Nctid:
NCT06611761
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007592", "term"=>"Joint Diseases"}], "ancestors"=>[{"id"=>"D000009140", "term"=>"Musculoskeletal Diseases"}], "browseLeaves"=>[{"id"=>"M10621", "name"=>"Joint Diseases", "asFound"=>"Arthropathy", "relevance"=>"HIGH"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M1700", "name"=>"Ropivacaine", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}]}}, "documentSection"=>{"largeDocumentModule"=>{"largeDocs"=>[{"date"=>"2023-10-10", "size"=>91206, "label"=>"Study Protocol, Statistical Analysis Plan, and Informed Consent Form", "hasIcf"=>true, "hasSap"=>true, "filename"=>"Prot_SAP_ICF_000.pdf", "typeAbbrev"=>"Prot_SAP_ICF", "uploadDate"=>"2024-09-22T16:14", "hasProtocol"=>true}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>166}, "targetDuration"=>"1 Day", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-10-12", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-09-02", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-22", "studyFirstSubmitQcDate"=>"2024-09-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-09-02", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Postoperative pain", "timeFrame"=>"The measurement of pain intensity according to the numerical rating scale at preoperative and at the 1st, 2nd, 12th ant 24th postoperative hours", "description"=>"The measurement of pain intensity according to the numerical rating scale (NRS) from 0 (absence of pain) to 10 (maximum pain endured)"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["shoulder arthroscopy", "suprascapular nerve", "axillary nerve", "multimodal analgesic strategies"], "conditions"=>["Analgesia", "Shoulder Arthropathy Associated With Other Conditions", "Suprascapular and Axillary Nerve Block"]}, "referencesModule"=>{"references"=>[{"pmid"=>"32712453", "type"=>"BACKGROUND", "citation"=>"Laumonerie P, Dalmas Y, Tibbo ME, Robert S, Faruch M, Chaynes P, Bonnevialle N, Mansat P. Sensory innervation of the human shoulder joint: the three bridges to break. J Shoulder Elbow Surg. 2020 Dec;29(12):e499-e507. doi: 10.1016/j.jse.2020.07.017. Epub 2020 Jul 23."}, {"pmid"=>"32987232", "type"=>"BACKGROUND", "citation"=>"Yamak Altinpulluk E, Teles AS, Galluccio F, Simon DG, Olea MS, Salazar C, Fajardo Perez M. Pericapsular nerve group block for postoperative shoulder pain: A cadaveric radiological evaluation. J Clin Anesth. 2020 Dec;67:110058. doi: 10.1016/j.jclinane.2020.110058. Epub 2020 Sep 26. No abstract available."}, {"pmid"=>"28786899", "type"=>"BACKGROUND", "citation"=>"Eckmann MS, Bickelhaupt B, Fehl J, Benfield JA, Curley J, Rahimi O, Nagpal AS. Cadaveric Study of the Articular Branches of the Shoulder Joint. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):564-570. doi: 10.1097/AAP.0000000000000652."}, {"pmid"=>"31050830", "type"=>"BACKGROUND", "citation"=>"Gonzalez-Arnay E, Jimenez-Sanchez L, Garcia-Simon D, Valdes-Vilches L, Salazar-Zamorano CH, Boada-Pie S, Aguirre JA, Eichenberger U, Fajardo-Perez M. Ultrasonography-guided anterior approach for axillary nerve blockade: An anatomical study. Clin Anat. 2020 May;33(4):488-499. doi: 10.1002/ca.23394. Epub 2019 May 15."}, {"pmid"=>"18514113", "type"=>"RESULT", "citation"=>"Checcucci G, Allegra A, Bigazzi P, Gianesello L, Ceruso M, Gritti G. A new technique for regional anesthesia for arthroscopic shoulder surgery based on a suprascapular nerve block and an axillary nerve block: an evaluation of the first results. Arthroscopy. 2008 Jun;24(6):689-96. doi: 10.1016/j.arthro.2008.01.019. Epub 2008 Mar 21."}, {"pmid"=>"34669181", "type"=>"RESULT", "citation"=>"Galluccio F, Fajardo Perez M, Yamak Altinpulluk E, Hou JD, Lin JA. Evaluation of Interfascial Plane and Pericapsular Nerve Blocks to the Shoulder Joint: A Preliminary Analysis of Shoulder Anterior Capsular Block. Pain Ther. 2021 Dec;10(2):1741-1754. doi: 10.1007/s40122-021-00326-0. Epub 2021 Oct 20."}, {"pmid"=>"29659438", "type"=>"RESULT", "citation"=>"Neuts A, Stessel B, Wouters PF, Dierickx C, Cools W, Ory JP, Dubois J, Jamaer L, Arijs I, Schoorens D. Selective Suprascapular and Axillary Nerve Block Versus Interscalene Plexus Block for Pain Control After Arthroscopic Shoulder Surgery: A Noninferiority Randomized Parallel-Controlled Clinical Trial. Reg Anesth Pain Med. 2018 Oct;43(7):738-744. doi: 10.1097/AAP.0000000000000777."}, {"pmid"=>"34871240", "type"=>"RESULT", "citation"=>"Sun C, Zhang X, Ji X, Yu P, Cai X, Yang H. Suprascapular nerve block and axillary nerve block versus interscalene nerve block for arthroscopic shoulder surgery: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2021 Nov 5;100(44):e27661. doi: 10.1097/MD.0000000000027661."}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study was to evaluate the analgesic efficacy of suprascapular and axillary nerve block for shoulder arthroscopy surgery", "detailedDescription"=>"An observational study of paired cohorts, not randomized, was designed with the aim of comparing the postoperative analgesic effectiveness of two regional analgesic techniques: the shoulder anterior capsular block associated with the suprascapular nerve block performed via an anterior approach versus the suprascapular and axillary nerve blocks performed posteriorly in patients with shoulder surgery via arthroscopy in procedures that cause intense postoperative pain."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"After approval of the study by Galician Drug Research Ethics Committee, Spain (CEIm-G) and obtaining informed consent from the participants, patients undergoing shoulder arthroscopy surgery consecutively over the course of one year were included who met the study inclusion criteria.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients over 18 years of age.\n* ASA (Physical Status Classification System) I - III.\n* Having been scheduled for shoulder arthroscopy surgery.\n\nExclusion Criteria:\n\nAny contraindication for performing regional anesthetic techniques:\n\n* Infection at the puncture point.\n* Alteration of hemostasis.\n* Allergy to local anesthetics.\n* Patient refusal to participate in the study.\n* Inability to evaluate postoperative pain.\n* Known neuropathy of the operated limb.\n* Patients who required conversion to open surgery."}, "identificationModule"=>{"nctId"=>"NCT06611761", "briefTitle"=>"Prospective Observational Study on the Analgesic Effectiveness of Blocking the Suprascapular and Axillary Nerves in Shoulder Arthroscopy.", "organization"=>{"class"=>"OTHER", "fullName"=>"Fundación para la Investigación Biosanitaria del Principado de Asturias"}, "officialTitle"=>"Prospective Observational Study on the Analgesic Effectiveness of Blocking the Shoulder´s Anterior Capsule and the Suprascapular Nerve by the Anterior Approach Versus Blocking of the Suprascapular and Axillary Nerves by the Posterior Approach in Shoulder Arthroscopy.", "orgStudyIdInfo"=>{"id"=>"2023/491"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"SHAC block + anterior SSN block", "description"=>"Group of patients undergoing shoulder arthroscopy who underwent a block of the anterior capsule of the shoulder (SHAC block) with the suprascapular nerve block (SSN block) performed via an anterior approach with 20 ml of 0.20% ropivacaine", "interventionNames"=>["Procedure: Shoulder arthroscopy"]}, {"label"=>"Posterior SSN + AN blocks", "description"=>"Group of patients undergoing shoulder arthroscopy who underwent a suprascapular and axillary nerve block performed via a posterior approach with 20 ml of 0.20% ropivacaine", "interventionNames"=>["Procedure: Shoulder arthroscopy"]}], "interventions"=>[{"name"=>"Shoulder arthroscopy", "type"=>"PROCEDURE", "description"=>"Shoulder arthroscopy in procedures that cause intense postoperative pain", "armGroupLabels"=>["Posterior SSN + AN blocks", "SHAC block + anterior SSN block"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"33001", "city"=>"Oviedo", "state"=>"Asturias", "country"=>"Spain", "facility"=>"FINBA", "geoPoint"=>{"lat"=>43.36029, "lon"=>-5.84476}}], "overallOfficials"=>[{"name"=>"Bárbara María Jiménez Gómez, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Central University Hospital of Asturias, 33001, Spain"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Jose Manuel López González", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Principal investigator", "investigatorFullName"=>"Jose Manuel López González", "investigatorAffiliation"=>"Fundación para la Investigación Biosanitaria del Principado de Asturias"}}}}
