Prospective Single-Arm Pilot Study for CT-Guided, Temporary Celiac Ganglion Block as a Test Before Celiac Ganglion Resection for Dysautonomia-Related Bowel Dysmotility
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Amount of solid food intake by mouth per day
研究概览
简要总结
Dysautonomia is malfunction of the autonomic nervous system. It usually results from overactivity of the sympathetic portion and over-secretion of acetylcholine. Symptoms depend on the organ involved by this sympathetic overstimulation. Involvement of the gastrointestinal system results in chronic dysmotility, nausea, vomiting, food intolerance, weight loss and need for feeding tube placement and/or parenteral feeding. Autonomic celiac ganglia resection has been shown to alleviate symptoms as it interrupts the sympathetic stimulation to the gastrointestinal (GI) system, however there is no pre surgery test to confirm the diagnosis. The investigators' objective is to temporarily block the celiac ganglion with a long acting anesthetic (liposomal bupivacaine). If symptoms abate the diagnosis is confirmed and patient will proceed to surgery.
详细描述
Problem:
Dysautonomia is malfunction of the autonomic nervous system. It usually results from overactivity of the sympathetic portion and over-secretion of acetylcholine. Symptoms depend on the organ involved by this sympathetic overstimulation. A partial list of dysautonomia-related conditions is shown below:
Affected Level Manifestation Cardiac innervation Postural Orthostatic Tachycardia Syndrome Skin Hyperhidrosis Arteries Raynaud's phenomenon Kidneys Hypertension Small nerve fibers Reflex Sympathetic Dystrophy Pain fibers Complex regional pain syndrome GI system Chronic GI dysmotility/irritable bowel syndrome (IBS) The last one (Chronic GI dysmotility) usually affects young females, presenting after puberty. Symptoms include chronic abdominal pain, intestinal angina, chronic nausea/vomiting, inability to take po, need for total parenteral nutrition (TPN) or G-tube feeding. Further, the patients' condition is often complicated by opioid dependence, malnutrition, weight loss, social isolation etc. Many such patients are misdiagnosed as having Median Arcuate Ligament Syndrome (MALS) and are referred to surgery for ligament release. Though some of the patients do get partial relief, this temporary relief is due to the partial interruption of the sympathetic nerves during surgery. Repeat surgery to complete celiac ganglion resection is often necessary. Occasionally surgeons refer patients for a Computer Tomography (CT) guided temporary celiac ganglion block to confirm (or exclude) sympathetic system dysfunction as the cause of the patients symptoms. However negative or positive predictive value of this test has not been studies rigorously.
Research Hypothesis:
The investigators' hypothesis is that a low-risk, outpatient test can confirm (or exclude) dysautonomia as the cause of the patient's symptoms. The experimental test is CT-guided, celiac ganglion temporary block with liposomal bupivacaine.
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
盲法说明
Since this is a single arm study, no masking will be performed
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with dysautonomia-related GI dysmotility, misdiagnosed as having MALS after MALS surgery fails to relieve symptoms
- •Patients with known dysautonomia-related dysmotility and related symptoms
排除标准
- •Allergy to liposomal bupivacaine
- •Platelets < 50 thousand
- •International normalised ration (INR) > 1.7
研究组 & 干预措施
Test group
10 patients with presumptive diagnosis of dysautonomia with chronic nausea, vomiting and food intolerance
干预措施: Celiac ganglion block (Procedure)
Test group
10 patients with presumptive diagnosis of dysautonomia with chronic nausea, vomiting and food intolerance
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Amount of solid food intake by mouth per day
时间窗: 2 days post celiac ganglion block
Over the 2 days post Celiac Ganglion block, the investigators will monitor the patient (outpatient) for amount of solid food intake (grams) per day.
Change in abdominal pain as assessed by patient reported pain on scale 1-10 (10 worse)
时间窗: Baseline and 2 days post-celiac ganglion block
Patients with GI involvement of dysautonomia have abdominal pain which is worse with solid food intake. The patient's ability to take solid food without pain will be evaluated on scale 1-10 with 10 being worse pain.
次要结局
- Number of episodes of nausea/vomiting per day(2 days post celiac ganglion block)
- Change in amount of analgesic medications used(Baseline and 2 days post celiac ganglion block)