Comparison of Transdiscal and Paravertebral Approaches for Neurolytic Splanchnic Nerve Block in the Treatment of Upper Abdominal Cancer Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Numerical rating scale (NRS)
研究概览
简要总结
This study aims to compare the efficacy of fluoroscopy-guided paravertebral (PV) and transdiscal (TD) approaches for splanchnic nerve neurolysis in patients with upper abdominal cancer-related pain (e.g., gastric, pancreatic, and hepatic malignancies). Treatment response will be assessed using the Numerical Rating Scale (NRS), and the impact of both techniques on quality of life will be evaluated with the EORTC QLQ-C30 questionnaire.
详细描述
Cancer-related pain (CRP) is a complex and challenging condition to manage. Pain may be somatic, visceral, or neuropathic in origin, and more than 50% of patients present with a mixed pain pattern at the time of diagnosis. In addition to medical therapies such as opioids and adjuvant analgesics, various interventional procedures are used in the management of CRP. Among these, neurolytic nerve and plexus blocks represent effective options for patients with pain refractory to conservative treatment. Chemical neurolysis, as a minimally invasive neurolytic plexus block technique, provides effective analgesia by targeting both sensory afferent fibers and sympathetic fibers innervating visceral organs. Identifying the most appropriate block according to pain localization plays a crucial role in achieving successful pain control.
Splanchnic nerve neurolysis is an established interventional technique for the management of upper abdominal cancer pain associated with pancreatic, gastric, and hepatic malignancies. Both the paravertebral (PV) and transdiscal (TD) approaches have been shown to effectively reduce cancer-related abdominal pain and significantly improve quality of life in affected patients. However, comparative data between these two techniques remain limited.
The primary aim of this study is to compare the efficacy of paravertebral (PV) and transdiscal (TD) splanchnic nerve neurolysis in patients with severe upper abdominal cancer pain refractory to medical therapy, using the Numerical Rating Scale (NRS) for pain assessment. Secondary aims include evaluating the impact of these techniques on quality of life using the EORTC QLQ-C30 questionnaire, comparing changes in opioid consumption, comparing procedure duration and fluoroscopy imaging time, and determining the incidence of adverse events.
A total of 56 patients, 28 in each group, will be enrolled. Pain intensity will be assessed using the NRS before the procedure and at 3 days, 1 month, and 3 months after the intervention. Quality of life will be evaluated using the EORTC QLQ-C30 questionnaire before the procedure and at 1 and 3 months post-intervention. Procedure-related adverse events will be recorded.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe abdominal pain (NRS > 6) due to upper intra-abdominal organ malignancies (such as gastric, pancreatic, or hepatic cancer).
- •Failure of pain control with conservative treatment modalities.
排除标准
- •Presence of local anatomical variations
- •Localized or systemic infection involving the procedural site
- •Pregnancy
- •Coagulopathy
- •Presence of unstable psychiatric disorders
研究组 & 干预措施
transdiscal splanchnic neurolysis group
Transdiscal splanchnic neurolysis for upper gastrointestinal malignancy pain
干预措施: transdiscal splanchnic neurolysis (Procedure)
paravertebral splanchnic neurolysis group
Paravertebral splanchnic neurolysis for upper gastrointestinal malignancy pain
干预措施: paravertebral splanchnic neurolysis (Procedure)
结局指标
主要结局
Numerical rating scale (NRS)
时间窗: Change from baseline to post-treatment day 3, and at 1 and 3 months.
NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
次要结局
- EORTC QLQ-C30 questionnaire(Change from baseline to 1st and 3rd month after treatment)
- Fluoroscopy imaging time(During procedure)
研究者
Gökhan Yıldız
Supervisor Investigator
Ankara Etlik City Hospital
