Comparison of cooled versus conventional radiofrequency ablation of thoracic splanchnic nerves for the management of cancer pain: A prospective exploratory randomized controlled study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in pain NRS(numeric rating scale) score at rest
研究概览
简要总结
This prospective randomised controlled study seeks to address this gap in the literature by comparing the outcomes of cooled RFA and conventional RFA for the management of chronic abdominal cancer pain for 18 months in 60 patients at All India Institute of Medical Sciences Rishikesh. The aim is to compare and evaluate the analgesia obtained by cooled versus conventional radiofrequency ablation of the splanchnic nerve in the management of upper abdominal cancer pain.The primary objective is to evaluate the change in pain scores following the procedure. Secondary outcomes include change in sleep score, change in analgesic requirement, and procedure-related complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18-70 years.
- •Patients of both sexes who have experienced upper abdominal pain (visceral pain with NRS greater than 4) for a duration of more than 3 months.
- •Patients who were taking the maximum tolerable dose of opioids. 4) Splanchnic nerve accessible for bilateral neurolysis.
排除标准
- •Patient refusal,
- •Organ failure,
- •Coagulation disorders,
- •Local infection at the puncture site,
- •Allergy to the contrast dye,
- •Pregnant women,
- •Psychiatric illness that affects cooperation.
结局指标
主要结局
Change in pain NRS(numeric rating scale) score at rest
时间窗: Baseline, 1 week, 1 month, and 3 months post-intervention
次要结局
- Change in sleep score (PSQI-The Pittsburgh Sleep Quality Index)(Baseline, 1 week, 1 month, and 3 months post-intervention)
- Change in analgesic requirement (medication quantification scale)(Baseline to 3 months post-intervention)
- To assess the complications of the intervention(3 months)
研究者
Karthik Pandian
All India Institute of Medical Sciences, Rishikesh