Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 5:13 PM
Study NCT ID:
NCT04783194
Status:
COMPLETED
Last Update Posted:
2022-12-21
First Post:
2021-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexamethasone Plus Bupivacaine Versus Bupivacaine in Bilateral Trans-incisional Paravertebral Block in Lumbar Spine Surgeries .
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-20', 'studyFirstSubmitDate': '2021-02-28', 'studyFirstSubmitQcDate': '2021-03-03', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First time to analgesic requirement', 'timeFrame': '1st 24 hour', 'description': 'After extubation, an IV PCA system will be connected to the patient (Accufuser Plus® 100 mL: Woo Young Medical Co, Korea). PCA will be prepared with 60 mL of normal saline containing 60 mg of morphine, and the system will be programmed to give a 0.5 mL bolus dose with a lockout interval of 8 min. basal rate will not be present. PCA will be discontinued at 24 h after surgery, and at that time, oral analgesics begin.'}], 'secondaryOutcomes': [{'measure': 'Total opioid consumption .', 'timeFrame': '1st 24 hour', 'description': 'Total opioid consumption in the first 24 h postoperatively .'}, {'measure': 'Visual analogue scale (VAS)', 'timeFrame': '1st 24 hours postoperatively', 'description': 'Pain scores will be evaluated by a blinded observer anesthesiologist at the time of arrival in the PACU and 10, 20, and 30 min and 1, 2, 4, 6, 12, and 24 h thereafter using a visual analog scale (VAS) (ranging from0-10 cm: where 0 = no pain, 10 = worst pain). The patients Will be instructed about the usage of the PCA system and the VAS preoperatively'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare addition of dexamethasone to bupivacaine versus bupivacaine alone for trans-incisional bilateral paravertebral block for postoperative analgesia in elective lumbar spine surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* physical status American Society of Anesthesiologists (ASA) I or II.\n\nExclusion Criteria:\n\n* refuse to participate have a body mass index (BMI) \\>30 kg/m2 ASA physical status \\>II have major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological) coagulation abnormalities infection at the injection site tumor in the paravertebral space sepsis Severe chest deformity or scoliosis, due to the possibility of injection into the meninges an allergy or contraindications to the drugs used in the study uncontrolled diabetes patients with active gastric ulceration a history of drug addiction or alcohol abuse a psychiatric illness mental retardation interfering with the evaluation of pain scores.'}, 'identificationModule': {'nctId': 'NCT04783194', 'briefTitle': 'Dexamethasone Plus Bupivacaine Versus Bupivacaine in Bilateral Trans-incisional Paravertebral Block in Lumbar Spine Surgeries .', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Dexamethasone Plus Bupivacaine Versus Bupivacaine in Bilateral Trans-incisional Paravertebral Block in Lumbar Spine Surgeries, a Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'FMASU R 47/2020/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone + bupivacaine in bilateral TiPVB in lumbar spine surgery', 'description': 'Dexamethasone plus bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery for postoperative analgesia', 'interventionNames': ['Drug: Dexamethasone+ Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine in bilateral TiPVB in lumbar spine surgery', 'description': 'Bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery for postoperative analgesia', 'interventionNames': ['Drug: Bupivacaine']}], 'interventions': [{'name': 'Dexamethasone+ Bupivacaine', 'type': 'DRUG', 'description': 'Dexamethasone plus bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery.', 'armGroupLabels': ['Dexamethasone + bupivacaine in bilateral TiPVB in lumbar spine surgery']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'Bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery.', 'armGroupLabels': ['Bupivacaine in bilateral TiPVB in lumbar spine surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Amin Mohammed Alansary Amin Ahmed Helwa', 'investigatorAffiliation': 'Ain Shams University'}}}}