Epidural versus non-epidural or no analgesia in labour (Review) Anim-Somuah M, Smyth RMD, Jones L ThisisareprintofaCochranereview,preparedandmaintainedbyTheCochraneCollaborationandpublishedinTheCochraneLibrary 2011,Issue12 http://www.thecochranelibrary.com Epiduralversusnon-epiduralornoanalgesiainlabour(Review) Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. TABLE OF CONTENTS HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 PLAINLANGUAGESUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Figure1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Figure2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 AUTHORS’CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 CHARACTERISTICSOFSTUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 DATAANDANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Analysis1.1.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome1Woman’sperceptionofpainrelief inlabour. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84 Analysis1.2.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome2Instrumentaldelivery. . . 85 Analysis1.3.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome3Caesareansection. . . . 86 Analysis1.4.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome4Apgarscorelessthan7at5 minutes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Analysis1.5.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome5Maternalsatisfactionwithpain reliefinlabour-proportionratingexcellentorverygood. . . . . . . . . . . . . . . . . . . . 89 Analysis1.6.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome6Long-termbackache. . . 90 Analysis1.7.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome7Lengthoffirststageoflabour (minutes). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91 Analysis1.8.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome8Lengthofsecondstageoflabour (minutes). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92 Analysis1.9.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome9Oxytocinaugmentation. . 93 Analysis1.10.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome10Caesareansectionforfetal distress. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 Analysis1.11. Comparison 1Epiduralversusnon-epidural analgesia inlabour,Outcome11Caesareansectionfor dystocia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 Analysis1.12.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome12Timeofadministrationofpain relieftotimepainreliefwassatisfactory. . . . . . . . . . . . . . . . . . . . . . . . . . 96 Analysis1.13.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome13Woman’sperceptionofpain reliefduringfirststageoflabour. . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 Analysis1.14.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome14Woman’sperceptionofpain reliefduringthesecondstageoflabour. . . . . . . . . . . . . . . . . . . . . . . . . . 97 Analysis1.15.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome15Maternalsatisfactionwith childbirthexperience. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 Analysis1.16.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome16Perceivedfeelingofpoor controlinlabour. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 Analysis1.17.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome17Needforadditionalmeansof painrelief. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 Analysis1.18.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome18Maternalsatisfactionwithpain reliefinlabour-continuousdata. . . . . . . . . . . . . . . . . . . . . . . . . . . . 99 Analysis1.19.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome19Maternalhypotensionas definedbytrialauthors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 Analysis1.20.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome20Postnataldepression(authors definition,onmedication,orself-reported). . . . . . . . . . . . . . . . . . . . . . . . 101 Epiduralversusnon-epiduralornoanalgesiainlabour(Review) i Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. Analysis1.21.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome21Motorblockade. . . . 101 Analysis1.22.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome22Respiratory depression requiringoxygenadministration. . . . . . . . . . . . . . . . . . . . . . . . . . . . 102 Analysis1.23.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome23Headache. . . . . . 102 Analysis1.24.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome24Perinealtraumarequiring suturing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103 Analysis1.25.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome25Nauseaandvomiting. . 103 Analysis1.26.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome26Itch. . . . . . . . 104 Analysis1.27.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome27Fever>38degreesC. . 105 Analysis1.28.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome28Shivering. . . . . . 105 Analysis1.29.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome29Drowsiness. . . . . 106 Analysis1.30.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome30Urinaryretention. . . 107 Analysis1.31.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome31Cathetherisationduring labour. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 Analysis1.32.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome32Malposition. . . . . 108 Analysis1.33.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome33Surgicalamniotomy. . 108 Analysis1.34.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome34Neonatalintensivecareunit admission. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 Analysis1.35.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome35Acidosisdefinedbycord arterialpH<7.2atdelivery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110 Analysis1.36.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome36Acidosisdefinedbycord arterialpH<7.15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 Analysis1.37.Comparison1Epiduralversusnon-epiduralanalgesiainlabour,Outcome37Naloxoneadministration. 112 Analysis1.38.Comparison 1Epiduralversusnon-epidural analgesiainlabour,Outcome38Meconiumstaining of liquor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113 Analysis6.1.Comparison6Sensitivityanalysisofprimaryoutcomesbasedonexclusionofstudieswithhighorunclear riskofbiasforallocationconcealment,Outcome1Maternalsatisfactionwithpainreliefinlabour-proportionrating excellentorverygood. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114 Analysis6.2.Comparison6Sensitivityanalysisofprimaryoutcomesbasedonexclusionofstudieswithhighorunclearrisk ofbiasforallocationconcealment,Outcome2Needforadditionalmeansofpainrelief. . . . . . . . . 115 Analysis7.1.Comparison7Sensitivityanalysisofprimaryoutcomesbasedonexclusionofstudieswithhighorunclearrisk ofbiasforincompleteoutcomedata,Outcome1Maternalsatisfactionwithpainreliefinlabour-proportionrating excellentorverygood. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116 Analysis7.2.Comparison7Sensitivityanalysisofprimaryoutcomesbasedonexclusionofstudieswithhighorunclearrisk ofbiasforincompleteoutcomedata,Outcome2Needforadditionalmeansofpainrelief. . . . . . . . 117 FEEDBACK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117 WHAT’SNEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 CONTRIBUTIONSOFAUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 DECLARATIONSOFINTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 SOURCESOFSUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120 DIFFERENCESBETWEENPROTOCOLANDREVIEW . . . . . . . . . . . . . . . . . . . . . 120 INDEXTERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120 Epiduralversusnon-epiduralornoanalgesiainlabour(Review) ii Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. [InterventionReview] Epidural versus non-epidural or no analgesia in labour MillicentAnim-Somuah1,RebeccaMDSmyth2,LeanneJones3 1TamesideHospitalNHSFoundationTrust,Ashton-under-Lyne,UK.2SchoolofNursing,MidwiferyandSocialWork,TheUniversity ofManchester,Manchester,UK.3CochranePregnancyandChildbirthGroup,DepartmentofWomen’sandChildren’sHealth,The UniversityofLiverpool,Liverpool,UK Contact address: Millicent Anim-Somuah, Tameside Hospital NHS Foundation Trust, Fountain Street, Ashton-under-Lyne, OL6 9RW,[email protected]. Editorialgroup:CochranePregnancyandChildbirthGroup. Publicationstatusanddate:Newsearchforstudiesandcontentupdated(nochangetoconclusions),publishedinIssue12,2011. Reviewcontentassessedasup-to-date: 30September2011. Citation: Anim-Somuah M, SmythRMD, JonesL. Epidural versusnon-epidural or no analgesia in labour. CochraneDatabase of SystematicReviews2011,Issue12.Art.No.:CD000331.DOI:10.1002/14651858.CD000331.pub3. Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. ABSTRACT Background Epiduralanalgesiaisacentralnerveblocktechniqueachievedbyinjectionofalocalanaestheticclosetothenervesthattransmitpain andiswidelyusedasaformofpainreliefinlabour.However,thereareconcernsregardingunintendedadverseeffectsonthemother andinfant. Objectives Toassesstheeffectsofallmodalitiesofepiduralanalgesia(includingcombined-spinal-epidural) onthemotherandthebaby,when comparedwithnon-epiduralornopainreliefduringlabour. Searchmethods WesearchedtheCochranePregnancyandChildbirthGroup’sTrialsRegister(31March2011). Selectioncriteria Randomisedcontrolledtrialscomparingallmodalitiesofepiduralwithanyformofpainreliefnotinvolvingregionalblockade,orno painreliefinlabour. Datacollectionandanalysis Twoofthereviewauthorsindependentlyassessedtrialsforeligibility,methodologicalqualityandextractedalldata.Weentereddata intoRevMananddoublecheckeditforaccuracy.Primaryanalysiswasbyintentiontotreat;weconductedsubgroupandsensitivity analyseswheresubstantialheterogeneitywasevident. Mainresults Weincluded38studiesinvolving9658women;allbutfivestudiescomparedepiduralanalgesiawithopiates.Epiduralanalgesiawas foundtoofferbetterpainrelief(meandifference(MD)-3.36,95%confidenceinterval(CI)-5.41to-1.31,threetrials,1166women); areductionintheneedforadditionalpainrelief(riskratio(RR)0.05,95%CI0.02to0.17,15trials,6019women);areducedrisk ofacidosis(RR0.80,95%CI0.68to0.94,seventrials,3643women);andareducedriskofnaloxoneadministration(RR0.15,95% CI0.10to0.23,10trials,2645women).However,epiduralanalgesiawasassociatedwithanincreasedriskofassistedvaginalbirth (RR1.42,95%CI1.28to1.57,23trials,7935women),maternalhypotension(RR18.23,95%CI5.09to65.35,eighttrials,2789 Epiduralversusnon-epiduralornoanalgesiainlabour(Review) 1 Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. women),motor-blockade(RR31.67,95%CI4.33to231.51,threetrials,322women),maternalfever(RR3.34,95%CI2.63to 4.23,sixtrials,2741women),urinaryretention(RR17.05,95%CI4.82to60.39,threetrials,283women),longersecondstageof labour(MD13.66minutes,95%CI6.67to20.66,13trials,4233women),oxytocinadministration(RR1.19,95%CI1.03to1.39, 13trials,5815women)andanincreasedriskofcaesareansectionforfetaldistress(RR1.43,95%CI1.03to1.97,11trials,4816 women).Therewasnoevidenceofasignificantdifferenceintheriskofcaesareansectionoverall(RR1.10,95%CI0.97to1.25,27 trials,8417women),long-termbackache(RR0.96,95%CI0.86to1.07,threetrials,1806women),Apgarscorelessthansevenatfive minutes(RR0.80,95%CI0.54to1.20,18trials,6898women),andmaternalsatisfactionwithpainrelief(RR1.31,95%CI0.84 to2.05,seventrials,2929women).Wefoundsubstantialheterogeneityforthefollowingoutcomes:painrelief;maternalsatisfaction; needforadditional meansofpainrelief;lengthofsecondstageoflabour;andoxytocinaugmentation. Thiscouldnotbeexplained bysubgrouporsensitivityanalyses,wheredataallowedanalysis.Nostudiesreportedonrarebutpotentiallyseriousadverseeffectsof epiduralanalgesia. Authors’conclusions Epidural analgesia appearstobeeffectiveinreducing painduring labour.However,women whouse thisformof painreliefare at increased risk of having an instrumental delivery.Epidural analgesia hadno statistically significant impact on therisk of caesarean section, maternalsatisfaction withpainreliefandlong-termbackache anddidnotappear tohaveanimmediateeffectonneonatal statusasdeterminedbyApgarscores.Furtherresearchmaybehelpfultoevaluaterarebutpotentiallysevereadverseeffectsofepidural analgesiaonwomeninlabourandlong-termneonataloutcomes. PLAIN LANGUAGE SUMMARY Epiduralsforpainreliefinlabour Painreliefisimportantforwomeninlabour.Pharmacological methodsofpainreliefinclude inhalationofnitrousoxide, injection ofopioids andregional analgesiawithanepiduralforacentralnerveblock.Epiduralsarewidelyusedforpainreliefinlabour and involveaninjectionofalocalanaestheticintothelowerregionofthespineclosetothenervesthattransmitpain.Epiduralsolutionsare givenbybolusinjection,continuousinfusionorusingapatient-controlledpump.Lowerconcentrationsoflocalanaestheticareneeded whentheyaregiventogetherwithanopiate,allowingwomentomaintaintheabilitytomovearoundduringlabourandtobeardown. Epiduralanalgesiamaysometimesgiveinadequateanalgesia,whichmaybeduetonon-uniformspreadoflocalanaesthetic.Combined spinal-epiduralinvolvesasingleinjectionoflocalanaestheticoropiateintothecerebralspinalfluidforfastonsetofpainreliefaswell asinsertionoftheepiduralcatheterforcontinuingpainrelief.Sideeffectssuchasitchiness,drowsiness,shiveringandfeverhavebeen reportedandrarebutpotentiallysevereadverseeffectsofepiduralanalgesiadooccur. Thereviewidentified38randomisedcontrolledstudiesinvolving9658women.Allbutfivestudiescomparedepiduralanalgesiawith opiates.Epiduralsrelievedlabourpainbetterthanothertypesofpainmedicationbutledtomoreuseofinstrumentstoassistwith thebirth.Caesareandeliveryratesdidnotdifferoverallandnorwerethereeffectsoftheepiduralonthebabysoonafterbirth;fewer babies neededadrug(naloxone)tocounter opiate usebythemotherforpainrelief.Theriskof caesareansectionforfetaldistress wasincreased.Womenwhousedepiduralsweremorelikelytohavealongerdelivery(secondstageoflabour),neededtheirlabour contractionsstimulatedwithoxytocin,experiencedverylowbloodpressure,wereunabletomoveforaperiodoftimeafterthebirth (motor blockage), had problems passing urine (fluid retention) and suffered fever. Long-term backache was no different. Further researchonreducingtheadverseoutcomeswithepiduralswouldbehelpful. BACKGROUND (Neilson2011),andshareagenericprotocol(Jones2011). ThisreviewisoneinaseriesofCochranereviewsexaminingpain managementinlabour.Thesereviewscontributetoanoverview Painreliefisanimportantissueforwomeninlabour.Thelevelof ofsystematicreviewsofpainmanagementforwomeninlabour painexperiencedandtheeffectivenessofpainreliefmayinfluence Epiduralversusnon-epiduralornoanalgesiainlabour(Review) 2 Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. a woman’s satisfaction with labour and delivery and may have ingofpainfulimpulsesfromthenervesastheycrosstheepidu- immediate and long-term emotional and psychological effects( ralspaceresultsinanalgesiawhichshouldbeapparentwithin10 Christiansen 2002).The type of pain reliefused in labour may to 20 minutes of administration. The anaesthetic placed in the impact on breastfeeding and mother-infant interaction (Walker epiduralspaceexertsaconcentration specificeffect,affectingall 1997). themodalitiesofsensation oftheblockednervestovaryingde- grees, such thatadministration of alower-dose anaesthetic(e.g. Womenexperiencevaryingdegreesofpaininlabourandexhibit 0.125% bupivacaine) partially selectively blocks painful stimuli anequallyvaryingrangeofresponsestoit.Anindividual’sreaction whilepreservingmotorfunction,whereashigherdosesofanaes- tothepainoflabourmaybeinfluencedbythecircumstancesof theticaffordcompletesensoryandmotorblockadelimitingmo- herlabour,theenvironment,herculturalbackground,preparation bilityinlabour.Blockingofsympatheticnervesoccursatvarying towardsherlabourandthesupportavailabletoher(Brownridge concentrationsandmanifestsasvasodilatationandhypotension. 1991; McCrea 2000; Rowlands 1998). Need for pain relief in labourisalsoinfluencedbythetypeofonsetoflabour (sponta- Epiduralanalgesiaisconsideredtobeeffectiveforreducingpainin neousorinduced)andmedicalinterventionssuchasinstrumental labour(Brownridge1991;Howell2001).Thechoiceofdrugsand vaginaldeliveryandepisiotomy.Severalmethodsofrelievingpain dosagevariesfrominstitutiontoinstitution.Protocolsregarding inlabourandvariouscopingstrategieshavebeenadvocated,rang- thecareofwomenusingepiduralanalgesiaalsovaryamonghos- ingfromlimitedinterventionsuchasbreathingexercisestomed- pitals.Epiduralsolutionsareadministeredeitherbybolus,contin- icaltechniqueslikeepiduralanalgesia.Regardlessoftheintensity uousinfusionorpatient-controlledpump.Anintermittenttech- of the pain experiencedand response generated, itis important nique involvesinjections of local anaestheticthrough acatheter thatwhatevermethodisusedtoamelioratematernaldiscomfort, positionedintheepiduralspace.Bolusesofhigherconcentrations, itisbotheffectiveandsafeforthemotherandbaby. as used in the earlier years, have been associated with a dense Relaxationtherapies,distractiontechniquesandcontinuoussup- motorblockresultinginreducedmobility,decreasedpelvictone portare believedtohelpwomen in labour to use their own re- and impairment of the bearing down effortin thesecond stage sourcestocopewithpain.Othernon-pharmacological methods oflabour(Thornton2001).Morerecentlytherehasbeenatrend usedforrelievingpainincludeacupressure, acupuncture, reflex- tousealowerconcentrationoflocalanaestheticincombination withavarietyofopiates;thesecombinationsprovideanalgesicef- ology,aromatherapy,transcutaneous electricalnervestimulation andintradermalinjectionofsterilewater(Martensson1999).Re- fectwhileallowingthewomantomaintainsomemotorfunction, portedeffectivenessofthesemethodsvary(Dowswell2009;Ranta suchastheabilitytomoveduringherlabourandretainherability 1994;Smith2011a;Smith2011b).Therearedatatoshowthat tobeardown(COMET2001;Russell2000).Combinedspinal- womenwhohavecontinuousintrapartumsupportarelesslikely epidural(CSE)involvesasingleinjectionoflocalanaestheticand/ tohavepainreliefinlabour(Hodnett2011)andmeasures,such oropiateintothecerebralspinalfluidaswellasinsertionofthe epiduralcatheter.CSEcombinestheadvantagesofspinalanalge- aslabouringinwater,massage,acupunctureandhypnosismaybe sia (faster onset of pain relief, more reliable analgesia) with the helpfultherapiesfor pain management inlabour (Chang 2002; Cluett2009;Cyna2004).Efficacyofothermethodssuchasau- advantages of epidural analgesia such as continuing pain relief, dioanalgesia and music therapy remains to be assessed (Cluett potentiallymaintainedthroughouttheentiredurationoflabour 2009).Pharmacologicalmethodslikeinhalationofnitrousoxide, (Hughes2003).Epiduralanalgesiaallowsthewomantoremain parenteralinjectionofopioidsandregionalanalgesiaintheform alertduringlabour.Theregionaladministrationofepiduraldrugs mayhelpavoidsomesystemicsideeffectsofanalgesicmedication ofepiduralandcombinedspinalepiduralarealsocommonlyused torelievepaininlabour. onthebaby,suchasopioid-inducedneonatalrespiratorydepres- sion.Afunctioningepiduralallowstheoptionofregionalanaes- Epiduralanalgesiawasfirstusedinobstetricpracticein1946and thesia for interventions such as caesarean section or manual re- itsuseinlabourhassteadilyincreaseduntilthelastdecade(DOH movalofretainedplacenta,therebyavoidingtherisksassociated 2005).Approximately20% ofwomenintheUK(DOH2005; withgeneralanaesthesia(Hibbard1996).However,spinalanaes- Khor2000)and58%ofwomenintheUSA(Declercq2002)use thesiacanalsobeusedforthispurpose. thisformofpainrelief.However,thereisconsiderablevariation intheavailabilityanduseofepiduralanalgesiabetweenhospitals Although epidural analgesia may provide effectivepain reliefin in the same country (DOH 2005). Epidural analgesia is a cen- labour,itmaysometimesgiveinadequateanalgesiawhichmaybe tralnerveblockade technique,which involvestheinjectionof a duetonon-uniformspreadoflocalanaesthetic.Reportedmater- local anaesthetic into the lower region of the spine close to the nalcomplicationsincludehypotension-areductioninmaternal nervesthattransmitpainfulstimulifromthecontracting uterus bloodpressure(BP).Severesuddenhypotension(morethan20% and birth canal. The anaesthetic inhibits nerve conduction by decreaseinbaselineBP)mayresultinaclinicallysignificantde- blockingsodiumchannelsinnervemembranes,therebyprevent- creaseinutero-placentalbloodflow,whichcouldpotentiallyaffect ingthepropagationofnerveimpulsesalongthesefibres.Block- deliveryofoxygentothebaby.Thismayespeciallycompromise Epiduralversusnon-epiduralornoanalgesiainlabour(Review) 3 Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. ababywithinadequatereserves(Vincent1998).Forthisreason WeincludedabstractsofunpublishedmanuscriptsofRCTs,and intravenousfluidsmaybegivenbeforeadministeringtheepidu- excludedquasi-randomisedtrials. raldrugs(fluidpreload)toattenuatethedecreaseinmaternalBP. Sideeffectssuchasitchiness,drowsiness,shiveringandfeverhave alsobeenreported(Buggy1995;Eberle1996).Womenmayde- Typesofparticipants velopurinaryretentionwhileusingepiduralanalgesia.Thismay Pregnant women requesting pain relief in labour, regardless of necessitate theinsertion of acatheter todrain the bladder. Uri- parityandwhetherlabourwasspontaneousorinduced. nary retention in the postpartum period has been attributed to longlaboursinwomenusingepiduralanalgesia(Liang2002).Less commonsideeffectsreportedareaccidentalpunctureofthedura, Typesofinterventions whichcansometimescausesevereheadache-post-duralpuncture We considered all forms of epidural administration, compared headache(1%)(Stride1993).Thisresolvesspontaneouslyinsome withanyformofpainreliefnotinvolving regional blockade,or women;however,abloodpatchmaybeneededwhentheheadache nopainrelief.Trialscomparing differenttechniquesof epidural ispersistent.Thisinvolvesasterileinjectionof15mlto20mlof arethesubjectofanotherreview(Hughes2003). thewoman’sfreshbloodintotheepiduralspace(Bromage1999; ThisreviewisoneinaseriesofCochranereviewsexaminingpain Vincent1998).Thisresolvestheheadachefor60%ofwomen. managementinlabour.Thesereviewscontributetoanoverviewof systematicreviewsofinterventionsforpainmanagementinlabour, Epiduralanalgesiamayinfluencethecourseoflabour.Therehave andshareagenericprotocol.Toavoidduplication,thedifferent beensuggested associations with malpositions of thefetalhead, methodsofpainmanagementhavebeenlistedinaspecificorder, prolongedlabour,increaseduseofoxytocinandofinstrumental fromoneto15. Individual reviewsfocusingonparticularinter- deliveries(Eberle1996);possibleeffectsontheriskofcaesarean ventionsincludecomparisonswithonlytheinterventionaboveit sectioncontinuetobedebated(Lieberman2002).Effectsofepidu- onthelist.Methodsofpainmanagementidentifiedinthefuture ralanalgesiaontheneonatemaybemixed.HighercordpHvalues willbeaddedtotheendofthelist.Thecurrentlistisasfollows. andlessnaloxoneuseatbirthhavebeenreported(Halpern1998), 1. Placebo/notreatment ashasagreaterneedforneonatalresuscitation(COMET2001). 2. Hypnosis(Madden2011) Ithasbeensuggestedthatbabiesofwomenwhouseepiduralanal- 3. Biofeedback(Barragán2011) gesiamaybemorepronetolowbloodsugarinthefirsthoursafter 4. Intracutaneousorsubcutaneoussterilewaterinjection birth(Swanstrom1981b). (Derry2011) The aim of this review is to assess the effectivenessof analgesia 5. Immersioninwater(Cluett2009) andbenefitsaffordedbyepidural,andtheriskofpotentialadverse 6. Aromatherapy(Smith2011a) effects when compared with non-epidural methods of relieving 7. Relaxationtechniques(yoga,music,audio) paininlabourornopainrelief. 8. Acupunctureoracupressure(Smith2011b) 9. Manualmethods(massage,reflexology)(Smith2011c) 10. Transcutaneouselectricalnervestimulation(TENS) OBJECTIVES (Dowswell2009) 11. Inhaledanalgesia(Klomp2011) Toassesstheeffectsandsafetyofallmodalitiesofepiduralanal- 12. Opioids(Ullman2010) gesia(includingcombined-spinalepidural),duringlabouronthe 13. Non-opioiddrugs(Othman2011) womanandthebaby,whencomparedwithotherformsofpain 14. Localanaestheticnerveblocks(Novikova2011) reliefornopainrelief. 15. Epidural(includingcombinedspinalepidural)(Simmons 2007) Accordingly, this review includes comparisons of any form of METHODS epiduraladministration,comparedwith:1.placebo/notreatment; 2. hypnosis; 3. biofeedback; 4. intracutaneous or subcutaneous sterilewaterinjection;5.immersioninwater;6.aromatherapy;7. relaxationtechniques(yoga,music,audio);8.acupunctureoracu- Criteriaforconsideringstudiesforthisreview pressure; 9. manual methods(massage, reflexology);10. TENS; 11.inhaledanalgesia;12.opioids;13.non-opioiddrugs;and14. localanaestheticnerveblocks. Typesofstudies Randomisedcontrolledtrials(RCTs)comparingepiduralanalge- Typesofoutcomemeasures siawithalternativeformsofpainreliefornopainreliefinlabour. Epiduralversusnon-epiduralornoanalgesiainlabour(Review) 4 Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. Primaryoutcomes Otheroutcomes Cost(asdefinedbytrialists) Effectsofinterventions Painintensity(asdefinedbytrialists) Secondaryoutcomes Satisfactionwithpainrelief(asdefinedbytrialists) Lengthoffirststageoflabour Senseofcontrolinlabour(asdefinedbytrialists) Lengthofsecondstageoflabour Satisfactionwithchildbirthexperience(asdefinedbytrialists) Oxytocinaugmentation Needforothermeansofpainrelief Caesareansectionforfetaldistress Caesareansectionfordystocia Safetyofinterventions Effect(negative)onmother/babyinteraction Searchmethodsforidentificationofstudies Breastfeeding(atspecifiedtimepoints) Assistedvaginalbirth Caesareansection Sideeffects(formother) Electronicsearches • Long-termbackache(asdefinedbytrialauthors) WesearchedtheCochranePregnancyandChildbirthGroupTrials • Maternalhypotension(asdefinedbyauthors) RegisterbycontactingtheTrialsSearchCo-ordinator(31March • Postnataldepression(authors’definition,treatmentfor 2011). depressionorselfreported) TheCochranePregnancyandChildbirthGroup’sTrialsRegister • Motorblockade ismaintainedbytheTrialsSearchCo-ordinatorandcontainstrials • Respiratorydepressionrequiringoxygenadministration identifiedfrom: • Uterinerupture 1. quarterlysearchesoftheCochraneCentralRegisterof • Headache ControlledTrials(CENTRAL); • Headacherequiringbloodpatch 2. weeklysearchesofMEDLINE; • Venousthromboembolicevents 3. weeklysearchesofEMBASE; • Perinealtraumarequiringsuturing 4. handsearchesof30journalsandtheproceedingsofmajor • Nauseaand/orvomiting conferences; • Itching 5. weeklycurrentawarenessalertsforafurther44journals • Fever plusmonthlyBioMedCentralemailalerts. • Shivers DetailsofthesearchstrategiesforCENTRAL, MEDLINE and • Drowsiness EMBASE,thelistofhandsearchedjournalsandconferencepro- • Urinaryretention ceedings,andthelistofjournalsreviewedviathecurrentaware- • Catheterisationduringlabour ness service can be found in the ‘Specialized Register’ section • Othermorbidity(e.g.impairedconsciousness,meningitis, withintheeditorialinformationabouttheCochranePregnancy intensivecareunitadmission,paralysis) andChildbirthGroup. • Malposition(asdefinedbytrialauthors) Trialsidentifiedthroughthesearchingactivitiesdescribedabove • Surgicalamniotomy areeachassignedtoareviewtopic(ortopics).TheTrialsSearch Sideeffects(forbaby) Co-ordinatorsearchestheRegisterforeachreviewusingthetopic • AcidosisasdefinedbycordbloodarterialpHlessthan7.2 listratherthankeywords. • AcidosisasdefinedbycordbloodarterialpHlessthan7.15 Wedidnotapplyanylanguagerestrictions. • Naloxoneadministration • Neonatalhypoglycaemia(lessthanorequalto1.67mmol/l) • Birthtrauma Datacollectionandanalysis • Long-termneonatalcomplication Weusedthefollowingmethodswhenassessinganyreportsiden- • Meconiumstainingofliquor tifiedbythesearch. Admissiontospecialcarebabyunit/neonatal intensive careunit (asdefinedbytrialists) Selectionofstudies Apgarscorelessthansevenatfiveminutes Poorinfantoutcomesatlong-termfollow-up(asdefinedbytrialists Threereviewauthors(MillicentAnim-Somuah(MA),RSmyth -e.g.seizures,disabilityinchildhood) (RS), L Jones (LJ)) independently assessed for inclusion all the Epiduralversusnon-epiduralornoanalgesiainlabour(Review) 5 Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. potentialstudiesweidentifiedasaresultofthesearchstrategy.We (3.1)Blindingofparticipantsandpersonnel(checkingfor resolvedanydisagreementthroughdiscussion. possibleperformancebias) Wedescribedforeachincludedstudythemethodsused,ifany,to blindstudyparticipantsandpersonnelfromknowledgeofwhich interventionaparticipantreceived.Weconsideredthatstudiesare Dataextractionandmanagement atlowriskofbiasiftheywereblinded,orifjudgedthatthelackof We designed a form to extract data. For eligible studies, three blindingwouldbeunlikelytoaffectresults.Weassessedblinding reviewauthors(MA,RS,LJ)extractedthedatausingtheagreed separatelyfordifferentoutcomesorclassesofoutcomes. form.Weresolveddiscrepanciesthroughdiscussion.Weentered Weassessedthemethodsas: dataintoReviewManagersoftware(RevMan2011)andchecked • low,highorunclearriskofbiasforparticipants; foraccuracy. • low,highorunclearriskofbiasforpersonnel. When information regarding any of the above was unclear, we attempted to contact authors of the original reports to provide (3.2)Blindingofoutcomeassessment(checkingforpossible furtherdetails. detectionbias) Wedescribedforeachincludedstudythemethodsused,ifany,to blindoutcomeassessorsfromknowledgeofwhichinterventiona Assessmentofriskofbiasinincludedstudies participantreceived. Weassessedblindingseparatelyfordifferent outcomesorclassesofoutcomes. Two review authors independently assessedrisk of bias foreach Weassessedmethodsusedtoblindoutcomeassessmentas: study using the criteria outlined in the Cochrane Handbook for • low,highorunclearriskofbias. Systematic Reviews of Interventions (Higgins 2011). We resolved any disagreement by discussion or by involving a third assessor (LJ). (4)Incompleteoutcomedata(checkingforpossibleattrition biasduetotheamount,natureandhandlingofincomplete outcomedata) (1)Randomsequencegeneration(checkingforpossible Wedescribedforeachincludedstudy, andfor eachoutcome or selectionbias) classofoutcomes,thecompletenessofdataincludingattritionand exclusionsfromtheanalysis.Westatedwhetherattritionandex- Wedescribedforeachincludedstudythemethodusedtogenerate clusionswerereportedandthenumbersincludedintheanalysisat theallocationsequenceinsufficientdetailtoallowanassessment eachstage(comparedwiththetotalrandomisedparticipants),rea- ofwhetheritshouldproducecomparablegroups. sonsforattritionorexclusionwherereported,andwhethermiss- Weassessedthemethodas: ingdatawerebalancedacrossgroupsorwererelatedtooutcomes. • lowriskofbias(anytrulyrandomprocess,e.g.random Wheresufficientinformation isreported,orcanbe suppliedby numbertable;computerrandomnumbergenerator); thetrialauthors,wewillre-includemissing dataintheanalyses • highriskofbias(anynon-randomprocess,e.g.oddoreven whichweundertake. dateofbirth;hospitalorclinicrecordnumber);or Weassessedmethodsas: • unclearriskofbias. • lowriskofbias(e.g.nomissingoutcomedata;missing outcomedatabalancedacrossgroups,lessthan20%loss); • highriskofbias(e.g.numbersorreasonsformissingdata imbalancedacrossgroups;‘astreated”analysisdonewith (2)Allocationconcealment(checkingforpossibleselection substantialdepartureofinterventionreceivedfromthatassigned bias) atrandomisation); We described for each included study the methodused tocon- • unclearriskofbias. cealallocationtointerventionspriortoassignmentandassessed whetherintervention allocationcouldhavebeenforeseeninad- vanceof,orduringrecruitment,orchangedafterassignment. (5)Selectivereporting(checkingforreportingbias) Weassessedthemethodsas: We described for each included study how we investigated the • lowriskofbias(e.g.telephoneorcentralrandomisation; possibilityofselectiveoutcomereportingbiasandwhatwefound. consecutivelynumberedsealedopaqueenvelopes); Weassessedthemethodsas: • highriskofbias(openrandomallocation;unsealedornon- • lowriskofbias(whereitisclearthatallofthestudy’spre- opaqueenvelopes,alternation;dateofbirth); specifiedoutcomesandallexpectedoutcomesofinteresttothe • unclearriskofbias. reviewhavebeenreported); Epiduralversusnon-epiduralornoanalgesiainlabour(Review) 6 Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. • highriskofbias(wherenotallthestudy’spre-specified Unitofanalysisissues outcomeshavebeenreported;oneormorereportedprimary outcomeswerenotpre-specified;outcomesofinterestare reportedincompletelyandsocannotbeused;studyfailsto Cluster-randomisedtrials includeresultsofakeyoutcomethatwouldhavebeenexpected Wewouldincludecluster-randomisedtrialsintheanalysesalong tohavebeenreported); withindividuallyrandomisedtrials,andadjusttheirsamplesizes • unclearriskofbias. orstandarderrorsusingthemethodsdescribedintheHandbook usinganestimateoftheintra-clustercorrelationco-efficient(ICC) derivedfromthetrial(ifpossible),fromasimilartrialorfroma (6)Otherbias(checkingforbiasduetoproblemsnot studyofasimilarpopulation.IfweusedICCsfromothersources, coveredby(1)to(5)above) wewouldreportthisandconductsensitivityanalysestoinvestigate Wedescribedforeachincludedstudyanyimportantconcernswe theeffectofvariation intheICC.Ifweidentifiedboth cluster- hadaboutotherpossiblesourcesofbias. randomisedtrialsandindividually-randomisedtrials,weplanned Weassessedwhethereachstudywasfreeofotherproblemsthat tosynthesisetherelevantinformation.Weconsidereditreasonable couldputitatriskofbias: tocombinetheresultsfrombothiftherewaslittleheterogeneity • lowriskofotherbias; betweenthestudydesignsandtheinteractionbetweentheeffectof • highriskofotherbias; interventionandthechoiceofrandomisationunitwasconsidered • unclearwhetherthereisriskofotherbias. tobeunlikely. Wewouldalsoacknowledgeheterogeneityintherandomisation (7)Overallriskofbias unitandperformasensitivityanalysistoinvestigatetheeffectsof therandomisationunit. Wemadeexplicitjudgementsaboutwhetherstudieswereathigh risk of bias, according to the criteria given in the Handbook ( Higgins 2011). With reference to (1) to (6) above, we assessed Dealingwithmissingdata the likely magnitude and direction of the bias and whether we Forincludedstudies,wenotedlevelsofattrition.Weexploredthe considereditlikelytoimpactonthefindings. Weexploredthe impactofincludingstudieswithhighlevelsofmissingdatainthe impactofthelevelofbiasthroughundertakingsensitivityanalyses overallassessmentoftreatmenteffectbyusingsensitivityanalysis. -seeSensitivityanalysis. For all outcomes, we carried out analyses, as far as possible, on an intention-to-treat basis, i.e. we attempted toinclude all par- Measuresoftreatmenteffect ticipantsrandomised toeachgroupintheanalyses, andallpar- ticipantsanalysedinthegrouptowhichtheywereallocated,re- gardlessofwhetherornottheyreceivedtheallocatedintervention. Dichotomousdata Thedenominatorforeachoutcomeineachtrialwasthenumber Fordichotomousdata,wepresentedresultsassummaryriskratio randomised minus any participants whose outcomes are known with95%confidenceintervals. tobemissing. Continuousdata Assessmentofheterogeneity For continuous data, we used the mean difference if outcomes We assessedstatistical heterogeneityineachmeta-analysis using weremeasuredinthesamewaybetweentrials.Weusedthestan- theT²,I²andChi²statistics.Weregardedheterogeneityassub- dardisedmeandifferencetocombinetrialsthatmeasuredthesame stantialifT²wasgreaterthanzeroandeitherI²wasgreaterthan outcome,butusedifferentmethods. 30%ortherewasalowPvalue(lessthan0.10)intheChi²test forheterogeneity. Ordinaldata Forordinaldatameasuredonscales(e.g.painmeasuredonvisual Assessmentofreportingbiases analogue scales) we analysed as continuous data and the inter- Iftherewere10ormorestudiesinthemeta-analysisweplannedto ventioneffectwasexpressedasadifferenceinmeans.Forordinal investigatereportingbiases(suchaspublicationbias)usingfunnel data (e.g.satisfactionwithpainrelief)measuredonshorterordi- plots.Wewouldassessfunnelplotasymmetryvisually,andwould nalscalese.g.(excellent,verygood,good)weanalysedasdichoto- useformaltestsforfunnelplotasymmetry.Forcontinuous out- mousdatabycombiningcategories(e.g.excellentandverygood) comeswewouldusethetestproposedbyEgger1997,andfordi- andtheinterventioneffectwasexpressedusingriskratios. chotomousoutcomeswewouldusethetestproposedbyHarbord Epiduralversusnon-epiduralornoanalgesiainlabour(Review) 7 Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
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