Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-24 @ 3:32 PM
Study NCT ID:
NCT03967392
Status:
COMPLETED
Last Update Posted:
2019-05-30
First Post:
2019-05-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Bupivacaine Versus Bupivacaine-dexamethasone Infiltration for Postoperative Analgesia in Skin Graft Donor Sites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'DOUBLE BLINDED RANDOMELY CONTROLLED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-26', 'studyFirstSubmitDate': '2019-05-22', 'studyFirstSubmitQcDate': '2019-05-26', 'lastUpdatePostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Rating scale for pain assesment during the first postoperative 12 hours', 'timeFrame': '4 MONTHS', 'description': 'TREATMENT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bupivacaine,dexamethasone,Analgesia,Skin Graft ,Donor'], 'conditions': ['Postoperative Pain Atskin Graft Site']}, 'descriptionModule': {'briefSummary': 'Background: Skin grafting; both partial and complete thickness is frequently used in reconstruction of traumatic soft tissue defects. It is of great value not only for functional and aesthetic purposes in the field of plastic surgery, but also for other surgical specialties.\n\nOf all the problems in the early postoperative period, pain is considered the most important, ameliorating it can lead to significant reduction in postoperative morbidity and faster recovery of the skin donor site.\n\nObjective: To evaluate use of dexamethasone as adjuvant for bupivacaine in subcutaneous local anesthesia infiltration for skin graft donor sites, on quality of pain relief and total dose of analgesic requirements in the early hours postoperatively.\n\nMethods: 97 patients were randomly allocated to receive local bupivacaine infiltration (group LB), or dexamethasone plus bupivacaine (group LB + D) in skin donor site after skin harvesting. In addition to basic demographic data; patients were compared for Numerical Rating Scale (NRS), total dose of morphine or morphine equivalents, time to 1st breakthrough pain, and duration of surgery.\n\nKeywords: Donor site. skin graft. Breakthrough pain. Rescue analgesia. Bupivacaine', 'detailedDescription': 'The patients included in the study were randomly allocated to 1 of 2 parallel groups: 1) bupivacaine plus dexamethasone (LB+D) group (n = 50): received 20 ml bupivacaine 0.5% + 18 ml normal saline + 8 mg dexamethasone 2 ml, 2) bupivacaine only (LB) group (n = 50): received 20 ml bupivacaine 0.5% + 20 ml normal saline. A random allocation sequence was generated electronically using online randomization service from https://www.random.org. The project medicine was prepared by 2 independent assistants not involved in other parts of the study. All persons involved were blinded to the randomized allocation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': '18-75 YEARS', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anesthesiologists Physical Status classification I-II and scheduled for split thickness skin grafting to cover full thickness skin burn or degloving injury after trauma.\n\nExclusion Criteria:\n\n* were inability to cooperate.\n* immunosuppressive therapy.\n* Body Mass Index \\> 35.\n* diabetes.\n* lower-limb neuropathy.\n* daily intake of glucocorticoids or opioids.\n* patients who need area of coverage more than 10 cm2.\n* allergy to any drug used in the study.\n* alcohol or drug abuse.\n* American Society of Anesthesiologists Physical Status classification III or more.'}, 'identificationModule': {'nctId': 'NCT03967392', 'briefTitle': 'Comparison of Bupivacaine Versus Bupivacaine-dexamethasone Infiltration for Postoperative Analgesia in Skin Graft Donor Sites', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Comparison of Bupivacaine Versus Bupivacaine-dexamethasone Infiltration for Postoperative Analgesia in Skin Graft Donor Sites, a Randomized Trial', 'orgStudyIdInfo': {'id': 'Ain Shams UNIVER'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP X(xylocaine)', 'description': '20 ml bupivacaine 0.5% + 20 ml normal saline.', 'interventionNames': ['Drug: Xylocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GROUPX(Dxylocaine and dexamethasone)', 'description': '20 ml bupivacaine 0.5% + 18 ml normal saline + 8 mg dexamethasone 2 ml', 'interventionNames': ['Drug: Xylocaine']}], 'interventions': [{'name': 'Xylocaine', 'type': 'DRUG', 'description': 'TREATMENT', 'armGroupLabels': ['GROUP X(xylocaine)', 'GROUPX(Dxylocaine and dexamethasone)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ramymahrose', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anesthesia at faculty of medicine ain shams university', 'investigatorFullName': 'RAMY AHMED', 'investigatorAffiliation': 'Ain Shams University'}}}}