Neurolytic Block Techniques In Abdominal Visceral Cancer Pain
64 patients around the world
Available in Brazil
Double-blind randomized clinical trial.
The objective of the study is to compare the analgesic efficacy of splanchnic nerve
neurolysis with alcohol to celiac plexus block with alcohol, with pain relief as the
primary outcome. It also aims to quantify the adverse effects of the techniques as
secondary outcomes. The sample size calculation will be based on comparing the mean pain
scores on the Numerical Rating Scale of patients in the Control Group and the
Intervention Group, evaluated after completing the second month of treatment. A
two-tailed t-test will be sufficient and will require an adequate sample size. Therefore,
for the chosen sample design with a significance level of α=5%, a power of 1-β=80%,
assuming M1=5.0 and M2=3.5 and a standard deviation of 2.0, the sample size required is
n=58. the sample size required is n=58. Considering a 10% dropout rate, the final sample
size will be increased to 64 participants. Convenience sampling (a non-probabilistic
sampling method) will be used. Participants will be randomly allocated to the groups
using a list generated by a program obtained at https://www.randomizer.org. The
proportion between the participants in the groups will be 1:1, with 32 patients allocated
to the Intervention arm and 32 to the Control arm. The allocation of the total 64
participants will be determined by randomly assigned sequential letters (A or B)
generated by the computer (website https://www.randomizer.org), randomly assigning
numbers from 0 to 64 to each group: Control Group (Celiac Block) and Intervention Group
(Splanchnic Nerve Block). The Control Group will receive celiac plexus neurolysis with
absolute alcohol, and the Intervention Group will receive splanchnic nerve neurolysis
with alcohol. The statistical analysis will be performed in program R version 3.5.1. The
results obtained will be presented as mean + standard deviation for continuous data or
absolute frequency for described data. For quantitative variables, the Student's t-test
will be used for normally distributed data, or the Mann-Whitney test for non-normally
distributed data. For qualitative variables, the chi-square test will be used or Fisher's
exact test. Significant difference is defined as p < 0.05. Data will be collected and
managed using REDCap data capture tools.
Instituto do Cancer do Estado de São Paulo
1Research sites
64Patients around the world
This study is for people with
Bile Duct Cancer
Colorectal cancer
Colon cancer
Esophageal cancer
Pancreatic cancer
Liver cancer
Gastrointestinal Cancer
Stomach Cancer
Duodenal Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
Patients over 18 years of age.
Presence of localized visceral pain in the upper abdomen originating from cancer of the stomach, duodenum, distal esophagus, ascending and transverse colon, liver, biliary tract, or pancreas.
Ineffectiveness of analgesic treatment with third-step opioids according to the WHO analgesic ladder: Patients using opioids (≥ 60 mg/day morphine equivalents), antidepressants (tricyclic or dual-action) at any dosage, gabapentinoids at any dosage.
Presence of side effects from analgesia that are difficult to control with medication.
Presence of ascites.
Presence of deep vein thrombosis.
Presence of hepatic failure: child-pugh score class B and class C.
Presence renal failure: estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m² will not be eligible for acceptance.
Use of any anticoagulant medication.
Clinical coagulation disorder: INR more than 1.5 or Prothrombin Activity less than 70% or more than 13.5 seconds; or Prolonged aPTT more than 40 seconds.
Cardiovascular failure: NYHA class III or class IV.
Refusal to participate in the study.
Sites
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
Av. Dr. Arnaldo, 251 - Consolação, São Paulo - SP, 01255-090, Brazil
StudyCONCERN
SponsorInstituto do Cancer do Estado de São Paulo
Study typeInterventional
Conditions
Bile Duct CancerColon cancerEsophageal cancerPancreatic cancerLiver cancerStomach CancerDuodenal Cancer