Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-02-23 @ 10:03 PM
Study NCT ID:
NCT04790292
Status:
COMPLETED
Last Update Posted:
2021-03-16
First Post:
2021-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Dexamethasone Added to Intra-articular Morphine and Bupivacaine for Post-operative Analgesia After Knee Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-12', 'studyFirstSubmitDate': '2021-03-01', 'studyFirstSubmitQcDate': '2021-03-05', 'lastUpdatePostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analogue score(VAS) at rest and movement', 'timeFrame': 'first 24 hours post operative', 'description': 'visual analogue score(VAS) will be used to measure pain score (VAS score 0 cm= no pain, VAS score 10 cm = worst possible pain) when the patient is fully conscious (0) and at 2, 4, 6, 8, 10, 12, 18, 24 hours post-operatively'}], 'secondaryOutcomes': [{'measure': 'Rescue analgesia time', 'timeFrame': 'first 24 hours post operative', 'description': 'Time to first analgesia requirement (considering the extubation is zero time)'}, {'measure': 'Total analgesic consumption', 'timeFrame': 'first 24 hours post operative', 'description': 'intramuscular diclofenac sodium 75mg will be given as rescue analgesic when VAS ≥ 4. Total diclofenac consumption will be recorded'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dexamethasone', 'Bupivacaine', 'Morphine'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'A randomized double-blinded clinical trial was carried out on 40 patients undergoing knee arthroscopy. Patients were divided randomly into two equal groups. All drugs used were injected intra-articularly at the end of arthroscopy. In the control group, patients were administered 10mg morphine added to bupivacaine 25mg. In the study group, patients were administered 10mg morphine and 8mg dexamethasone added to bupivacaine 25mg. Visual analog score for pain at rest and movement, time to first analgesic request, total analgesic consumption, duration of analgesia and adverse effects were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Minimum Age: 18 years Maximum Age: 65 years Sex: Both Gender Based: No Accepts Healthy Volunteers: No\n\nCriteria:\n\nInclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I and II\n* Scheduled for minor arthroscopic knee surgeries (meniscectomy, chondroplasty, minor ligament repair and diagnostic arthroscopy)\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status above (II)\n* Undergoing major knee surgeries\n* History of allergies to any of the used drugs\n* History of diabetes mellitus\n* Contraindications of morphine use (e.g. asthmatic patient, chronic obstructive pulmonary disease, and addiction)'}, 'identificationModule': {'nctId': 'NCT04790292', 'briefTitle': 'Impact of Dexamethasone Added to Intra-articular Morphine and Bupivacaine for Post-operative Analgesia After Knee Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Impact of Dexamethasone Added to Intra-articular Morphine and Bupivacaine for Post-operative Analgesia After Knee Arthroscopy', 'orgStudyIdInfo': {'id': 'FMASU MS 20/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group M', 'description': 'group M 10mg morphine +0.25% bupivacaine', 'interventionNames': ['Drug: group M']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group MD', 'description': 'group MD 10mg morphine + 8mg dexamethasone +0.25% bupivacaine', 'interventionNames': ['Drug: group MD']}], 'interventions': [{'name': 'group M', 'type': 'DRUG', 'description': '10mg morphine in 5ml normal saline + 10ml of 0.25% bupivacaine ( total volume 15 ml) were injected intra-articularly', 'armGroupLabels': ['group M']}, {'name': 'group MD', 'type': 'DRUG', 'description': '10mg morphine + 8mg dexamethasone completed to 5 ml with normal saline + 10 ml of 0.25% bupivacaine (total volume of 15ml) were injected intra-articularly', 'armGroupLabels': ['group MD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Heba F Abd El-Aziz Toulan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Heba Fouad Abd El-Aziz Toulan', 'investigatorAffiliation': 'Ain Shams University'}}}}