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临床试验/NCT06871605
NCT06871605招募中不适用

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

Diskapi Teaching and Research Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Numerical rating scale (NRS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

transversalis fascia plane block group

Active Comparator

transversalis fascia plane block for chronic postherniorrhaphy inguinal pain

干预措施: ultrasound-guided transversalis fascia plane block (Procedure)

ilioinguinal and iliohypogastric nerve block group

Active Comparator

ilioinguinal and iliohypogastric nerve block for chronic postherniorrhaphy inguinal pain

干预措施: ultrasound-guided ilioinguinal and iliohypogastric nerve block group (Procedure)

结局指标

主要结局

Numerical rating scale (NRS)

时间窗: Change from baseline to 1st and 3rd month after treatment

NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)

次要结局

  • procedure-related adverse events(Change from baseline to 1st and 3rd month after treatment)
  • patient satisfaction likert scale(Change from baseline to 30 minutes after procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Damla Yürük

Supervisor Investigator

Diskapi Teaching and Research Hospital

研究点 (1)

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