Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Freeman L

PROVIDER: S-EPMC6181333 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Freeman Liv L Middeldorp Johanna J van den Akker Eline E Oudijk Martijn M Bax Caroline C van Huizen Marloes M Radder Celine C Fong Bianca B Bloemenkamp Kitty K Dahan Albert A Struys Michel M Mol Ben Willem BW van Lith Jan J van den Akker-van Marle Elske E

PloS one 20181011 10

<h4>Objective</h4>To compare the costs of a strategy of patient controlled remifentanil versus epidural analgesia for pain relief in labour.<h4>Design</h4>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.<h4>Population</h4>Pregnant women of intermediate to high risk beyond 32 weeks gestation who planned vaginal delivery.<h4>Methods</h4>Women were randomised befo ...[more]

PMID: 30307986

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Project description: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.

Project description:ObjectivesTo explore women's experiences of remifentanil or pethidine for labour pain and infant feeding behaviours at 6weeks post partum.DesignQualitative postnatal sub-study to the randomised controlled trial of remifentanil intravenous patient controlled analgesia (PCA) versus intramuscular pethidine for pain relief in labour (RESPITE). Semistructured telephone interviews were conducted at 6 weeks post partum, and thematic analysis was undertaken.SettingWomen recruited to the RESPITE trial from seven UK hospitals.ParticipantsEighty women consented and 49 (30 remifentanil group and 19 pethidine group) completed the interview.ResultsEight themes emerged which encompassed women's antenatal plans for pain management (Birth Expectations) through to their future preferences for pain relief (Reflections for Future Choices). Many women who used remifentanil felt it provided effective pain relief (Effectiveness of Pain Relief), whereas women in the pethidine group expressed more mixed views. Both groups described side effects, with women using pethidine frequently reporting nausea (Negative Physiological Responses) and women using remifentanil describing more cognitive effects (Cognitive Effects). Some women who used remifentanil reported restricted movements due to technical aspects of drug administration and fear of analgesia running out (Issues with Drug Administration). Women described how remifentanil enabled them to maintain their ability to stay focused during the birth (Enabling a Sense of Control). There was little difference in reported breastfeeding initiation and continuation between pethidine and remifentanil groups (Impact on Infant Behaviour and Breastfeeding).ConclusionsQualitative insights from a follow-up study to a trial which explored experiences of intravenous remifentanil PCA with intramuscular pethidine injection found that remifentanil appeared to provide effective pain relief while allowing women to remain alert and focused during labour, although as with pethidine, some side effects were noted. Overall, there was little difference in reported breastfeeding initiation and duration between the two groups.Trial registration numberISRCTN29654603.

Project description:BackgroundUp to 80% of women use some form of pharmacological analgesia during labour and birth. The side effects of pharmacological agents are often incompatible with the concurrent use of non-pharmacological pain-relieving strategies, such as water immersion, ambulation and upright positioning, or may have negative effects on both the mother and foetus. Sterile water injections given into the skin of the lumbar region have been demonstrated to reduce back pain during labour. However, the injections given for back pain have no effect on abdominal contraction pain. The analgesic efficacy of sterile water injections for abdominal pain during childbirth is unknown. The injections cause an immediate, brief but significant pain that deters some women from using the procedure. This study aims to investigate the use of water injections given intradermally into the abdomen to relieve labour contraction pain. A vapocoolant spray will be applied to the skin immediately prior to the injections to reduce the injection pain.MethodsIn this pragmatic, placebo-controlled trial, 154 low-risk women in labour at term with a labour pain score ≥ 60 on a 100-ml visual analogue scale (VAS) will be randomly allocated to receive either six injections of sterile water or a sodium chloride 0.9% solution as a placebo (0.1-0.3 ml per injection). Three injections are given along the midline from the fundus to the supra-pubis and three laterally across the supra-pubis. The primary outcome will be the difference in VAS score 30 min post-injection between the groups. Secondary outcomes include VAS score of the injection pain on administration, VAS score of labour pain at 60 and 90 min and maternal and neonatal birth outcomes.DiscussionAccess to effective pain relief during labour is fundamental to respectful and safe maternity care. Pharmacological analgesics should support rather than limit other non-pharmacological strategies. Sterile water injections have the potential to provide an alternative form of labour pain relief that is easy to administer in any labour and birth setting and is compatible with other non-pharmacological choices.Trial registrationANZCTR ACTRN12621001036808 . Registered on 05 August 2021.

Project description:ObjectiveTo explore whether an ultrasound-guided pudendal nerve block (PNB) could decrease anaesthetic use, thereby shortening the length of the second stage of labour in women undergoing epidural analgesia.DesignProspective, single-centre, randomised, double-blind, controlled trial.SettingAn obstetric centre in a general hospital in China.Participants72 nulliparous women were randomised, and 71 women completed the study.InterventionAn ultrasound-guided bilateral PNB was administered to all study participants; the PNB group were given 0.25% ropivacaine 10 mL, while the control group were given 10 mL saline.Main outcome measureThe primary outcome measure was the duration of the second stage of labour. Secondary outcomes included additional bolus administration, total hourly bupivacaine consumption, difference in thickness between the contracted and relaxed rectus abdominis muscle before (DRAM1) and 30 min after (DRAM2) PNB, urge to defecate, maternal cooperation, preservation of the lower limb motor function, tightness of the perineum, and Numeric Rating Scale (NRS) score for pain.ResultsThe duration of the second stage of labour was shorter in the PNB group than in the control group (difference of 33.8 min (95% CI 15.6 to 52.0), p<0.001). Additional bolus administration and total hourly bupivacaine consumption were lower in the PNB group than in the control group (p<0.001). DRAM2 was greater (p<0.001), rate of parturient women with the urge to defecate was higher (p=0.014), maternal cooperation was superior (p=0.002), and lower limb motor function preservation was greater (p=0.004) in the PNB group relative to the control group. Tightness of the perineum was eliminated from the results due to the inconsistent application of the criteria by the nursing staff. There was no significant difference in NRS scores between the groups.ConclusionsNulliparous women with epidural analgesia who received an ultrasound-guided bilateral PNB may reduce their need for bupivacaine and consequently shorten the length of the second stage of labour, therein indicating that a bilateral PNB may serve as an additional effective adjunct method of labour analgesia.Trial registration numberChiCTR-IOR-16009121.

Project description:BackgroundAbout a third of women experience severe back pain during labour. Injecting small volumes of intracutaneous sterile water into the lumbar region can be used to relieve this pain, however the procedure is controversial and previous reviews call for high quality trials to establish efficacy. We evaluated the impact on birth outcomes and analgesic effects of sterile water injections.MethodsA multicentre, double-blind trial undertaken between December 2012 and December 2017 in one British and 15 Australian maternity units. Women experiencing severe back-pain in labour were assigned (1:1) by an independently generated randomisation schedule stratified by site to injections of either sterile water or saline placebo. Participants and caregivers were blinded to group allocation. The primary outcome was caesarean delivery rate. Main secondary outcomes included at least 30% or 50% reduction in self-reported pain scores at 30, 60 and 90 minutes after treatment. Intention to treat analysis were used and the level of significance for the multiple clinical outcomes was set at p<0.001 with the Bonferroni correction applied. The study is registered with the ACTRN Registry number, ACTRN1261100022195.FindingsBetween December 9, 2012, and December 15, 2017, 1166 women were recruited and randomised: 587 women received sterile water injections (SWI) and 579 a saline placebo. Seven women in the SWI group and 12 in the placebo group were excluded as consent was not completed, leaving 580 and 567, respectively, included in the analysis. The proportions of caesarean delivery were 17·1% (82 of 580) in the SWI group and 14·8% (82 of 567) in the placebo (RR 1·16, 95% CI 0·88-1.51; p = 0·293). At 30 min post treatment 60·8% (330 of 543) of women in the SWI group reported a 30% reduction in self-reported pain compared to 31·4% (163 of 520) placebo (RR 1·94, 95% CI 1·68-2·24; p=<0·001) and 43·3% (235 of 534) SWI reported a 50% reduction versus 18·1% (94 of 520) placebo (RR 2·39, 95% CI 1·95-2·94; p=<0·001). The analgesic effect of SWI compared to placebo remained significant at 60 and 90 min post-treatment. There were no significant differences in other maternal or neonatal outcomes.InterpretationCompared to placebo, injections of sterile water did not reduce rates of caesarean delivery. For the main secondary outcome of pain relief the intervention did result in significantly more women reporting at least 30% and 50% reduction in pain for up to 90 min. Water injections have no effect on birth outcomes though can be an effective treatment for the relief of labour-related back pain.Funded by the National Health and Medical Research Council.

Project description:Postoperative pain after major open gynecologic surgeries requires appropriate pain management.This study aimed at comparing perioperative patient controlled epidural analgesia (PCEA) and patient controlled intravenous analgesia (PCA) after gynecologic oncology surgeries.In this clinical trial study, 90 patients with American society of anesthesiologists (ASA) class I or II scheduled for gynecologic oncologic surgeries were randomly allocated to two groups (45 patients each group) to receive: patient-controlled epidural analgesia with bupivacaine and fentanyl (PCEA group), or patient controlled intravenous analgesia (IV PCA group) with fentanyl, pethidine and ondansetron. Postoperative pain was assessed over 48 hours using the visual analog scale (VAS). The frequency of rescue analgesia was recorded. Occurrence of any concomitant events such as nausea, vomiting, ileus, purities, sedation and respiratory complications were recorded postoperatively.There were no statistically significant differences in demographic data including; age, weight, ASA physical status, duration of surgery, intraoperative bleeding, and the amount of blood transfusion (P > 0.05), between the two studied groups. Severity of postoperative pain was not significantly different between the two groups (P > 0.05); however, after first patient mobilization, pain was significantly lower in the epidural group than the IV group (P < 0.001). There was no significant difference between the two groups regarding the incidence of complications such as nausea, vomiting, purities or ileus (P > 0.05). Nevertheless, the incidence and severity of sedation was significantly higher in the IV group (P < 0.001). Respiratory depression was higher in the IV group than the epidural group; this difference, however, was not significant (P = 0.11). In the epidural group, only 10 patients (22.2%) had mild and transient lower extremities parenthesis.Both intravenous and epidural analgesic techniques with combination of analgesics provide proper postoperative pain control after major gynecologic cancer surgeries without any significant complications. Regarding lower sedative and respiratory depressant effects of epidural analgesia, it seems that this method is a safer technique for postoperative pain relief in these patients.

Dataset Information

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

Objective

Design

Population

Methods

Main outcome measures

Results

Conclusion

Publications

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

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