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临床试验/CTRI/2024/11/077512
CTRI/2024/11/077512招募中不适用

Enhancing Splanchnic Neurolysis With Dexmedetomidine: A Double-Blind Randomized Controlled Trial

All India Institute of Medical Sciences2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年12月9日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
96
试验地点
2
主要终点
Peri-procedural pain score measured in VAS scale

研究概览

简要总结

Enhancing Splanchnic Neurolysis with Dexmedetomidine: A Double-Blind Randomized Controlled Trial

IntroductionUpper gastrointestinal (GI) malignancies, including cancers of the oesophagus, stomach, pancreas, liver, and gallbladder, present a substantial burden globally [1], with a particularly higher prevalence in Asia. Chronic abdominal pain is a distressing symptom for individuals with upper GI cancer, significantly affecting their quality of life and potentially contributing to disease progression [5,6]. While pharmacotherapy, mainly opioids, is commonly employed for pain management, it has inherent limitations and potential side effects [10].

Interventional therapies such as sympathetic neurolytic blocks targeting the celiac plexus or the splanchnic plexus of nerves have shown effectiveness in alleviating pain associated with upper GI cancers [18-23]. These procedures involve the injection of local anaesthetic drugs or neurolytic agents to block pain signals. Studies have suggested comparable efficacy between celiac plexus neurolysis and splanchnic neurolysis.

Common neurolytic agents such as alcohol and phenol are used for chemical neurolysis but can induce severe pain during injection, and in the initial period after injection due to degradation of the underlying tissue and nerves. This periprocedural and immediate post-procedural burning pain may last up to 24 hours till the drug gives its full effect [52]. This burning pain may be very distressing for the patient. Generally, a local anaesthetic injection is given before the injection of a neurolytic agent to minimize this burning pain. Dexmedetomidine, an alpha-adrenergic agent, has emerged as a promising adjunct for pain management in neurolysis procedures, showing improvement in pain outcomes and reduced opioid consumption without significant side effects. Additionally, Dexmedetomidine may help alleviate the burning pain associated with alcohol injections.

A recent study [47] suggested that adding Dexmedetomidine to the chemical splanchnic neurolysis process reduced the burning pain due to tissue degradation and thus led to reduced morphine consumption. Nonetheless, this study had limitations, including a small sample size, variable drug dilutions of Lignocaine and Dexmedetomidine injected before alcohol injection and a brief follow-up period, highlighting the need for further investigation.

By elucidating the comparative effectiveness and safety profiles of Dexmedetomidine and Lignocaine as adjuncts to alcohol during chemical neurolysis, we aim to offer clinicians evidence-based insights into selecting the optimal approach for pain relief in alcohol neurolysis procedures. Improved pain control not only positively impacts patient satisfaction and quality of life but also enhances procedural outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Adult patients aged 18 years and above.
  • Diagnosis of upper gastrointestinal malignancy with abdominal pain (gastric, pancreatic, liver, or gallbladder cancers).
  • Ability to provide informed consent to participate in the study.
  • Eastern Cooperative Oncology Group (ECOG) physical status classification I-III.

排除标准

  • Patients with contraindications to splanchnic neurolysis.
  • Known allergy or hypersensitivity to Lignocaine, Dexmedetomidine, or any other study medications.
  • History of severe cardiac disease, including significant arrhythmias, heart block, or severe heart failure.
  • Coagulopathy or bleeding disorders.
  • Inability to provide informed consent or comply with study procedures.

结局指标

主要结局

Peri-procedural pain score measured in VAS scale

时间窗: During alcohol injection and 5 minutes post-injection

次要结局

  • To compare the post-procedural VAS scores(1hr, 2hrs, 6hrs, 12hrs, 24hrs)
  • To compare the opioid consumption in the first 24 hours post-procedure among different groups.(24 hours)
  • To evaluate and compare the incidence of complications (during the procedure and first 24 hours post-procedure) such as hypotension, bradycardia, and burning pain from alcohol injection, across study groups.(24 hours)
  • To assess patient-reported satisfaction levels with pain control and overall procedural experience.(24 hours)
  • To compare pain scores and analgesic consumption at follow-up(1 week, 2 weeks, 1 month, 2 months)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Allwin J

All India Institute of Medical Sciences, New Delhi

研究点 (2)

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