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临床试验/NCT06244667
NCT06244667已完成不适用

Comparison of Different Local Anesthetics in Cervical Facet Medial Branch Blockade

Ankara University2 个研究点 分布在 2 个国家目标入组 114 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
114
试验地点
2
主要终点
change of pain intensity

研究概览

简要总结

Neck pain is a common disease in society. In studies, the annual and lifetime prevalence was found to be 37.2% and 48.5%, respectively (1). Neck pain may be axial or radicular. Causes of axial neck pain include cervical strain, discogenic pain, cervical facet pain, spondylosis, whiplash, and myofascial pain. (2) Cervical facet degeneration is a common cause of axial neck pain (3). Pain originating from the cervical facet joint is localized to the midline of the neck and increases with neck extension. (2) Diagnosis is made by physical examination and radiological imaging. The distribution patterns of pain originating from the cervical facet joint vary depending on the level of the joint involved

详细描述

Neck pain is a common disease in society. Causes of axial neck pain include cervical strain, discogenic pain, cervical facet pain, spondylosis, whiplash, and myofascial pain. Cervical facet degeneration is a common cause of axial neck pain. Pain originating from the cervical facet joint is localized to the midline of the neck and increases with neck extension. Diagnosis is made by physical examination and radiological imaging. The distribution patterns of pain originating from the cervical facet joint vary depending on the level of the joint involved.

Conservative treatment methods for facet joint pain are medical treatment and various physical therapy modalities. Interventional pain treatments are on the agenda for patients who cannot achieve effective pain palliation with conservative treatment. Since facet joints are innervated by the dorsal ramus, medial branch of the spinal nerves, medial branch blockade is applied in the treatment of facet-related pain. In cervical facet medial branch blockade, a mixture of local anesthetic and steroid is injected. Studies have found that adding steroids to local anesthetics increases injection effectiveness. Although there is no consensus on the type of steroid to be used, it is safer to use dexamethasone, a particle-free steroid, considering the dense vascular structure of the cervical region. However, the types of local anesthetic used in cervical facet medial branch blockade vary between studies. The type of local anesthetic used in cervical facet medial branch blockade in our clinic varies. There is only one study in the literature comparing local anesthetic types. Researchers compared the effectiveness of lidocaine and bupivacaine in cervical facet medial branch blockade without adding steroids. Researchers stated that lidocaine has a faster effect and longer duration of effect. Since there is no consensus on the type of local anesthetic, prilocaine or lidocaine is preferred in practice. This study aims to compare the effectiveness of lidocaine and prilocaine added to dexamethasone in cervical facet medial branch blockade, one of the routine treatment methods in our clinic.

Within the scope of the study, patients deemed suitable for cervical facet medial branch injection will be randomly numbered for prilocaine or lidocaine injection through the computer program. 57 patients will receive lidocaine + steroid injection, 57 patients will receive prilocaine + steroid injection. Cervical facet medial branch injections will be administered. The evaluations of the patients before and after the procedure will be recorded by the researcher who is blind to the procedure performed. Demographic information of the patients, including age, gender, comorbidities, pain duration, and facet injection level, will be recorded before the procedure. Before the procedure, pain intensity will be evaluated using the NRS 11 scale, and functionality will be evaluated using the Neck Disability Index (NDI). The amount of medication used by the patients (non-steroidal anti-inflammatory analgesics, opioids, muscle relaxants) will also be noted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 20-79
  • A history of axial cervical pain without radicular symptoms for at least 3 months
  • NRS score of 4 and above
  • Not having had a cervical interventional procedure in the last year
  • Patients who cannot achieve adequate pain palliation with pharmacological and physical treatment modalities

排除标准

  • Patients experiencing cervical radicular pain due to disc herniation or foraminal stenosis and neck pain due to cervical canal stenosis
  • Patients with previous cervical surgery
  • Patients with psychiatric illnesses that are unstable/uncontrolled with medical treatment
  • Pregnant patients
  • Bleeding diathesis
  • Patients who received epidural steroid injection within the last year
  • Patients with known allergies to the substances administered during the procedure (local anesthetic, steroid, contrast material)
  • Patients with cervical spondylosis, radiculopathy, myelopathy, spondylolisthesis, compression fracture, previous discitis, sequestered disc, overt disc herniation

结局指标

主要结局

change of pain intensity

时间窗: 1 month

Change from baseline in pain scores on the Numeric Rating Scale at 1 month in both groups

change of participants functionality

时间窗: 1 month

Change of participants functionality (Neck Disability Score) at 1 month in both groups

participants satisfaction

时间窗: 1 month

Participants satistification degree (satisfied", "uncertain" or "dissatisfied") at 1 month in both groups

次要结局

  • difference of drug use between groups(1 month)
  • drug use in groups(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hanzade Aybuke Unal

Director

Ankara University

研究点 (2)

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