Comparison Between Retrolaminar and Medial Branch Block in Cervical Facet Joint Arthropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Numerical rating score
研究概览
简要总结
Cervical facet joints have been implicated as a source of chronic pain in 54-67 % patients with chronic posterior neck pain.1 Intraarticular injections, medial branch nerve blocks and neurolysis of medial branch nerves have been described in managing chronic neck pain of facet joint origin.2 The evidence for long-term therapeutic benefits of intraarticular injections of facet joints is limited. Medial branch nerve blocks show moderate evidence of long-term benefit with evidence of side effects.3 Paraneuraxial nerve blocks have become very popular clinically, due to their clinical and anatomical characteristics. These techniques are comparable to neuraxial nerve blocks in terms of success rate and analgesic efficacy and may confer many of advantages over neuraxial nerve blocks.4 Retrolaminar blocks are among this family that are near but not within the neuraxis like spinals or epidurals.5 Most reports and studies of retrolaminar blocks have been in the context of anesthesia for truncal surgery and truncal pain syndromes (thoracic and abdominal).6 Postoperative and pain treatment cervical retrolaminar blocks studies are currently sparse.7 The major advantage of this technique is minimizing or even eliminating the risk of pneumothorax. Additionally, the risks of nerve root damage and inadvertent injection into a dural sleeve, an intervertebral foramen, or the epidural or intrathecal spaces should also be decreased.8
详细描述
This prospective randomized open comparative study will be conducted in pain clinic, Mansoura University Hospitals. The study will be approved by the Ethics Research Committee of the Faculty of Medicine, Mansoura University and will be carried out in compliance with the Helsinki Declaration. Informed written consent will be signed from every patient participating in this study after full description of all details of every aspect in this study.
The study participants were randomly grouped on a scale of 1:1, using a computer-generated list of random numbers. The distribution results were sealed in an opaque envelope and kept by the study administrator. On the day of block, the study manager handed the envelope to the anesthesiologist who will perform the block.
Grouping:
- Group M: cervical medial branch block will done at the affected dermatomal level using 1 mL of a mixture of 0.5 mL 1% lidocaine and 0.5 mL dexamethasome (8mg/2ml).
- Group R: cervical retrolaminar block was done using 5 mL of a mixture of 3 mL 1% lidocaine and 2 mL dexamethasome (8mg/2ml) for each affected dermatomal level.
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 (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients more than 18 years old of both genders with cervical facet joint arthropathy confirmed by magnetic resonance imaging (MRI) and neck manual examination and not responding to conservative treatments
- •numeric rating scale (NRS) ≥ 4 that ranged from 0 (no pain) to 10 (extreme pain).,
- •American society of Anesthesiology Physical Status class I and II,
- •Body mass index ˂ 30
排除标准
- •The exclusion criteria are patient refusal
- •local or systemic sepsis, coagulopathy,
- •unstable cardiovascular and respiratory diseases,
- •previous neurological deficits,
- •history of psychiatric disorders,
- •history of drug abuse,
- •distorted local anatomy,
- •those who were allergic to the used medications .
研究组 & 干预措施
Group medial branch block
cervical medial branch block will done at the affected dermatomal level using 1 mL of a mixture of 0.5 mL 1% lidocaine and 0.5 mL dexamethasome (8mg/2ml).
干预措施: Medial Branch Block (Other)
Group retrolaminar block
cervical retrolaminar block was done using 5 mL of a mixture of 3 mL 1% lidocaine and 2 mL dexamethasome (8mg/2ml) for each affected dermatomal level.
干预措施: Retrolaminar block (Other)
结局指标
主要结局
Numerical rating score
时间窗: after 3 month from block
from zero to 10 (where 0 no pain, 10 the worst pain)
次要结局
- Neck disability index(after 2 weeks from injection)
研究者
Nevert Adel
assist. prof. of anesthesia and pain management
Mansoura University