Comparison Of Neurolytic Block Techniques For The Treatment Of Abdominal Visceral Pain And Their Influence On The Quality Of Life Of Patients With Cancer

Instituto do Cancer do Estado de São Paulo

Status and phase: Begins enrollment this month; Phase 3; Phase 2

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

Treatments: Procedure: Celiac Plexus Neurolysis - 5ml absolute acohol; Procedure: Splanchnic nerve neurolysis - 5ml absolute acohol

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 blinded randomized clinical trial.

The objective of the study is to compare the analgesic efficacy of splanchnic nerve neurolysis with alcohol versus celiac plexus block with alcohol, with the primary outcome being pain relief, and 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. Considering a 10% dropout rate, our final sample size will be n=64 in total. Consequently, the sample size will be increased from 58 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 with normal distribution or Mann-Whitney for non-distributed data normal.

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 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

Exclusion criteria

• 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

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 with spontaneous breathing with oxygen support, will be placed in a horizontal prone position. Fluoroscopy will be used to locate the first lumbar vertebra, which will serve as a reference for the puncture site. Two 22GX15 cm needles will be introduced bilaterally up to 6 cm from the midline at the level of L1 and directed superiorly to 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 is removed, and the absence of blood, cerebrospinal fluid, or urine returning through the needle is verified. In the absence of any of these signs, 2 ml of non-ionic contrast will be administered through the needle to confirm the correct positioning of the needle in the retroperitoneum. After confirming the needle location, 5 ml of absolute alcohol will be injected bilaterally.

Treatment:

Procedure: Celiac Plexus Neurolysis - 5ml absolute acohol

SPLANCHNIC NERVE BLOCK

Experimental group

Description:

The patient, under spontaneous breathing with oxygen , will be placed in a horizontal prone position and supported on cushions positioned under the iliac crests and chest. Maintaining a mark over T11, the fluoroscopy machine will be placed 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 the junction of the rib with the vertebral body. The needle will be introduced using a coaxial visualization so that it reaches the lateral aspect of the vertebral body, near the costo-vertebral angle. With the fluoroscopy machine 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 observed. non-ionic contrast will be injected to confirm the needle position, both in the anteroposterior and profile views. Finally, 5 ml of absolute alcohol will be injected into each needle.

Treatment:

Procedure: Splanchnic nerve neurolysis - 5ml absolute acohol