Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT04782960
Status:
UNKNOWN
Last Update Posted:
2021-03-04
First Post:
2021-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Subconjunctival Bupivacaine in Strabismus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2021-02-16', 'studyFirstSubmitQcDate': '2021-03-02', 'lastUpdatePostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '24 hours postoperatively', 'description': 'Will be evaluated according to satisfaction score (poor=0, fair=1, good=2, excellent=3)'}, {'measure': 'Visual analog scale (VAS) pain score', 'timeFrame': '30 minutes after extubation', 'description': 'Range, 0\\_10;0,no pain ;10,worst pain'}, {'measure': 'Visual analog scale (VAS) pain score', 'timeFrame': '60 minutes after extubation', 'description': 'Range, 0\\_10;0,no pain ;10,worst pain'}, {'measure': 'Visual analog scale (VAS) pain score', 'timeFrame': '2 hours after extubation', 'description': 'Range, 0\\_10;0,no pain ;10,worst pain'}, {'measure': 'Visual analog scale (VAS) pain score', 'timeFrame': '4 hours after extubation', 'description': 'Range, 0\\_10;0,no pain ;10,worst pain'}, {'measure': 'Visual analog scale (VAS) pain score', 'timeFrame': '6 hours after extubation', 'description': 'Range, 0\\_10;0,no pain ;10,worst pain'}, {'measure': 'Visual analog scale (VAS) pain score', 'timeFrame': '12 hours after extubation', 'description': 'Range, 0\\_10;0,no pain ;10,worst pain'}, {'measure': 'Visual analog scale (VAS) pain score', 'timeFrame': '24 hours after extubation', 'description': 'Range, 0\\_10;0,no pain ;10,worst pain'}], 'primaryOutcomes': [{'measure': 'Visual analog scale (VAS) pain score', 'timeFrame': '5 minutes after extubation', 'description': 'Range, 0\\_10;0,no pain ;10,worst pain'}], 'secondaryOutcomes': [{'measure': 'Nausea and vomiting', 'timeFrame': '24 hours postoperatively', 'description': 'Operation related side effect'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Subconjunctival bupivacaine.', 'Strabismus surgery.', 'Postoperative analgesia.'], 'conditions': ['Anesthesia, Local']}, 'descriptionModule': {'briefSummary': 'This study aimed to assess the effectiveness of the Subconjunctival bupivacaine on postoperative pain in Strabismus surgery under general anaesthesia.', 'detailedDescription': '40 patients will schedule for elective Strabismus surgery under general anaesthesia and randomly allocated into two groups to receive Subconjunctival 0.5%Bupivacaine group(B) or Subconjunctival placebo 0.9% normal saline group at the end of the surgery and assess the postoperative pain at 0th,30th, 60th,2nd h, 4h,6h,12h,24h.and post operative nausea and vomiting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients aged 14 \\_30 years old with body mass index 18\\_28kg/m.\n* American Anaesthesiologist Association physical states I,II.\n* singed informed consent to participate in the study and were scheduled for strabismus operations under general anaesthesia.\n\nExclusion Criteria:\n\n* were patients with chronic pain.\n* ocular hypertension.\n* inability to communicate.\n* history of hematological disease.\n* allergy to local anesthetic drugs.'}, 'identificationModule': {'nctId': 'NCT04782960', 'briefTitle': 'Subconjunctival Bupivacaine in Strabismus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University'}, 'officialTitle': 'The Effect of Subconjunctival Bupivacaine Injection in Squint Surgery for Postoperative Analgesia', 'orgStudyIdInfo': {'id': 'Subconjunctival bupivacaine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '20 patients receive Subconjunctival bupivacaine of the end of the surgery', 'description': '20 patients receive Subconjunctival bupivacaine in the end of operation and monitoring postoperative pain score', 'interventionNames': ['Drug: Iocal anaesthetic bupivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '20 patients receive Subconjunctival placebo in the end of operation', 'description': '20 patients receive Subconjunctival placebo in the end of operation and monitoring postoperative pain score', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Iocal anaesthetic bupivacaine', 'type': 'DRUG', 'otherNames': ['Group (p)'], 'description': 'Local anaesthetic Subconjunctival bupivacaine', 'armGroupLabels': ['20 patients receive Subconjunctival bupivacaine of the end of the surgery']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Group (s)'], 'description': '0.9 saline', 'armGroupLabels': ['20 patients receive Subconjunctival placebo in the end of operation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Abeer Sh Goda', 'role': 'CONTACT', 'email': 'Asg06@fayoum.edu.eg', 'phone': '01005151706'}, {'name': 'Amr H Mahmoud, Msc', 'role': 'CONTACT', 'email': 'Ah1240@fayoum.edu.eg', 'phone': '01004349592', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'Mohammad A Hamed, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fayoum University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecture of Anesthesiology', 'investigatorFullName': 'abeer shaban', 'investigatorAffiliation': 'Fayoum University'}}}}