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腰椎术后综合征疼痛管理:经透视引导下骶管硬膜外注射的随机、双盲、阳性对照临床试验一年结果。

Management of pain of post lumbar surgery syndrome: one-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections.

机构信息

Pain Management Center of Paducah, Paducah, KY, USA.

出版信息

Pain Physician. 2010 Nov-Dec;13(6):509-21.


DOI:
PMID:21102963
Abstract

BACKGROUND: Post lumbar surgery syndrome represents a cluster of nomenclature and syndromes following spine surgery wherein the expectations of the patient and spine surgeon are not met, with persistent pain following lumbar surgery. Multiple causes have been speculated to cause pain after lumbar surgery. Epidural steroid injections are most commonly used in managing post surgical pain in the lumbar spine. However, there is a paucity of evidence of epidural injections in managing chronic low back pain with or without lower extremity pain in post surgery syndrome. STUDY DESIGN: A randomized, double-blind, active controlled trial. SETTING: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. OBJECTIVES: To evaluate the effectiveness of caudal epidural injections in patients with chronic low back and lower extremity pain after surgical intervention with post lumbar surgery syndrome. METHODS: One-hundred forty patients were randomly assigned to one of 2 groups; Group I patients received caudal epidural injections with local anesthetic (lidocaine 0.5%), whereas Group II patients received caudal epidural injections with 0.5% lidocaine 9 mL mixed with 1 mL of 6 mg non-particulate Celestone. Randomization was performed by computer-generated random allocation sequence by simple randomization. OUTCOMES ASSESSMENT: Multiple outcome measures were utilized which included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3 months, 6 months, and 12 months post-treatment. Significant pain relief and disability reduction were described as 50% or more reduction in scores from baseline. RESULTS: Combined pain relief (>/=50%) and disability reduction was recorded in 53% of the patients in the local anesthetic group, and 59% of patients in the local anesthetic and steroid group with no significant differences noted with or without steroid over a period of one-year. However, the data from the successful group showed improvement in 70% of patients in Group I and 75% of patients in Group II. The average procedures per year were 4 with an average total relief per year of 38.1 ± 14.5 weeks in Group I and 38.4 ± 13.2 weeks in Group II over a period of 52 weeks in the successful group. LIMITATIONS: The results of this study are limited by the lack of a placebo group and one-year outcomes. CONCLUSION: Caudal epidural injections in chronic function-limiting low back pain in post surgery syndrome without facet joint pain may be effective in a significant proportion of patients with improvement in functional status and significant pain relief. CLINICAL TRIAL: NCT00370799.

摘要

背景:腰椎手术后综合征是脊柱手术后出现的一组命名和综合征,表现为患者和脊柱外科医生的期望未得到满足,腰椎手术后持续存在疼痛。多种原因被推测会导致腰椎手术后疼痛。硬膜外类固醇注射是最常用于管理腰椎手术后疼痛的方法。然而,在管理术后综合征中伴有或不伴有下肢疼痛的慢性下腰痛方面,硬膜外注射的证据很少。 研究设计:一项随机、双盲、主动对照试验。 设置:美国的介入性疼痛管理实践、专科转诊中心、私人执业环境。 目的:评估在接受腰椎手术后综合征的慢性下腰痛和下肢痛的患者中,骶管硬膜外注射治疗的有效性。 方法:140 名患者被随机分配到两组之一;第 I 组患者接受局部麻醉(利多卡因 0.5%)的骶管硬膜外注射,第 II 组患者接受 0.5%利多卡因 9 毫升混合 1 毫升 6 毫克非颗粒 Celestone 的骶管硬膜外注射。通过简单随机化的计算机生成随机分配序列进行随机分组。 结果评估:使用了多种结局评估指标,包括数字评分量表(NRS)、Oswestry 残疾指数 2.0(ODI)、就业状况和阿片类药物摄入,并在治疗后 3 个月、6 个月和 12 个月进行评估。描述为基线评分减少 50%或更多的显著疼痛缓解和残疾减轻。 结果:局部麻醉组中有 53%的患者和局部麻醉加类固醇组中有 59%的患者出现联合疼痛缓解(>/=50%)和残疾减轻,但在一年期间,使用或不使用类固醇均无显著差异。然而,成功组的数据显示,第 I 组中有 70%的患者和第 II 组中有 75%的患者得到改善。每年平均进行 4 次手术,在成功组的 52 周内,第 I 组的平均总缓解时间为 38.1±14.5 周,第 II 组为 38.4±13.2 周。 局限性:本研究结果受到缺乏安慰剂组和一年结局的限制。 结论:在没有小关节疼痛的术后综合征中,慢性功能受限的下腰痛患者的骶管硬膜外注射可能对相当一部分患者有效,可改善功能状态并显著缓解疼痛。 临床试验:NCT00370799。

相似文献

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Pain Physician. 2010

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引用本文的文献

[1]
Treatment modalities for patients with Persistent Spinal Pain Syndrome Type II: A systematic review and network meta-analysis.

Commun Med (Lond). 2025-3-5

[2]
Systematic review of the effectiveness of caudal epidural steroid injections in the treatment of chronic low back or radicular pain.

Interv Pain Med. 2022-10-3

[3]
Non-Invasive Treatments for Failed Back Surgery Syndrome: A Systematic Review.

Global Spine J. 2023-5

[4]
Effect of Previous Caudal Block to Predict Successful Outcome after Adhesiolysis using a Steerable Catheter in Lumbar Failed Back Surgery Syndrome: A Retrospective Study.

Int J Med Sci. 2022

[5]
Sonographic Guidance for Caudal Epidural Steroid Injection: A Diagnostic Tool.

Turk J Anaesthesiol Reanim. 2021-12

[6]
Ultrasound-guided epidural block in axial spondyloarthritis patients with limited spine mobility: a randomized controlled trial.

Korean J Pain. 2021-1-1

[7]
The use of sonographic guidance in caudal epidural steroid injections.

Korean J Pain. 2018-10

[8]
Chronic postsurgical pain: current evidence for prevention and management.

Korean J Pain. 2018-7

[9]
The Results of Treating Failed Back Surgery Syndrome by Adhesiolysis: Comparing the One- and Three-Day Protocols.

Anesth Pain Med. 2017-8-22

[10]
Neuropathic Pain after Spinal Surgery.

Asian Spine J. 2017-8

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