Permanent Celiac Plexus Block: Comparison of Pain Score in Unilateral and Bilateral Posterior Percutaneous Approach

NCT06316908 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: ERC-2019/A187
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective, interventional, non-randomized study was to compare pain score in unilateral and bilateral posterior percutaneous neurolytic celiac plexus block (NCPB) in upper abdominal cancer patients. The main questions it aimed to answer are:

1. 1.Whether unilateral or bilateral NCPB technique has a better pain relief
2. 2.Was there any difference in terms of complication rates between these two approaches All participants were having upper abdominal cancer whether operated or non-operable cancer were given a unilateral or bilateral neurolytic celiac plexus block.

Conditions

Abdominal Cancer; Cancer Pain; Cancer of Pancreas

Outcome Measures

Primary Outcomes (1)

• Pain Score using the Visual Analog Scale

  The visual analog scale consists of a 10 cm long horizontal line, with a minimum value of 0 (no pain) and a maximum value of 10 (worst pain imaginable). Higher scores indicate a worse outcome.

  6 months post-procedure

Secondary Outcomes (3)

• Change in Mean Arterial Pressure

  4 hours post-procedure

• Incidence of Patient-Reported Nausea Feeling

  24 hours post-procedure

• Incidence of Vomiting

  24 hours post-procedure

Study Arms (2)

Unilateral Approach Group

ACTIVE COMPARATOR

Patients in this group have received a unilateral percutaneous posterior approach for NCPB. The procedure was performed under fluoroscopic guidance

Drug: Unilateral Neurolytic Celiac Plexus Block with Absolute Alcohol

Bilateral Approach Group

ACTIVE COMPARATOR

Patients in this group have undergone a bilateral percutaneous posterior approach for NCPB, following the same procedural guidance.

Drug: Bilateral Neurolytic Celiac Plexus Block with Absolute Alcohol

Interventions

Unilateral Neurolytic Celiac Plexus Block with Absolute Alcohol DRUG

Participants assigned to the unilateral neurolytic celiac plexus block group underwent a minimally invasive procedure where a solution of absolute alcohol was injected unilaterally into the celiac plexus under image guidance. The procedure was performed by an experienced interventional pain specialist. Prior to the injection, local anesthesia was administered to minimize discomfort. Once positioned correctly, a needle was inserted into the designated area, and a small amount of absolute alcohol was injected to disrupt the neural pathways responsible for transmitting pain signals from the abdominal region. The intervention aims to provide long-term pain relief for participants suffering from chronic abdominal pain.

Unilateral Approach Group

Bilateral Neurolytic Celiac Plexus Block with Absolute Alcohol DRUG

Participants allocated to the bilateral neurolytic celiac plexus block group underwent a similar minimally invasive procedure as described above, with the exception that the injection of absolute alcohol was administered bilaterally into the celiac plexus. The procedure was performed by an experienced interventional pain specialist under image guidance, with local anesthesia administered prior to the injection to ensure patient comfort. Following correct needle placement, absolute alcohol was injected into both sides of the celiac plexus to disrupt neural pathways responsible for transmitting pain signals from the abdominal region. The intervention aims to provide comparable or potentially enhanced long-term pain relief compared to the unilateral approach, with the additional benefit of targeting both sides of the celiac plexus.

Bilateral Approach Group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All upper abdominal malignancy adult patients
• on palliative care,
• having a visual analog scale (VAS) of more than 7

You may not qualify if:

• Patients on anti-coagulant medications,
• having an INR \> 1.50 and or
• Platelets count \< 80000,
• inability to provide informed consent, or
• those who have previously undergone celiac plexus intervention.

Sponsors & Collaborators

• Sindh Institute of Urology and Transplantation: lead

Study Sites (1)

Sindh Institute of Urology and Transplantation

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Conditions

Cancer Pain; Pancreatic Neoplasms

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Muhammad Q Abbas, MCPS, FCPS

  Professor Dept of Anaesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anaesthesia

Model Details: Unilateral Approach Group: Patients in this group have received a unilateral percutaneous posterior approach for NCPB. The procedure was performed under fluoroscopic guidance. Bilateral Approach Group: Patients in this group have undergone a bilateral percutaneous posterior approach for NCPB, following the same procedural guidance.

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: March 19, 2024
• Study Start: February 25, 2020
• Primary Completion: July 15, 2022
• Study Completion: March 15, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)