Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-11 @ 6:34 PM
Study NCT ID:
NCT03356704
Status:
COMPLETED
Last Update Posted:
2018-07-19
First Post:
2017-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Plexus Block for Hip Fracture Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 593}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2017-10-26', 'studyFirstSubmitQcDate': '2017-11-28', 'lastUpdatePostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative hypotension', 'timeFrame': '1 day', 'description': 'Decrease of at least 30% of mean arterial pressure'}], 'secondaryOutcomes': [{'measure': 'measure the total consumption of the vasopressive molecules', 'timeFrame': '1 day', 'description': 'measure the total consumption of the vasopressive molecules (necessary when the voltage drops by more than 30% compared to the average reference voltage) : Use of vasoactive drugs'}, {'measure': 'Length of stay', 'timeFrame': '1 day', 'description': 'Length of stay'}, {'measure': 'compare the use of emergency antalgics', 'timeFrame': '1 day', 'description': 'compare the use of emergency antalgics : opioids consumption'}, {'measure': 'Inhospital mortality', 'timeFrame': '1 day', 'description': 'Inhospital mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adults'], 'conditions': ['Hip Fractures']}, 'referencesModule': {'references': [{'pmid': '34217841', 'type': 'DERIVED', 'citation': 'Mounet B, Choquet O, Swisser F, Biboulet P, Bernard N, Bringuier S, Capdevila X. Impact of multiple nerves blocks anaesthesia on intraoperative hypotension and mortality in hip fracture surgery intermediate-risk elderly patients: A propensity score-matched comparison with spinal and general anaesthesia. Anaesth Crit Care Pain Med. 2021 Aug;40(4):100924. doi: 10.1016/j.accpm.2021.100924. Epub 2021 Jul 1.'}]}, 'descriptionModule': {'briefSummary': 'Hip fracture surgery requires high risk anesthetic procedure for elderly patients (1). General anesthesia, continuous spinal anesthesia and peripheral nerve blocks are three anesthetic techniques possible. Continuous spinal anesthesia has proven its efficacity to provide an intraoperative haemodynamic stability wich guarantees good patients outcomes (2), in comparison with general anesthesia but there is poor evidence in the literature concerning the use of peripheral nerve blocks.\n\nThe primary objective of this study was to compare intraoperative haemodynamic stability provides by peripheral nerve block versus general anesthesia and continuous spinal anesthesia.\n\nSecondary outcomes included : use of vasoactive drugs, opioids consumption, lengh of stay and inhospital mortality.', 'detailedDescription': 'After receiving the ethic approval from the "CERAR", the investigators retrospectively identified all patients who underwent hip fracture surgery from January 1 2015, to December 31, 2016 in the CHU of Montpellier. The exclusion criteria were: multiple trauma victims, two hip fractures in the same patient and single shot spinal anesthesia. In our institution the investigators used to perform three types of anesthesia: general anesthesia (GA), continuous spinal anesthesia (CSA) and combined plexus blocks (CPB). The investigators therefore made three groups GA, CSA and CPB and used a propensity score to make these groups comparable. The matching criteria were age, arterial hypertension, ASA status, Frailty score, chronic cardiac failure and type of surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All adults patients operated for hip fracture between 1 January 2015 and 31 December 2016.', 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adult\n* Hip fracture surgery\n\nExclusion criteria:\n\n* Multiple trauma victims\n* Second hip fracture in same patient\n* Single shot spinal anesthesia'}, 'identificationModule': {'nctId': 'NCT03356704', 'briefTitle': 'Combined Plexus Block for Hip Fracture Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Is the Combined Plexus Block a Real Alternative for Hip Fracture Surgery in the Elderly? A Comparison With General Anesthesia and Continuous Spinal Anesthesia Using a Propensity Score in a Retrospective Cohort Study.', 'orgStudyIdInfo': {'id': 'RECHMPL17_0229'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General anaesthesia', 'description': 'Patient who had surgery for femoral neck fracture from January 2014 to December 2016 and had general anesthesia', 'interventionNames': ['Other: no intervention']}, {'label': 'continued spinal anesthesia', 'description': 'Patient who had surgery for femoral neck fracture from January 2014 to December 2016 and had continued spinal anesthesia', 'interventionNames': ['Other: no intervention']}, {'label': 'peripheral nerve blocks', 'description': 'Patient who had surgery for femoral neck fracture from January 2014 to December 2016 and had peripheral nerve blocks', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'Observational study', 'armGroupLabels': ['General anaesthesia', 'continued spinal anesthesia', 'peripheral nerve blocks']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Xavier Capdevila, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}