Comparison of radiofrequency ablation versus chemical neurolysis (phenol) of splanchnic nerve in the management of chronic upper abdominal pain : A Randomised control trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in pain NRS score from baseline to 3 months post
研究概览
简要总结
upper abdominal chronic pain can indeed be a burden , often indicative of various conditions . There are various modes of treatment for chronic abdominal pain not responding to conservative management which include splanchnic nerve neurolysis , celiac plexus neurolysis , implantable intrathecal drug delivering devices and spinal cord stimulators .Disparities in access to pain management resources add another layers of complexity , emphasizing the need for interventions that are not only effective but also adaptable to diverse healthcare landscapes . Hence we decided to do this study .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •â‰¥ 18 year of both sex who suffered from upper abdominal pain (visceral pain with VAS ≥4)for a duration of more than 3 months.
- •Â Patients who were taking the maximum tolerable dose of opioids. 3) 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 score from baseline to 3 months post
时间窗: Baseline , 7 days , 1 month , 3 month
intervention.
时间窗: Baseline , 7 days , 1 month , 3 month
次要结局
- Change in karnofsky performance status scale from baseline to 3 months post(intervention.)
- Change in sleep score from baseline to 3 months post intervention.(Baseline , 7 days , 1 month , 3 month)
- Change in Analgesic requirement (medication quantification scale) from baseline to 3(months post intervention.)
研究者
Sridhar M
AIIMS Rishikesh