A Prospective Evaluation of the Safety and Clinical Effects of Ultrasound-guided Cervical Medial Branch Blocks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Delayed complications
研究概览
简要总结
In this study we will prospectively examine the safety and clinical effects of ultrasound-guided cervical medial branch blocks.
详细描述
While several clinical trials have found that ultrasound guidance provides similar accuracy to fluoroscopy and reduces performance times for cervical medial branch blocks, larger studies documenting safety-related outcomes are lacking. In addition, although cervical medial branch blocks are an accepted tool to diagnose neck pain originating from the cervical facets, there are reports of long-lasting analgesic effects in a subset of patients, suggesting that these blocks may have long-term benefits. We therefore propose to prospectively examine the incidence of adverse events, as well as the clinical long-term effects of ultrasound-guided cervical medial branch blocks, in a cohort of pain clinic patients undergoing these procedures as part of their usual care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting patients over 18 years of age undergoing cervical medial branch blocks as part of their usual care and who have a pain intensity of at least 5/10 (at rest or on movement) and a pain duration of at least 4 months.
排除标准
- •Inability to communicate or complete follow up questionnaires
- •Known bleeding disorder or coagulopathy
- •Patients on antiplatelet medication other than aspirin and those on anticoagulants (coumadin, AT III agents)
- •Inability to visualize targeted structures on ultrasound
- •Presence of acute radiculopathy of new onset neurological symptoms in the upper extremities
- •Patients with bilateral neck pain if only one side is treated
结局指标
主要结局
Delayed complications
时间窗: 14 days after block
Proportion of patients with delayed block-related complications including any of the following: redness/irritation/swelling at injection site, hematoma, infection, skin bruising, soreness at injection site or increased pain, any neurological symptoms (new onset radicular pain, numbness/weakness or paresthesia in upper extremities).
Immediate complications
时间窗: Immediately after block
Proportion of patients with immediate block-related complications including any of the following: vasovagal, local anesthetic toxicity (dizziness, tinnitus, altered LOC, seizure) and trauma to non-targeted neural structures (paresthesia or other neuro symptoms)
次要结局
- PHQ-9(Pre-block then at 1,2 and 3 months post block.)
- GAD-7(Pre-block then at 1,2 and 3 months post block.)
- PCS(Pre-block then at 1,2 and 3 months post block.)
- Patient reported pain(Pre-block, then every 2 weeks for 3 months.)
- NDI(Pre-block, then every 2 weeks for 3 months.)
- PGIC(Pre-block, then every 2 weeks for 3 months.)
研究者
Roderick Finlayson
Professor
University of British Columbia