Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-05 @ 6:18 AM
Study NCT ID:
NCT02973451
Status:
COMPLETED
Last Update Posted:
2018-09-05
First Post:
2016-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Guided Transversus Abdominis Plane Block Versus Trocar Site Infiltration in Gynecologic Laparoscopy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-03', 'studyFirstSubmitDate': '2016-11-22', 'studyFirstSubmitQcDate': '2016-11-23', 'lastUpdatePostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Scores', 'timeFrame': '24 Hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Post Operative Local Anaesthesia']}, 'descriptionModule': {'briefSummary': 'to compare between Laparoscopic Guided Transversus Abdominis Plane Block and Trocar Site Infiltration as postoperative analgesia in Gynecologic Laparoscopic surgery.', 'detailedDescription': 'two groups of patients who are eligible for Gynecologic Laparoscopy were randomized to either Laparoscopic Guided Transversus Abdominis Plane Block or Trocar Site Infiltration at the end of the operation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients Need Gynecologic Laparoscopy\n\nExclusion Criteria:\n\n* diagnosed with chronic pain syndrome\n* have a postoperative intraperitoneal drain\n* necessitating alteration to laparotomy.'}, 'identificationModule': {'nctId': 'NCT02973451', 'briefTitle': 'Laparoscopic Guided Transversus Abdominis Plane Block Versus Trocar Site Infiltration in Gynecologic Laparoscopy.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Laparoscopic Guided Transversus Abdominis Plane Block Versus Trocar Site Local Anesthetic Infiltration in Gynecologic Laparoscopy.', 'orgStudyIdInfo': {'id': '3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic', 'description': 'Laparoscopic Guided Transversus Abdominis Plane Block using Bupivacaine', 'interventionNames': ['Drug: Laparoscopic Guided Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'local', 'description': 'Trocar Site Infiltration of Bupivacaine', 'interventionNames': ['Drug: local Bupivacaine']}], 'interventions': [{'name': 'Laparoscopic Guided Bupivacaine', 'type': 'DRUG', 'otherNames': ['marcaine'], 'description': 'Bupivacaine Laparoscopic GuidedTransversus Abdominis Plane Block', 'armGroupLabels': ['Laparoscopic']}, {'name': 'local Bupivacaine', 'type': 'DRUG', 'otherNames': ['marcaine'], 'description': 'Bupivacaine Trocar Site Infiltration', 'armGroupLabels': ['local']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Zagazig University', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'ibrahim A el sharkwy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zagazig University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'IBRAHIM ABD ELGAFOR', 'investigatorAffiliation': 'Zagazig University'}}}}