Coeliac Plexus vs Splanchnic Nerve Neurolysis for Upper Abdominal Cancer Pain
Effect of Coeliac Plexus Versus Splanchnic Nerve Neurolysis in Pain Management With Upper Abdominal Malignancies
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Dhaka, Bangladéš, 1000
- Nábor
- Bangladesh Medical University
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Kontakt:
- Kazi Mahzabin Arin, MD
- Telefonní číslo: +8801754057689
- E-mail: kazimahzabinarin@bsmmu.edu.bd
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Kontakt:
- AKM Akhtaruzzaman, MD
- E-mail: akhtaruzzaman.akm@bmu.ac.bd
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Vrchní vyšetřovatel:
- Nadia Sultana, MD
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Dílčí vyšetřovatel:
- Kazi Mahzabin Arin, MD
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Dílčí vyšetřovatel:
- Md Mostafa Kamal, MD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Zásahová skupina
|
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 mL of 70% alcohol, preceded by 2-3 mL of 0.25% bupivacaine.
A 1 mL saline flush is given during needle withdrawal to prevent track formation.
Patients are monitored immediately and for 2 hours post-procedure for complications including hypotension, diarrhea, back pain, shoulder pain, pneumothorax, or neurological changes.
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Aktivní komparátor: Kontrolní skupina
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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 monitored immediately and for 2 hours post-procedure for adverse effects including hypotension, diarrhea, back pain, shoulder pain, or neurological changes.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Pain intensity reduction as measured by the Visual Analog Scale (VAS)
Časové okno: Baseline, Immediately after the intervention, at 7 days, 1 month, and 3 months post-procedure
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This measure evaluates the effectiveness of Neurolytic Splanchnic Nerve Block (NSNB) compared to Neurolytic Coeliac Plexus Block (NCPB) in reducing pain in patients with upper abdominal malignancies.
Zero indicates no pain, and 10 indicates the worst possible pain.
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Baseline, Immediately after the intervention, at 7 days, 1 month, and 3 months post-procedure
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Opioid Consumption
Časové okno: Baseline, Day 7, 1 month, and 3 months post-procedure.
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This measures whether the intervention reduces the need for systemic opioids.
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Baseline, Day 7, 1 month, and 3 months post-procedure.
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Quality of Life using scores from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
Časové okno: Baseline, 1 month and 3 months post-procedure.
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This assesses functional, symptom, and global health aspects of patient well-being following nerve block interventions.
Scores range from 0 to 100.
Higher scores indicate better global health and functioning, while higher symptom scores indicate worse symptoms.
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Baseline, 1 month and 3 months post-procedure.
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Incidence of immediate or delayed complications, including hypotension, diarrhea, back pain, shoulder pain, pneumothorax, or neurological changes.
Časové okno: Immediately post-procedure and during follow-up visits up to 3 months.
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This evaluates the safety profile of NSNB compared to NCPB
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Immediately post-procedure and during follow-up visits up to 3 months.
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Shwita AH, Amr YM, Okab MI. Comparative Study of the Effects of the Retrocrural Celiac Plexus Block Versus Splanchnic Nerve Block, C-arm Guided, for Upper Gastrointestinal Tract Tumors on Pain Relief and the Quality of Life at a Six-month Follow Up. Korean J Pain. 2015 Jan;28(1):22-31. doi: 10.3344/kjp.2015.28.1.22. Epub 2015 Jan 2.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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