Epidural fentanyl for postoperative analgesia after lumbar canalWord格式文档下载.docx

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Epidural fentanyl for postoperative analgesia after lumbar canalWord格式文档下载.docx

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Epidural fentanyl for postoperative analgesia after lumbar canalWord格式文档下载.docx

reducepostoperativepainandenhanceearlymobilization.However,therehavebeenconcerns

aboutopiate-relatedcomplications,suchasrespiratorydepressionandurinaryretentioninwhat

isgenerallyanelderlypopulationofpatients.

PURPOSE:

Toassesstheanalgesicefficacyofbolusepiduralfentanyladministeredintraopera-

tivelyafterlumbardecompressionfordegenerativecanalstenosis.

STUDYDESIGN/SETTING:

Patient-blindedrandomizedcontrolledtrialconductedattwouni-

versityneurosurgicalcenters.

PATIENTSAMPLE:

Adults（olderthan18years）withneurogenicclaudicationand/orlowerlimb

radiculopathyandconcordantlumbarspinalcanalstenosisdemonstratedonmagneticresonance

imaging.Patientswithpreviouslumbarspinalsurgery,acontraindicationtofentanyl,orrequiring

instrumentationwereexcluded.

OUTCOMEMEASURES:

Theprimaryoutcomemeasurewaspatient-reportedVisualAnalogue

Score（VAS）forpainrecordedpreoperatively,inrecovery,andonthefirstandsecondpostoperative

daysifthepatientremainedinthehospital.Secondaryoutcomesweredurationofsurgery,lengthof

stay,andanysideeffectsorcomplications.

METHODS:

Patientsunderwentaonetothreelevellumbarcanaldecompressionasrequired,via

amidlineincision,undergeneralanesthesia.Beforewoundclosureeithernodrug（control）or

a100-mgbolusoffentanylwasadministeredviaanepiduralcatheterinserted10cmrostraltothe

operatedlevel.Patientswereblindedtogroupallocation,andanalysiswasbyintentiontotreat.

ThetrialwasapprovedbytheNationalHealthServiceResearchEthicsServiceandtheMedicines

andHealthcareproductsRegulatoryAgency.Nocommercialorothersourceoffundingwasreceived.

RESULTS:

Sixtypatientswererandomized,29tofentanyland31tocontrol.Demographics,du-

rationofsurgery,andpreoperativeVASwerenotsignificantlydifferentbetweenthegroups.VASin

recoverywassignificantlylowerinpatientstreatedwithfentanyl（mean[standarddeviation]:

2.6[2.7]vs.4.7[2.4];

p5.003）.LaterVASandpostoperativelengthofstayweresimilarbetween

groups.Morepatientsinthefentanylgrouprequiredtemporaryurinarycatheterization,butthere

wasnosignificantdifferenceintheincidenceofsideeffects.

引言

背景和

目的

科学背景和对试验理由的解释

Postoperativebackpainiscommonafterlumbardecompressionandoftenthekeyfactorlimitingearlymobilizationanddischargefromthehospital.Allpatientsreceive

oralanalgesiaandsomerequireparenteralopiates,which

themselveshavesideeffectsandimpactonthelengthof

stay.Variousstrategiesofdeliveringlocalorregionalanalgesiaintraoperativelyatthesurgicalsitehavebeeninvestigated,typicallyinvolvinglocalanesthetics,steroids,or

opiatesadministeredasabolusdoseorcontinuousinfusion

intheparaspinalmusclesandsubcutaneouslayers,epidural

space,orintrathecally[1–6].

Arandomizedtrialcomparingstandardpatient-controlledintravenousmorphineanalgesia（IV-PCA）with

48-hourepiduralinfusionoffentanylviaacatheterinserted

atwoundclosuredemonstratedsignificantlylowerpain

scoresat12,24,and48hours,withcorrespondinglyreducedopiateconsumptioninthetreatmentarm[7].More

recently,arandomizedtrialofbolusintrathecalfentanyl

（15mg）beforeclosureshowedasimilarprofileofdecreasedpainscoresandopiaterequirementscomparedwith

IV-PCA[8].However,intrathecaladministrationcarries

apotentiallyhigherriskofacuteopioid-relatedsideeffects,

includingrespiratorydepression,whereascontinuousepiduralinfusionsimposelimitsonmobilizingintheinitial

postoperativeperiod.Nonetheless,thesestudiesdidsuggest

fentanylasagoodchoiceforregionalanalgesiaafterlumbarspinesurgery,althoughtheoptimalrouteandmodeof

administrationremainsunclear.

具体目的或假设

Wehypothesizedthatasinglebolusofepiduralfentanyl

couldprovideasimilarlevelofanalgesia,reducingtherisk

ofcomplicationsandallowingpatientstomobilizeearly

aftersurgery.Theobjectiveofthispatient-blindedrandomizedcontrolledtrialwastoassesstheefficacyofa100-mgbolusepiduralfentanylonpostoperativepainafterlumbarcanaldecompressionperformedfordegenerativespinalstenosis.

方法

试验

设计

描述试验设计（诸如平行设计、析因设计）包括受试者分配入各组的比例

Thiswasabalanced（1:

1）randomization,patient-blinded,controlled,parallel-groupstudyconductedattwoneurosurgicalunitsintheUnitedKingdom.

试验开始后对试验方法所作的重要改变（如合格受试者的挑选标准），并说明原因

Therewerenochangesto

thedesignorprotocolduringthecourseofthetrial.

受试

者

受试者的合格标准

Eligiblepatientswereadults（olderthan18years）with

aclinicalsyndromeofneurogenicclaudicationand/orlower

limbradiculopathy,concordantlumbarspinalcanalstenosisdemonstratedonmagneticresonanceimaging,andinwhom

therewerenocontraindicationstosurgery.Exclusioncriteriaincludedpatientsrequiringinstrumentation,ahistoryofbpreviouslumbarspinalsurgery,oracontraindicationtofentanyladministration.

资料收集的场所和地点

Bothstudycentersaregeneralneurosurgicalunitswithinuniversityteachinghospitals,serving

atotalpopulationofapproximately6million.

干预

措施

详细描述各组干预措施的细节以使他人能够重复，包括它们实际上是在何时、如何实施的

Patientsunderwentaonetothreelevellumbarcanalde-

compressionasrequired,inthestandardpronepositionon

aWilsonframe,viaamidlineincision,undergeneralanes-

thesia.Patientswererandomlyallocatedtoeitherreceive

100mgoffentanylin10mL0.9%wt/volsalinesolution,

ornothing,intotheepiduralspaceattheconclusionofthe

decompression,beforewoundclosure.Thedrugwasdeliv-

eredthrougha16-gaugePortexcatheter（SmithsMedical,

Ashford,Kent,UK）passedintotheepiduralspaceatthede-

compressedlevelthenadvanced10cmrostrallybefore

slowlyinjecting.PatientswerenotplacedintheTrendelen-

burgpositionduringthedeliveryoffentanyltoavoidexces-

siverostralmigration.Bydeliveringthebolus2to3levels

abovethelaminectomy,asurgicaldraincanstillbeusedif

required.Toavoidaccidentalintrathecaldosing,thefentanyl

solutionwasnotadministeredifapatientsustainedadural

tearwithcerebrospinalfluid（CSF）leakduringsurgery.As

aprecautionagainstthepossibilityofrespiratorydepression,

patientsinthetrialwerekeptinatheaterrecoveryareaforat

least1houraftertheepiduraladministrationoffentanyl.

结局

指标

完整而确切的说明预先设定的主要和次要结局指标，包括它们是何时、如何测评的

Theprimaryoutcomemeasurewaspatient-reportedpain

measuredbyvisualanaloguescore（VAS）from0（nopain）

to10（worstpain）in0.5increments.VASswereobtained

beforesurgery,intherecoveryroomoncetheeffectsofanesthesiahadresolved,andonthefirstandsecondpostoperativedaysifthepatienthadnotbeendischarged.Secondary

outcomemeasureswerethelengthofinpatientstayandany

sideeffectsorcomplications,includingpruritis,nauseaor

vomiting,andurinaryretention.Therewerenochanges

tooutcomeassessmentsduringthetrial.

试验开始后对结局指标是否有任何更改，并说明原因

样本量

如何确定样本量

必要时，解释中期分析和试验中止原则

Nointerimanalyseswereperformed.

随机方法

序列

产生

产生随机分配序列的方法

Therandomizationsequencewasgeneratedbycomputerandstratifiedbythecenter.

随机方法的类型，任何限定的细节（怎样分区组和各区组样本多少）

分配

隐藏

用于执行随机分配序列的机制（如编按序编码的封藏法），描述干预措施分配之前为隐藏序列号所采取的步骤

实施

谁产生随机分配序列，谁招募受试者，谁给受试者分配干预措施

盲法

11a

如果实施了盲法，分配干预措施之后对谁设盲（例如受试者、医护提供者、结局评估者），以及盲法是如何实施的

Treatmentallocationwasconcealedin

opaqueenvelopesthatwereopenedbytheoperatingsurgeonbeforesurgery.Patientswereblindedtowhetheror

nottheyreceivedfentanyl.

11b

如有必要，描述干预措施的相似之处

统计学方法

12a

用于比较各组主要和次要结局指标的统计学方法

Continuousvariableswerecomparedwiththeindependentt-testorMann-WhitneyUtestasappropriate,andcategoricalvariableswerecomparedwiththechi-squaretest.

Multiplelinearregressionwasperformedinasingleblock

withallindependentvariablesenteredinthemodel.Statisticalsignificancewassetatp!

.05.

12b

附加分析的方法，诸如亚组分析和校正分析

结果

受试者流程

13a

随机分配到各组的受试者例数，接收已知分配治疗的例数，以及纳入主要结局分析的例数

29patientstothetreatmentarmand31tocontrolarm（Fig.1）.

13b

随机分组后，各组脱落和被剔除的例数，并说明原因

募集

受试者

14a

招募期和随访时间的长短，并说明具体日期

fromJanuary2007toJune2009

14b

为什么试验中断或停止

基线

资料

用一张表格列出每组受试者的基线数据，包括人口学资料和临床特征

Demographicandoperativedetailsofthetwogroupswerecomparable（Table1）,

纳入

分析例数

各组纳入每种分析的受试者数目（分母），以及是否按最初的分组分析

Table2Primaryoutcome

Table3Secondaryoutcomes

结果和估计值

17a

各组每一项主要和次要结局指标的结果，效应估计值及其精确性（如95%可信区间）

Theprimaryanalysiswasintentiontotreatandinvolved

allpatientsrandomlyassignedforwhomVASdatawererecorded（Table2）.Paininrecoverywassignificantlylower

intheepiduralfentanylgroupcomparedwiththatinthe

controlgroup,bothintermsofaverageVASandtheproportionofpatientsreportingscoresof5andmore（odds

ratio0.25,95%confidenceinterval0.08–0.78;

Table2,

Fig.2）.SubsequentVASscoresat24-and48-hourspostoperativelywerenotsignificantlydifferentbetweenthe

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