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硬膜外芬太尼用于腰椎管减压术后镇痛:一项随机对照试验。

Epidural fentanyl for postoperative analgesia after lumbar canal decompression: a randomized controlled trial.

机构信息

Department of Neurosurgery, Addenbrooke's Hospital, Hills Rd., Cambridge, UK.

出版信息

Spine J. 2012 Aug;12(8):646-51. doi: 10.1016/j.spinee.2012.07.007. Epub 2012 Aug 25.

DOI:10.1016/j.spinee.2012.07.007
PMID:22926408
Abstract

BACKGROUND CONTEXT

Postoperative back pain is common after decompression surgery for lumbar stenosis and often delays discharge from hospital. Achieving regional analgesia by intraoperative 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 intraoperatively after lumbar decompression for degenerative canal stenosis.

STUDY DESIGN/SETTING: Patient-blinded randomized controlled trial conducted at two university 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-μg bolus of fentanyl was administered via an epidural catheter inserted 10 cm rostral to the operated level. Patients were blinded to group allocation, and analysis was by intention to treat. The trial was approved by the National Health Service Research Ethics Service and the Medicines and 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, duration of surgery, and preoperative VAS were not significantly different between the groups. VAS in recovery was significantly lower in patients treated with fentanyl (mean [standard deviation]: 2.6 [2.7] vs. 4.7 [2.4]; p=.003). Later VAS and postoperative length of stay were similar between groups. More patients in the fentanyl group required temporary urinary catheterization, but there was no significant difference in the incidence of side effects.

CONCLUSIONS

Bolus epidural fentanyl provides effective short-term postoperative analgesia after lumbar canal decompression and may be a useful adjunct to pain management in patients undergoing lumbar spine surgery.

摘要

背景

腰椎管狭窄减压术后常发生术后腰痛,且常导致住院时间延长。术中椎管内给予阿片类药物行硬膜外镇痛,可减少术后疼痛,促进早期活动,有望减轻术后腰痛。然而,对于老年患者,椎管内给予阿片类药物可能会引起与药物相关的并发症,如呼吸抑制和尿潴留。

目的

评估腰椎管减压术后硬膜外注射芬太尼镇痛在治疗退行性椎管狭窄引起的术后腰痛的疗效。

研究设计/地点:在 2 家大学神经外科中心进行的患者设盲随机对照试验。

患者样本

神经源性跛行和/或下肢根性痛且磁共振成像显示有相应的腰椎管狭窄的成年患者。排除有腰椎手术史、芬太尼禁忌证或需要内固定的患者。

主要结局指标

患者报告的术前、恢复时和术后第 1 天和第 2 天的视觉模拟评分(VAS)是主要结局指标。如果患者仍在住院,记录疼痛。次要结局指标为手术时间、住院时间以及任何副作用或并发症。

方法

患者接受经正中切口行 1 至 3 个节段的腰椎管减压术,全麻下进行。切口缝合前,根据分组,在手术水平上方 10cm 处插入的硬膜外导管中给予 100μg 芬太尼(实验组)或不给予药物(对照组)。患者对分组情况设盲,分析采用意向治疗。试验获得英国国家卫生服务系统伦理审查服务和药品和保健品管理局的批准。未接受任何商业或其他来源的资助。

结果

共 60 例患者随机分组,29 例接受芬太尼治疗,31 例接受对照组治疗。两组患者的人口统计学、手术时间和术前 VAS 无显著差异。实验组患者在恢复时的 VAS 明显更低(均值[标准差]:2.6[2.7] vs. 4.7[2.4];p=0.003)。两组患者的后续 VAS 和术后住院时间相似。实验组中更多的患者需要临时导尿,但副作用发生率无显著差异。

结论

腰椎管减压术后硬膜外注射芬太尼可提供有效的短期术后镇痛,可能有助于腰椎手术患者的疼痛管理。

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