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Upper Abdominal MalignanciesNCT07653906

Coeliac Plexus vs Splanchnic Nerve Neurolysis for Upper Abdominal Cancer Pain

A study testing Neurolytic Coeliac Plexus Block (NCPB) and Neurolytic Splanchnic Nerve Block (NSNB) in people with Upper Abdominal Malignancies, run by Bangladesh Medical University at 1 site in Bangladesh.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Upper Abdominal Malignancies
What is being tested?
Neurolytic Coeliac Plexus Block (NCPB) and Neurolytic Splanchnic Nerve Block (NSNB)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteBangladesh
Study dates
1 May 2026to 31 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bangladesh1 site, 1 recruiting
  • Bangladesh Medical University

    Dhaka, 1000

    Kazi Mahzabin Arin, MD, +8801754057689, kazimahzabinarin@bsmmu.edu.bd

    AKM Akhtaruzzaman, MD, akhtaruzzaman.akm@bmu.ac.bd

    Recruiting

Other trials in Bangladesh

About this study

Official title: 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)?

Read more

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.
Read the detailed description

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.

Being tested
Neurolytic Coeliac Plexus Block (NCPB), Neurolytic Splanchnic Nerve Block (NSNB)
Keywords
Upper abdominal cancer, Splanchnic nerve block, Coeliac plexus block, Analgesic efficacy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neurolytic Coeliac Plexus Block (NCPB)Procedure or surgery

    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.

  • Neurolytic Splanchnic Nerve Block (NSNB)Procedure or surgery

    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.

Study groups in NCT07653906
Study groupRoleWhat they receive
Control groupActive comparatorNot described
Receives: Procedure: Neurolytic Coeliac Plexus Block (NCPB)
Intervention GroupExperimentalNot described
Receives: Procedure: Neurolytic Splanchnic Nerve Block (NSNB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain intensity reduction as measured by the Visual Analog Scale (VAS)

    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.

    Measured: Baseline, Immediately after the intervention, at 7 days, 1 month, and 3 months post-procedure

Secondary outcomes (3)
  1. Opioid Consumption

    This measures whether the intervention reduces the need for systemic opioids.

    Measured: Baseline, Day 7, 1 month, and 3 months post-procedure.

  2. Quality of Life using scores from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)

    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.

    Measured: Baseline, 1 month and 3 months post-procedure.

  3. Incidence of immediate or delayed complications, including hypotension, diarrhea, back pain, shoulder pain, pneumothorax, or neurological changes.

    This evaluates the safety profile of NSNB compared to NCPB

    Measured: Immediately post-procedure and during follow-up visits up to 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start1 May 2026
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07653906
Sponsor's protocol ID
BMU/2026/1940
Status last verified
Sep 2026
First submitted
12 Jun 2026
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 8505748
  • 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.

    PubMed 25589943

Questions about this trial

What is this clinical trial studying?

A study testing Neurolytic Coeliac Plexus Block (NCPB) and Neurolytic Splanchnic Nerve Block (NSNB) in people with Upper Abdominal Malignancies, run by Bangladesh Medical University at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity reduction as measured by the Visual Analog Scale (VAS) (time frame: Baseline, Immediately after the intervention, at 7 days, 1 month, and 3 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07653906, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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