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Coeliac Plexus vs Splanchnic Nerve Neurolysis for Upper Abdominal Cancer Pain

12. juni 2026 opdateret af: Kazi Mahzabin Arin, Bangladesh Medical University

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

44

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Bangladesh
      • Dhaka, Bangladesh, 1000
        • Rekruttering
        • Bangladesh Medical University
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Nadia Sultana, MD
        • Underforsker:
          • Kazi Mahzabin Arin, MD
        • Underforsker:
          • Md Mostafa Kamal, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Interventionsgruppe
Procedure: Neurolytic Splanchnic Nerve Block (NSNB)
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.
Aktiv komparator: Kontrolgruppe
Procedure: Neurolytic Coeliac Plexus Block (NCPB)
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain intensity reduction as measured by the Visual Analog Scale (VAS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Opioid Consumption
Tidsramme: 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)
Tidsramme: 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.
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bangladesh Medical University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2026

Primær færdiggørelse (Anslået)

30. oktober 2026

Studieafslutning (Anslået)

31. januar 2027

Datoer for studieregistrering

Først indsendt

12. juni 2026

Først indsendt, der opfyldte QC-kriterier

12. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BMU/2026/1940

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