Comparison of Analgesic Effects of CT-Guided Celiac Plexus Neurolysis With Pharmacotherapy as Palliative Care of Upper Gastrointestinal Malignancies
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
- 否
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
干预措施: CT-guided celiac plexus neurolysis (Procedure)
Standard pharmacotherapy
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
Dr Usama Sardar
Dr.
Mayo Hospital Lahore
