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Cervical Medial Branch Block Versus Ipsilateral Cervical Erector Spinae Plane Block (CERVESP)

2026年5月12日 更新者:Ülkü Sabuncu、Ankara City Hospital Bilkent

Ultrasound-Guided Cervical Medial Branch Block Versus Ipsilateral Cervical Erector Spinae Plane Block in Cervical Facetogenic Pain: A Prospective Randomized Controlled Study

This prospective randomized controlled study aims to compare the analgesic effectiveness of ultrasound-guided cervical medial branch block and ipsilateral cervical erector spinae plane block in patients with cervical facetogenic pain.

Patients with chronic cervical facet-mediated pain will be randomized into two intervention groups. Pain intensity, functional status, meaningful pain response rates, analgesic consumption, and patient satisfaction will be evaluated during follow-up.

The primary objective is to determine whether cervical erector spinae plane block provides comparable short-term pain relief to cervical medial branch block.

研究概览

详细说明

Cervical facet joints are an important source of chronic axial neck pain. Diagnostic cervical medial branch block is commonly used to identify facet-mediated pain and may also provide short-term analgesic benefit. However, this procedure requires precise targeting of the cervical medial branches and may be technically demanding in some patients.

The cervical erector spinae plane block is an ultrasound-guided interfascial plane block that may provide analgesia through cranio-caudal spread of local anesthetic along the paraspinal fascial plane. Although it has been increasingly used for perioperative and chronic pain indications, its role in cervical facetogenic pain has not been clearly established.

This study will compare the short-term analgesic effectiveness of ultrasound-guided cervical medial branch block and ipsilateral cervical erector spinae plane block in patients with clinically suspected cervical facetogenic pain. Eligible patients will be randomized to receive one of the two ultrasound-guided interventions. Pain intensity, functional disability, meaningful pain response, analgesic use, patient satisfaction, and procedure-related adverse events will be assessed during follow-up.

The study is designed to determine whether cervical erector spinae plane block can provide clinically meaningful pain relief comparable to cervical medial branch block in this patient population.

研究类型

介入性

注册 (估计的)

130

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age between 18 and 80 years
  • Chronic neck pain lasting at least 3 months
  • Clinical findings suggestive of cervical facetogenic pain
  • Numeric Rating Scale pain score ≥4
  • Ability to provide informed consent

Exclusion Criteria:

  • Cervical radiculopathy or myelopathy
  • Major neurological deficit
  • Infection at the injection site
  • Coagulopathy or anticoagulant therapy contraindicating intervention
  • Allergy to local anesthetics
  • Pregnancy
  • Previous cervical interventional pain procedure within the last 3 months
  • Severe psychiatric disease

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Cervical Medial Branch Block
Ultrasound-guided cervical medial branch block will be performed at the clinically suspected symptomatic cervical facet levels.
Ultrasound-guided cervical medial branch block performed at clinically suspected symptomatic cervical facet levels using local anesthetic for diagnostic and analgesic purposes.
实验性的:Cervical Erector Spinae Plane Block

Ultrasound-guided ipsilateral cervical erector spinae plane block will be performed at the symptomatic cervical level.

I

Ultrasound-guided ipsilateral cervical erector spinae plane block performed at the symptomatic cervical level using local anesthetic for analgesic purposes.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Meaningful Pain Response
大体时间:Time Frame: 1 hour after the procedure
Proportion of patients achieving at least 50% reduction in Numeric Rating Scale (NRS) pain score during the early post-procedural period.
Time Frame: 1 hour after the procedure

次要结果测量

结果测量
措施说明
大体时间
NRS24
大体时间:at 24 Hours
Change in pain intensity measured using the 11-point Numeric Rating Scale (0=no pain, 10=worst imaginable pain).
at 24 Hours
NRS1
大体时间:1 week after the procedure
Change in pain intensity measured using the 11-point Numeric Rating Scale.( 0=no pain, 10=worst imaginable pain)
1 week after the procedure
NDI
大体时间:Baseline and 1 week after the procedure

Functional disability associated with neck pain assessed using the Neck Disability Index.0 = no disability 50 = complete disability

Higher scores indicate greater neck-related functional disability (worse outcome).

Baseline and 1 week after the procedure
GPE
大体时间:1 week after the procedure

Patient-reported global improvement evaluated using a 7-point Global Perceived Effect scale. The GPE scale ranges from -5 to +5, where:

-5 = vastly worse 0 = no change

+5 = completely recovered

1 week after the procedure
Analgesic Consumption
大体时间:24 hours and 1 week after the procedure
Need for rescue analgesic medication after the procedure.
24 hours and 1 week after the procedure
Patient Satisfaction
大体时间:1 week after the procedure
Patient satisfaction regarding the procedure.
1 week after the procedure
Complications
大体时间:Perioperative/Periprocedural
Procedure-related adverse events and complications.
Perioperative/Periprocedural

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月31日

初级完成 (估计的)

2026年9月30日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年4月28日

首先提交符合 QC 标准的

2026年5月12日

首次发布 (实际的)

2026年5月19日

研究记录更新

最后更新发布 (实际的)

2026年5月19日

上次提交的符合 QC 标准的更新

2026年5月12日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 123456 (Innovate UK)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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