Clinical trial
Permanent Celiac Plexus Block: Comparison of Pain Score in Unilateral and Bilateral Posterior Percutaneous Approach
Name
ERC-2019/A187
Description
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. Whether unilateral or bilateral NCPB technique has a better pain relief
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.
Pain scores and adverse events at multiple time points post-procedure were recorded.
Trial arms
Trial start
2020-02-25
Estimated PCD
2022-07-15
Trial end
2023-03-15
Status
Completed
Phase
Early phase I
Treatment
Unilateral Neurolytic Celiac Plexus Block with Absolute Alcohol
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.
Arms:
Unilateral Approach Group
Bilateral Neurolytic Celiac Plexus Block with Absolute Alcohol
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.
Arms:
Bilateral Approach Group
Size
30
Primary endpoint
Pain Score using the Visual Analog Scale
6 months post-procedure
Eligibility criteria
Inclusion Criteria:
* All upper abdominal malignancy adult patients
* on palliative care,
* having a visual analog scale (VAS) of more than 7
Exclusion Criteria:
* 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Unilateral Approach Group: Patients in this group have received a unilateral percutaneous posterior approach for NCPB. The procedure was performed under fluoroscopic guidance.\n\nBilateral Approach Group: Patients in this group have undergone a bilateral percutaneous posterior approach for NCPB, following the same procedural guidance.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2024-03-19
1 organization
2 products
3 indications
Organization
Sindh Institute of Urology and TransplantationIndication
Abdominal CancerIndication
Cancer PainIndication
Pancreatic Cancer