). Maternal and neonatal outcomes were comparable between both groups.
CONCLUSION: In women in labour, patient controlled analgesia with remifentanil is not equivalent to epidural analgesia with respect to scores on satisfaction with pain relief. Satisfaction with pain relief was significantly higher in women who were allocated to and received epidural analgesia.
TRIAL REGISTRATION: Netherlands Trial Register NTR2551.
OBJECTIVE: Combined spinal-epidural analgesia (CSEA) is sometimes used for difficult births, but whether it contributes to postpartum pelvic muscle disorder is unclear. This randomized controlled trial examined whether CSEA given during labor affects the electrophysiological index of postpartum pelvic floor muscle function.
METHODS: A consecutive sample of primiparous women who delivered vaginally at term were randomly assigned to a CSEA group (n = 143) and control group (n = 142) between June 2013 and June 2014. All were assessed 6-8 weeks later for electrophysiological function of pelvic floor muscle.
RESULTS: The two groups were similar in the degree of muscle strength, muscle fatigue, and pelvic dynamic pressure of pelvic floor muscle. The CSEA and control groups showed similar proportions of women with normal muscle strength (score ≥4) in type I pelvic fibers (23.1% vs. 14.1%, P = 0.051) and type II pelvic fibers (28.0% vs. 24.6%, P = 0.524). The groups also contained similar proportions of women who showed no fatigue in type I fibers (54.5% vs. 48.6%, P = 0.315) or type II fibers (88.8% vs. 87.3%, P = 0.699). Similarly low proportions of women in the CSEA group and control group showed normal pelvic dynamic pressure (11.2% vs. 7.7%, P = 0.321). However, women in the CSEA group spent significantly less time in labor than those in the control group (7.25 vs. 9.52 h, P <0.001).
CONCLUSIONS: CSEA did not affect the risk of postpartum pelvic muscle disorder in this cohort of primiparous women who gave birth vaginally. A significant shorter duration of labour was observed in the CSEA-group.
TRIAL REGISTRATION: ClinicalTrials.gov NCT02334150.
BACKGROUND: Safe and effective alternatives are required in labor when epidural analgesia is not appropriate. We hypothesized that patient-controlled IV remifentanil labor analgesia would not be inferior to patient-controlled epidural labor analgesia.
METHODS: This randomized nonblinded controlled noninferiority study in healthy women with a singleton fetus and vertex presentation was performed at 1 site. Women were randomized to receive patient-controlled IV analgesia titrated from 20 mcg up to a maximum bolus dose of 60 mcg with a lockout interval of 1 to 2 minutes, or patient-controlled epidural analgesia 0.1% bupivacaine with 2 mcg/mL fentanyl (initiation bolus 15 mL; maintenance bolus 10 mL, lockout interval 20 minutes, basal infusion 5 mL/h). Crossover was permitted after 30 minutes. The primary study outcome was efficacy (assessed as hourly numerical rating scale [NRS] pain score [11-point NRS] and maternal satisfaction [11-point NRS]); the secondary outcome was safety (maternal apnea). Supplementary oxygen was administered continuously during the respiratory monitoring period. During the first hour of analgesia, the heart rate, respiratory rate, pulse oximetry (SpO2), and end-tidal CO2, as an indication of apnea, were compared. Apnea lasting >40 seconds was managed by light stimulation by the attending anesthesiologist.
RESULTS: Forty women were recruited to the following groups: remifentanil n = 19 (1 exclusion), epidural n = 20. Four crossed over: 3 from the remifentanil to epidural group and 1 from the epidural to remifentanil group. Mean (± SD) baseline NRS pain scores were similar, 8.4 ± 1.5 for remifentanil and 8.7 ± 1.2 for epidural analgesia, P = 0.52. Baseline adjusted mean NRS reduction at 30 minutes for remifentanil was -4.5 (± 0.6) vs -7.1(± 0.6) for epidural analgesia, P < 0.0001 for both. Pain score at 30 minutes was 3.7 ± 2.8 for remifentanil and 1.5 ± 2.2 for epidural analgesia, P = 0.009. Remifentanil was inferior to epidural analgesia with respect to the NRS at all time points, because the observed difference in NRS was greater than the expected -1.5 units. Maternal satisfaction was 8.6 ± 1.4 for the remifentanil group and 9.1 ± 1.5 for epidural group, P = 0.26. Mean respiratory rate was lower in the remifentanil group, 18 ± 4 vs 21 ± 4 breaths/min in the epidural group, P = 0.03. Mean SpO2 was lower in the remifentanil group 96.8% ± 1.4 vs 98.4 ± 1.2 for epidural group, P < 0.0001. There were 9 apnea events; all occurred in 5 women receiving remifentanil (5/19 [26.3%], P = 0.046). Apgar scores and neonatal respiratory outcomes were similar.
CONCLUSION: IV remifentanil is inferior to epidural analgesia for provision of labor analgesia; however, remifentanil does provide a satisfactory level of labor analgesia. Laboring women receiving remifentanil require suitable monitoring to detect and alert for apnea.
