Transdiscal vs Paravertebral Neurolytic Splanchnic Nerve Block for Upper Abdominal Cancer Pain

Официальное название

Comparison of Transdiscal and Paravertebral Approaches for Neurolytic Splanchnic Nerve Block in the Treatment of Upper Abdominal Cancer Pain

Обзор

This study aims to compare the efficacy of fluoroscopy-guided paravertebral (PV) and transdiscal (TD) approaches for splanchnic nerve neurolysis in patients with upper abdominal cancer-related pain (e.g., gastric, pancreatic, and hepatic malignancies). Treatment response will be assessed using the Numerical Rating Scale (NRS), and the impact of both techniques on quality of life will be evaluated with the EORTC QLQ-C30 questionnaire.

Подробное описание

Cancer-related pain (CRP) is a complex and challenging condition to manage. Pain may be somatic, visceral, or neuropathic in origin, and more than 50% of patients present with a mixed pain pattern at the time of diagnosis. In addition to medical therapies such as opioids and adjuvant analgesics, various interventional procedures are used in the management of CRP. Among these, neurolytic nerve and plexus blocks represent effective options for patients with pain refractory to conservative treatment. Chemical neurolysis, as a minimally invasive neurolytic plexus block technique, provides effective analgesia by targeting both sensory afferent fibers and sympathetic fibers innervating visceral organs. Identifying the most appropriate block according to pain localization plays a crucial role in achieving successful pain control.

Splanchnic nerve neurolysis is an established interventional technique for the management of upper abdominal cancer pain associated with pancreatic, gastric, and hepatic malignancies. Both the paravertebral (PV) and transdiscal (TD) approaches have been shown to effectively reduce cancer-related abdominal pain and significantly improve quality of life in affected patients. However, comparative data between these two techniques remain limited.

The primary aim of this study is to compare the efficacy of paravertebral (PV) and transdiscal (TD) splanchnic nerve neurolysis in patients with severe upper abdominal cancer pain refractory to medical therapy, using the Numerical Rating Scale (NRS) for pain assessment. Secondary aims include evaluating the impact of these techniques on quality of life using the EORTC QLQ-C30 questionnaire, comparing changes in opioid consumption, comparing procedure duration and fluoroscopy imaging time, and determining the incidence of adverse events.

A total of 56 patients, 28 in each group, will be enrolled. Pain intensity will be assessed using the NRS before the procedure and at 3 days, 1 month, and 3 months after the intervention. Quality of life will be evaluated using the EORTC QLQ-C30 questionnaire before the procedure and at 1 and 3 months post-intervention. Procedure-related adverse events will be recorded.

Вмешательства

• Процедура transdiscal splanchnic neurolysis
  With the patient in the prone position, the T11-T12 vertebral levels were identified under anteroposterior fluoroscopic guidance, and the C-arm was adjusted to align the superior and inferior endplates of the T11-T12 intervertebral disc. The fluoroscope was then rotated obliquely to position the tip of the T12 superior articular process at the midpoint of the T11 vertebral body. After local anesthesia with 2 mL of 1% lidocaine, a spinal needle was advanced to the target point. The ideal final ne
• Процедура paravertebral splanchnic neurolysis
  Under C-arm fluoroscopic guidance, the inferior border of the T11 vertebral body was used as a reference, and the fluoroscope was adjusted to a 15-20° craniocaudal and approximately 15-20° oblique angle. The needle entry point was selected slightly inferior to the T11 transverse process, and after local anesthesia with 2 mL of 1% lidocaine, the spinal needle was advanced along the lateral aspect of the vertebral body. On lateral fluoroscopic view, the needle tip was positioned at the anterior tw

Первичные конечные точки

• Numerical rating scale (NRS) [Срок оценки: Change from baseline to post-treatment day 3, and at 1 and 3 months.]

Вторичные конечные точки (2)

• EORTC QLQ-C30 questionnaire [Срок оценки: Change from baseline to 1st and 3rd month after treatment]
• Fluoroscopy imaging time [Срок оценки: During procedure]

Критерии участия

Критерии включения

• Severe abdominal pain (NRS > 6) due to upper intra-abdominal organ malignancies (such as gastric, pancreatic, or hepatic cancer).
• Failure of pain control with conservative treatment modalities.

Критерии исключения

• Presence of local anatomical variations
• Localized or systemic infection involving the procedural site
• Pregnancy
• Coagulopathy
• Presence of unstable psychiatric disorders

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

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Ankara Etlik City Hospital — Ankara

Идентификаторы

NCT: NCT07445386 · Transdiscal vs Paravert SNB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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