Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:46 AM
Study NCT ID:
NCT05691933
Status:
UNKNOWN
Last Update Posted:
2023-01-25
First Post:
2023-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Regional Block for Upper Abdominal Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-21', 'studyFirstSubmitDate': '2023-01-11', 'studyFirstSubmitQcDate': '2023-01-11', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative morphine requirements for 24 hours', 'timeFrame': '24 hours postoperatively', 'description': 'Visual analogue score will be measured every 2 hours'}], 'secondaryOutcomes': [{'measure': 'Pain assessment', 'timeFrame': '24 hours postoperatively', 'description': 'Visual analogue score will be assessed every 2hours postoperatively'}, {'measure': 'Rescue analgesia', 'timeFrame': '24 hours postoperatively', 'description': '0.5 microgram/kg fentanyl will be given if VAS score more than 4'}, {'measure': 'Side effects', 'timeFrame': '24 hours postoperatively', 'description': 'Any side effect related to fentanyl or block'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perioperative Analgesia in Major Upper Abdominal Surgery']}, 'referencesModule': {'references': [{'pmid': '24918191', 'type': 'BACKGROUND', 'citation': 'Hughes M, McNally S, McKeown DW, Wigmore S. Effect of analgesic modality on outcome following open liver surgery: a systematic review of postoperative analgesia. Minerva Anestesiol. 2015 May;81(5):541-56. Epub 2014 Jun 11.'}, {'pmid': '25484494', 'type': 'BACKGROUND', 'citation': 'Rosero EB, Cheng GS, Khatri KP, Joshi GP. Evaluation of epidural analgesia for open major liver resection surgery from a US inpatient sample. Proc (Bayl Univ Med Cent). 2014 Oct;27(4):305-12. doi: 10.1080/08998280.2014.11929141.'}]}, 'descriptionModule': {'briefSummary': 'Pain control after major upper abdominal surgeries is an essential step to guard against postoperative complications such as lung atelectasis. This major step can be achieved by opioids or regional blocks.\n\nRegional blocks allow better pain control and avoid side effects of opioid based pain control', 'detailedDescription': 'Ultrasound guided External oblique intercostal plane block for perioperative analgesia in major upper abdominal surgery: Prospective randomized controlled study\n\nIntroduction:\n\nPain control is a vital component to achieve enhanced recovery after major upper abdominal surgery. Effective postoperative pain control will reduce the incidence of numerous postoperative complications, can facilitate early mobilization and may result in earlier recovery.\n\nPain control is historically achieved by the administration of opioids, which is associated with well-documented side effects, such as sedation, respiratory depression, pruritus, hallucinations and postoperative nausea and vomiting (PONV). Epidural analgesia, another routinely used analgesic technique, offers equivalent or superior pain scores when compared to conventional systemic opioids. Enhanced recovery following major upper abdominal surgery has gained attention even though there is limited evidence on the efficacy and effectiveness of existing analgesic techniques.\n\nThe external oblique intercostal plane block is a new modality that will be used to improve pain-related outcomes after major upper abdominal surgeries, and has not been extensively investigated. Therefore, we will test the hypothesis that external oblique intercostal plane block can reduce cumulative opioid consumption for the patients undergoing major upper abdominal surgery when added to conventional multi-model intravenous analgesic technique.\n\nThe aim of this prospective comparative investigation is to assess the impact of external oblique intercostal plane block in a multimodal perioperative analgesic regimen and any related side effects in patients undergoing major upper abdominal surgery.\n\nPatients and Methods:\n\nA prospective study will be carried out in Alexandria Main University Hospital on 120 American society of anaesthesiologists (ASA) II, III physical status aged 20-60 years scheduled for major upper abdominal surgery, after approval of the Medical Ethics Committee and an informed written consent. Patients will be categorized into two equal groups, group I (60) will be subjected to bilateral external oblique intercostal plane block and group II (60) will be subjected to morphine infusion at a rate of 0.03mg/kg/h. During the patient stay in the ICU, total analgesic requirements will be measured in both groups. Also, sedation level, duration of intubation and length of ICU stay will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing upper abdominal surgeries\n\nExclusion Criteria:\n\n* BMI above 40\n\n * allergy for drugs used\n * complicated cases\n * patient refusal\n * chronic opioid use\n * cognitive dysfunction\n * chronic kidney disease\n* Liver failure'}, 'identificationModule': {'nctId': 'NCT05691933', 'briefTitle': 'Regional Block for Upper Abdominal Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Ultrasound Guided External Oblique Intercostal Plane Block for Perioperative Analgesia in Major Upper Abdominal Surgery: Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': '0305400'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Block group', 'description': 'Patients will be subjected to bilateral external oblique intercostal plane block', 'interventionNames': ['Procedure: Block group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Opioid group', 'description': 'Patients will be subjected to morphine infusion at a rate of 0.03mg/kg/h', 'interventionNames': ['Procedure: Morphine infusion']}], 'interventions': [{'name': 'Block group', 'type': 'PROCEDURE', 'description': 'Patient will be subjected to bilateral external oblique intercostal plane block', 'armGroupLabels': ['Block group']}, {'name': 'Morphine infusion', 'type': 'PROCEDURE', 'description': 'Patients will be subjected to morphine infusion at a rate of 0.03mg/kg/h', 'armGroupLabels': ['Opioid group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Abdelmawla, MD', 'role': 'CONTACT', 'email': 'M_abdelmawla12@alexmed.edu.eg', 'phone': '+201114748411'}, {'name': 'Maha Ghanem, MD', 'role': 'CONTACT', 'email': 'Ghanemmaha@yahoo.com', 'phone': '+20127498435'}]}, 'ipdSharingStatementModule': {'url': 'http://www.alexu.edu.eg', 'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'One year', 'ipdSharing': 'YES', 'description': 'Data will be shared on request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}