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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Cancer; Cancer Pain; Cancer of Pancreas
• Intervention / Treatment: Drug: Unilateral Neurolytic Celiac Plexus Block with Absolute Alcohol; Drug: Bilateral Neurolytic Celiac Plexus Block with Absolute Alcohol

Detailed Description

After Institutional Research Committee clearance and Ethical Review Committee approval from the Sindh Institute of Urology & Transplantation, the patients were divided into two groups, 15 patients in each group. Forty milliliters of the study drug were prepared in a 50 milliliters (mL) syringe by a pharmacy person. Patients were nil per oral (NPO) for six hours and after a written informed consent, patients were brought in the operating room. A 20-gauge (G) intravenous (I/V) cannula was passed and started injection ringer lactate at 10 mL/kg body weight, for all patients except diabetic mellitus who received normal saline. Monitors were applied as per American Society of Anesthesiologist (ASA) standards i.e., electrocardiogram (ECG), oxygen saturation (SpO2), and non-invasive blood pressure (NIBP), and vitals were recorded at intervals of 5 minutes (min). Patients were then positioned prone on the operation table and their arms were rested on the arm board. Pillows were placed under the abdomen between the ribs and iliac crest.

First, a mark was made between the 12 Thoracic (T12) and 1st Lumbar (L1) vertebra under the Fluoroscopic C arm view. Then a line was drawn between the points at 5 and 7 cm lateral from the spinous process of the L3 vertebra. Injection 2% plain xylocaine 3-5 milliliters (mL) was locally infiltrated and a 20-centimeter (cm) 22gauge (G) Chiba needle was inserted at an angle of 45 degrees with the skin and directed medially and in cephalic direction. After making contact with the body of the L1 vertebra needle was withdrawn and reinserted with an increased angle between the needle shaft and the skin until the tip of the needle slipped off the body of the L1 vertebra. Then the needle was advanced 1-1.5 cm in front of the T12 & L1 vertebrae. The position of the needle was confirmed in the anterior and lateral views of the vertebra with the help of radiopaque dye under a fluoroscopic C arm view. After the proper confirmation of the tip of the needle, 40 mL of absolute alcohol was injected into the unilateral block. Whereas, in the bilateral technique 20 mL absolute alcohol on both sides were injected. During and after the drug administration the pattern of the drug distribution was observed very carefully anterior to the body of the L1 vertebra and psoas fascia, and any visceral and I/V drug administration was avoided. After alcohol administration, 0.25 % Bupivacaine 5 mL was given, and then withdrawn the needle. The patient remained in the prone position for 20 mins. After the patients were turned supine and shifted to the post-anesthesia care unit (PACU) for monitoring of vitals for 30 mins after which they shifted to the ward. Pain score was recorded immediately and then at 30 mins in PACU, then at 6, 12, and 24 hours. Patients were discharged after 24 hours or when stable, pain score was recorded on telephonic conversation/ outpatient clinic visits at 7 days, 1 month, 3 months, and 6 months after the procedure or till death if the patient expired before 6 months.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Sindh Institute of Urology and Transplantation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Unilateral Approach Group; 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; 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.
Active Comparator: Bilateral Approach Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Arterial Pressure	Change in mean arterial pressure from baseline (pre-procedure) to 4 hours post-procedure. Mean arterial pressure was measured by a non-invasive automated blood pressure reader.	4 hours post-procedure
Incidence of Patient-Reported Nausea Feeling	Nausea was defined as patient reported feeling of urge to vomit. The incidence will be reported as the percentage of patients who report experiencing nausea at least once during the follow-up period.	24 hours post-procedure
Incidence of Vomiting	The occurrence and frequency of vomiting was documented through patient self-reporting or clinical observation.	24 hours post-procedure

Collaborators and Investigators

• Sponsor: Sindh Institute of Urology and Transplantation
• Investigators: Principal Investigator: Muhammad Q Abbas, MCPS, FCPS, Professor Dept of Anaesthesia

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2020
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: January 21, 2024
• First Submitted That Met QC Criteria: March 16, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Cancer Pain; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: ERC-2019/A187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes