Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-03-03 @ 6:15 AM
Study NCT ID:
NCT02787018
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2016-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2016-05-14', 'studyFirstSubmitQcDate': '2016-05-31', 'lastUpdatePostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Onset of sensory block', 'timeFrame': 'every 3 minutes until 45 minutes after injection of drug', 'description': 'Sensory block in the territories of median nerve (palmar surface of index finger), ulnar nerve (palmar surface of little finger), radial nerve (dorsal surface of first web space/ thumb) and musculocutaneous nerve (lateral side of volar surface of forearm) will be assessed by pinprick test using a 3-point scale:\n\n0 - normal sensation,\n\n1. \\- loss of sensation of pinprick (analgesia),\n2. \\- loss of sensation of touch (anaesthesia). Complete sensory block will be defined as grade 2 sensory block in 3 or more nerve territories.'}, {'measure': 'Onset of motor block', 'timeFrame': 'every 3 minutes until 45 minutes after injection of drug', 'description': 'Motor block will be evaluated by thumb flexion/ opposition (median nerve), thumb extension (radial nerve), finger abduction (ulnar nerve) and elbow flexion with forearm in full supination (musculocutaneous nerve) on a 3-point scale for motor function:\n\n0 - normal motor function,\n\n1. \\- reduced motor strength but able to move,\n2. \\- complete motor block. Complete motor block will be defined as grade 2 motor block in 3 or more nerve territories.'}, {'measure': 'Duration of analgesia', 'timeFrame': 'Up to 24 hours after onset of block'}], 'secondaryOutcomes': [{'measure': 'Duration of sensory block', 'timeFrame': 'Up to 24 hours after onset of block', 'description': 'time from onset of sensory block to complete recovery of anaesthesia on all nerves.'}, {'measure': 'Duration of motor block', 'timeFrame': 'Up to 24 hours after onset of block', 'description': 'time from onset of motor block to the recovery of complete motor function of the hand and forearm'}, {'measure': 'Incidence of side effects of drugs', 'timeFrame': 'Forty-eight hours following the injection of local anesthetics', 'description': 'Side effects like bradycardia, tachycardia, hypotension, sedation, neurological deficit will be evaluated'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Brachial plexus block', 'Ropivacaine', 'Dexmedetomidine', 'Dexamethasone', 'Adjuvants, anesthesia'], 'conditions': ['Brachial Plexus Block']}, 'referencesModule': {'references': [{'pmid': '24413428', 'type': 'BACKGROUND', 'citation': 'Choi S, Rodseth R, McCartney CJ. Effects of dexamethasone as a local anaesthetic adjuvant for brachial plexus block: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2014 Mar;112(3):427-39. doi: 10.1093/bja/aet417. Epub 2014 Jan 10.'}, {'pmid': '25538527', 'type': 'BACKGROUND', 'citation': 'Das A, Majumdar S, Halder S, Chattopadhyay S, Pal S, Kundu R, Mandal SK, Chattopadhyay S. Effect of dexmedetomidine as adjuvant in ropivacaine-induced supraclavicular brachial plexus block: A prospective, double-blinded and randomized controlled study. Saudi J Anaesth. 2014 Nov;8(Suppl 1):S72-7. doi: 10.4103/1658-354X.144082.', 'retractions': [{'pmid': '32934651', 'source': 'Saudi J Anaesth. 2020 Jul-Sep;14(3):422'}]}, {'pmid': '25886227', 'type': 'BACKGROUND', 'citation': 'Kumar S, Palaria U, Sinha AK, Punera DC, Pandey V. Comparative evaluation of ropivacaine and ropivacaine with dexamethasone in supraclavicular brachial plexus block for postoperative analgesia. Anesth Essays Res. 2014 May-Aug;8(2):202-8. doi: 10.4103/0259-1162.134506.'}, {'pmid': '24753763', 'type': 'BACKGROUND', 'citation': 'Zhang Y, Wang CS, Shi JH, Sun B, Liu SJ, Li P, Li EY. Perineural administration of dexmedetomidine in combination with ropivacaine prolongs axillary brachial plexus block. Int J Clin Exp Med. 2014 Mar 15;7(3):680-5. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'The investigators want to compare the effectiveness of dexamethasone and dexmedetomidine as an adjuvant to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset of block and duration of analgesia, so that the investigators can choose the better adjuvant for the investigators routine practice of regional anesthesia.', 'detailedDescription': 'Ropivacaine is a newer local anesthetic which is structurally related to bupivacaine, but has fewer side effects. It is more cardio stable than bupivacaine, but the onset of action is delayed and the duration of action is shorter than bupivacaine making its use during regional anesthesia less preferable to many anesthesiologists. Steroids like dexamethasone, or alpha-2 agonists like dexmedetomidine are being studied as adjuvants to ropivacaine for brachial plexus block to improve its anesthetic properties and have shown favorable outcome in terms of shortening the onset of block and prolonging the duration of action. But no study has been done to compare their effects. So in this study the investigators want to compare the effectiveness of dexamethasone and dexmedetomidine as an adjuvant to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset of block and duration of analgesia, so that the investigators can choose the better adjuvant for the investigators routine practice of regional anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients of American Society of Anesthesiologists Physical Status I and II undergoing elective upper limb surgery under supraclavicular brachial plexus block\n\nExclusion Criteria:\n\n* Patient's refusal to participate\n* Patients weighing less than 40 kg\n* Allergy to study drugs\n* Infection at the site of injection\n* Patients with preexisting neurological deficit\n* Patients with diabetes mellitus\n* Patients on steroids preoperatively\n* Patients with bleeding disorder or coagulopathy\n* Abnormalities in ECG like AV block or symptomatic bradycardia\n* Patients receiving adrenoreceptor agonist or antagonist therapy preoperatively\n* Requirement of conversion to general anesthesia due to inadequate block"}, 'identificationModule': {'nctId': 'NCT02787018', 'briefTitle': 'Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block', 'organization': {'class': 'OTHER', 'fullName': 'B.P. Koirala Institute of Health Sciences'}, 'officialTitle': 'Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block', 'orgStudyIdInfo': {'id': 'IRC/641/015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Block with Ropivacaine and Normal saline', 'description': 'Patients will receive brachial plexus block with 20 ml 0.5% ropivacaine with 1ml normal saline: Total volume 21 ml', 'interventionNames': ['Drug: Ropivacaine and Normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Block with Ropivacaine and Dexamethasone', 'description': 'Patients will receive brachial plexus block with 20ml 0.5% ropivacaine with 4mg (1ml) dexamethasone: Total volume 21 ml', 'interventionNames': ['Drug: Ropivacaine and Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Block with Ropivacaine and Dexmedetomidine', 'description': 'Patients will receive brachial plexus block with 20ml 0.5% ropivacaine with 50mcg (1ml) dexmedetomidine: Total volume 21 ml', 'interventionNames': ['Drug: Ropivacaine and Dexmedetomidine']}], 'interventions': [{'name': 'Ropivacaine and Normal saline', 'type': 'DRUG', 'description': 'Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 1 ml normal saline', 'armGroupLabels': ['Block with Ropivacaine and Normal saline']}, {'name': 'Ropivacaine and Dexamethasone', 'type': 'DRUG', 'description': 'Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 4mg (1ml) dexamethasone', 'armGroupLabels': ['Block with Ropivacaine and Dexamethasone']}, {'name': 'Ropivacaine and Dexmedetomidine', 'type': 'DRUG', 'description': 'Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 50 mcg (1ml) dexmedetomidine', 'armGroupLabels': ['Block with Ropivacaine and Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56700', 'city': 'Dharān', 'state': 'Koshi', 'country': 'Nepal', 'facility': 'B. P. Koirala Institute of Health Sciences', 'geoPoint': {'lat': 26.81436, 'lon': 87.27972}}], 'overallOfficials': [{'name': 'Parineeta Thapa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BPKIHS, Dharan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B.P. Koirala Institute of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Parineeta Thapa', 'investigatorAffiliation': 'B.P. Koirala Institute of Health Sciences'}}}}