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

Not Applicable

Recruiting

• Conditions: Inguinal Hernia; Groin Hernia

• Registration Number: NCT06871605
• Lead Sponsor: Diskapi Teaching and Research Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2025-02-11
• Study First Submitted: 2025-02-11
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-12
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-08-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Numerical rating scale (NRS)	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)

Secondary Outcome Measures

Name	Time	Method
procedure-related adverse events	Change from baseline to 1st and 3rd month after treatment	Any adverse events that occur during and after the TFP and II-IH block procedures will be recorded.
patient satisfaction likert scale	Change from baseline to 30 minutes after procedure	Patient satisfaction is measured using a five-point Likert scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied and 5 = very satisfied).

Trial Locations

Locations (1)

Diskapi Training and Research Hospital; 🇹🇷 Ankara, Turkey