Clinical trial NCT06316908: Permanent Celiac Plexus Block: Comparison of Pain Score in Unilateral and Bilateral Posterior Percutaneous Approach
Official title: Permanent Celiac Plexus Block: Comparison of Pain Score in Unilateral and Bilateral Posterior Percutaneous Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abdominal Cancer
Cancer Pain
Cancer of Pancreas
Lead sponsor: Sindh Institute of Urology and Transplantation
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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. 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.

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.

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.

Primary outcomes:
measure: Pain Score using the Visual Analog Scale
timeFrame: 6 months post-procedure
Secondary outcomes:
measure: Change in Mean Arterial Pressure
timeFrame: 4 hours post-procedure
measure: Incidence of Patient-Reported Nausea Feeling
timeFrame: 24 hours post-procedure
measure: Incidence of Vomiting
timeFrame: 24 hours post-procedure
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Sindh Institute of Urology and Transplantation
state: Sindh
Study officials:
affiliation: Professor Dept of Anaesthesia
name: Muhammad Q Abbas, MCPS, FCPS
role: PRINCIPAL_INVESTIGATOR
References: