Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-01-04 @ 12:57 PM
Study NCT ID:
NCT05624866
Status:
UNKNOWN
Last Update Posted:
2023-10-31
First Post:
2022-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine Versus Triamcinolone Treatment in Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D014221', 'term': 'Triamcinolone'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment Investigate if, and to what extent,carapl tunnel hydro-dissection using DEX or triamcinolone (TM) along with saline, under ultrasound guidance, can improve the clinical condition, change in nerve conduction parameters of patients with CTS and delay or avoid the surgical intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2022-10-31', 'studyFirstSubmitQcDate': '2022-11-14', 'lastUpdatePostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain visual analoge scale visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain', 'timeFrame': '6 months', 'description': 'visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain'}], 'secondaryOutcomes': [{'measure': 'change of cross sectional area of the median nerve', 'timeFrame': '6 months', 'description': 'change of cross sectional area of the median nerve mm2'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'Carpal tunnel syndrome (CTS) is a common mononeuropathy due to entrapment of the median nerve in the carpal tunnel. a lot of modalities are available for treatment of mild to moderate CTS.', 'detailedDescription': 'Carpal tunnel syndrome (CTS) is a common mononeuropathy due to entrapment of the median nerve in the carpal tunnel. a lot of modaleties are available for treatment of mild to moderate CTS.\n\nIn case of failed conservative oral therapey, local hydro-dessction of the median nerve can be done with saline alone. local anethetics, steroids, hyalase,and ozone have been utilized to augment the symptoms reliefe.\n\nDexmeditomidine (DEX) has been studied as adjuvant for nerve block to aumnet the pain reliefe. Recently, it has been discovered that DEX can offer some antinflammatory effects when injected in the perineural area. Upon such discovery, the goal of this study has been built.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients\n* complaining of carpal tunnel syndrome of 3 month duration or more\n* diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study\n\nExclusion Criteria:\n\n* patient refusal\n* infection at the site of intervention\n* allergy to utilized drugs\n* diabetic\n* previous surgery in the site of injection\n* previous injection in the targeted site within the last year'}, 'identificationModule': {'nctId': 'NCT05624866', 'briefTitle': 'Dexmedetomidine Versus Triamcinolone Treatment in Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Dexmedetomidine Versus Triamcinolone Local Injection for Pain Alleviation in Patients With Carpal Tunnel Syndrome; A Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': '17200681'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmeditomidine group', 'description': 'injection of 1 microgram/kg dexmeditomidine + 10 cc saline injection nearby median nerve as hydro-dissection', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triamcinolone group', 'description': 'injection of 40 mg triamcinolone + 10 cc saline injection nearby median nerve as hydro-dissection', 'interventionNames': ['Drug: Triamcinolone']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'injection of 1 microgram/kg dexmeditomidine + 10 cc saline injection nearby median nerve as hydro-dissection', 'armGroupLabels': ['Dexmeditomidine group']}, {'name': 'Triamcinolone', 'type': 'DRUG', 'description': 'injection of 40 mg triamcinolone + 10 cc saline injection nearby median nerve as hydro-dissection', 'armGroupLabels': ['Triamcinolone group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Emad Said, Professor', 'role': 'CONTACT', 'email': 'emadzarief@aun.edu.eg', 'phone': '01007046058'}, {'name': 'Rafeek Aziz, Assistant lecturer', 'role': 'CONTACT', 'email': 'rafeek_aziz@med.aun.du.eg', 'phone': '01006018620'}], 'facility': 'Assiut Universit Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Emad Zarief , MD', 'investigatorAffiliation': 'Assiut University'}}}}