Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-01-01 @ 2:17 AM
Study NCT ID:
NCT01969006
Status:
WITHDRAWN
Last Update Posted:
2014-12-17
First Post:
2013-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ilioinguinal Block in Laparoscopic Inguinal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], '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': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Another study has been planned, so we did not initiate this one.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2014-12-16', 'studyFirstSubmitDate': '2013-10-21', 'studyFirstSubmitQcDate': '2013-10-21', 'lastUpdatePostDateStruct': {'date': '2014-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative pain', 'timeFrame': '1 year', 'description': 'VAS score of pain from:\n\n1. wound\n2. abdomen\n3. shoulder'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['inguinal hernia, postoperative pain, localanesthesia, nerve blockage'], 'conditions': ['Post Operative Pain as Estimated by the Sue of the VAS Score']}, 'descriptionModule': {'briefSummary': 'This study is undertaken to clarify whether intraoperative blockage with 40 ml of ½ % Marcaine© of the nerves in the ilio-inguinal canal may decrease postoperative pain after laparoscopic inguinal hernia repair.\n\nPatients will be randomised to injection of Marcaine© og a needle prick per-operatively.\n\nPain will be estimated using the VAS score in:\n\n1\\. the wound 2 the abdomen 3 the shoulder\n\nScoring will be performed:\n\n1. pre-operatively\n2. 1 hour postoperatively\n3. at discharge from the hospital d day 1,2 and 3 post OP\n\ne. 1 year post OP', 'detailedDescription': 'as above'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 year\n2. Informed consent\n3. a diagnosis of an inguinal hernia\n4. ASA group ≤ 3\n5. BMI ≤ 35\n\nExclusion Criteria:\n\n1. Communication problems\n2. No consent\n3. Open procedure (not laparoscopic)\n4. ASA-group 4\n5. Use of Steroid or immunosuppressive tretament\n6. Regular morphine use.'}, 'identificationModule': {'nctId': 'NCT01969006', 'briefTitle': 'Ilioinguinal Block in Laparoscopic Inguinal Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Randers Regional Hospital'}, 'officialTitle': 'Effect of Ilioinguinal Blockage on Postoperative Pain After Laparoscopic Inguinal Herna Repair', 'orgStudyIdInfo': {'id': 'ILIOINGUINAL01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Injection of Marcaine ½ %', 'description': 'Injection of 40 ml of Marcaine ½ % 2 cm medial, 2 cm downwards from the Anterior Iliac Spine', 'interventionNames': ['Drug: Marcaine ½%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Needle prick', 'description': 'Needle prick 2 cm medial and 2 cm downwards from the Anterior Iliac spine', 'interventionNames': ['Procedure: Needle prick']}], 'interventions': [{'name': 'Marcaine ½%', 'type': 'DRUG', 'armGroupLabels': ['Injection of Marcaine ½ %']}, {'name': 'Needle prick', 'type': 'PROCEDURE', 'armGroupLabels': ['Needle prick']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8700', 'city': 'Horsens', 'country': 'Denmark', 'facility': 'Horsens Regions Hospital', 'geoPoint': {'lat': 55.86066, 'lon': 9.85034}}, {'zip': '8900', 'city': 'Randers', 'country': 'Denmark', 'facility': 'Randers regions Hospital', 'geoPoint': {'lat': 56.4607, 'lon': 10.03639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Randers Regional Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regionshospitalet Horsens', 'class': 'OTHER'}, {'name': 'Denmark', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Surgeon phd, ass proffessor', 'investigatorFullName': 'Thorbjorn Sommer', 'investigatorAffiliation': 'Randers Regional Hospital'}}}}