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      Epidural versus non‐epidural or no analgesia for pain management in labour

      systematic-review
      , , ,
      Cochrane Pregnancy and Childbirth Group
      The Cochrane Database of Systematic Reviews
      John Wiley & Sons, Ltd

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          Abstract

          Background

          Epidural analgesia is a central nerve block technique achieved by injection of a local anaesthetic close to the nerves that transmit pain, and is widely used as a form of pain relief in labour. However, there are concerns about unintended adverse effects on the mother and infant. This is an update of an existing Cochrane Review ( Epidural versus non‐epidural or no analgesia in labour), last published in 2011.

          Objectives

          To assess the effectiveness and safety of all types of epidural analgesia, including combined‐spinal‐epidural (CSE) on the mother and the baby, when compared with non‐epidural or no pain relief during labour.

          Search methods

          We searched Cochrane Pregnancy and Childbirth’s Trials Register (ClinicalTrials.gov), the WHO International Clinical Trials Registry Platform (ICTRP) (30 April 2017), and reference lists of retrieved studies.

          Selection criteria

          Randomised controlled trials comparing all types of epidural with any form of pain relief not involving regional blockade, or no pain relief in labour. We have not included cluster‐randomised or quasi‐randomised trials in this update.

          Data collection and analysis

          Two review authors independently assessed trials for inclusion and risks of bias, extracted data and checked them for accuracy. We assessed selected outcomes using the GRADE approach.

          Main results

          Fifty‐two trials met the inclusion criteria and we have included data from 40 trials, involving over 11,000 women. Four trials included more than two arms. Thirty‐four trials compared epidural with opioids, seven compared epidural with no analgesia, one trial compared epidural with acu‐stimulation, one trial compared epidural with inhaled analgesia, and one trial compared epidural with continuous midwifery support and other analgesia. Risks of bias varied throughout the included studies; six out of 40 studies were at high or unclear risk of bias for every bias domain, while most studies were at high or unclear risk of detection bias. Quality of the evidence assessed using GRADE ranged from moderate to low quality.

          Pain intensity as measured using pain scores was lower in women with epidural analgesia when compared to women who received opioids (standardised mean difference ‐2.64, 95% confidence interval (CI) ‐4.56 to ‐0.73; 1133 women; studies = 5; I 2 = 98%; low‐quality evidence) and a higher proportion were satisfied with their pain relief, reporting it to be "excellent or very good" (average risk ratio (RR) 1.47, 95% CI 1.03 to 2.08; 1911 women; studies = 7; I 2 = 97%; low‐quality evidence). There was substantial statistical heterogeneity in both these outcomes. There was a substantial decrease in the need for additional pain relief in women receiving epidural analgesia compared with opioid analgesia (average RR 0.10, 95% CI 0.04 to 0.25; 5099 women; studies = 16; I 2 = 73%; Tau 2 = 1.89; Chi 2 = 52.07 (P < 0.00001)). More women in the epidural group experienced assisted vaginal birth (RR 1.44, 95% CI 1.29 to 1.60; 9948 women; studies = 30; low‐quality evidence). A post hoc subgroup analysis of trials conducted after 2005 showed that this effect is negated when trials before 2005 are excluded from this analysis (RR 1.19, 95% CI 0.97 to 1.46). There was no difference between caesarean section rates (RR 1.07, 95% CI 0.96 to 1.18; 10,350 women; studies = 33; moderate‐quality evidence), and maternal long‐term backache (RR 1.00, 95% CI 0.89 to 1.12; 814 women; studies = 2; moderate‐quality evidence). There were also no clear differences between groups for the neonatal outcomes, admission to neonatal intensive care unit (RR 1.03, 95% CI 0.95 to 1.12; 4488 babies; studies = 8; moderate‐quality evidence) and Apgar score less than seven at five minutes (RR 0.73, 95% CI 0.52 to 1.02; 8752 babies; studies = 22; low‐quality evidence). We downgraded the evidence for study design limitations, inconsistency, imprecision in effect estimates, and possible publication bias.

          Side effects were reported in both epidural and opioid groups. Women with epidural experienced more hypotension, motor blockade, fever, and urinary retention. They also had longer first and second stages of labour, and were more likely to have oxytocin augmentation than the women in the opioid group. Women receiving epidurals had less risk of respiratory depression requiring oxygen, and were less likely to experience nausea and vomiting than women receiving opioids. Babies born to women in the epidural group were less likely to have received naloxone. There was no clear difference between groups for postnatal depression, headache, itching, shivering, or drowsiness. Maternal morbidity and long‐term neonatal outcomes were not reported.

          Epidural analgesia resulted in less reported pain when compared with placebo or no treatment, and with acu‐stimulation. Pain intensity was not reported in the trials that compared epidural with inhaled analgesia, or continuous support. Few trials reported on serious maternal side effects.

          Authors' conclusions

          Low‐quality evidence shows that epidural analgesia may be more effective in reducing pain during labour and increasing maternal satisfaction with pain relief than non‐epidural methods. Although overall there appears to be an increase in assisted vaginal birth when women have epidural analgesia, a post hoc subgroup analysis showed this effect is not seen in recent studies (after 2005), suggesting that modern approaches to epidural analgesia in labour do not affect this outcome. Epidural analgesia had no impact on the risk of caesarean section or long‐term backache, and did not appear to have an immediate effect on neonatal status as determined by Apgar scores or in admissions to neonatal intensive care. Further research may be helpful to evaluate rare but potentially severe adverse effects of epidural analgesia and non‐epidural analgesia on women in labour and long‐term neonatal outcomes.

          Plain language summary

          Epidurals for pain relief in labour

          What is the issue?

          We set out to assess the effectiveness of all kinds of epidural analgesia (including combined‐spinal‐epidural) on the mother and the baby, when compared with non‐epidural or no pain relief during labour.

          Why is this important?

          Pain relief is important for women in labour. Pharmacological methods of pain relief include breathing in of nitrous oxide, injection of opioids and local analgesia with an epidural for a central nerve block. Epidurals are widely used for pain relief in labour and involve an injection of a local anaesthetic into the lower region of the back close to the nerves that transmit pain. Epidural solutions are given by bolus injection (a large, rapid injection), continuous infusion or using a patient‐controlled pump. Lower concentrations of local anaesthetic when given together with an opiate allow women to maintain the ability to move around during labour and to actively participate in the birth. Combined‐spinal‐epidural involves a single injection of local anaesthetic or opiate into the cerebral spinal fluid for fast onset of pain relief, as well as insertion of the epidural catheter for continuing pain relief. Side effects such as itchiness, drowsiness, shivering and fever have been reported. Rare but potentially severe adverse effects of epidural analgesia can occur, such as severe long‐lasting headache after the injection, or nerve injury.

          What evidence did we find?

          We searched for evidence in April 2017 and identified 40 trials, involving over 11,000 women, that contributed information to this review. The trials varied in the quality of their methods.

          All but six studies compared epidural analgesia with injected opioid drugs. Epidurals may relieve labour pain more effectively than opioids, and more women may be more satisfied with epidural as pain relief. Overall, women using epidural analgesia may be more likely to require forceps or ventouse to assist with the birth when compared with opioid drugs. However we did not see this effect in studies conducted since 2005, where the use of lower concentrations of local anaesthetic and more modern epidural techniques such as patient‐controlled epidural analgesia (PCEA) were more likely. Epidural in comparison to opioids probably makes little or no difference to caesarean section rates, women with long‐term backache, effects on the baby at birth or the number of babies who were admitted to neonatal intensive care.

          Women who used epidurals can have problems passing urine and can suffer fever. There are highly variable findings such as a longer labour, experiencing very low blood pressure, and being unable to move for a period of time after the birth (motor blockade), probably due to higher concentrations of local anaesthetic being used in the epidural or the use of epidural infusions rather than epidural doses of pain relief administered at intervals. However, women who received opioid drugs also showed some side effects such as a slowing of their breathing so that they needed to wear an oxygen mask, and more nausea and vomiting. More babies whose mothers received opioids were given a drug to counteract the effects of the opioids. There was no difference between women in the epidural or opioid groups for postnatal depression, headaches, itching, shivering, or drowsiness.

          Women with epidurals reported less pain compared to women with placebo or no treatment, or acu‐stimulation. Pain was not reported in the trials that compared epidural with inhaled analgesia, or continuous support.

          What does this mean?

          Epidurals may reduce pain during labour more effectively than any other form of pain relief, and may increase maternal satisfaction with pain relief. However, some women who have an epidural instead of opioid drugs may be more likely to have an assisted vaginal birth, but this finding probably reflects the higher concentrations of local anaesthetics used traditionally rather than the low concentrations of modern epidurals. Further research would be helpful, using more consistent measures of reducing the adverse outcomes with epidurals.

          Related collections

          Most cited references113

          • Record: found
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          Pain management for women in labour: an overview of systematic reviews.

          The pain that women experience during labour is affected by multiple physiological and psychosocial factors and its intensity can vary greatly.  Most women in labour require pain relief. Pain management strategies include non-pharmacological interventions (that aim to help women cope with pain in labour) and pharmacological interventions (that aim to relieve the pain of labour). To summarise the evidence from Cochrane systematic reviews on the efficacy and safety of non-pharmacological and pharmacological interventions to manage pain in labour. We considered findings from non-Cochrane systematic reviews if there was no relevant Cochrane review. We searched the Cochrane Database of Systematic Reviews (The Cochrane Library 2011, Issue 5), The Cochrane Database of Abstracts of Reviews of Effects (The Cochrane Library 2011, Issue 2 of 4), MEDLINE (1966 to 31 May 2011) and EMBASE (1974 to 31 May 2011) to identify all relevant systematic reviews of randomised controlled trials of pain management in labour. Each of the contributing Cochrane reviews (nine new, six updated) followed a generic protocol with 13 common primary efficacy and safety outcomes. Each Cochrane review included comparisons with placebo, standard care or with a different intervention according to a predefined hierarchy of interventions. Two review authors extracted data and assessed methodological quality, and data were checked by a third author. This overview is a narrative summary of the results obtained from individual reviews. We identified 15 Cochrane reviews (255 included trials) and three non-Cochrane reviews (55 included trials) for inclusion within this overview. For all interventions, with available data, results are presented as comparisons of: 1. Intervention versus placebo or standard care; 2. Different forms of the same intervention (e.g. one opioid versus another opioid); 3. One type of intervention versus a different type of intervention (e.g. TENS versus opioid). Not all reviews included results for all comparisons. Most reviews compared the intervention with placebo or standard care, but with the exception of opioids and epidural analgesia, there were few direct comparisons between different forms of the same intervention, and even fewer comparisons between different interventions. Based on these three comparisons, we have categorised interventions into: " What works" ,"What may work", and "Insufficient evidence to make a judgement".WHAT WORKSEvidence suggests that epidural, combined spinal epidural (CSE) and inhaled analgesia effectively manage pain in labour, but may give rise to adverse effects. Epidural, and inhaled analgesia effectively relieve pain when compared with placebo or a different type of intervention (epidural versus opioids). Combined-spinal epidurals relieve pain more quickly than traditional or low dose epidurals. Women receiving inhaled analgesia were more likely to experience vomiting, nausea and dizziness.When compared with placebo or opioids, women receiving epidural analgesia had more instrumental vaginal births and caesarean sections for fetal distress, although there was no difference in the rates of caesarean section overall. Women receiving epidural analgesia were more likely to experience hypotension, motor blockade, fever or urinary retention. Less urinary retention was observed in women receiving CSE than in women receiving traditional epidurals. More women receiving CSE than low-dose epidural experienced pruritus.  WHAT MAY WORKThere is some evidence to suggest that immersion in water, relaxation, acupuncture, massage and local anaesthetic nerve blocks or non-opioid drugs may improve management of labour pain, with few adverse effects.  Evidence was mainly limited to single trials. These interventions relieved pain and improved satisfaction with pain relief (immersion, relaxation, acupuncture, local anaesthetic nerve blocks, non-opioids) and childbirth experience (immersion, relaxation, non-opioids) when compared with placebo or standard care. Relaxation was associated with fewer assisted vaginal births and acupuncture was associated with fewer assisted vaginal births and caesarean sections.INSUFFICIENT EVIDENCEThere is insufficient evidence to make judgements on whether or not hypnosis, biofeedback, sterile water injection, aromatherapy, TENS, or parenteral opioids are more effective than placebo or other interventions for pain management in labour. In comparison with other opioids more women receiving pethidine experienced adverse effects including drowsiness and nausea.  Most methods of non-pharmacological pain management are non-invasive and appear to be safe for mother and baby, however, their efficacy is unclear, due to limited high quality evidence. In many reviews, only one or two trials provided outcome data for analysis and the overall methodological quality of the trials was low. High quality trials are needed.There is more evidence to support the efficacy of pharmacological methods, but these have more adverse effects. Thus, epidural analgesia provides effective pain relief but at the cost of increased instrumental vaginal birth.It remains important to tailor methods used to each woman's wishes, needs and circumstances, such as anticipated duration of labour, the infant's condition, and any augmentation or induction of labour.A major challenge in compiling this overview, and the individual systematic reviews on which it is based, has been the variation in use of different process and outcome measures in different trials, particularly assessment of pain and its relief, and effects on the neonate after birth. This made it difficult to pool results from otherwise similar studies, and to derive conclusions from the totality of evidence. Other important outcomes have simply not been assessed in trials; thus, despite concerns for 30 years or more about the effects of maternal opioid administration during labour on subsequent neonatal behaviour and its influence on breastfeeding, only two out of 57 trials of opioids reported breastfeeding as an outcome. We therefore strongly recommend that the outcome measures, agreed through wide consultation for this project, are used in all future trials of methods of pain management.
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            • Abstract: found
            • Article: not found

            The risk of cesarean delivery with neuraxial analgesia given early versus late in labor.

            Epidural analgesia initiated early in labor (when the cervix is less than 4.0 cm dilated) has been associated with an increased risk of cesarean delivery. It is unclear, however, whether this increase in risk is due to the analgesia or is attributable to other factors. We conducted a randomized trial of 750 nulliparous women at term who were in spontaneous labor or had spontaneous rupture of the membranes and who had a cervical dilatation of less than 4.0 cm. Women were randomly assigned to receive intrathecal fentanyl or systemic hydromorphone at the first request for analgesia. Epidural analgesia was initiated in the intrathecal group at the second request for analgesia and in the systemic group at a cervical dilatation of 4.0 cm or greater or at the third request for analgesia. The primary outcome was the rate of cesarean delivery. The rate of cesarean delivery was not significantly different between the groups (17.8 percent after intrathecal analgesia vs. 20.7 percent after systemic analgesia; 95 percent confidence interval for the difference, -9.0 to 3.0 percentage points; P=0.31). The median time from the initiation of analgesia to complete dilatation was significantly shorter after intrathecal analgesia than after systemic analgesia (295 minutes vs. 385 minutes, P<0.001), as was the time to vaginal delivery (398 minutes vs. 479 minutes, P<0.001). Pain scores after the first intervention were significantly lower after intrathecal analgesia than after systemic analgesia (2 vs. 6 on a 0-to-10 scale, P<0.001). The incidence of one-minute Apgar scores below 7 was significantly higher after systemic analgesia (24.0 percent vs. 16.7 percent, P=0.01). Neuraxial analgesia in early labor did not increase the rate of cesarean delivery, and it provided better analgesia and resulted in a shorter duration of labor than systemic analgesia. Copyright 2005 Massachusetts Medical Society.
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              Combined spinal-epidural versus epidural analgesia in labour.

              Traditional epidural techniques have been associated with prolonged labour, use of oxytocin augmentation and increased incidence of instrumental vaginal delivery. The combined spinal-epidural (CSE) technique has been introduced in an attempt to reduce these adverse effects. CSE is believed to improve maternal mobility during labour and provide more rapid onset of analgesia than epidural analgesia, which could contribute to increased maternal satisfaction. To assess the relative effects of CSE versus epidural analgesia during labour. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (28 September 2011) and reference lists of retrieved studies. We updated the search on 30 June 2012 and added the results to the awaiting classification section. All published randomised controlled trials (RCTs) involving a comparison of CSE with epidural analgesia initiated for women in the first stage of labour. Cluster-randomised trials were considered for inclusion. Quasi RCTs and cross-over trials were not considered for inclusion in this review. Three review authors independently assessed the trials identified from the searches for inclusion, assessed trial quality and extracted the data. Data were checked for accuracy. Twenty-seven trials involving 3274 women met our inclusion criteria. Twenty-six outcomes in two sets of comparisons involving CSE versus traditional epidurals and CSE versus low-dose epidural techniques were analysed.Of the CSE versus traditional epidural analyses five outcomes showed a significant difference. CSE was more favourable in relation to speed of onset of analgesia from time of injection (mean difference (MD) -2.87 minutes; 95% confidence interval (CI) -5.07 to -0.67; two trials, 129 women); the need for rescue analgesia (risk ratio (RR) 0.31; 95% CI 0.14 to 0.70; one trial, 42 women); urinary retention (RR 0.86; 95% CI 0.79 to 0.95; one trial, 704 women); and rate of instrumental delivery (RR 0.81; 95% CI 0.67 to 0.97; six trials, 1015 women). Traditional epidural was more favourable in relation to umbilical venous pH (MD -0.03; 95% CI -0.06 to -0.00; one trial, 55 women). There were no data on maternal satisfaction, blood patch for post dural puncture headache, respiratory depression, umbilical cord pH, rare neurological complications, analgesia for caesarean section after analgesic intervention or any economic/use of resources outcomes for this comparison. No differences between CSE and traditional epidural were identified for mobilisation in labour, the need for labour augmentation, the rate of caesarean birth, incidence of post dural puncture headache, maternal hypotension, neonatal Apgar scores or umbilical arterial pH.For CSE versus low-dose epidurals, three outcomes were statistically significant. Two of these reflected a faster onset of effective analgesia from time of injection with CSE and the third was of more pruritus with CSE compared to low-dose epidural (average RR 1.80; 95% CI 1.22 to 2.65; 11 trials, 959 women; random-effects, T² = 0.26, I² = 84%). There was no significant difference in maternal satisfaction (average RR 1.01; 95% CI 0.98 to 1.05; seven trials, 520 women; random-effects, T² = 0.00, I² = 45%). There were no data on respiratory depression, maternal sedation or the need for labour augmentation. No differences between CSE and low-dose epidural were identified for need for rescue analgesia, mobilisation in labour, incidence of post dural puncture headache, known dural tap, blood patch for post dural headache, urinary retention, nausea/vomiting, hypotension, headache, the need for labour augmentation, mode of delivery, umbilical pH, Apgar score or admissions to the neonatal unit. There appears to be little basis for offering CSE over epidurals in labour, with no difference in overall maternal satisfaction despite a slightly faster onset with CSE and conversely less pruritus with low-dose epidurals. There was no difference in ability to mobilise, maternal hypotension, rate of caesarean birth or neonatal outcome. However, the significantly higher incidence of urinary retention, rescue interventions and instrumental deliveries with traditional techniques would favour the use of low-dose epidurals. It is not possible to draw any meaningful conclusions regarding rare complications such as nerve injury and meningitis.
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                Author and article information

                Contributors
                ma.somuah@tgh.nhs.uk , metsas@aol.com
                Journal
                Cochrane Database Syst Rev
                Cochrane Database Syst Rev
                14651858
                10.1002/14651858
                The Cochrane Database of Systematic Reviews
                John Wiley & Sons, Ltd (Chichester, UK )
                1469-493X
                21 May 2018
                May 2018
                18 May 2018
                : 2018
                : 5
                : CD000331
                Affiliations
                Tameside Hospital NHS Foundation Trust Fountain Street Ashton‐under‐Lyne UK OL6 9RW
                The University of Manchester deptDivision of Nursing Midwifery and Social Work Jean McFarlane Building Oxford Road Manchester UK M13 9PL
                Women's and Children's Hospital deptDepartment of Women's Anaesthesia 72 King William Road Adelaide South Australia Australia 5006
                The University of Liverpool deptCochrane Pregnancy and Childbirth Group, Department of Women's and Children's Health First Floor, Liverpool Women's NHS Foundation Trust Crown Street Liverpool UK L8 7SS
                Article
                PMC6494646 PMC6494646 6494646 CD000331.pub4 CD000331
                10.1002/14651858.CD000331.pub4
                6494646
                29781504
                9b784c28-3d6d-4fbc-8500-1e0ace0959ca
                Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
                History
                Categories
                Pregnancy & childbirth
                Pain during labour

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