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临床试验/NCT07761650
NCT07761650已完成不适用

Comparison of Analgesic Effects of CT-Guided Celiac Plexus Neurolysis With Pharmacotherapy as Palliative Care of Upper Gastrointestinal Malignancies

Mayo Hospital Lahore1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年5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
发起方
入组人数
110
试验地点
1
主要终点
Average pain score at baseline and after 4 weeks of treatment

研究概览

简要总结

After enrolment, patients were randomly assigned to two groups by means of a lottery procedure, whereby each patient blindly chose one of two labelled slips, resulting in group assignment to receive. Group A patients were subjected to CT-guided celiac plexus neurolysis, and Group B patients to standard pharmacotherapy for managing the pain over a period of four weeks.

CT-guided celiac plexus neurolysis under the supervision of the principal investigator, using local anaesthetic and absolute ethanol injection for neurolysis, was carried out using aseptic technique. Baseline demographic information, which included age, gender, nature of malignancy, and the duration of disease, was recorded using a predesigned proforma. Pain severity was measured by the Visual Analogue Scale (VAS), a recognised 0-10 scale where 0 = no pain to 10 indicating the worst imaginable pain, at baseline and after 4 weeks of treatment. The major outcome measure was the average pain score at four weeks in both groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Biopsy proven upper GI malignancy with severe abdominal pain
  • Patients aged 18 to 65 years of either gender

排除标准

  • Pregnant and lactating females
  • Anemia (hemoglobin <10 g/dL)
  • Massive ascites
  • Chronic renal failure
  • Patients with known allergy or intolerance to drugs used during celiac plexus neurolysis (CT guided technique).

研究组 & 干预措施

CT-guided celiac plexus neurolysis

Experimental

干预措施: CT-guided celiac plexus neurolysis (Procedure)

Standard pharmacotherapy

Active Comparator

干预措施: Standard pharmacotherapy (Procedure)

结局指标

主要结局

Average pain score at baseline and after 4 weeks of treatment

时间窗: Baseline to 4 weeks

Pain severity was measured by the Visual Analogue Scale (VAS), a recognized 0-10 scale where zero is equivalent to no pain and 10 indicates the worst imaginable pain, at baseline and after 4 weeks of treatment.

次要结局

未报告次要终点

研究者

发起方
Mayo Hospital Lahore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Usama Sardar

Dr.

Mayo Hospital Lahore

研究点 (1)

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