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临床试验/NCT06678061
NCT06678061已完成不适用

Efficacy of Radiofrequency Splanchnic Denervation Compared to Neurolytic Retrocrural Celiac Plexus Block for Patients with Chronic Upper Abdominal Cancer Pain

Assiut University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

NourhanMohammedAlaaElgalaly

PRINCIPLE INVESTIGATOR

Assiut University

研究点 (2)

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