Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT05663658
Status:
COMPLETED
Last Update Posted:
2023-05-26
First Post:
2022-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
External Oblique Intercostal Plane Block for Laparoscopic Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-25', 'studyFirstSubmitDate': '2022-12-15', 'studyFirstSubmitQcDate': '2022-12-15', 'lastUpdatePostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption', 'timeFrame': 'Postoperative 24 hours', 'description': 'The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.'}], 'secondaryOutcomes': [{'measure': 'Postoperative visual analog scale scores', 'timeFrame': 'Postoperative 24 hours', 'description': 'Postoperative pain will be assessed using a visual analog scale (VAS) (from 0 = no pain to 10 = maximum possible pain) for the first 24 hours.'}, {'measure': 'Time to first rescue analgesic', 'timeFrame': 'postoperative 24 hours', 'description': 'The time for administration of first rescue analgesic will be recorded.'}, {'measure': 'Rescue analgesic drug consumption', 'timeFrame': 'postoperative 24 hours', 'description': 'The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours.'}, {'measure': 'Incidence of postoperative nausea and vomiting', 'timeFrame': 'postoperative 24 hours', 'description': 'Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Analgesia', 'Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '38499943', 'type': 'DERIVED', 'citation': 'Kavakli AS, Sahin T, Koc U, Karaveli A. Ultrasound-Guided External Oblique Intercostal Plane Block for Postoperative Analgesia in Laparoscopic Sleeve Gastrectomy: A Prospective, Randomized, Controlled, Patient and Observer-Blinded Study. Obes Surg. 2024 May;34(5):1505-1512. doi: 10.1007/s11695-024-07174-9. Epub 2024 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'The external oblique intercostal (EOI) plane block is a novel approach upper abdominal wall analgesia. The EOI plane block can provide dermatomal sensory blockade of T6-T10 at the anterior axillary line and T6-T9 at the midline. It may be used for postoperative analgesia in obese patients because it is superficial and rapidly identifiable and performed in the supine position. the aim of this study is to investigate the postoperative analgesic efficacy of external oblique intercostal plane block in obese patients undergoing laparoscopic sleeve gastrectomy.\n\nResearchers will compare the external oblique intercostal plane block group with control group to see if the EOI plane block is effective for postoperative analgesia in patients undergoing sleeve gastrectomy.', 'detailedDescription': 'Patients scheduled for elective laparoscopic sleeve gastrectomy will be separated into 2 groups: Control Group and External Oblique Intercostal Plane Block Group. Patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia. Patients in External Oblique Intercostal Plane Block Group will be performed bilateral External Oblique Intercostal Plane Block before the surgery and received patient controlled analgesia with morphine for postoperative analgesia. Morphine consumption for first postoperative 24 hours, visual analog scale scores, time to need for first rescue analgesia, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 80 years\n* Patients with American Society of Anesthesiology (ASA) physical status II-III\n* Patients scheduled for a laparoscopic sleeve gastrectomy\n\nExclusion Criteria:\n\n* Allergy to local anesthetics\n* Coagulopathy\n* Skin infection at the EOI Plane Block area\n* Advanced hepatic or renal failure\n* Chronic pain syndromes\n* Alcohol or drug abuse\n* Severe pulmonary and/or cardiovascular disease\n* Psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT05663658', 'briefTitle': 'External Oblique Intercostal Plane Block for Laparoscopic Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Istinye University'}, 'officialTitle': 'External Oblique Intercostal Plane Block for Postoperative Analgesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': 'anestezi1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'The patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia', 'interventionNames': ['Other: Intravenous morphine patient control device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'External oblique intercostal plane block group', 'description': 'The patients in external oblique intercostal plane block group will be received EOI plane block and patient controlled analgesia with morphine for postoperative analgesia', 'interventionNames': ['Other: Intravenous morphine patient control device', 'Other: External oblique intercostal plane block']}], 'interventions': [{'name': 'Intravenous morphine patient control device', 'type': 'OTHER', 'description': '24-hour morphine consumption will be recorded', 'armGroupLabels': ['Control group', 'External oblique intercostal plane block group']}, {'name': 'External oblique intercostal plane block', 'type': 'OTHER', 'description': 'External oblique intercostal plane block will be administered before the surgery.', 'armGroupLabels': ['External oblique intercostal plane block group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istinye University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Ali Sait Kavakli, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istinye University'}, {'name': 'Taylan Sahin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istinye University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istinye University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}