Upper Abdominal Malignancies, Upper Gastrointestinal Cancer
Conditions
Keywords
Upper Gastrointestinal Malignancies, Celiac Plexus Neurolysis, Pharmacotherapy, Palliative Care, Visual Analogue Scale, Pain Management
Brief summary
After enrolment, patients were randomly assigned to two groups by means of a lottery procedure, whereby each patient blindly chose one of two labelled slips, resulting in group assignment to receive. Group A patients were subjected to CT-guided celiac plexus neurolysis, and Group B patients to standard pharmacotherapy for managing the pain over a period of four weeks. CT-guided celiac plexus neurolysis under the supervision of the principal investigator, using local anaesthetic and absolute ethanol injection for neurolysis, was carried out using aseptic technique. Baseline demographic information, which included age, gender, nature of malignancy, and the duration of disease, was recorded using a predesigned proforma. Pain severity was measured by the Visual Analogue Scale (VAS), a recognised 0-10 scale where 0 = no pain to 10 indicating the worst imaginable pain, at baseline and after 4 weeks of treatment. The major outcome measure was the average pain score at four weeks in both groups.
Interventions
PROCEDURECT-guided celiac plexus neurolysis
Under intermittent CT guidance, one or two 20-22-gauge Chiba needles are advanced via a posterior paravertebral approach to the anterolateral aspect of the aorta at the level of the celiac axis. Correct needle placement is confirmed by CT imaging and the injection of a small amount of nonionic contrast material to ensure appropriate spread and exclude intravascular or intrathecal positioning. Following negative aspiration for blood or cerebrospinal fluid, a test dose of local anesthetic (commonly 5-10 mL of 1% lidocaine) is administered to minimize procedural pain and assess for adverse effects. Subsequently, a neurolytic agent, typically 15-25 mL of 95-100% absolute alcohol or 6-10% phenol on each side depending on the technique used, is slowly injected under CT guidance to achieve circumferential spread around the celiac plexus. A final CT scan is obtained to document the distribution of the neurolytic solution and exclude immediate complications.
PROCEDUREStandard pharmacotherapy
Patients will be provided with the standard oral and intravenous analgesics such as fentanyl and oxycodone.
Sponsors
Mayo Hospital Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Biopsy proven upper GI malignancy with severe abdominal pain * Patients aged 18 to 65 years of either gender
Exclusion criteria
* Pregnant and lactating females * Anemia (hemoglobin \<10 g/dL) * Massive ascites * Chronic renal failure * Patients with known allergy or intolerance to drugs used during celiac plexus neurolysis (CT guided technique).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average pain score at baseline and after 4 weeks of treatment | Baseline to 4 weeks | Pain severity was measured by the Visual Analogue Scale (VAS), a recognized 0-10 scale where zero is equivalent to no pain and 10 indicates the worst imaginable pain, at baseline and after 4 weeks of treatment. |
Countries
Pakistan
Outcome results
None listed