Transversalis Fascia Plane vs Ilioinguinal and Iliohypogastric Nerve Block for the Treatment of CPIP

Официальное название

Comparison of Ultrasound-guided Transversalis Fascia Plane Block With Ultrasound-guided Ilioinguinal and Iliohypogastric Nerve Block in the Treatment of Chronic Post-herniorrhaphy Inguinal Pain

Обзор

The aim of this study was to compare the efficacy of ultrasound (US)-guided transversalis fascia plane block (TFP) and ilioinguinal (II) and iliohypogastric (IH) nerve block in the treatment of chronic post-herniorrhaphy inguinal pain (CPIP) refractory to conservative treatments. For this evaluation, a numerical rating scale (NRS) will be used before and after both interventions.

Подробное описание

Chronic post-herniorrhaphy inguinal pain (CPIP) after inguinal hernia surgery significantly affects quality of life and daily activities. The incidence of this condition ranges from 15% to 53% and its management is often challenging. CPIP is defined as pain lasting more than three months and can be diagnosed if no organic cause can be found to explain the pain at the end of this period. There are various methods in the treatment of CPIP, including medical therapy, nerve blocks and surgical intervention.

The inguinal region is mainly innervated by the ilioinguinal (II) and iliohypogastric (IH) nerves. These nerves are the most commonly damaged structures after inguinal hernia surgery.

However, the II and IH nerves can be easily blocked in isolation throughout their entire course in the groin area or in the abdominal wall at different injection sites using fascial plane blocks such as transversalis fascia plan block (TFP). These blocks are frequently preferred because of their ease of application and wide analgesic effects. Therefore, studies investigating the efficacy of fascial blocks that provide ease of application are increasing.

Although TFP and II-IH blocks have been used in the treatment of acute postoperative inguinal pain, they have been used in a limited number of studies for CPIP; however, no study has compared the efficacy and advers effect rates of these methods.

The primary aim of this study is to compare the efficacy of these two treatment modalities. The secondary aim is to determine the incidence of adverse events associated with US-guided TFP and II-IH nerve block therapy. A total of at least 80 patients will be enrolled for comparison, 40 patients in each group. The NRS score will be compared both within and between groups before, 1 month after and 3 months after treatment.

Вмешательства

• Процедура ultrasound-guided transversalis fascia plane block
  With the patient in the lateral decubitus position, an 8-12 Hz linear ultrasound (US) probe is placed transversely over the iliac crest. The external oblique (EO), internal oblique (IO) and transversus abdominis (TA) muscles are identified so that the abdominal muscles are in the field of view. The TA muscle is then advanced posteriorly until it tapers to the thoracolumbar fascia with its aponeurosis adjacent to the quadratus lumborum (QL) muscle. The 22 gauge block needle is advanced in plane w
• Процедура ultrasound-guided ilioinguinal and iliohypogastric nerve block group
  With the patient in the supine position, an 8-12 Hz linear ultrasound (US) probe is placed medial and cephalal to the anterior superior iliac spine (ASIS), transversely between the ASIS and the umbilicus. The external oblique (EO), internal oblique (IO) and transversus abdominis (TA) muscles are identified so that the abdominal muscles are in the field of view. The II-IH nerves are hyperechogenic in the fascial plane between the IO and TA muscles. A 22 gauge block needle is advanced in plane wit

Первичные конечные точки

• Numerical rating scale (NRS) [Срок оценки: Change from baseline to 1st and 3rd month after treatment]

Вторичные конечные точки (2)

• procedure-related adverse events [Срок оценки: Change from baseline to 1st and 3rd month after treatment]
• patient satisfaction likert scale [Срок оценки: Change from baseline to 30 minutes after procedure]

Критерии участия

Критерии включения

• Complaints of inguinal pain >12 weeks post-herniorrhaphy surgery
• >18 years of age
• Failure of conservative pain management

Критерии исключения

• Other causes of inguinal pain (haematoma, infection, tubo-ovarian disease, abscess, etc., gynaecological, urological and organic pathologies after inguinal hernia, etc.)
• Pregnancy
• Coagulopathy, antiaggregant/anticoagulant/antiplatelet use
• Unstable psychiatric illness

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

• Diskapi Training and Research Hospital — Ankara

Идентификаторы

NCT: NCT06871605 · TFP vs II-IH for CPIP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗