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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Dhaka、バングラデシュ、1000
- 募集
- Bangladesh Medical University
-
コンタクト：
- Kazi Mahzabin Arin, MD
- 電話番号：+8801754057689
- メール：kazimahzabinarin@bsmmu.edu.bd
-
コンタクト：
- AKM Akhtaruzzaman, MD
- メール：akhtaruzzaman.akm@bmu.ac.bd
-
主任研究者：
- Nadia Sultana, MD
-
副調査官：
- Kazi Mahzabin Arin, MD
-
副調査官：
- Md Mostafa Kamal, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：介入グループ
|
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.
|
|
アクティブコンパレータ：対照群
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain intensity reduction as measured by the Visual Analog Scale (VAS)
時間枠：Baseline, Immediately after the intervention, at 7 days, 1 month, and 3 months post-procedure
|
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.
|
Baseline, Immediately after the intervention, at 7 days, 1 month, and 3 months post-procedure
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Opioid Consumption
時間枠：Baseline, Day 7, 1 month, and 3 months post-procedure.
|
This measures whether the intervention reduces the need for systemic opioids.
|
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)
時間枠：Baseline, 1 month and 3 months post-procedure.
|
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.
|
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.
時間枠：Immediately post-procedure and during follow-up visits up to 3 months.
|
This evaluates the safety profile of NSNB compared to NCPB
|
Immediately post-procedure and during follow-up visits up to 3 months.
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- BMU/2026/1940
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。