Liv M. Freeman

Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

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.

Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial.

BackgroundPain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments.Methods/designThe proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia.Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief.Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity), mode of delivery and maternal and neonatal side effects.The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared.DiscussionThis study, considering cost effectiveness of remifentanil as first choice analgesia versus epidural analgesia, could strongly improve the care for 180.000 women, giving birth in the Netherlands yearly by giving them access to pain relief during labour, 24 hours a day.Trial registration numberDutch Trial Register NTR2551, http://www.trialregister.nl

A retrospective study on persistent pain after childbirth in the Netherlands

Reported prevalence rates of persistent postpartum pain (PPP) range from less than 1% to almost 20%. The aim of this study was to examine the prevalence of PPP in a Dutch cohort and to evaluate a possible causal role for specific risk factors on the development of chronic pain after childbirth. A questionnaire was sent to 960 postpartum women approximately 2 years after delivery. Primary outcome was pain that arose from childbirth at follow-up, and secondary outcomes included quality of life (QoL) and Hospital Anxiety and Depression Scale scores. Tested risk factors included mode of labor analgesia, history of negative effect, history of chronic pain, delivery route, parity, and ethnicity. A total of 495 (51.6%) women participated. At a mean time of 2.3 postpartum years, 7.3% of women reported any pain and 6.1% reported significant pain related to the delivery. Compared to spontaneous delivery, cesarean delivery provided protection against persistent pain (odds ratio, 0.12; 95% CI, 0.01–0.63, P<0.05). None of the other risk factors, including remifentanil use for labor pain, were of influence on the prevalence of persistent pain. Women with PPP experienced greater negative effects and had lower QoL scores compared to women without pain. In this cohort of Dutch patients, PPP is a serious problem with a great impact on the physical and mental health of women.

A comprehensive representation of the birth-experience: identification and prioritization of birth-specific domains based on a mixed-method design

BackgroundIn obstetrics, effectiveness and cost-effectiveness studies often present several specific outcomes with likely contradicting results and may not reflect what is important for women. A birth-specific outcome measure that combines the core domains into one utility score would solve this problem. The aim of this study was to investigate which domains are most relevant for women’s overall experience of labor and birth and should be included in such a measure.MethodsA sequential mixed-method design with three steps was applied. First, the domains were identified by literature review and online focus groups consisting of pregnant women, women who recently gave birth, and their partners. Second, in a prioritizing task, women who recently gave birth and professionals (midwives, gynecologists, and researchers) selected and ranked their top seven domains. Third, the domains that were most frequently selected and had the highest ranking scores determined the basis for a consensus discussion with experts, whereby the definitive list of domains was formed.ResultsIn the first step, 34 birth-specific domains were identified, which cover domains regarding the caregivers, intrapersonal aspects of the mother, partner support, and contextual and medical aspects of birth. Based on the prioritizing task results (step 2) of 96 women and 89 professionals, this list was reduced to 14 most relevant domains. In a consensus discussion, the final seven domains were selected by combining several of the 14 remaining domains and giving priority to the domains indicated to be relevant by mothers. The seven definite domains were: 1) availability of competent health professionals; 2) health professionals’ support; 3) provision of information; 4) health professionals’ response to needs and requests; 5) feelings of safety; 6) worries about the child’s health; and 7) experienced duration until the first contact with the child.ConclusionsThe experienced availability and quality of received care, concerns about safety and the baby’s health, and first contact with the baby are regarded as key aspects for a mother’s overall birth experience. Therefore, these domains are considered to be the most crucial for inclusion in a birth-specific outcome measure.

Labour pain with remifentanil patient-controlled analgesia versus epidural analgesia: a randomised equivalence trial.

To distinguish satisfaction with pain relief using remifentanil patient‐controlled analgesia (RPCA) compared with epidural analgesia (EA) in low‐risk labouring women.

Good reliability and validity for a new utility instrument measuring the birth experience, the Labor and Delivery Index.

OBJECTIVES To validate the Labor and Delivery Index (LADY-X), a new delivery-specific utility measure. STUDY DESIGN AND SETTING In a test-retest design, women were surveyed online, 6 to 8 weeks postpartum and again 1 to 2 weeks later. For reliability testing, we assessed the standard error of measurement (S.E.M.) and the intraclass correlation coefficient (ICC). For construct validity, we tested hypotheses on the association with comparison instruments (Mackey Childbirth Satisfaction Rating Scale and Wijma Delivery Experience Questionnaire), both on domain and total score levels. We assessed known-group differences using eight obstetrical indicators: method and place of birth, induction, transfer, control over pain medication, complications concerning mother and child, and experienced control. RESULTS The questionnaire was completed by 308 women, 257 (83%) completed the retest. The distribution of LADY-X scores was skewed. The reliability was good, as the ICC exceeded 0.80 and the S.E.M. was 0.76. Requirements for good construct validity were fulfilled: all hypotheses for convergent and divergent validity were confirmed, and six of eight hypotheses for known-group differences were confirmed as all differences were statistically significant (P-values: <0.001-0.023), but for two tests, difference scores did not exceed the S.E.M. CONCLUSION The LADY-X demonstrates good reliability and construct validity. Despite its skewed distribution, the LADY-X can discriminate between groups. With the preference weights available, the LADY-X might fulfill the need for a utility measure for cost-effectiveness studies for perinatal care interventions.

An economic analysis of patient controlled remifentanil and epidural analgesia as pain relief in labour (RAVEL trial); a randomised controlled trial

Objective To compare the costs of a strategy of patient controlled remifentanil versus epidural analgesia for pain relief in labour. Design We performed a multicentre randomised controlled trial in 15 hospitals in the Netherlands, the RAVEL trial. Costs were analysed from a health care perspective alongside the RAVEL trial. Population Pregnant women of intermediate to high risk beyond 32 weeks gestation who planned vaginal delivery. Methods Women were randomised before the onset of labour, to receive either patient controlled remifentanil or epidural analgesia when pain relief was requested during labour. Main outcome measures Primary outcome for effectiveness was satisfaction with pain relief, expressed as the area under the curve (AUC). A higher AUC represents higher satisfaction with pain relief. Here, we present an economic analysis from a health care perspective including costs from the start of labour to ten days postpartum. Health-care utilization was documented in the Case Report Forms and by administering an additional questionnaire. Results The costs in the patient controlled remifentanil group (n = 687) and in the epidural group (n = 671) were €2900 versus €3185 respectively (mean difference of -€282 (95% CI -€611 to €47)). The (non-significant) higher costs in the epidural analgesia group could be mainly attributed to higher costs of neonatal admission. Conclusion From an economic perspective, there is no preferential pain treatment in labouring intermediate to high risk women. Since patient controlled remifentanil is not equivalent to epidural analgesia with respect to AUC for satisfaction with pain relief we recommend epidural analgesia as the method of choice. However, if appropriately counselled on effect and side effects there is, from an economic perspective, no reason to deny women patient controlled remifentanil.

Pharmacological pain relief and fear of childbirth in low risk women; secondary analysis of the RAVEL study

BackgroundFear of childbirth may reduce the womens’ pain tolerance during labour and may have impact on the mother-infant interaction. We aimed to assess (1) the association between fear of childbirth antepartum and subsequent request for pharmacological pain relief, and (2) the association between the used method of pain relief and experienced fear of childbirth as reported postpartum in low risk labouring women.MethodsSecondary analysis of the RAVEL study, a randomised controlled trial comparing remifentanil patient controlled analgesia (PCA) and epidural analgesia to relieve labour pain. The RAVEL study included 409 pregnant women at low risk for obstetric complications at 18 midwifery practices and six hospitals in The Netherlands (NTR 3687). We measured fear of childbirth antepartum and experienced fear of childbirth reported postpartum, using the Wijma Delivery Expectancy/Experience Questionnaire.ResultsWomen with fear of childbirth antepartum more frequently requested pain relief compared to women without fear of childbirth antepartum, but this association did not reach statistical significance (adjusted odds ratio (aOR2.0; 95% confidence interval (CI) 0.8–4.6). Women who received epidural analgesia more frequently reported fear of childbirth postpartum compared to women who did not receive epidural analgesia (aOR3.5; CI 1.5–8.2), while the association between remifentanil-PCA and fear of childbirth postpartum was not statistically significant (aOR1.7; CI 0.7–4.3).ConclusionsWomen with fear of childbirth antepartum more frequently requested pain relief compared to women without fear of childbirth antepartum, but this association was not statistically significant. Women who received pharmacological pain relief more frequently reported that they had experienced fear of childbirth during labour compared to women who did not receive pain relief. Based on our data epidural analgesia with continuous infusion does not seem to be preferable over remifentanil-PCA as method of pain relief when considering fear of childbirth postpartum.Trial registrationNetherlands Trial Register 3687; Register date: 5 Nov 2012.