Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT06871605
Status:
RECRUITING
Last Update Posted:
2025-03-12
First Post:
2025-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transversalis Fascia Plane vs Ilioinguinal and Iliohypogastric Nerve Block for the Treatment of CPIP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2025-02-11', 'studyFirstSubmitQcDate': '2025-03-11', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical rating scale (NRS)', 'timeFrame': 'Change from baseline to 1st and 3rd month after treatment', 'description': 'NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)'}], 'secondaryOutcomes': [{'measure': 'procedure-related adverse events', 'timeFrame': 'Change from baseline to 1st and 3rd month after treatment', 'description': 'Any adverse events that occur during and after the TFP and II-IH block procedures will be recorded.'}, {'measure': 'patient satisfaction likert scale', 'timeFrame': 'Change from baseline to 30 minutes after procedure', 'description': 'Patient satisfaction is measured using a five-point Likert scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied and 5 = very satisfied).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasonography', 'Ilioinguinal and iliohypogastric nerve', 'Transversalis Fascia Plane Block'], 'conditions': ['Inguinal Hernia', 'Groin Hernia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nHowever, 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.\n\nAlthough 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Complaints of inguinal pain \\>12 weeks post-herniorrhaphy surgery\n* \\>18 years of age\n* Failure of conservative pain management\n\nExclusion Criteria:\n\n* Other causes of inguinal pain (haematoma, infection, tubo-ovarian disease, abscess, etc., gynaecological, urological and organic pathologies after inguinal hernia, etc.)\n* Pregnancy\n* Coagulopathy, antiaggregant/anticoagulant/antiplatelet use\n* Unstable psychiatric illness'}, 'identificationModule': {'nctId': 'NCT06871605', 'briefTitle': 'Transversalis Fascia Plane vs Ilioinguinal and Iliohypogastric Nerve Block for the Treatment of CPIP', 'organization': {'class': 'OTHER', 'fullName': 'Diskapi Teaching and Research Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'TFP vs II-IH for CPIP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'transversalis fascia plane block group', 'description': 'transversalis fascia plane block for chronic postherniorrhaphy inguinal pain', 'interventionNames': ['Procedure: ultrasound-guided transversalis fascia plane block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ilioinguinal and iliohypogastric nerve block group', 'description': 'ilioinguinal and iliohypogastric nerve block for chronic postherniorrhaphy inguinal pain', 'interventionNames': ['Procedure: ultrasound-guided ilioinguinal and iliohypogastric nerve block group']}], 'interventions': [{'name': 'ultrasound-guided transversalis fascia plane block', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['transversalis fascia plane block group']}, {'name': 'ultrasound-guided ilioinguinal and iliohypogastric nerve block group', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['ilioinguinal and iliohypogastric nerve block group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Gevher Rabia Genç Perdecioğlu', 'role': 'CONTACT', 'email': 'gevhergenc@gmail.com', 'phone': '5332009184', 'phoneExt': 'TR'}, {'name': 'Damla Yuruk', 'role': 'CONTACT', 'email': 'damlayuruk@hotmail.com', 'phone': '5319932378', 'phoneExt': 'TR'}], 'facility': 'Diskapi Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Gozde EROL', 'role': 'CONTACT', 'email': 'gozde.canakli@gmail.com', 'phone': '5325827856', 'phoneExt': 'TR'}], 'overallOfficials': [{'name': 'Gevher Rabia Genc Perdecioğlu', 'role': 'STUDY_CHAIR', 'affiliation': 'Diskapi TRH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Teaching and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Supervisor Investigator', 'investigatorFullName': 'Damla Yürük', 'investigatorAffiliation': 'Diskapi Teaching and Research Hospital'}}}}