Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT05037994
Status:
COMPLETED
Last Update Posted:
2021-11-16
First Post:
2021-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suprascapular Nerve Block With Oral Gabapentin For Pain Management In Frozen Shoulder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000077206', 'term': 'Gabapentin'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-14', 'studyFirstSubmitDate': '2021-09-03', 'studyFirstSubmitQcDate': '2021-09-03', 'lastUpdatePostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The total dose of diclofenac sodium', 'timeFrame': '6 weeks', 'description': 'Indicator for analgesia required'}], 'primaryOutcomes': [{'measure': 'Visual analogue scale', 'timeFrame': '6 weeks', 'description': '10cm line where zero means no pain and ten means worse imaginary pain'}], 'secondaryOutcomes': [{'measure': 'Range of passive and active movements', 'timeFrame': '6 weeks', 'description': 'by goniometer'}, {'measure': 'Patients satisfaction', 'timeFrame': '6 weeks', 'description': 'by questionnaire with 3 degrees\n\n1. Fair\n2. Good\n3. Excellent'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Shoulder']}, 'descriptionModule': {'briefSummary': 'The patients will be randomly allocated into two equal groups (each 20 patients) using sealed opaque numbered envelopes:\n\nControl Group (C Group) : Patients receive continuous US suprascapular nerve block only.\n\nGabapentin Group (G Group) : Patients receive continuous US suprascapular nerve block with oral gabapentin 300 mg once daily at bed time.\n\nBoth groups compared as regard:\n\nVisual Analogue Scale Range of passive and active movements Patients satisfaction complication related to block The total dose of diclofenac sodium'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index ≥ 18 Kg/m2 ≤ 30Kg/m2\n* ASA I, II or III.\n* Cooperative patients.\n\nExclusion Criteria:\n\n* local infection at site of injection.\n* coagulopathy\n* previous history of mental disorders or chronic drug abuse (opioids, tranquilizers)\n* known hypersensitivity to any of the drugs used in the study.'}, 'identificationModule': {'nctId': 'NCT05037994', 'briefTitle': 'Suprascapular Nerve Block With Oral Gabapentin For Pain Management In Frozen Shoulder', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Ultrasound Guided Continuous Suprascapular Nerve Block With Oral Gabapentin For Pain Management In Patients With Frozen Shoulder', 'orgStudyIdInfo': {'id': '6909'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group (C Group)', 'description': 'Patients will receive continuous US suprascapular nerve block only.', 'interventionNames': ['Procedure: Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine']}, {'type': 'EXPERIMENTAL', 'label': 'Gabapentin Group (G Group)', 'description': 'Patients will receive continuous US suprascapular nerve block with oral gabapentin 300 mg once daily at bed time.', 'interventionNames': ['Procedure: Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine']}], 'interventions': [{'name': 'Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine', 'type': 'PROCEDURE', 'otherNames': ['Oral gabapentin 300 mg at bed time in GG'], 'description': 'The high frequency linear ultrasound transducer (Sonosite 6-13 MHz) in a transverse orientation will be placed over the scapular Spine.\n\nMoving the transducer cephalad the suprascapular fossa will be identified. 18 gauge touhy needle will be inserted in plane after subcutaneous local anesthesia infiltration with 1 ml lidocaine 2% Real-time imaging will be used to direct injection of 2 ml lidocaine 2% to test perineural spread of injectate after confirmation of the position of tip of needle injection of 40mg methyl prednisolone diluted in 5 ml bupivacaine 0.5% will be done through the needle to anesthetize the nerve and create space for catheter insertion. After catheter insertion another 2 ml lidocaine 2% will be injected through the catheter to confirm position perineural in the scapular notch. Lastly Catheter will be fixed via skin tunnel and secured with skin sutures and adhesive tap.', 'armGroupLabels': ['Control Group (C Group)', 'Gabapentin Group (G Group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Amr Shaaban Elshafei', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'AHMAD S HEGAB, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant professor of Anesthesia & Surgical Intensive Care Faculty of Medicine - Zagazig University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'AMR SHAABAN ELSHAFEI', 'investigatorFullName': 'Amr Shaaban Elshafei', 'investigatorAffiliation': 'Zagazig University'}}}}