Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-03-10 @ 7:22 PM
Study NCT ID:
NCT03610893
Status:
COMPLETED
Last Update Posted:
2019-05-01
First Post:
2018-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D001134', 'term': 'Arm Injuries'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-29', 'studyFirstSubmitDate': '2018-07-04', 'studyFirstSubmitQcDate': '2018-07-31', 'lastUpdatePostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor block duration', 'timeFrame': '24 hours after block', 'description': 'Elapsed time since the end of LA injection until return of hand and fingers movement'}], 'secondaryOutcomes': [{'measure': 'Sensory block duration', 'timeFrame': '24 hours after block', 'description': 'Elapsed time since the end of LA injection until return of hand and fingers sensation'}, {'measure': 'Analgesic block duration', 'timeFrame': '24 hours after block', 'description': 'Elapsed time since the end of LA injection until first sensation of pain in surgical area'}, {'measure': 'Block performance time', 'timeFrame': '1 hour before surgery', 'description': 'Elapsed time from skin desinfection until the end of LA injection'}, {'measure': 'Intensity of pain during block procedure', 'timeFrame': '1 hour before surgery', 'description': 'Evaluated with a numeric rating score from 0 to 10'}, {'measure': 'Block onset time', 'timeFrame': '1 hour before surgery', 'description': 'Time required to reach a minimal sensorimotor composite score of 14 points out of a maximum of 16 points'}, {'measure': 'Sensory and motor block score', 'timeFrame': '30 minutes post injection', 'description': 'Sensorimotor block assessed every 5 minutes until 30 minutes using a 16-point composite score evaluating sensory and motor block of musculocutaneus, medium, radial and ulnar nerves.\n\nSensation will be assessed with ice in each nerve territory with a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.\n\nMotor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.\n\nSuccesfull blocks at 30 minutes correlate with a final score ( sum of all individual sensory and motor scores) of at least 14 points out of 16.'}, {'measure': 'Incidence of complete block', 'timeFrame': '30 minutes post injection', 'description': 'Percentage of blocks with a minimal sensorimotor composite score of 14 points out of a maximum of 16 points at 30 minutes post injection'}, {'measure': 'Perioperative glycemic levels', 'timeFrame': 'Perioperative period', 'description': 'Capillary dextrose measurements at pre block, 1 hour post-surgery and 6 hours post-surgery'}, {'measure': 'Perioperative median artery pressure (MAP)', 'timeFrame': '2 hours after surgery', 'description': 'Average of MAP and HR registered during preblock, intraoperative and up to 2 hours of postoperative period'}, {'measure': 'Perioperative heart rate (HR)', 'timeFrame': '2 hours after surgery', 'description': 'Average MAP registered during preblock, intraoperative and up to 2 hours of postoperative period'}, {'measure': 'Postoperative persistent sedation', 'timeFrame': '2 hours after surgery', 'description': 'Persistent sedation after surgery using Ramsay sedation scale.\n\n1= anxious agitated or restless; 2= co-operative, oriented and tranquil; 3= responds to command only; 4= brisk response to light pain or loud auditory stimulus; 5= sluggish response to light pain or loud auditory stimulus; 6= no response.'}, {'measure': 'Respiratory depression', 'timeFrame': '2 hours after surgery', 'description': 'Low respiratory rate (lower than 8 breaths per minute) or persistent oxygen requirement (pulse oximetry lower than 90% without supplementary oxygen)'}, {'measure': 'Incidence of block side effects', 'timeFrame': '2 hours after surgery', 'description': 'Presence of paresthesia, local anesthetic systemic toxicity, vascular puncture, pneumothorax, hemidiaphragmatic paralysis, Horner syndrome or hoarseness'}, {'measure': 'Persistent neurologic deficit', 'timeFrame': '7 days post surgery', 'description': 'Presence of persistent sensory or motor postoperative deficit'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nerve block adjuvants', 'dexamethasone', 'dexmedetomidine', 'nerve block duration'], 'conditions': ['Pain, Postoperative', 'Pain, Acute', 'Upper Extremity Injury']}, 'referencesModule': {'references': [{'pmid': '25629321', 'type': 'RESULT', 'citation': 'Abdallah FW, Johnson J, Chan V, Murgatroyd H, Ghafari M, Ami N, Jin R, Brull R. Intravenous dexamethasone and perineural dexamethasone similarly prolong the duration of analgesia after supraclavicular brachial plexus block: a randomized, triple-arm, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):125-32. doi: 10.1097/AAP.0000000000000210.'}, {'pmid': '23587875', 'type': 'RESULT', 'citation': 'Desmet M, Braems H, Reynvoet M, Plasschaert S, Van Cauwelaert J, Pottel H, Carlier S, Missant C, Van de Velde M. I.V. and perineural dexamethasone are equivalent in increasing the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder surgery: a prospective, randomized, placebo-controlled study. Br J Anaesth. 2013 Sep;111(3):445-52. doi: 10.1093/bja/aet109. Epub 2013 Apr 15.'}, {'pmid': '24413428', 'type': 'RESULT', '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': '23587874', 'type': 'RESULT', 'citation': 'Abdallah FW, Brull R. Facilitatory effects of perineural dexmedetomidine on neuraxial and peripheral nerve block: a systematic review and meta-analysis. Br J Anaesth. 2013 Jun;110(6):915-25. doi: 10.1093/bja/aet066. Epub 2013 Apr 15.'}, {'pmid': '26649424', 'type': 'RESULT', 'citation': 'Abdallah FW, Dwyer T, Chan VW, Niazi AU, Ogilvie-Harris DJ, Oldfield S, Patel R, Oh J, Brull R. IV and Perineural Dexmedetomidine Similarly Prolong the Duration of Analgesia after Interscalene Brachial Plexus Block: A Randomized, Three-arm, Triple-masked, Placebo-controlled Trial. Anesthesiology. 2016 Mar;124(3):683-95. doi: 10.1097/ALN.0000000000000983.'}, {'pmid': '27015546', 'type': 'RESULT', 'citation': 'Leurcharusmee P, Aliste J, Van Zundert TC, Engsusophon P, Arnuntasupakul V, Tiyaprasertkul W, Tangjitbampenbun A, Ah-Kye S, Finlayson RJ, Tran DQ. A Multicenter Randomized Comparison Between Intravenous and Perineural Dexamethasone for Ultrasound-Guided Infraclavicular Block. Reg Anesth Pain Med. 2016 May-Jun;41(3):328-33. doi: 10.1097/AAP.0000000000000386.'}, {'pmid': '27663451', 'type': 'RESULT', 'citation': 'Aliste J, Leurcharusmee P, Engsusophon P, Gordon A, Michelagnoli G, Sriparkdee C, Tiyaprasertkul W, Tran DQ, Van Zundert TC, Finlayson RJ, Tran DQH. A randomized comparison between intravenous and perineural dexamethasone for ultrasound-guided axillary block. Can J Anaesth. 2017 Jan;64(1):29-36. doi: 10.1007/s12630-016-0741-8. Epub 2016 Sep 23.'}, {'pmid': '28252523', 'type': 'RESULT', 'citation': 'Chong MA, Berbenetz NM, Lin C, Singh S. Perineural Versus Intravenous Dexamethasone as an Adjuvant for Peripheral Nerve Blocks: A Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2017 May/Jun;42(3):319-326. doi: 10.1097/AAP.0000000000000571.'}, {'pmid': '28178091', 'type': 'RESULT', 'citation': 'Hussain N, Grzywacz VP, Ferreri CA, Atrey A, Banfield L, Shaparin N, Vydyanathan A. Investigating the Efficacy of Dexmedetomidine as an Adjuvant to Local Anesthesia in Brachial Plexus Block: A Systematic Review and Meta-Analysis of 18 Randomized Controlled Trials. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):184-196. doi: 10.1097/AAP.0000000000000564.'}, {'pmid': '31300595', 'type': 'DERIVED', 'citation': 'Aliste J, Layera S, Bravo D, Fernandez D, Jara A, Garcia A, Finlayson RJ, Tran DQ. Randomized comparison between perineural dexamethasone and dexmedetomidine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2019 Jul 11:rapm-2019-100680. doi: 10.1136/rapm-2019-100680. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'When used as perineural (PN) adjuvants to local anesthetics (LAs), dexamethasone (DX) and dexmedetomidine (DXD) have been well documented to prolong the duration of peripheral nerve blocks. These drugs have important differences in terms of cost and safety profiles. This randomized controlled trial (RCT) will compare PN DX and PN DXD for ultrasound-guided infraclavicular brachial plexus blocks (ICBs).\n\nSince analgesic and sensory duration can be influenced by factors different to block, motor block duration is the main outcome. The protocol is designed as an equivalency trial and hypothesize that both drugs result in similar durations. The equivalency margin is set at 3 hrs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 75 years\n* American Society of Anesthesiologists classification 1-3\n* body mass index between 20 and 35\n\nExclusion Criteria:\n\n* adults who are unable to give their own consent\n* pre-existing neuropathy (assessed by history and physical examination)\n* coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)\n* renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)\n* hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)\n* allergy to local anesthetics (LAs)\n* pregnancy\n* prior surgery in the infraclavicular region\n* chronic pain syndromes requiring opioid intake at home'}, 'identificationModule': {'nctId': 'NCT03610893', 'briefTitle': 'Dexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks', 'organization': {'class': 'OTHER', 'fullName': 'University of Chile'}, 'officialTitle': 'A Randomized Comparison Between Perineural Dexamethasone and Perineural Dexmedetomidine as Adjuvants for Ultrasound-Guided Infraclavicular Blocks', 'orgStudyIdInfo': {'id': '953/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Perineural dexamethasone', 'description': 'addition of dexamethasone to local anesthetics in infraclavicular brachial plexus block', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Perineural dexmedetomidine', 'description': 'addition of dexmedetomidine to local anesthetics in infraclavicular brachial plexus block', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Dexamethasone as perineural local anesthetic adjuvant', 'armGroupLabels': ['Perineural dexamethasone']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Dexmedetomidine as perineural local anesthetic adjuvant', 'armGroupLabels': ['Perineural dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8380456', 'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'Hospital Clínico Universidad de Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Instructor', 'investigatorFullName': 'Julian Aliste', 'investigatorAffiliation': 'University of Chile'}}}}