Trials / Not Yet Recruiting

Not Yet RecruitingNCT06978673

Neurolytic Block Techniques In Abdominal Visceral Cancer Pain

Comparison of Neurolytic Block Techniques for the Treatment of Abdominal Visceral Pain and Their Influence On The Quality of Life of Patients With Cancer

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 64 (estimated)

Sponsor: Instituto do Cancer do Estado de São Paulo · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

The neurolytic blocks of sympathetic chains are commonly used for the treatment of cancer-related pain. This study aims to compare celiac plexus neurolysis and splanchnic nerve neurolysis for the treatment of abdominal visceral pain and its influence on the quality of life of patients with cancer.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Splanchnic nerve neurolysis - 5 ml of absolute alcohol (100%)	Splanchnic neurolysis will be performed with 5 ml of absolute alcohol on each side at the level of the eleventh thoracic vertebra.
PROCEDURE	Celiac Plexus Neurolysis - 5 ml of absolute alcohol (100%)	Celiac plexus neurolysis will be performed with 5 ml of absolute alcohol on each side at the level of the first lumbar vertebra.

Timeline

Start date: 2025-05-30
Primary completion: 2026-05-01
Completion: 2026-12-01
First posted: 2025-05-18
Last updated: 2025-06-03

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT06978673. Inclusion in this directory is not an endorsement.