Coeliac Plexus vs Splanchnic Nerve Neurolysis for Upper Abdominal Cancer Pain

Официальное название

Effect of Coeliac Plexus Versus Splanchnic Nerve Neurolysis in Pain Management With Upper Abdominal Malignancies

Обзор

The goal of this clinical trial is to determine whether Neurolytic Splanchnic Nerve Block (NSNB) reduces pain in adults with upper abdominal malignancies. It will also evaluate the safety of Neurolytic Splanchnic Nerve Block (NSNB). The main questions it aims to answer are: Does NSNB reduce pain intensity compared to Neurolytic Coeliac Plexus Block (NCPB), as measured by the Visual Analog Scale (VAS)? What adverse effects do participants experience when receiving Neurolytic Splanchnic Nerve Block (NSNB)? Investigators will compare Neurolytic Splanchnic Nerve Block (NSNB) with Neurolytic Coeliac Plexus Block (NCPB) to determine which intervention provides more effective and safer pain relief. Participants will: * receive either NSNB or NCPB under fluoroscopic guidance * be monitored immediately and for 2 hours after the procedure for any complications Have their pain intensity recorded immediately after the procedure, and at 7 days, 1 month, and 3 months * be evaluated for quality-of-life using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 3 (EORTC QLQ-C30) at 1 month and 3 months. * have their opioid consumption tracked throughout the study.

Подробное описание

This study is a quasi-experimental, interventional trial conducted at the Division of Pain Medicine \& Regional Anaesthesia, Department of Anaesthesia, Analgesia and Intensive Care Medicine, Bangladesh Medical University, Dhaka. Adult patients diagnosed with upper abdominal malignancies (including pancreatic, gastric, hepatic, or biliary origin) who report moderate to severe pain (VAS ≥5) and have no contraindications for nerve blocks will be enrolled.

Eligible participants will be allocated in a 1:1 ratio into two groups. The control group will receive a fluoroscopy-guided Neurolytic Coeliac Plexus Block (NCPB). The procedure involves patient positioning in the prone posture with abdominal flexion, identification of anatomical landmark L1 under posteroanterior and oblique C-arm fluoroscopy, skin infiltration with local anesthetic, and injection of 3 mL 0.25% bupivacaine, followed by 20 mL of 70% alcohol for neurolysis, with 1 mL saline flush during needle withdrawal to prevent tract formation. The study group will receive a fluoroscopy-guided Neurolytic Splanchnic Nerve Block (NSNB) using a similar approach, with needle placement at the T11-T12 level, 3 mL of local anesthetic, and 10 mL of 70% alcohol for neurolysis.

Baseline evaluations will include a complete blood count, a coagulation profile (prothrombin time, bleeding time, clotting time, INR), a Visual Analog Scale (VAS) pain score, and a quality-of-life assessment using the EORTC QLQ-C30. Participants will be monitored immediately and for 2 hours post-procedure for complications, including hypotension, diarrhea, back or shoulder pain, pneumothorax, or neurological changes.

Follow-up assessments will occur immediately post-procedure, at 7 days, 1 month, and 3 months. Pain intensity, opioid consumption, and quality-of-life scores will be recorded.

This study aims to provide comparative data on analgesic efficacy, opioid-sparing effects, safety, and quality-of-life outcomes between NCPB and NSNB in patients with upper abdominal malignancies.

Вмешательства

• Процедура Neurolytic Coeliac Plexus Block (NCPB)
  Fluoroscopy-guided neurolytic coeliac plexus block performed on adult patients with upper abdominal malignancies. Patients are positioned prone with a pillow under the abdomen. Using posteroanterior and oblique C-arm fluoroscopy, the T12-L1 vertebral bodies are identified. After local anesthetic infiltration, 3 mL of 0.25% bupivacaine is injected, followed by 20 mL of 70% alcohol for neurolysis. A 1 mL saline flush is given during needle withdrawal to prevent track formation. Patients are monito
• Процедура Neurolytic Splanchnic Nerve Block (NSNB)
  Fluoroscopy-guided neurolytic splanchnic nerve block performed in adults with upper abdominal malignancies. Patients are positioned prone with proper support. Using posteroanterior and lateral C-arm fluoroscopy, T11-T12 vertebral bodies and the junction of the rib and vertebral body are identified. After local anesthetic infiltration, a Chiba needle is advanced to the anterior one-third of the lateral vertebral body. Contrast dye is injected to confirm placement. Neurolysis is performed using 10

Первичные конечные точки

• Pain intensity reduction as measured by the Visual Analog Scale (VAS) [Срок оценки: Baseline, Immediately after the intervention, at 7 days, 1 month, and 3 months post-procedure]

Вторичные конечные точки (3)

• Opioid Consumption [Срок оценки: Baseline, Day 7, 1 month, and 3 months post-procedure.]
• Quality of Life using scores from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) [Срок оценки: Baseline, 1 month and 3 months post-procedure.]
• Incidence of immediate or delayed complications, including hypotension, diarrhea, back pain, shoulder pain, pneumothorax, or neurological changes. [Срок оценки: Immediately post-procedure and during follow-up visits up to 3 months.]

Критерии участия

Критерии включения

• Adult patient
• Both genders
• Diagnosed case of upper abdominal malignancy (pancreatic, gastric, hepatic, or biliary origin)
• Experiencing moderate to severe pain (≥5 on a 10 point visual analog scale)
• Patients who are conscious and can communicate
• No Contraindication for nerve block (e.g., coagulopathy, anticoagulant drugs)

Критерии исключения

• Previous coeliac plexus block, splanchnic nerve block, or major abdominal nerve ablation
• Severe spinal deformities or anatomical distortion at the coeliac plexus or splanchnic nerve site
• Local or systemic infection at or near the block site
• Known allergy to local anesthetics or neurolytic agents
• Pregnancy
• Lactating mother
• Cognitive impairment or psychiatric illness

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Bangladesh · 1 центр

• Bangladesh Medical University — Dhaka

Публикации

• Yan BM, Myers RP. Neurolytic celiac plexus block for pain control in unresectable pancreatic cancer. Am J Gastroenterol. 2007 Feb;102(2):430-8. doi: 10.1111/j.1572-0241.2006.00967.x. Epub 2006 Nov 13. PMID 17100960
• Wiechowska-Kozlowska A, Boer K, Wojcicki M, Milkiewicz P. The efficacy and safety of endoscopic ultrasound-guided celiac plexus neurolysis for treatment of pain in patients with pancreatic cancer. Gastroenterol Res Pract. 2012;2012:503098. doi: 10.1155/2012/503098. Epub 2012 Feb 7. PMID 22474439
• Warner NS, Moeschler SM, Warner MA, Hoelzer BC, Eldrige JS, Bendel MA, Mauck WD, Watson JC, Gazelka HM, Lamer TJ, Kor DJ, Hooten WM. Bleeding Complications in Patients Undergoing Celiac Plexus Block. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):488-93. doi: 10.1097/AAP.0000000000000409. PMID 27203395
• van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol. 2007 Sep;18(9):1437-49. doi: 10.1093/annonc/mdm056. Epub 2007 Mar 12. PMID 17355955
• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7. PMID 26742998
• Marret E, Kurdi O, Zufferey P, Bonnet F. Effects of nonsteroidal antiinflammatory drugs on patient-controlled analgesia morphine side effects: meta-analysis of randomized controlled trials. Anesthesiology. 2005 Jun;102(6):1249-60. doi: 10.1097/00000542-200506000-00027. PMID 15915040
• Lu F, Li X, Song L, Ye L, Wang X, Wang R. Efficacy and Safety of Celiac Plexus Neurolysis Versus Splanchnic Nerve Neurolysis in the Management of Abdominal Cancer Pain: A Meta-analysis of 359 Patients. Pain Physician. 2024 Jan;27(1):1-10. PMID 38285023
• Davies DD. Incidence of major complications of neurolytic coeliac plexus block. J R Soc Med. 1993 May;86(5):264-6. doi: 10.1177/014107689308600507. PMID 8505748

Идентификаторы

NCT: NCT07653906 · BMU/2026/1940

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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