Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 7:01 PM
Study NCT ID:
NCT04551833
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2020-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Supraclavicular Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077554', 'term': 'Levobupivacaine'}], 'ancestors': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2020-03-18', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of postoperative analgesia in hours', 'timeFrame': '24 hours', 'description': 'Duration of postoperative analgesia in hours'}], 'secondaryOutcomes': [{'measure': 'The anesthesia onset time', 'timeFrame': '20 minutes', 'description': 'Anasthesia onset'}, {'measure': 'Dose of Paracetamol as rescue analgesia in mg', 'timeFrame': '24 hours', 'description': 'Rescue Analgesia in mg'}, {'measure': 'Presence of complications and side effects', 'timeFrame': '24 hours', 'description': 'complications and side effects'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Regional Anesthesia']}, 'referencesModule': {'references': [{'pmid': '28740419', 'type': 'BACKGROUND', 'citation': 'Zhao WL, Ou XF, Liu J, Zhang WS. Perineural versus intravenous dexamethasone as an adjuvant in regional anesthesia: a systematic review and meta-analysis. J Pain Res. 2017 Jul 4;10:1529-1543. doi: 10.2147/JPR.S138212. eCollection 2017.'}, {'pmid': '29121400', 'type': 'BACKGROUND', 'citation': 'Pehora C, Pearson AM, Kaushal A, Crawford MW, Johnston B. Dexamethasone as an adjuvant to peripheral nerve block. Cochrane Database Syst Rev. 2017 Nov 9;11(11):CD011770. doi: 10.1002/14651858.CD011770.pub2.'}, {'pmid': '25948899', 'type': 'BACKGROUND', 'citation': 'Nagpal V, Rana S, Singh J, Chaudhary SK. Comparative study of systemically and perineurally administered tramadol as an adjunct for supraclavicular brachial plexus block. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):191-5. doi: 10.4103/0970-9185.155147.'}]}, 'descriptionModule': {'briefSummary': "The investigator's aim will be to compare the efficacy of perineural tramadol and dexamethasone added to levobupivacaine in prolonging postoperative analgesia in patient undergoing open reduction and internal fixation for forearm fractures.\n\nPrimary outcome: duration of postoperative analgesia. Secondary outcome: include \\[The anesthesia onset time, total rescue analgesic consumption in the 1st 24-hour and the presence of complications and side effects.", 'detailedDescription': 'Strategies to prolong brachial plexus nerve blocks analgesia beyond the pharmacological duration of the local anaesthetic used include placement of indwelling perineural catheters to allow prolonged infusion or the co-administration of adjuvants such as epinephrine, alpha 2 agonists (as clonidine and dexmedetomidine), midazolam, or the corticosteroid dexamethasone .\n\nDexamethasone improves the quality and duration of peripheral nerve block over local anaesthetic alone. This is thought to be mediated by attenuating the release of inflammatory mediators, reducing ectopic neuronal discharge, and inhibiting potassium channel-mediated discharge of nociceptive C-fibres .\n\nTramadol is a unique opioid with two modes of action for inhibition of pain, an opioid action mediated by the μ receptor and a non-opioid action mediated by α-2-adrenergic and serotoninergic activity .The monoaminergic activity of tramadol inhibits the descending pain pathways, resulting in suppression of nociceptive transmission at the spinal level . Tramadol also exhibits local anaesthetic properties by blocking K+ channels .Many studies have characterized the effects of tramadol as an adjuvant to local anaesthetic in brachial plexus block .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologist physical status I-II patients older than 18years and scheduled for internal fixation for forearm fractures\n* Both sexes\n\nExclusion Criteria:\n\n* Patients with known allergy to the study drugs\n* Skin infection at site of needle puncture\n* Significant organ dysfunction\n* Coagulopathy\n* Drug or alcohol abuse\n* Epilepsy and psychiatric illness that would interfere with perception and assessment of pain'}, 'identificationModule': {'nctId': 'NCT04551833', 'briefTitle': 'Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Supraclavicular Block', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Under Ultrasound Guided Supraclavicular Block of Forearm Fractures', 'orgStudyIdInfo': {'id': 'supraclavicular block'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group (T) : 30 patients (Tramadol group)', 'description': 'Patient will receive 0.4 mL/kg of 0.5% Levobupivacaine plus 1.5 mg/kg Tramadol.', 'interventionNames': ['Drug: Levobupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Group (D) : 30 patients (Dexamethasone group):', 'description': 'Patient will receive 0.4 mL/kg of 0.5% Levobupivacaine plus 8mg of Dexamethasone', 'interventionNames': ['Drug: Levobupivacaine']}], 'interventions': [{'name': 'Levobupivacaine', 'type': 'DRUG', 'description': 'Tramadol versus Dexamethasone as adjuvant to Levobupvacain', 'armGroupLabels': ['Group (D) : 30 patients (Dexamethasone group):', 'Group (T) : 30 patients (Tramadol group)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Esraa Gamal Abdel Nasser, Resident', 'role': 'CONTACT', 'email': 'esraagamalabdelnasser@gmail.com', 'phone': '+201069721653'}, {'name': 'Mohamed Hassan Bakri, Professor', 'role': 'CONTACT', 'email': 'mhbakri@gmail.com', 'phone': '+201066356375'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of Anesthesia, ICU and Pain management', 'investigatorFullName': 'Esraa Gamal', 'investigatorAffiliation': 'Assiut University'}}}}