Efficacy of Radiofrequency Splanchnic Denervation Compared to Neurolytic Retrocrural Celiac Plexus Block for Patients with Chronic Upper Abdominal Cancer Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- the Numeric Pain Rating Scale (NRS) pain scale
研究概览
简要总结
To compare between the efficacy of radiofrequency splanchnic denervation and neurolytic retrocrural celiac plexus block in chronic upper abdominal cancer pain
详细描述
Abdominal cancers are not uncommon, according to WHO latest updates in cancer epidemiology published in 2020, the percentage of new cases incidence is rapidly increasing as follow: Colon (6.0%), Stomach (5.6%), Liver (4.7%), Esophagus (3.1%), Pancreas (2.6%), and Gall bladder (0.6%).
Pain is one of the chief complains in cancer patients and the leading cause for seeking medical advice. In abdominal malignancies, visceral pain is poorly localized due to both fewer receptors participating in the process of visceral pain and the scarce representation within the primary somatosensory cortex. The challenge in identifying the pain generators and effectively treat this condition explains the tendency for abdominal pain to become chronic and frustration associated with its management for both the patient and the health care provider. Effective analgesia has become sometimes difficult to institute in abdominal cancer patients because the dose-response is unpredictable and the analgesic doses may be poorly tolerated in patients who are debilitated and using several other drugs as they are usually old age, complaining of nausea, repeated vomiting, and dehydration, elevated liver enzymes especially in liver affection by primary or secondary lesions.
Many patients may have residual symptoms that impact their quality of life despite thoughtful pharmacologic and surgical treatment. So, Non pharmacologic strategies, including physical therapy, integrated and complementary medicine, lifestyle modifications, and interventional procedures may also be useful adjuncts to surgical and pharmacologic therapy.
Thus, the neurolytic sympathetic block has been proposed as an efficient, relatively simple, and repeatable method of management, bringing both relief of pain and allowing the discontinuation of drugs or at least a decrease in their dosage.
Frequently used nerve ablation and modulation methods include conventional radiofrequency ablation (RFA) using heat and chemical ablation using alcohol.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 20-70 years old, with upper GIT tumors, including cancer of the lower third of the esophagus, stomach cancer, pancreatic cancer, cancer liver, and cancer of the biliary tract,
- •Abdominal cancer pain: includes patients with NRS pain score ≥
- •Included participants should show adequate response to diagnostic block for the splanchnic nerves, i.e. reduction of NRS pain score > 50% at least for 2 hours
排除标准
- •a- Patient's refusal. b- Patients medical condition as: coagulopathies, moderate or major cardiac/respiratory incapacitating diseases, liver or renal failure, infection either systemic or localized and anatomical anomalies or lesions at the spine.
- •c- Any psychiatric illness that would interfere with the perception and the assessment of pain, and any reason that would result in the protocol violation
研究组 & 干预措施
radiofrequency splanchnic denervation
Radiofrequency ablation of splenic nerve. The nerves were then anesthetized with 2 mL of 2% lidocaine before RF performed. In RFA group, lesion will be performed at 80 degrees celsius for 3 lesions 2 minutes each on both sides.
干预措施: radiofrequency (Device)
Celiac plexuc block
Neurolytic ablation of the celiac plexus.Two milliliter of contrast material will be injected in each side for confirmation a test injection with 5 mL of 2% lidocaine to both sides, and wait for 5 minutes then inject 5 ml of 100% alcohol will in each side after 5 minutes to allow the local anesthetic to take action. 1 ml of 2%
干预措施: radiofrequency (Device)
结局指标
主要结局
the Numeric Pain Rating Scale (NRS) pain scale
时间窗: 6 months
Change in the Numeric Pain Rating Scale (NRS) pain scale at the first 2 weeks compared to the pre-procedural pain
次要结局
- Patient Health Questionnaire (PHQ-9)(6 months)
- Functional Assessment of Chronic Illness Therapy or Cancer Therapy (FACT)(6 months)
- 1- Total opioid consumption(6 months)
研究者
NourhanMohammedAlaaElgalaly
PRINCIPLE INVESTIGATOR
Assiut University
