Inguinal HerniaNCT06871605
Transversalis Fascia Plane vs Ilioinguinal and Iliohypogastric Nerve Block for the Treatment of CPIP
A study testing ultrasound-guided transversalis fascia plane block and ultrasound-guided ilioinguinal and iliohypogastric nerve block group in people with Inguinal Hernia and Groin Hernia, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia, Groin Hernia
- What is being tested?
- ultrasound-guided transversalis fascia plane block and ultrasound-guided ilioinguinal and iliohypogastric nerve block group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Feb 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complaints of inguinal pain >12 weeks post-herniorrhaphy surgery
- >18 years of age
- Failure of conservative pain management
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Diskapi Training and Research Hospital
Ankara
Gevher Rabia Genç Perdecioğlu, 5332009184 ext. TR, gevhergenc@gmail.com
Damla Yuruk, 5319932378 ext. TR, damlayuruk@hotmail.com
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Inguinal Hernia, Groin Hernia
- Being tested
- ultrasound-guided transversalis fascia plane block, ultrasound-guided ilioinguinal and iliohypogastric nerve block group
- Keywords
- Ultrasonography, Ilioinguinal and iliohypogastric nerve, Transversalis Fascia Plane Block
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided transversalis fascia plane blockProcedure or surgery
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.
ultrasound-guided ilioinguinal and iliohypogastric nerve block groupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| transversalis fascia plane block group | Active comparator | transversalis fascia plane block for chronic postherniorrhaphy inguinal pain Receives: 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 Receives: Procedure: ultrasound-guided ilioinguinal and iliohypogastric nerve block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from baseline to 1st and 3rd month after treatment
Secondary outcomes (2)
procedure-related adverse events
Any adverse events that occur during and after the TFP and II-IH block procedures will be recorded.
Measured: Change from baseline to 1st and 3rd month after treatment
patient satisfaction likert scale
Patient satisfaction is measured using a five-point Likert scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied and 5 = very satisfied).
Measured: Change from baseline to 30 minutes after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start11 Feb 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- Gevher Rabia Genc Perdecioğlu, Study chair, Diskapi TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871605
- Sponsor's protocol ID
- TFP vs II-IH for CPIP
- Status last verified
- Mar 2025
- First submitted
- 11 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06871605
- Acronym / sponsor ID
- TFP vs II-IH for CPIP
- Conditions
- Inguinal Hernia, Groin Hernia
- Keywords
- Ultrasonography, Ilioinguinal and iliohypogastric nerve, Transversalis Fascia Plane Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transversalis fascia plane block group | Active comparator | Procedure: ultrasound-guided transversalis fascia plane blocktransversalis fascia plane block for chronic postherniorrhaphy inguinal pain |
| ilioinguinal and iliohypogastric nerve block group | Active comparator | Procedure: ultrasound-guided ilioinguinal and iliohypogastric nerve block groupilioinguinal and iliohypogastric nerve block for chronic postherniorrhaphy inguinal pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Complaints of inguinal pain >12 weeks post-herniorrhaphy surgery
- >18 years of age
- Failure of conservative pain management
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound-guided transversalis fascia plane blockWith 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. | Procedure or surgery | transversalis fascia plane block group |
| ultrasound-guided ilioinguinal and iliohypogastric nerve block groupWith 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. | Procedure or surgery | ilioinguinal and iliohypogastric nerve block group |
Primary outcome
Numerical rating scale (NRS)
Time frame: 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)
2 secondary outcomes
procedure-related adverse events
Time frame: Change from baseline to 1st and 3rd month after treatment
patient satisfaction likert scale
Time frame: Change from baseline to 30 minutes after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
Related trials for Inguinal Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gevher Rabia Genc Perdecioğlu study chair
Diskapi TRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guided transversalis fascia plane block and ultrasound-guided ilioinguinal and iliohypogastric nerve block group in people with Inguinal Hernia and Groin Hernia, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gozde EROL (5325827856 ext. TR, gozde.canakli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical rating scale (NRS) (time frame: Change from baseline to 1st and 3rd month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.