MRI Observation After Ganglionic Local Opioid Analgesia at the Ganglion Cervicale Superius
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Distribution of the injected fluid in the area of the superior cervical ganglion
研究概览
简要总结
The blockade of the superior cervical ganglion (GCS) of the sympathetic trunk is a very special form of therapy. The transoral blocking technique, also known as GLOA (ganglionic local opioid analgesia), is very suitable for achieving GCS. A total of 5 μg of sufentanil in 2 ml of sodium chlorid are applied.
Since no imaging evidence of the injected substances has been published for a GLOA in a living person, it is planned to carry out an MRI examination immediately after the ganglionic local opioid analgesia in order to show the spread and distribution pattern of the injected substance. It is also planed to show a correlation of the spread of the injected substance with the efficacy of the intervention.
To determine the interrater reliability, the GLOA is carried out alternately by 2 different examiners and the existing MRI images of the GLOA are assessed by an radiologist and anatomist in a blinded manner.
In a follow-up after 1 and 3 months, the questionnaires and pain scores are evaluated again.
详细描述
The blockade of the superior cervical ganglion (GCS) of the sympathetic trunk is a very special form of therapy. It is successfully used for numerous, often protracted diseases that severely impair the patient's quality of life, such as idiopathic facial pain syndromes or trigeminal neuralgia. The transoral blocking technique, also known as GLOA (ganglionic local opioid analgesia), is very suitable for achieving GCS. With this technique, a Sprotte cannula is inserted into the pharyngeal recess (Rosenmueller) located behind the palatopharyngeal arch and pierced through the pharyngeal wall into the parapharyngeal space. A total of 5 μg of sufentanil in 2 ml of sodium chlorid are applied.
Since no imaging evidence of the injected substances has been published for a GLOA in a living person, it is planned to carry out an MRI examination immediately after the ganglionic local opioid analgesia in order to show the spread and distribution pattern of the injected substance. It is also planed to show a correlation of the spread of the injected substance with the efficacy of the intervention. For this, different questionnaires (NRS, quality of life, sleep quality, patient satisfaction) are carried out before and after the intervention.
To determine the interrater reliability, the GLOA is carried out by 2 different examiners and the existing MRI images of the GLOA are assessed by an radiologist and anatomist in a blinded manner.
In a follow-up after 1 and 3 months, the questionnaires and pain scores are evaluated again.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trigeminal neuralgia
- •Postherpetic neuralgia
- •Glossopharyngeal neuralgia
- •Atypical facial pain
排除标准
- •psychosis
- •language barrier
- •Pregnant and breastfeeding women
- •Seizure disorders (epilepsy)
- •Increased risk of bleeding
结局指标
主要结局
Distribution of the injected fluid in the area of the superior cervical ganglion
时间窗: immediately after the intervention
MRI verified distribution of the injected fluid in the area of the superior cervical ganglion
次要结局
- Quality of life questionnaire(Before first and after last GLOA. After 1 and 3 month (follow up))
- Pain assessed by NRS(baseline, immediately after intervention, After 1 and 3 month (follow up))
- Patient satisfaction assessed by satisfaction questionaire(Before first and after last GLOA. After 1 and 3 month (follow up))
- Sleep quality assessed by sleep quality questionnaire(Before first and after last GLOA. After 1 and 3 month (follow up))
- Efficacy prediction based on MRI verified fluid spread(immediately after the intervention)
研究者
Rudolf Likar
Prim. Univ. Prof. Dr. MSc.
Klinikum Klagenfurt am Wörthersee