Nctid:
NCT06230575
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M5220", "name"=>"Breast Neoplasms", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>100}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-02", "completionDateStruct"=>{"date"=>"2025-07-25", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-02-18", "studyFirstSubmitDate"=>"2024-01-21", "studyFirstSubmitQcDate"=>"2024-01-21", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-20", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-06-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"time to receive first postoperative analgesic", "timeFrame"=>"First 24 hours postoperatively", "description"=>"time to first dose of rescue opioid analgesic"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Analgesia"]}, "descriptionModule"=>{"briefSummary"=>"Breast surgeries are common operative procedures that require appropriate postoperative analgesia.", "detailedDescription"=>"Numerous pain relief techniques, including several new regional anesthesia techniques, are available for control of acute pain after breast surgery."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "genderBased"=>true, "genderDescription"=>"Female patients with breast cancer", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* female cancer breast patient\n* age from 18- 65\n\nExclusion Criteria:\n\n* coagulation defect\n* Patient refusal\n* abnormal kidney and or liver function tests"}, "identificationModule"=>{"nctId"=>"NCT06230575", "briefTitle"=>"Locoregional Blocks for Breast Cancer Surgeries", "organization"=>{"class"=>"OTHER", "fullName"=>"National Cancer Institute, Egypt"}, "officialTitle"=>"Locoregional Blocks for Breast Cancer Surgeries", "orgStudyIdInfo"=>{"id"=>"AP2312-301-072"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"erector spinae block", "interventionNames"=>["Procedure: erector spinae block"]}, {"type"=>"EXPERIMENTAL", "label"=>"retrolaminar block", "interventionNames"=>["Procedure: retrolaminar block"]}, {"type"=>"EXPERIMENTAL", "label"=>"serratus anterior block", "interventionNames"=>["Procedure: serratus anterior block"]}, {"type"=>"EXPERIMENTAL", "label"=>"pectoral nerve block", "interventionNames"=>["Procedure: pectoral nerve block"]}], "interventions"=>[{"name"=>"erector spinae block", "type"=>"PROCEDURE", "description"=>"Erector spinae plane block", "armGroupLabels"=>["erector spinae block"]}, {"name"=>"retrolaminar block", "type"=>"PROCEDURE", "description"=>"Retrolaminar block", "armGroupLabels"=>["retrolaminar block"]}, {"name"=>"serratus anterior block", "type"=>"PROCEDURE", "description"=>"Serratus anterior plane block", "armGroupLabels"=>["serratus anterior block"]}, {"name"=>"pectoral nerve block", "type"=>"PROCEDURE", "description"=>"Pectoral nerve block", "armGroupLabels"=>["pectoral nerve block"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"11796", "city"=>"Cairo", "status"=>"RECRUITING", "country"=>"Egypt", "contacts"=>[{"name"=>"Walaa Y Elsabeeny, MD", "role"=>"CONTACT", "email"=>"Walaa.elsabeeny@nci.cu.edu.eg", "phone"=>"+201007798466", "phoneExt"=>"+2"}], "facility"=>"Walaa Y Elsabeeny", "geoPoint"=>{"lat"=>30.06263, "lon"=>31.24967}}], "centralContacts"=>[{"name"=>"Walaa Y Elsabeeny, MD", "role"=>"CONTACT", "email"=>"Walaa.elsabeeny@nci.cu.edu.eg", "phone"=>"+201007798466", "phoneExt"=>"+2"}], "overallOfficials"=>[{"name"=>"Walaa Y Elsabeeny, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Assistant professor of Anesthesia, Surgical critical care and Pain Management, National Cancer Institute, Cairo University"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Cancer Institute, Egypt", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Assistant professor of Anesthesia, Surgical Critical care and Pain management", "investigatorFullName"=>"Walaa Youssef Elsabeeny", "investigatorAffiliation"=>"National Cancer Institute, Egypt"}}}}
