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

NCT06871605 | Recruiting

• 1 other identifier: TFP vs II-IH for CPIP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia; Groin Hernia

Keywords

Ultrasonography; Ilioinguinal and iliohypogastric nerve; Transversalis Fascia Plane Block

Outcome Measures

Primary Outcomes (1)

• Numerical rating scale (NRS)

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

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

Secondary Outcomes (2)

• 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

Study Arms (2)

transversalis fascia plane block group

ACTIVE COMPARATOR

transversalis fascia plane block for chronic postherniorrhaphy inguinal pain

Procedure: ultrasound-guided transversalis fascia plane block

ilioinguinal and iliohypogastric nerve block group

ACTIVE COMPARATOR

ilioinguinal and iliohypogastric nerve block for chronic postherniorrhaphy inguinal pain

Procedure: ultrasound-guided ilioinguinal and iliohypogastric nerve block group

Interventions

ultrasound-guided transversalis fascia plane block PROCEDURE

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 with the US probe. After placing the needle tip in the virtual triangular plane between the posterior edge of the TA muscle, the QL and the underlying transversalis fascia, 4 mL of 0.5% bupivacaine + 2 mL of a total of 8 mg dexamethasone + 4 mL of saline are injected for a total volume of 10 mL.

transversalis fascia plane block group

ultrasound-guided ilioinguinal and iliohypogastric nerve block group PROCEDURE

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 with the US probe. When the needle tip is advanced to the II and IH nerves, 4 mL of 0.5% bupivacaine + 2 mL total 8 mg dexamethasone + 4 mL saline is injected for a total volume of 10 mL.

ilioinguinal and iliohypogastric nerve block group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Diskapi Training and Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gevher Rabia Genc Perdecioğlu

  Diskapi TRH

  STUDY CHAIR

Central Study Contacts

Gozde EROL

CONTACT

5325827856; gozde.canakli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor Investigator

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: March 12, 2025
• Study Start: February 11, 2025
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

TU (1)