Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-28 @ 1:50 AM
Study NCT ID:
NCT04005404
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2019-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Surgical Treatment of Hip Fractures Under Peripheral Regional Anesthesia
Sponsor:
Organization:
Raw JSON
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{'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days after surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Intertrochanteric Femoral Fractures', 'description': 'Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%\n\nRopivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%\n\nRopivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'deathsNumAffected': 6, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Neck Femur Fractures', 'description': 'Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375%\n\nRopivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375%\n\nRopivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375%', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 3, 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'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'heart failure', 'notes': 'heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'myocardial infarction', 'notes': 'myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'urinary tract infection', 'notes': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumonia', 'notes': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'wound 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'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-29', 'size': 165075, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-06-29T14:55', 'hasProtocol': True}, {'date': '2019-06-29', 'size': 18049, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-11-04T17:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Differentiated analysis for the subgroups "subtrochanteric femoral fractures", "intertrochanteric femoral fractures" and "neck femur fractures"'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-10', 'studyFirstSubmitDate': '2019-06-29', 'resultsFirstSubmitDate': '2020-06-29', 'studyFirstSubmitQcDate': '2019-07-01', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-10', 'studyFirstPostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success Rate (Supplemental Medication)', 'timeFrame': 'during surgery', 'description': 'number of participants with need for supplemental analgesic medication (sufentanil)'}, {'measure': 'Success Rate (Conversion to General Anesthesia)', 'timeFrame': 'during surgery', 'description': 'number of participants with need for conversion to general anesthesia'}], 'secondaryOutcomes': [{'measure': 'Circulation Stability', 'timeFrame': 'during surgery', 'description': 'number of participants with need for application of ephedrine and/or norepinephrine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Regional Anesthesia', 'Ultrasonography', 'Hip Fractures', 'Lumbosacral Plexus'], 'conditions': ['Hip Fractures']}, 'referencesModule': {'references': [{'pmid': '30386022', 'type': 'BACKGROUND', 'citation': 'Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17.'}, {'pmid': '18354367', 'type': 'BACKGROUND', 'citation': 'Akkaya T, Comert A, Kendir S, Acar HI, Gumus H, Tekdemir I, Elhan A. Detailed anatomy of accessory obturator nerve blockade. Minerva Anestesiol. 2008 Apr;74(4):119-22.'}, {'pmid': '9479711', 'type': 'BACKGROUND', 'citation': 'Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.'}, {'pmid': '29397119', 'type': 'BACKGROUND', 'citation': 'Coburn M, Sanders RD, Maze M, Nguyen-Pascal ML, Rex S, Garrigues B, Carbonell JA, Garcia-Perez ML, Stevanovic A, Kienbaum P, Neukirchen M, Schaefer MS, Borghi B, van Oven H, Tognu A, Al Tmimi L, Eyrolle L, Langeron O, Capdevila X, Arnold GM, Schaller M, Rossaint R; HIPELD Study Investigators. The hip fracture surgery in elderly patients (HIPELD) study to evaluate xenon anaesthesia for the prevention of postoperative delirium: a multicentre, randomized clinical trial. Br J Anaesth. 2018 Jan;120(1):127-137. doi: 10.1016/j.bja.2017.11.015. Epub 2017 Nov 21.'}, {'pmid': '30032877', 'type': 'BACKGROUND', 'citation': 'Duan X, Coburn M, Rossaint R, Sanders RD, Waesberghe JV, Kowark A. Efficacy of perioperative dexmedetomidine on postoperative delirium: systematic review and meta-analysis with trial sequential analysis of randomised controlled trials. Br J Anaesth. 2018 Aug;121(2):384-397. doi: 10.1016/j.bja.2018.04.046. Epub 2018 Jun 22.'}, {'pmid': '30063657', 'type': 'BACKGROUND', 'citation': 'Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.'}, {'pmid': '26899415', 'type': 'BACKGROUND', 'citation': 'Guay J, Parker MJ, Gajendragadkar PR, Kopp S. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev. 2016 Feb 22;2(2):CD000521. doi: 10.1002/14651858.CD000521.pub3.'}, {'pmid': '28991122', 'type': 'BACKGROUND', 'citation': 'Guay J, Parker MJ, Griffiths R, Kopp SL. Peripheral Nerve Blocks for Hip Fractures: A Cochrane Review. Anesth Analg. 2018 May;126(5):1695-1704. doi: 10.1213/ANE.0000000000002489.'}, {'pmid': '26897445', 'type': 'BACKGROUND', 'citation': 'Johnston DF, Stafford M, McKinney M, Deyermond R, Dane K. Peripheral nerve blocks with sedation using propofol and alfentanil target-controlled infusion for hip fracture surgery: a review of 6 years in use. J Clin Anesth. 2016 Mar;29:33-9. doi: 10.1016/j.jclinane.2015.10.012. Epub 2016 Feb 2.'}, {'pmid': '28263244', 'type': 'BACKGROUND', 'citation': 'Nielsen TD, Moriggl B, Soballe K, Kolsen-Petersen JA, Borglum J, Bendtsen TF. A Cadaveric Study of Ultrasound-Guided Subpectineal Injectate Spread Around the Obturator Nerve and Its Hip Articular Branches. Reg Anesth Pain Med. 2017 May/Jun;42(3):357-361. doi: 10.1097/AAP.0000000000000587.'}, {'pmid': '28551063', 'type': 'BACKGROUND', 'citation': 'Sa M, Graca R, Reis H, Cardoso JM, Sampaio J, Pinheiro C, Machado D. [Superior gluteal nerve: a new block on the block?]. Braz J Anesthesiol. 2018 Jul-Aug;68(4):400-403. doi: 10.1016/j.bjan.2016.11.001. Epub 2017 May 24.'}, {'pmid': '26426575', 'type': 'BACKGROUND', 'citation': 'Sauter AR, Ullensvang K, Niemi G, Lorentzen HT, Bendtsen TF, Borglum J, Pripp AH, Romundstad L. The Shamrock lumbar plexus block: A dose-finding study. Eur J Anaesthesiol. 2015 Nov;32(11):764-70. doi: 10.1097/EJA.0000000000000265.'}, {'pmid': '29140962', 'type': 'BACKGROUND', 'citation': 'Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.'}, {'pmid': '22139964', 'type': 'BACKGROUND', 'citation': 'Taha AM. A simple and successful sonographic technique to identify the sciatic nerve in the parasacral area. Can J Anaesth. 2012 Mar;59(3):263-7. doi: 10.1007/s12630-011-9630-3. Epub 2011 Dec 3.'}, {'pmid': '28154824', 'type': 'BACKGROUND', 'citation': 'Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.'}, {'pmid': '28659127', 'type': 'BACKGROUND', 'citation': 'Van Waesberghe J, Stevanovic A, Rossaint R, Coburn M. General vs. neuraxial anaesthesia in hip fracture patients: a systematic review and meta-analysis. BMC Anesthesiol. 2017 Jun 28;17(1):87. doi: 10.1186/s12871-017-0380-9.'}, {'pmid': '26940645', 'type': 'BACKGROUND', 'citation': 'White SM, Moppett IK, Griffiths R, Johansen A, Wakeman R, Boulton C, Plant F, Williams A, Pappenheim K, Majeed A, Currie CT, Grocott MP. Secondary analysis of outcomes after 11,085 hip fracture operations from the prospective UK Anaesthesia Sprint Audit of Practice (ASAP-2). Anaesthesia. 2016 May;71(5):506-14. doi: 10.1111/anae.13415. Epub 2016 Mar 4.'}]}, 'descriptionModule': {'briefSummary': 'The study investigates whether treatment of proximal femoral fractures is possible using a peripheral regional anesthesia technique.', 'detailedDescription': 'The study investigates whether treatment of proximal femoral fractures is possible using a peripheral regional anesthesia technique.\n\nAfter positioning on the non-fractured side, a double injection technique is used (dual guidance concept: nerve stimulation and sonography).\n\nThe injections are performed parasacrally (blockade of the sacral plexus under the piriformis muscle) and lumbar paravertebrally (psoas compartment block and transmuscular quadratus lumborum block). Per block 20 ml ropivacaine 0.375% is administered (total dose: 225mg ropivacaine).\n\nThe study examines the success rate (rate of successfully performed nerve blockade; need for supplemental medication: sufentanil and/or propofol; conversion rate to general anesthesia), circulatory stability (need for application of ephedrine or norepinephrine) and side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* proximal femoral fracture\n* older then 18 years\n* written informed consent\n\nExclusion Criteria:\n\n* local or systematic inflammation\n* allergy to ropivacaine\n* participate in other studies\n* body mass index over 35\n* periprosthetic fractures'}, 'identificationModule': {'nctId': 'NCT04005404', 'briefTitle': 'Surgical Treatment of Hip Fractures Under Peripheral Regional Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Helios Research Center'}, 'officialTitle': 'Surgical Treatment of Proximal Femoral Fractures Under Peripheral Regional Anesthesia. A Prospective Pilot Study', 'orgStudyIdInfo': {'id': 'A 2018 0237'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intertrochanteric femoral fractures', 'description': 'geriatric patients with intertrochanteric femoral fracture who have consented to the study intervention', 'interventionNames': ['Drug: Ropivacaine (sciatic nerve block)', 'Drug: Ropivacaine (lumbar plexus block L2-L4)', 'Drug: Ropivacaine (lumbar plexus block Th12-L1)']}, {'type': 'EXPERIMENTAL', 'label': 'neck femur fractures', 'description': 'geriatric patients with neck of femur fracture who have consented to the study intervention', 'interventionNames': ['Drug: Ropivacaine (sciatic nerve block)', 'Drug: Ropivacaine (lumbar plexus block L2-L4)', 'Drug: Ropivacaine (lumbar plexus block Th12-L1)']}, {'type': 'EXPERIMENTAL', 'label': 'subtrochanteric femoral fractures', 'description': 'geriatric patients with subtrochanteric femoral fracture who have consented to the study intervention', 'interventionNames': ['Drug: Ropivacaine (sciatic nerve block)', 'Drug: Ropivacaine (lumbar plexus block L2-L4)', 'Drug: Ropivacaine (lumbar plexus block Th12-L1)']}], 'interventions': [{'name': 'Ropivacaine (sciatic nerve block)', 'type': 'DRUG', 'otherNames': ['parasacral sciatic nerve block (sacral plexus)'], 'description': 'injection of 20 ml ropivacaine 0.375%', 'armGroupLabels': ['intertrochanteric femoral fractures', 'neck femur fractures', 'subtrochanteric femoral fractures']}, {'name': 'Ropivacaine (lumbar plexus block L2-L4)', 'type': 'DRUG', 'otherNames': ['posts compartment block (lumbar plexus L2-L4)'], 'description': 'injection of 20 ml ropivacaine 0.375%', 'armGroupLabels': ['intertrochanteric femoral fractures', 'neck femur fractures', 'subtrochanteric femoral fractures']}, {'name': 'Ropivacaine (lumbar plexus block Th12-L1)', 'type': 'DRUG', 'otherNames': ['transmuscular quadratus lumborum block (lumbar plexus Th12-L1)'], 'description': 'injection of 20 ml ropivacaine 0.375%', 'armGroupLabels': ['intertrochanteric femoral fractures', 'neck femur fractures', 'subtrochanteric femoral fractures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19049', 'city': 'Schwerin', 'state': 'Mecklenburg-Vorpommern', 'country': 'Germany', 'facility': 'Helios Medical Center Schwerin, Department of Anesthesiology', 'geoPoint': {'lat': 53.62937, 'lon': 11.41316}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helios Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr.med.Ronald Seidel', 'investigatorAffiliation': 'Helios Research Center'}}}}