2020-02-25
2022-07-15
2023-03-15
30
NCT06316908
Sindh Institute of Urology and Transplantation
Sindh Institute of Urology and Transplantation
INTERVENTIONAL
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2024-01-21 | N/A | 2024-03-16 |
2024-03-16 | N/A | 2024-03-19 |
2024-03-19 | N/A | 2024-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
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
|
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
|
Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available