Epidural fentanyl for postoperative analgesia after lumbar canal.docx

1、Epidural fentanyl for postoperative analgesia after lumbar canalCONSORT 清单评价RCT论文论文部分条 目内 容评 价VAS文题摘要1a文题能识别是随机临床试验Epidural fentanyl for postoperative analgesia after lumbar canaldecompression: a randomized controlled trial是1b结构式摘要，包括试验设计、方法、结果、结论几个部分BACKGROUND CONTEXT: Postoperative back pain is co

2、mmon after decompression surgeryfor lumbar stenosis and often delays discharge from hospital. Achieving regional analgesia by intra-operative delivery of epidural opiates after lumbar canal decompression is a promising approach toreduce postoperative pain and enhance early mobilization. However, the

3、re have been concernsabout opiate-related complications, such as respiratory depression and urinary retention in whatis generally an elderly population of patients.PURPOSE: To assess the analgesic efficacy of bolus epidural fentanyl administered intraopera-tively after lumbar decompression for degen

4、erative canal stenosis.STUDY DESIGN/SETTING: Patient-blinded randomized controlled trial conducted at two uni-versity neurosurgical centers.PATIENT SAMPLE: Adults (older than 18 years) with neurogenic claudication and/or lower limbradiculopathy and concordant lumbar spinal canal stenosis demonstrate

5、d on magnetic resonanceimaging. Patients with previous lumbar spinal surgery, a contraindication to fentanyl, or requiringinstrumentation were excluded.OUTCOME MEASURES: The primary outcome measure was patient-reported Visual AnalogueScore (VAS) for pain recorded preoperatively, in recovery, and on

6、the first and second postoperativedays if the patient remained in the hospital. Secondary outcomes were duration of surgery, length ofstay, and any side effects or complications.METHODS: Patients underwent a one to three level lumbar canal decompression as required, viaa midline incision, under gene

7、ral anesthesia. Before wound closure either no drug (control) ora 100-mg bolus of fentanyl was administered via an epidural catheter inserted 10 cm rostral to theoperated level. Patients were blinded to group allocation, and analysis was by intention to treat.The trial was approved by the National H

8、ealth Service Research Ethics Service and the Medicinesand Healthcare products Regulatory Agency. No commercial or other source of funding was received.RESULTS: Sixty patients were randomized, 29 to fentanyl and 31 to control. Demographics, du-ration of surgery, and preoperative VAS were not signifi

9、cantly different between the groups. VAS inrecovery was significantly lower in patients treated with fentanyl (mean standard deviation:2.6 2.7 vs. 4.7 2.4; p5.003). Later VAS and postoperative length of stay were similar betweengroups. More patients in the fentanyl group required temporary urinary c

10、atheterization, but therewas no significant difference in the incidence of side effects.引言背景和目的2a科学背景和对试验理由的解释Postoperative back pain is common after lumbar decompression and often the key factor limiting early mobilization and discharge from the hospital. All patients receiveoral analgesia and some

11、 require parenteral opiates, whichthemselves have side effects and impact on the length ofstay. Various strategies of delivering local or regional analgesia intraoperatively at the surgical site have been investigated, typically involving local anesthetics, steroids, oropiates administered as a bolu

12、s dose or continuous infusionin the paraspinal muscles and subcutaneous layers, epiduralspace, or intrathecally 16.A randomized trial comparing standard patient-controlled intravenous morphine analgesia (IV-PCA) with48-hour epidural infusion of fentanyl via a catheter insertedat wound closure demons

13、trated significantly lower painscores at 12, 24, and 48 hours, with correspondingly reduced opiate consumption in the treatment arm 7. Morerecently, a randomized trial of bolus intrathecal fentanyl(15 mg) before closure showed a similar profile of decreased pain scores and opiate requirements compar

14、ed withIV-PCA 8. However, intrathecal administration carriesa potentially higher risk of acute opioid-related side effects,including respiratory depression, whereas continuous epidural infusions impose limits on mobilizing in the initialpostoperative period. Nonetheless, these studies did suggestfen

15、tanyl as a good choice for regional analgesia after lumbar spine surgery, although the optimal route and mode ofadministration remains unclear.2b具体目的或假设We hypothesized that a single bolus of epidural fentanylcould provide a similar level of analgesia, reducing the riskof complications and allowing p

16、atients to mobilize earlyafter surgery. The objective of this patient-blinded randomized controlled trial was to assess the efficacy of a 100-mg bolus epidural fentanyl on postoperative pain after lumbar canal decompression performed for degenerative spinal stenosis.方法试验设计3a描述试验设计（诸如平行设计、析因设计）包括受试者分

17、配入各组的比例This was a balanced (1:1) randomization, patient-blinded,controlled, parallel-group study conducted at two neurosurgical units in the United Kingdom.3b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There were no changes tothe design or protocol during the course of the trial.受试者4a受试者的合格标准Eligible patien

18、ts were adults (older than 18 years) witha clinical syndrome of neurogenic claudication and/or lowerlimb radiculopathy, concordant lumbar spinal canal stenosis demonstrated on magnetic resonance imaging, and in whomthere were no contraindications to surgery. Exclusion criteria included patients requ

19、iring instrumentation, a history of bprevious lumbar spinal surgery, or a contraindication to fentanyl administration. 4b资料收集的场所和地点Both study centers are general neurosurgical units within university teaching hospitals, servinga total population of approximately 6 million.干预措施5详细描述各组干预措施的细节以使他人能够重复，

20、包括它们实际上是在何时、如何实施的Patients underwent a one to three level lumbar canal de-compression as required, in the standard prone position ona Wilson frame, via a midline incision, under general anes-thesia. Patients were randomly allocated to either receive100 mg of fentanyl in 10 mL 0.9% wt/vol saline solut

21、ion,or nothing, into the epidural space at the conclusion of thedecompression, before wound closure. The drug was deliv-ered through a 16-gauge Portex catheter (Smiths Medical,Ashford, Kent, UK) passed into the epidural space at the de-compressed level then advanced 10 cm rostrally beforeslowly inje

22、cting. Patients were not placed in the Trendelen-burg position during the delivery of fentanyl to avoid exces-sive rostral migration. By delivering the bolus 2 to 3 levelsabove the laminectomy, a surgical drain can still be used ifrequired. To avoid accidental intrathecal dosing, the fentanylsolutio

23、n was not administered if a patient sustained a duraltear with cerebrospinal fluid (CSF) leak during surgery. Asa precaution against the possibility of respiratory depression,patients in the trial were kept in a theater recovery area for atleast 1 hour after the epidural administration of fentanyl.结

24、局指标6a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The primary outcome measure was patient-reported painmeasured by visual analogue score (VAS) from 0 (no pain)to 10 (worst pain) in 0.5 increments. VASs were obtainedbefore surgery, in the recovery room once the effects of anesthesia had resolved, and on the f

25、irst and second postoperative days if the patient had not been discharged. Secondaryoutcome measures were the length of inpatient stay and anyside effects or complications, including pruritis, nausea orvomiting, and urinary retention. There were no changesto outcome assessments during the trial.6b试验

26、开始后对结局指标是否有任何更改，并说明原因样本量7a如何确定样本量7b必要时，解释中期分析和试验中止原则No interim analyses were performed.随机方法序列产生8a产生随机分配序列的方法The randomization sequence was generated by computer and stratified by the center.8b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9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10谁产生随机分配序列，谁招募受试者，谁给受试

27、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Treatment allocation was concealed inopaque envelopes that were opened by the operating surgeon before surgery. Patients were blinded to whether ornot they received fentanyl.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Continuous varia

28、bles were compared with the independent t-test or Mann-Whitney U test as appropriate, and categorical variables were compared with the chi-square test.Multiple linear regression was performed in a single blockwith all independent variables entered in the model. Statistical significance was set at p!

29、.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29 patients to the treatment arm and 31 to control arm (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from January 2007 to June 200914b为什么试验中断或停止基线资料15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Demographic and operative det

30、ails of the two groups were comparable (Table 1),纳入分析例数16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Table 2 Primary outcomeTable 3 Secondary outcomes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）The primary analysis was intention to treat and involvedall patients randomly assigned for whom VAS data were record

31、ed (Table 2). Pain in recovery was significantly lowerin the epidural fentanyl group compared with that in thecontrol group, both in terms of average VAS and the proportion of patients reporting scores of 5 and more (oddsratio 0.25, 95% confidence interval 0.080.78; Table 2,Fig. 2). Subsequent VAS scores at 24- and 48-hours postoperatively were not significantly different between the