Coeliac Plexus vs Splanchnic Nerve Neurolysis for Upper Abdominal Cancer Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBangladesh Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Neurolytic Coeliac Plexus Block (NCPB)
Procedure/SurgeryFluoroscopy-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/SurgeryFluoroscopy-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.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Control groupActive comparator 1 intervention
Group B: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Baseline, Immediately after the intervention, at 7 days, 1 month, and 3 months post-procedureSecondary outcomes
1
Opioid Consumption
This measures whether the intervention reduces the need for systemic opioids.
Time frame
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.
Time frame
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
Time frame
Immediately post-procedure and during follow-up visits up to 3 months.Sponsors and contacts
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Source ClinicalTrials.gov