Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
Study NCT ID:
NCT06386250
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2024-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Regional Block, Caudal Block and Wound Infiltration in Inguinal Hernitomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D007268', 'term': 'Injections, Epidural'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007278', 'term': 'Injections, Spinal'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Regional block group (Group A), wound infiltration group (Group B), caudal block group (Group C)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2024-04-13', 'studyFirstSubmitQcDate': '2024-04-23', 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'postoperative pain intesity', 'timeFrame': '24 hours', 'description': 'Wong-Baker Faces pain Scale at 0, 1, 2, 4, 8, 24 hours after surgery in children more than 8 years of age.'}], 'primaryOutcomes': [{'measure': 'Postoperative pain intensity', 'timeFrame': '24 hours', 'description': 'Patients were assessed for postoperative pain intensity using FLACC pain scale at 0, 1, 2, 4, 8, 24 hours after surgery in children less than 8 years of age. Wong-Baker Faces pain Scale at 0, 1, 2, 4, 8, 24 hours after surgery in children more than 8 years of age.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative pain', 'inguinal herniotomy', 'children', 'regional block', 'caudal block', 'wound infilteration'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': "Background: Although Inguinal herniotomy in children is taken as a day care procedure, post-operative pain management still remain controversial in these cases and superiority of wound infiltration, caudal block or regional block over each isn't known.\n\nObjective: The objective of the study was compare regional block, caudal block and wound infiltration for post-operative pain management in children undergoing inguinal herniotomy", 'detailedDescription': 'Three hundred patients rom the department of pediatric surgery, KEMU/Mayo Hospital, were randomized in three study groups by a computer generated table. Regional block group (Group A), wound infiltration group (Group B), caudal block group (Group C). . Patients were assessed for postoperative pain intensity using FLACC pain scale at 0, 1, 2, 4, 8, 24 hours after surgery in children less than 8 years of age. Wong-Baker Faces pain Scale at 0, 1, 2, 4, 8, 24 hours after surgery in children more than 8 years of age. Patients were discharged after 24 hours. If pain score ≥ 4 was given intravenously, Ketoralac. Urinary retention was observed after 24 hours, wound infection was observed after 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both Male and female inguinal hernia patients\n* Patients from 3-12 years age Exclusion Criteria\n* History of allergy to any drugs used in study documented on history .Infection at the site of regional, caudal or local infiltration, documented on clinical examination.\n\n.Irreducible, obstructed or strangulated hernia, documented on clinical examination.'}, 'identificationModule': {'nctId': 'NCT06386250', 'acronym': 'Painseverity', 'briefTitle': 'Comparison of Regional Block, Caudal Block and Wound Infiltration in Inguinal Hernitomy', 'organization': {'class': 'OTHER', 'fullName': 'King Edward Medical University'}, 'officialTitle': 'Comparison of Regional Block, Caudal Block and Wound Infiltration for Post-operative Pain Management in Children Undergoing Inguinal Herniotomy', 'orgStudyIdInfo': {'id': '0005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'In group A, iliohypogastric and ilioinguinal nerves were blocked by using 0.25% bupivacaine 2ml/kg of combined with skin infiltration of adrenaline 1:200 000.', 'interventionNames': ['Procedure: regional block', 'Procedure: Caudal block', 'Procedure: Epidural']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'In group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site.', 'interventionNames': ['Procedure: regional block', 'Procedure: Caudal block', 'Procedure: Epidural']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'In group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1.', 'interventionNames': ['Procedure: regional block', 'Procedure: Caudal block', 'Procedure: Epidural']}], 'interventions': [{'name': 'regional block', 'type': 'PROCEDURE', 'otherNames': ['wound infilteration'], 'description': 'In group A, iliohypogastric and ilioinguinal nerves were blocked by using 0.25% bupivacaine 2ml/kg of combined with skin infiltration of adrenaline 1:200 000.', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}, {'name': 'Caudal block', 'type': 'PROCEDURE', 'otherNames': ['infilteration with 0.25% bupivacaine'], 'description': 'In group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site.', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}, {'name': 'Epidural', 'type': 'PROCEDURE', 'otherNames': ['injection Bupivacaine into epidural space'], 'description': 'In group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1.', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53711', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Muhammad Sharif', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Muhammad Sharif, FCPS', 'role': 'STUDY_CHAIR', 'affiliation': 'King edward Medical University/Mayo Hospital Lahore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'will be shared on request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Edward Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PROFESSOR', 'investigatorFullName': 'Muhammad Sharif', 'investigatorAffiliation': 'King Edward Medical University'}}}}