Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-02-21 @ 1:25 PM
Study NCT ID:
NCT05122351
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2021-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-11-24', 'releaseDate': '2023-02-13'}], 'estimatedResultsFirstSubmitDate': '2023-02-13'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000698', 'term': 'Analgesia'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-11', 'studyFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2021-11-13', 'lastUpdatePostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesia in Patients with Open Inguinal Hernia Surgeries', 'timeFrame': '6 months', 'description': 'Comparative Study Between The Efficacy Of Quadratus Lumborum Block by Bupivacaine infiltration VS Conventional Analgesia by paracetamol injection In Patients Undergoing Open Inguinal Hernia Surgical Repair'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia in Patients With Open Inguinal Hernia Surgeries']}, 'referencesModule': {'references': [{'pmid': '21928388', 'type': 'BACKGROUND', 'citation': 'Joshi GP, Rawal N, Kehlet H; PROSPECT collaboration; Bonnet F, Camu F, Fischer HB, Neugebauer EA, Schug SA, Simanski CJ. Evidence-based management of postoperative pain in adults undergoing open inguinal hernia surgery. Br J Surg. 2012 Feb;99(2):168-85. doi: 10.1002/bjs.7660. Epub 2011 Sep 16.'}, {'pmid': '11711938', 'type': 'BACKGROUND', 'citation': 'Rab M, Ebmer And J, Dellon AL. Anatomic variability of the ilioinguinal and genitofemoral nerve: implications for the treatment of groin pain. Plast Reconstr Surg. 2001 Nov;108(6):1618-23. doi: 10.1097/00006534-200111000-00029.'}, {'pmid': '25025697', 'type': 'BACKGROUND', 'citation': 'Bulka CM, Shotwell MS, Gupta RK, Sandberg WS, Ehrenfeld JM. Regional anesthesia, time to hospital discharge, and in-hospital mortality: a propensity score matched analysis. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):381-6. doi: 10.1097/AAP.0000000000000121.'}]}, 'descriptionModule': {'briefSummary': 'Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair', 'detailedDescription': 'Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 50 patients with ASA grade I to II, posted for open inguinal hernia surgery, elective , 18 to 60 years old , will be included in double blinded randomized study.\n\nExclusion Criteria:\n\n* Patient refusal\n* Patient with significant neurological , psychiatric or neuromuscular disease.\n* Pregnancy or lactating women.\n* Suspected Coagulopathy .\n* Morbid obesity.\n* Known allergy to some medications .\n* Septicaemia and local infection at the block site .\n* Alcoholism .\n* Drug abuse'}, 'identificationModule': {'nctId': 'NCT05122351', 'briefTitle': 'Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair', 'orgStudyIdInfo': {'id': 'Soh-Med-21-10-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group of Bupivacaine infiltration at the Quadratus Lumborum muscle', 'description': 'Patients will receive Quadratus Lumborum Block by infiltration of Bupivacaine as post operative analgesia in Open Inguinal Hernia surgery', 'interventionNames': ['Drug: Bupivacaine infiltration at the Quadratus Lumborum muscle Versus Paracetamol injection as analgesia in post operative Open Inguinal Hernia surgeries']}, {'type': 'EXPERIMENTAL', 'label': 'Group of paracetamol injection', 'description': 'Patients will receive post operative 1 gm paracetamol injection as analgesia in Open Inguinal Hernia surgery', 'interventionNames': ['Drug: Bupivacaine infiltration at the Quadratus Lumborum muscle Versus Paracetamol injection as analgesia in post operative Open Inguinal Hernia surgeries']}], 'interventions': [{'name': 'Bupivacaine infiltration at the Quadratus Lumborum muscle Versus Paracetamol injection as analgesia in post operative Open Inguinal Hernia surgeries', 'type': 'DRUG', 'description': 'Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair', 'armGroupLabels': ['Group of Bupivacaine infiltration at the Quadratus Lumborum muscle', 'Group of paracetamol injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor at Anesthesia and ICU department', 'investigatorFullName': 'Ahmed Mamdouh Ahmed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-02-13', 'type': 'RELEASE'}, {'date': '2023-11-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ahmed Mamdouh Ahmed, Resident doctor at Anesthesia and ICU department, Sohag University'}}}}