Nctid:
NCT06224179
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M4109", "name"=>"Anesthetics, Local", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>40}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-06-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-29", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-05-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"postoperative analgesia (VAS) during the 1st 24 hours in ICU", "timeFrame"=>"24 hours", "description"=>"Pain will be assessed on admission and at 2, 4, 8, 12 and 24 hours at rest and with passive flexion of hip and knee joint using visual analogue scale (VAS) ranging from 0 for no pain to 10 for worst pain."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Analgesia"]}, "descriptionModule"=>{"briefSummary"=>"Inadequately managed acute pain following abdominal surgery originates from somatic pain signals in the abdominal wall and is linked to various unfavorable postoperative outcomes. These consequences encompass patient distress, respiratory complications, delirium, myocardial ischemia, extended hospital stays, an elevated risk of chronic pain, heightened analgesic consumption, delayed bowel function, and an increased need for rescue analgesics.\n\nThis study aims to assess the postoperative analgesic efficacy of ultrasound-guided Transversus Abdominis Plane (TAP) block using oblique subcostal and posterior approaches in hepatectomy.", "detailedDescription"=>"Pain control is vital to achieve enhanced recovery after abdominal surgeries . TAP block had been demonstrated to improve pain related outcomes after abdominal surgeries.\n\nPostoperative pain management for patients undergoing hepatic resection is a challenge due to the risk of perioperative liver dysfunction.TAP block is a promising regional analgesic technique. This study aimed to evaluate the effect of US-guided subcostal approach versus combination of both subcostal and posterior approaches of TAP block\n\nThe patients will be randomly divided into two groups :\n\ngroup A will recieve oblique subcostal TAP block and group B will recieve both subcostal and posterior TAP block ."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"50 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* ASA I and II patients. aged 18 to 50 years. 70 to 80 kg.\n\nExclusion Criteria:\n\n* patients under 18 years of age.\n\n * History of Allergic reactions to study drugs.\n * Opioid or analgesic abuse, and chronic treatment with opioids, or non-steroidal anti-inflammatory drugs.\n * History of bleeding tendency or coagulopathy ."}, "identificationModule"=>{"nctId"=>"NCT06224179", "acronym"=>"U/STAP", "briefTitle"=>"Role of Ultrasound Guided Transversus Abdominis Plane Block in Pain Control After Hepatectomy", "organization"=>{"class"=>"OTHER", "fullName"=>"Ain Shams University"}, "officialTitle"=>"Ultrasound Guided Oblique Subcostal Transversus Abdominis Plane Block(TAP) Versus Both Subcostal and Posterior TAP Block as Postoperative Analgesia in Hepatectomy", "orgStudyIdInfo"=>{"id"=>"M S 96/2021"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Group A", "description"=>"Group A received ultrasound guided subcostal TAP block with 30 ml of local anesthetics and additives", "interventionNames"=>["Procedure: ultrasound guided subcostal TAP block"]}, {"type"=>"EXPERIMENTAL", "label"=>"Group B", "description"=>"Group B received ultrasound guided both subcostal and posterior TAP block with 30 ml of local anesthetics and additives at each side", "interventionNames"=>["Procedure: ultrasound guided combined posterior and subcostal TAP block"]}], "interventions"=>[{"name"=>"ultrasound guided subcostal TAP block", "type"=>"PROCEDURE", "description"=>"patients will be randomly divided into two groups using a computer generated random number chart.\n\nGroup A received ultrasound guided subcostal TAP block,", "armGroupLabels"=>["Group A"]}, {"name"=>"ultrasound guided combined posterior and subcostal TAP block", "type"=>"PROCEDURE", "description"=>"patients will be randomly divided into two groups using a computer generated random number chart.\n\nGroup B received ultrasound guided combined posterior and subcostal TAP block,", "armGroupLabels"=>["Group B"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Ahmed El-Dolah, lecturer of Anesthesia", "role"=>"CONTACT", "email"=>"a_wagih82@yahoo.com", "phone"=>"+20111113077"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Ain Shams University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"lecturer of anesthesia", "investigatorFullName"=>"Ahmed wagih Ezzat deusouky", "investigatorAffiliation"=>"Ain Shams University"}}}}
