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CONSORT 清单评价RCT论文
论文
部分 条 目 内 容 评价 文题
摘要 1a 文题能识别是随机临床试验 Epidural fentanyl for postoperative analgesia after lumbar canal
decompression: 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 common after decompression surgery
for 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 to
reduce postoperative pain and enhance early mobilization. However, there have been concerns
about opiate-related complications, such as respiratory depression and urinary retention in what
is generally an elderly population of patients.
PURPOSE: To assess the analgesic efficacy of bolus epidural fentanyl administered intraopera-
tively after lumbar decompression for degenerative 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 limb
radiculopathy and concordant lumbar spinal canal stenosis demonstrated on magnetic resonance
imaging. Patients with previous lumbar spinal surgery, a contraindication to fentanyl, or requiring
instrumentation were excluded.
OUTCOME MEASURES: The primary outcome measure was patient-reported Visual Analogue
Score (VAS) for pain recorded preoperatively, in recovery, and on the first and second postoperative
days if the patient remained in the hospital. Secondary outcomes were duration of surgery, length of
stay, and any side effects or complications.
METHODS: Patients underwent a one to three level lumbar canal decompression as required, via
a midline incision, under general anesthesia. Before wound closure either no drug (control) or
a 100-mg bolus of fentanyl was administered via an epidural catheter inserted 10 cm rostral to the
operated level. Patients were blinded to group allocation, and
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