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临床试验/CTRI/2024/11/077073
CTRI/2024/11/077073尚未招募2/3 期

Analgesic efficacy of celiac plexus neurolysis in patients undergoing percutaneous biliary intervention with upper abdominal malignancies

Pt. J.N.M. Medical College Raipur C.G.1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
25
试验地点
1
主要终点
Reduction in pain intensity in terms of NRS score

研究概览

简要总结

Malignant biliary obstruction is an enfeebling condition that can causes pain, jaundice, pruritus, anorexia, metabolic encephalopathy and later can cause mortality. For its definitive management biliary decompression is performed via endoscopic, percutaneous, and surgical approaches. Minimally invasive (Percutaneous) techniques are now choice of care, preferable to conventional surgical bypass because of lower intraprocedural morbidity and lower overall hospital stay.

Percutaneous biliary drains are often painful due to measures during PTBD provoke intense pain sensations of very short duration such as mechanical stretching of biliary tree, peritoneal transgressions or balloon dilatation procedures and caustic nature of bile which may inflame the skin near the insertion site, Therefore, another measures to be taken care about is the optimal pain management of the patients undergoing percutaneous biliary intervention.

 Another point of concern is the development of tolerance to opioid analgesics which is a major barrier to clinical opioid therapy. Opioid tolerance is a pharmacological phenomenon caused by repeated opioid exposure leads to receptor resistance that causes decreased analgesic effects. hence the effective means to ease the intractable visceral pain associated with abdominal malignancy is to interrupt the nociceptive impulses at the level of the celiac plexus or splanchnic nerves.

 So our aim of the study is to assess the Analgesic efficacy of celiac plexus neurolysis in patients undergoing percutaneous biliary intervention with upper abdominal malignancies.

Firstly the patient with upper GI malignancy with pain score equal to or more than 7 with biliary dilatation will be taken for study with no exclusion criteria should be met. After pre-operative assessment, proper written consent the patient will be divided into 2 groups, 1st group will receive Celiac plexus neurolysis for the management of pain followed by percutaneous biliary intervention while the 2nd group will be directed to percutaneous biliary intervention with support of intravenous analgesia inter-operatively.

 Our objective is to asses the peri-operative and post-operative (1 day) pain with the help of NRS (numerical response scale) in both groups.

Followed by comparison of mean NRS score in both groups using required software (SPSS) and calculate the test of significance.

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 85.00 Year(s)(—)
性别
All

入选标准

  • Adults with upper abdominal malignancy 2)Should have pain (score in NRS equals or more than 7 out of 10) 3) Should have biliary dilatation and clinical jaundice.

排除标准

  • Ascites, Hepatic encephalopathy, Patient denial, Active biliary infection.

结局指标

主要结局

Reduction in pain intensity in terms of NRS score

时间窗: Immediate and 1 day post op

次要结局

  • Complication rate(Day 0)

研究者

发起方
Pt. J.N.M. Medical College Raipur C.G.
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Vivek Patre

Pt. J.N.M. Medical college Raipur

研究点 (1)

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