Neurolytic Block Techniques In Abdominal Visceral Cancer Pain

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• PAIN SCORE [Срок оценки: 1st Day Post-procedure; 15th Day Post-procedure; 30th Day Post-procedure; 2nd Month Post-procedure]

Вторичные конечные точки (2)

• Quality of life assessment. [Срок оценки: 1st Day Post-procedure; 15th Day Post-procedure; 30th Day Post-procedure; 2nd Month Post-procedure]
• Adverse Events [Срок оценки: 1st Day Post-procedure; 15th Day Post-procedure; 30th Day Post-procedure; 2nd Month Post-procedure]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Instituto de Cancer Do Estado — São Paulo

Публикации

• Koyyalagunta D, Engle MP, Yu J, Feng L, Novy DM. The Effectiveness of Alcohol Versus Phenol Based Splanchnic Nerve Neurolysis for the Treatment of Intra-Abdominal Cancer Pain. Pain Physician. 2016 May;19(4):281-92. PMID 27228515
• Ahmed A, Arora D. Fluoroscopy-guided Neurolytic Splanchnic Nerve Block for Intractable Pain from Upper Abdominal Malignancies in Patients with Distorted Celiac Axis Anatomy: An Effective Alternative to Celiac Plexus Neurolysis - A Retrospective Study. Indian J Palliat Care. 2017 Jul-Sep;23(3):274-281. doi: 10.4103/IJPC.IJPC_28_17. PMID 28827930
• Uehara Y, Matsumoto Y, Kosugi T, Sone M, Nakamura N, Mizushima A, Miyashita M, Morita T, Yamaguchi T, Satomi E. Availability of and factors related to interventional procedures for refractory pain in patients with cancer: a nationwide survey. BMC Palliat Care. 2022 Sep 26;21(1):166. doi: 10.1186/s12904-022-01056-6. PMID 36154936
• Hochberg U, Ingelmo P, Sole E, Miro J, Rivera G, Perez J. Early Interventional Treatments for Patients with Cancer Pain: A Narrative Review. J Pain Res. 2023 May 18;16:1663-1671. doi: 10.2147/JPR.S405808. eCollection 2023. PMID 37223437
• Noble M, Gress FG. Techniques and results of neurolysis for chronic pancreatitis and pancreatic cancer pain. Curr Gastroenterol Rep. 2006 Apr;8(2):99-103. doi: 10.1007/s11894-006-0004-x. PMID 16533471
• Comlek S. Pain Control with Splanchnic Neurolysis in Pancreatic Cancer Patients Unresponsive to Celiac Plexus Neurolysis. J Pain Res. 2020 Aug 12;13:2023-2031. doi: 10.2147/JPR.S266689. eCollection 2020. PMID 32848449
• Yamamuro M, Kusaka K, Kato M, Takahashi M. Celiac plexus block in cancer pain management. Tohoku J Exp Med. 2000 Sep;192(1):1-18. doi: 10.1620/tjem.192.1. PMID 11128864
• Paul A, Borkar A. Fluoroscopy-Guided Splanchnic Nerve Block for Cancer-Associated Pain. Cureus. 2022 Oct 31;14(10):e30944. doi: 10.7759/cureus.30944. eCollection 2022 Oct. PMID 36465781

Идентификаторы

NCT: NCT06978673 · NP 076-210

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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