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腰椎融合术后患者自控静脉镇痛与患者自控硬膜外镇痛比较的前瞻性随机临床试验。

Prospective randomized clinical trial comparing patient-controlled intravenous analgesia with patient-controlled epidural analgesia after lumbar spinal fusion.

作者信息

Fisher Charles G, Belanger Lise, Gofton Edward G, Umedaly Hamed S, Noonan Vanessa K, Abramson Caroline, Wing Peter C, Brown Jennifer, Dvorak Marcel F

机构信息

Combined Neurosurgical and Orthopaedic Spine Program, Department of Orthopaedics, University of British Columbia, Vancouver Hospital and Health Sciences Centre.

出版信息

Spine (Phila Pa 1976). 2003 Apr 15;28(8):739-43.

Abstract

STUDY DESIGN

A prospective, randomized, double-blind clinical trial was conducted.

OBJECTIVE

To compare the efficacy of patient-controlled analgesia (PCA) with that of patient-controlled epidural analgesia (PCEA) in terms of overall patient satisfaction with postoperative pain management after lumbar spine fusion.

SUMMARY OF BACKGROUND DATA

In numerous surgical disciplines, PCEA and PCA have proved to be effective methods of postoperative pain control. The literature states that with PCEA, less opioid use is required during the immediate postoperative period to maintain equivalent pain control compared to PCA. Continuous epidural infusion has been assessed in spine fusion patients, but PCEA has not been evaluated. Furthermore, this is the first prospective randomized clinical trial to assess overall patient satisfaction while stratifying patients for both anxiety level and preoperative opioid use.

METHODS

For this study, 74 patients were assigned randomly to one of two treatment groups, with PCA and PCEA administered in a double-blind manner for a 3-day postoperative course. All the patients received both PCA and PCEA delivery systems. Assessment was by a blinded, independent observer. Overall patient satisfaction with pain management was assessed by a visual analog scale at the end of postoperative day 3. Secondary measures included: three scales from the Functional Independence Measure instrument; opioid quantity; side effects; and length of hospital stay.

RESULTS

Thirty-eight patients were randomized to PCA, and 36 were randomized to PCEA. No baseline variable differences between the groups were observed. The results showed no difference between the groups on the following measures: overall patient satisfaction with pain management, ambulation, and length of stay. The PCA patients used significantly more opioid than the PCEA patients.

CONCLUSIONS

Both postoperative analgesic regimens provided good overall patient satisfaction. The only clinical advantage of PCEA over PCA for spine fusion patients was the lower amount of opioid consumed, although the PCEA group experienced significantly more side effects than the PCA group. There were no other significant differences. Therefore, patient or physician preference could select either postoperative pain management delivery system.

摘要

研究设计

开展了一项前瞻性、随机、双盲临床试验。

目的

比较患者自控镇痛(PCA)和患者自控硬膜外镇痛(PCEA)在腰椎融合术后患者对疼痛管理总体满意度方面的疗效。

背景数据总结

在众多外科领域,PCEA和PCA已被证明是有效的术后疼痛控制方法。文献表明,与PCA相比,在术后即刻使用PCEA时,维持同等疼痛控制所需的阿片类药物用量更少。脊柱融合患者中已对持续硬膜外输注进行了评估,但尚未对PCEA进行评估。此外,这是第一项前瞻性随机临床试验,在对患者的焦虑水平和术前阿片类药物使用情况进行分层的同时评估患者的总体满意度。

方法

在本研究中,74例患者被随机分配到两个治疗组之一,PCA和PCEA以双盲方式给药,术后持续3天。所有患者均接受PCA和PCEA给药系统。由一名盲法、独立的观察者进行评估。术后第3天结束时,通过视觉模拟量表评估患者对疼痛管理的总体满意度。次要指标包括:功能独立性测量工具中的三个量表;阿片类药物用量;副作用;以及住院时间。

结果

38例患者被随机分配至PCA组,36例被随机分配至PCEA组。两组之间未观察到基线变量差异。结果显示,两组在以下指标上无差异:患者对疼痛管理的总体满意度、行走能力和住院时间。PCA组患者使用的阿片类药物明显多于PCEA组患者。

结论

两种术后镇痛方案均使患者总体满意度良好。对于脊柱融合患者,PCEA相对于PCA的唯一临床优势是阿片类药物消耗量较低,尽管PCEA组的副作用明显多于PCA组。没有其他显著差异。因此,患者或医生的偏好可以决定选择哪种术后疼痛管理给药系统。

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