Clinical Outcomes and Safety of Fluoroscopy-Guided Transdiscal Splanchnic Nerve Neurolysis in Patients With Upper Abdominal Cancer Pain: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in pain intensity
研究概览
简要总结
The goal of this prospective study is to learn whether fluoroscopy-guided transdiscal splanchnic nerve neurolysis can safely reduce severe upper abdominal cancer pain in adults with pancreatic, gastric, or hepatobiliary cancer. The study will also assess whether this procedure can reduce the need for opioid pain medicines and improve patients' functional status and quality of life.
The main questions it aims to answer are:
Does the procedure reduce patients' pain one month after treatment?
Does it reduce the amount of opioid pain medication patients need?
Does it improve functional status and quality of life?
What complications or side effects occur after the procedure?
How long does pain relief last, and how often is repeat treatment needed?
Participants will:
First receive a diagnostic splanchnic nerve block with local anesthetic.
If the diagnostic block provides at least 50% pain relief, undergo transdiscal splanchnic nerve neurolysis using fluoroscopy guidance.
Receive a neurolytic agent (absolute alcohol or phenol) through a needle placed at the T11-T12 or T12-L1 level.
Have their pain, opioid medication use, functional status, complications, and satisfaction assessed before treatment and during follow-up.
Complete follow-up assessments at 1 week, 1 month, 3 months, and 6 months after the procedure.
Complete a quality-of-life questionnaire before treatment and at 1 month.
The primary outcome will be the change in pain score on the 0-10 Numeric Rating Scale at 1 month after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥ 18 years. Confirmed diagnosis of pancreatic, gastric, or hepatobiliary malignancy with epigastric/upper abdominal pain.
- •Baseline NRS ≥ 7 despite optimized pharmacotherapy, or intolerable opioid side effects.
- •≥ 50% pain relief on diagnostic splanchnic nerve block. Able to provide informed consent.
排除标准
- •Coagulopathy (INR > 1.5, platelets < 50,000/µL). Local or systemic infection. Uncontrolled hypotension or severe cardiopulmonary compromise precluding prone positioning.
- •Intestinal obstruction. Known allergy to contrast, local anesthetic, or the neurolytic agent. Patient refusal.
研究组 & 干预措施
Chemical Neurolysis
Participant will undergo chemical neurolysis using the study specified neurolytic agent for management of chronic pain. the intervention will be administered according to study protocol, with participant followed prospectively for pain relief and treatment related outcomes
干预措施: Chemical Neurolysis (Procedure)
结局指标
主要结局
Change in pain intensity
时间窗: Baseline to 1 month after the procedure
Pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS), where 0 represents no pain and 10 represents the worst imaginable pain. The change in NRS pain score from baseline will be assessed following fluoroscopy-guided transdiscal splanchnic nerve neurolysis.
次要结局
- Change in quality of life(Baseline, 1 month, 3 months, and 6 months)
- Technical success of neurolysis(During the procedure)
- Opioid consumption(Baseline, 1 week, 1 month,)
研究者
Muhammad Shahid
Muhammad Shahid
Sahiwal medical college sahiwal