Neurolytic Block Techniques In Abdominal Visceral Cancer Pain (CONCERN)

Instituto do Cancer do Estado de São Paulo

Status: Not yet enrolling

Conditions: Cancer Pain; Cancer-related Pain; Sympathetic Ganglia; Pain Management; Cancer, Malignant Tumors; Visceral Pain; Abdominal Cancer; Celiac Ganglia

Treatments: Procedure: Splanchnic nerve neurolysis - 5 ml of absolute alcohol (100%); Procedure: Celiac Plexus Neurolysis - 5 ml of absolute alcohol (100%)

Study type: Interventional

Funder types: Other

Identifiers

NCT06978673

NP 076-210

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients aged 18 years or older Presence of localized visceral pain in the upper abdomen originating from cancer of the stomach, duodenum, distal esophagus, ascending or transverse colon, liver, biliary tract, or pancreas

Ineffectiveness of analgesic treatment with third-step opioids according to the WHO analgesic ladder, including:

Opioids (≥ 60 mg/day of morphine equivalents) Antidepressants (tricyclic or dual-action), at any dosage Gabapentinoids, at any dosage Presence of side effects from analgesics that are difficult to manage with medication

Exclusion criteria

Presence of ascites Presence of deep vein thrombosis Presence of hepatic failure: Child-Pugh class B or C Presence of renal failure: estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m² Use of any anticoagulant medication

Clinical coagulation disorder, defined as:

INR > 1.5 Prothrombin activity < 70% or prothrombin time > 13.5 seconds aPTT > 40 seconds Cardiovascular failure: NYHA class III

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups

CELIAC PLEXUS NEUROLYSIS

Active Comparator group

Description:

The patient, under sedation and breathing spontaneously with oxygen support, will be placed in the horizontal prone position. Fluoroscopy will be used to locate the first lumbar vertebra, which will serve as a reference for the puncture site. Two 22G × 15 cm needles will be introduced bilaterally, up to 6 cm from the midline at the level of L1, and directed superiorly toward the transverse process of L1 under coaxial vision. Once they reach the vertebral body bilaterally, the needles will be positioned anterior to the vertebral body of L1, in the retroperitoneal region. The needle stylet will be removed, and the absence of blood, cerebrospinal fluid, or urine returning through the needle will be verified. If none of these signs are present, 2 ml of non-ionic contrast will be administered through the needle to confirm proper positioning in the retroperitoneum. After confirmation, 5 ml of absolute alcohol will be injected bilaterally.

Treatment:

Procedure: Celiac Plexus Neurolysis - 5 ml of absolute alcohol (100%)

SPLANCHNIC NERVE NEUROLYSIS

Experimental group

Description:

The patient, under spontaneous breathing with oxygen support, will be placed in the horizontal prone position and supported by cushions placed under the iliac crests and chest. With a mark maintained over T11, the fluoroscopy machine will be positioned obliquely (approximately 45º), and the movement of the diaphragm-as well as its relationship with the vertebral body-will be observed during inspiration and expiration. The entry point will be at the junction of the rib and the vertebral body. The needle will be introduced using coaxial visualization to reach the lateral aspect of the vertebral body, near the costovertebral angle. With the fluoroscopy in profile, the needle will be advanced to the anterior third of the vertebral body, and any return of blood or cerebrospinal fluid will be checked. Non-ionic contrast will then be injected to confirm the needle position in both anteroposterior and lateral views. Finally, 5 ml of absolute alcohol will be injected through each needle.

Treatment:

Procedure: Splanchnic nerve neurolysis - 5 ml of absolute alcohol (100%)