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NCT Number: NCT07653906

Coeliac Plexus vs Splanchnic Nerve Neurolysis for Upper Abdominal Cancer Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bangladesh Medical University

Dhaka, 1000, Bangladesh

Location status: Recruiting

Location contact

AKM Akhtaruzzaman, MD

CONTACT

[email protected]

Kazi Mahzabin Arin, MD

CONTACT

[email protected]

+8801754057689

Kazi Mahzabin Arin, MD

SUB_INVESTIGATOR

Md Mostafa Kamal, MD

SUB_INVESTIGATOR

Nadia Sultana, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurolytic Coeliac Plexus Block (NCPB)

Procedure

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

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.

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Opioid Consumption

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

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

  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)

    Time frame: 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.

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

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

    This evaluates the safety profile of NSNB compared to NCPB

Sponsors and collaborators

Lead sponsor

Bangladesh Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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