Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-31 @ 1:36 AM
Study NCT ID:
NCT07049835
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-03
First Post:
2025-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ilioinguinal Nerve Block With Local Anesthetic vs. Placebo in Inguinal Hernia Repair Under Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will be a randomized prospective , double-blind, controlled trial conducted in a tertiary care surgical unit.\n\nA total of 100 patients (50 in each group) undergoing lower Inguinal hernia surgery will be enrolled based on power analysis.\n\nAnesthetic Technique\n\n* Group A: Spinal anesthesia will be administered using a standard technique with a 25G spinal needle, targeting the appropriate vertebral level.\n* Group B: In addition to spinal anesthesia, an ultrasound-guided ilioinguinal nerve block will be performed post to the surgical incision.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2025-06-25', 'studyFirstSubmitQcDate': '2025-06-25', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain management', 'timeFrame': '24 hours', 'description': 'Pain scores will be assessed using an 11-point numerical rating scale (0-10) at 1, 6, 12, and 24 hours postoperatively.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bupivacaine Hydrochloride', 'Spinal Anesthesia', 'Nerve Blocks', 'Iliohypogastric Nerve Neuralgia', 'Ilioinguinal Neuralgia', 'Adults', 'Lidocaine Hydrochloride', 'Normal Saline', 'Sulfentanyl'], 'conditions': ['Inguinal Hernias']}, 'referencesModule': {'references': [{'pmid': '16466122', 'type': 'BACKGROUND', 'citation': 'Yilmazlar A, Bilgel H, Donmez C, Guney A, Yilmazlar T, Tokat O. Comparison of ilioinguinal-iliohypogastric nerve block versus spinal anesthesia for inguinal herniorrhaphy. South Med J. 2006 Jan;99(1):48-51. doi: 10.1097/01.smj.0000197298.48311.80.'}, {'pmid': '31626118', 'type': 'BACKGROUND', 'citation': 'Zhou Y, Chen M, Zhang Y, Zhou H, Yu X, Chen G. Ilioinguinal/iliohypogastric nerve block versus transversus abdominis plane block for pain management following inguinal hernia repair surgery: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2019 Oct;98(42):e17545. doi: 10.1097/MD.0000000000017545.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative pain management remains a critical area of concern in surgical practices, especially in procedures involving the lower abdomen and pelvis. Inguinal Hernia is considered among few surgeries that may lead to chronic pain. Spinal anesthesia is a commonly utilized modality because of its efficacy in pain control and rapid recovery. However, the addition of peripheral nerve blocks, such as the ilioinguinal nerve block, may provide enhanced pain relief and reduce opioid consumption postoperatively. This study aims to evaluate the effectiveness of spinal anesthesia alone compared to spinal anesthesia supplemented with ultrasound-guided ilioinguinal and iliohypo-gastric nerve block in managing postoperative pain.', 'detailedDescription': 'Objectives\n\n1. Primary Objective: To compare the postoperative pain scores (using a standardized numerical rating scale) between patients receiving spinal anesthesia alone and those receiving spinal anesthesia with ultrasound-guided ilioinguinal nerve block.\n2. Secondary Objectives:\n\n * To assess the total opioid consumption in the first 24 hours post-surgery.\n * To evaluate the time to first analgesic request postoperatively.\n * Patient Satisfaction score post-op \\>\\> at rest , coughing , ambulation ( LEKENT SCORE ) .\n\nHypotheses\n\n* Hypothesis 1: Patients receiving spinal anesthesia with an ilioinguinal nerve block will experience significantly lower postoperative pain scores compared to those receiving spinal anesthesia alone.\n* Hypothesis 2: Patients receiving spinal anesthesia with an ilioinguinal nerve block will require less opioid medication in the first 24 hours post-surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-65 years\n* ASA physical status I-III\n* Scheduled for elective lower abdominal surgery (e.g., inguinal hernia repair, cesarean section)\n\nExclusion Criteria:\n\n* Allergy to local anesthetics\n* Coagulation disorders\n* Infection at the injection site\n* Patients with neurological conditions affecting lower limbs'}, 'identificationModule': {'nctId': 'NCT07049835', 'briefTitle': 'Ilioinguinal Nerve Block With Local Anesthetic vs. Placebo in Inguinal Hernia Repair Under Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Makassed General Hospital'}, 'officialTitle': 'A Double-Blind Randomized Controlled Trial of Ilioinguinal Nerve Block With Local Anesthetic vs. Placebo in Inguinal Hernia Repair Under Spinal Anesthesia', 'orgStudyIdInfo': {'id': 'MGH-06-25017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intrathecal Mixture Block', 'description': '15cc 0.25% of Bupivacaine + Dexamethasone 8 mg 2cc', 'interventionNames': ['Drug: Ilioinguinal/iliohypogastric Nerve Block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Intrathecal Placebo', 'description': '17 cc of Ns/s', 'interventionNames': ['Other: Ilioinguinal/iliohypogastric with Placebo Block']}], 'interventions': [{'name': 'Ilioinguinal/iliohypogastric Nerve Block', 'type': 'DRUG', 'description': '15cc 0.25% of Bupivacaine + Dexamethasone 8 mg 2cc', 'armGroupLabels': ['Intrathecal Mixture Block']}, {'name': 'Ilioinguinal/iliohypogastric with Placebo Block', 'type': 'OTHER', 'description': '17 cc of Placebo', 'armGroupLabels': ['Intrathecal Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Makassed General Hospital', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Makassed General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesia Attending', 'investigatorFullName': 'Mohamad-Ali Barada', 'investigatorAffiliation': 'Makassed General Hospital'}}}}