Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-20 @ 6:35 PM
Study NCT ID:
NCT06684535
Status:
COMPLETED
Last Update Posted:
2025-07-24
First Post:
2024-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2024-11-11', 'studyFirstSubmitQcDate': '2024-11-11', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to the 1st rescue analgesia', 'timeFrame': '48 hours postoperatively', 'description': 'Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated) will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Intraoperative fentanyl consumption', 'timeFrame': 'Intraoperatively', 'description': 'Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline.'}, {'measure': 'Total morphine consumption', 'timeFrame': '48 hours postoperatively', 'description': 'Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) \\> 3 to be repeated after 30 min if pain persists until the NRS \\< 4.'}, {'measure': 'Degree of pain', 'timeFrame': '48 hours postoperatively', 'description': 'Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.'}, {'measure': 'Heart rate', 'timeFrame': 'Every 15 min till the end of surgery', 'description': 'Heart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.'}, {'measure': 'Mean arterial pressure', 'timeFrame': 'Every 15 min till the end of surgery', 'description': 'Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.'}, {'measure': 'Incidence of adverse events', 'timeFrame': '48 hours postoperatively', 'description': 'Incidence of adverse events such as pneumothorax, local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dexmedetomidine', 'Adjuvant', 'External Oblique Intercostal Plane Block', 'Thoracotomy', 'Pain']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the role of dexmedetomidine as an adjuvant in external oblique intercostal plane block for post-thoracotomy pain.', 'detailedDescription': 'External oblique intercostal plane block (EOIPB) is a novel block that has been described as an important modification of the fascial plane blocks that can consistently involve the upper lateral abdominal walls.\n\nDexmedetomidine is a selective alpha 2- adrenoceptor agonist possessing sedative, anxiolytic, and analgesic properties without the development of respiratory depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Both sexes.\n* American Society of Anesthesiology (ASA) physical status I-III.\n* Scheduled for open thoracotomy.\n\nExclusion Criteria:\n\n* Patients with neurological or intellectual disability.\n* Infection at the injection site.\n* Drug abuse.\n* Allergic reaction to local anesthetics.\n* Coagulation abnormalities.\n* Pregnancy.\n* Body Mass Index (BMI) ≥35 kg/m2.\n* Severe cardiovascular problems.\n* Diabetic neuropathy.'}, 'identificationModule': {'nctId': 'NCT06684535', 'briefTitle': 'Dexmedetomidine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Role of Dexmedetomidine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '36264PR904/10/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine group', 'description': 'Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients will receive 29 ml bupivacaine 0.25% + 1 ml saline.', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg.', 'armGroupLabels': ['Dexmedetomidine group']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'Patients will receive 29 ml bupivacaine 0.25% + 1 ml saline.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Mohammed Said ElSharkawy', 'investigatorAffiliation': 'Tanta University'}}}}