Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT06537518
Status:
COMPLETED
Last Update Posted:
2024-08-05
First Post:
2024-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Difference Between Using Local and General Dexamethasone in Arthroscopic Anterior Cruciate Ligament Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2024-07-26', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) post-arthroscopic ACL management.', 'timeFrame': '6 months', 'description': 'Value of administration of dexamethasone enhancing the analgesic action of bupivacaine used in ACB after arthroscopic management of the ACL.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ACL Injury']}, 'descriptionModule': {'briefSummary': 'Arthroscopic knee injuries, such as the anterior cruciate ligament (ACL) injury, are common and often result in postoperative pain. Regional anesthetic techniques, such as femoral nerve block (FNB) and adductor canal block (ACB), can help alleviate pain and reduce opioid consumption. ACB, which blocks the saphenous nerve and obturator nerve branches, is preferred over FNB due to its potential to decrease mobility and increase falls risk. Dexamethasone, a potent glucocorticoid, is used as an adjuvant for ACB, but its perineural administration may carry neurotoxicity risks. Some pain physicians prefer intravenous administration to prolong the action of local anesthetics used in peripheral nerve blocks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with ACL injury;\n* Patients in class I, II according to American Society of Anesthesiologists (ASA) classification.\n\nExclusion Criteria:\n\n* Patients free of all Inclusion Criteria.'}, 'identificationModule': {'nctId': 'NCT06537518', 'briefTitle': 'The Difference Between Using Local and General Dexamethasone in Arthroscopic Anterior Cruciate Ligament Repair', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Adductor Canal Block With Dexamethasone Versus Adductor Canal Block With Systemic Dexamethasone in Arthroscopic Anterior Cruciate Ligament Repair', 'orgStudyIdInfo': {'id': 'RC 43-11-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IV anesthetic Group', 'interventionNames': ['Drug: Dexamethasone injection', 'Drug: Bupivacaine 0.375% Injectable Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Local anesthetic Group', 'interventionNames': ['Drug: Dexamethasone injection', 'Drug: Bupivacaine 0.5% Injectable Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Drug: Bupivacaine 0.375% Injectable Solution']}], 'interventions': [{'name': 'Dexamethasone injection', 'type': 'DRUG', 'description': 'Dexamethasone, a potent glucocorticoid, decreases the inflammatory response, tissue damage, and pain after surgical procedures; which can be injected locally or Intravenously.', 'armGroupLabels': ['IV anesthetic Group', 'Local anesthetic Group']}, {'name': 'Bupivacaine 0.375% Injectable Solution', 'type': 'DRUG', 'description': 'Isobaric bupivacaine (0.375%) is injected into the adductor canal deeply to the sartorius muscle around the saphenous nerve after ensuring negative aspiration space.', 'armGroupLabels': ['Control Group', 'IV anesthetic Group']}, {'name': 'Bupivacaine 0.5% Injectable Solution', 'type': 'DRUG', 'description': '20 ml of Bupivacain 0.5% was mixed with dexamethasone 8 mg is injected into the adductor canal deeply to the sartorius muscle around the saphenous nerve after ensuring negative aspiration space.', 'armGroupLabels': ['Local anesthetic Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'El Qalyoubia', 'country': 'Egypt', 'facility': 'Benha faculty of Medicine', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesiology, Pain, and ICU Department', 'investigatorFullName': 'Mahmoud Sharara', 'investigatorAffiliation': 'Benha University'}}}}