Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
Study NCT ID:
NCT04404959
Status:
UNKNOWN
Last Update Posted:
2022-07-12
First Post:
2020-05-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D004304', 'term': 'Dosage Forms'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-10', 'studyFirstSubmitDate': '2020-05-22', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mini Mental State examination', 'timeFrame': 'arrival to the emergency room', 'description': 'Mini Mental State examination on arrival to the emergency room'}, {'measure': 'Mini Mental State examination', 'timeFrame': '1-8 days postoperatively', 'description': 'Mini Mental State examination postoperatively'}, {'measure': 'Confusion Assessment Method', 'timeFrame': 'arrival to the emergency room', 'description': 'Confusion Assessment Method on arrival to the emergency room'}, {'measure': 'Confusion Assessment Method', 'timeFrame': '1-8 days postoperatively', 'description': 'Confusion Assessment Method postoperatively'}, {'measure': 'requests for analgesia', 'timeFrame': '1-8 days postoperatively', 'description': 'requests for analgesia postoperatively'}, {'measure': 'tramadol consumption', 'timeFrame': '1-8 days postoperatively', 'description': 'tramadol consumption postoperatively'}], 'primaryOutcomes': [{'measure': 'pain score 30 minutes after fascia iliaca block', 'timeFrame': '30 minutes after performance of fascia iliaca block', 'description': 'pain score by the use of Numeric Rating Scale (NRS) 30 minutes after fascia ilaca block, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"'}, {'measure': 'pain score 12 hours after fascia iliaca block', 'timeFrame': '12 hours after performance of fascia iliaca block', 'description': 'pain score by the use of Numeric Rating Scale (NRS) 12 hours after fascia ilaca block, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"'}], 'secondaryOutcomes': [{'measure': 'pain score 1-8 days after fascia iliaca block', 'timeFrame': '1-8 days after fascia iliaca block', 'description': 'pain score by the use of Numeric Rating Scale (NRS) 1-8 days after fascia ilaca block, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delirium', 'Delirium in Old Age', 'Hip Fractures', 'Dementia', 'Pain', 'Analgesia', 'Mental Status Change']}, 'referencesModule': {'references': [{'pmid': '32360090', 'type': 'BACKGROUND', 'citation': 'Unneby A, Svensson PO, Gustafson PY, Lindgren APB, Bergstrom U, Olofsson PB. Complications with focus on delirium during hospital stay related to femoral nerve block compared to conventional pain management among patients with hip fracture - A randomised controlled trial. Injury. 2020 Jul;51(7):1634-1641. doi: 10.1016/j.injury.2020.04.013. Epub 2020 Apr 20.'}, {'pmid': '32281905', 'type': 'BACKGROUND', 'citation': 'Zhao X, Yuan W. Perioperative Multicomponent Interdisciplinary Program Reduces Delirium Incidence in Elderly Patients With Hip Fracture. J Am Psychiatr Nurses Assoc. 2022 Mar;28(2):154-163. doi: 10.1177/1078390320915250. Epub 2020 Apr 13.'}, {'pmid': '32251149', 'type': 'BACKGROUND', 'citation': 'Poeran J, Cozowicz C, Zubizarreta N, Weinstein SM, Deiner SG, Leipzig RM, Friedman JI, Liu J, Mazumdar M, Memtsoudis SG. Modifiable factors associated with postoperative delirium after hip fracture repair: An age-stratified retrospective cohort study. Eur J Anaesthesiol. 2020 Aug;37(8):649-658. doi: 10.1097/EJA.0000000000001197.'}, {'pmid': '31942744', 'type': 'BACKGROUND', 'citation': 'Uysal AI, Altiparmak B, Yasar E, Turan M, Canbek U, Yilmaz N, Gumus Demirbilek S. The effects of early femoral nerve block intervention on preoperative pain management and incidence of postoperative delirium geriatric patients undergoing trochanteric femur fracture surgery: A randomized controlled trial. Ulus Travma Acil Cerrahi Derg. 2020 Jan;26(1):109-114. doi: 10.14744/tjtes.2019.78002.'}, {'pmid': '29278266', 'type': 'BACKGROUND', 'citation': 'Scurrah A, Shiner CT, Stevens JA, Faux SG. Regional nerve blockade for early analgesic management of elderly patients with hip fracture - a narrative review. Anaesthesia. 2018 Jun;73(6):769-783. doi: 10.1111/anae.14178. Epub 2017 Dec 26.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this trial will be to establish whether the ultrasound-guided suprainguinal fascia iliaca compartment block is capable of protecting geriatric patients with hip fracture from delirium as compared to placebo', 'detailedDescription': 'Geriatric patients suffer from hip fractures very often. Delirium is a perioperative neuropsychiatric complication that is characterized by sudden change of mental status, inattention, disorientation and memory impairment with fluctuations of symptoms during the day. Delirium causes increased morbidity and mortality, decreased postoperative functional activity and may predispose to dementia.\n\nPerioperative pain may be an important predisposing factor to delirium. Intravenous opioids have been widely used to relieve patients with hip fracture from pain, but they have a lot of complications and have been correlated with delirium as well. Fascia Iliaca compartment block is a peripheral compartment nerve block that is used in hip surgeries. Use of this compartment nerve block to protect geriatric patients from delirium has not been studied.\n\nThe objective of this trial will be to establish whether the ultrasound-guided suprainguinal fascia iliaca compartment block is capable of protecting geriatric patients with hip fracture from delirium as compared to placebo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* geriatric patients\n* American Society of Anesthesiologists (ASA) I-III\n* hip fracture patients\n\nExclusion Criteria:\n\n* dementia\n* communication or language barriers\n* patients with nutritional problems\n* bedridden patients'}, 'identificationModule': {'nctId': 'NCT04404959', 'acronym': 'Delirium-Hip', 'briefTitle': 'Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Aretaieion University Hospital'}, 'officialTitle': 'Correlation Between Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture', 'orgStudyIdInfo': {'id': 'Delirium-Pain-Hip Fracture'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'fascia iliaca compartment block with ropivacaine', 'description': 'in this arm, the fascia iliaca compartment block will be performed with 40 mL ropivacaine 0.25%', 'interventionNames': ['Other: fascia iliaca compartment block with ropivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'fascia iliaca compartment block with placebo', 'description': 'in this arm, the fascia iliaca compartment block will be performed with 40 mL normal saline', 'interventionNames': ['Other: fascia iliaca compartment block with placebo']}], 'interventions': [{'name': 'fascia iliaca compartment block with ropivacaine', 'type': 'OTHER', 'otherNames': ['medication in regional anesthetic technique'], 'description': 'the fascia iliaca compartment block catheter will be placed with the use of ultrasound till the day of surgery. Bolus doses will be given every 12 hours (40 ml of ropivacaine 0.25%)', 'armGroupLabels': ['fascia iliaca compartment block with ropivacaine']}, {'name': 'fascia iliaca compartment block with placebo', 'type': 'OTHER', 'otherNames': ['medication in regional anesthetic technique'], 'description': 'the fascia iliaca compartment block catheter will be placed with the use of ultrasound till the day of surgery. Bolus doses will be given every 12 hours (40 ml of normal saline)', 'armGroupLabels': ['fascia iliaca compartment block with placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14561', 'city': 'Kifissia', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Kassiani Theodoraki, Phd, DESA', 'role': 'CONTACT', 'email': 'ktheodoraki@hotmail.com', 'phone': '+306974634162'}, {'name': 'Krystallia vitoula, MD', 'role': 'CONTACT', 'email': 'kvitoula@yahoo.com'}], 'facility': 'KAT General Hospital of Athens', 'geoPoint': {'lat': 38.07438, 'lon': 23.81106}}], 'centralContacts': [{'name': 'Kassiani Theodoraki, PhD, DESA', 'role': 'CONTACT', 'email': 'ktheodoraki@hotmail.com', 'phone': '+306974634162'}, {'name': 'Krystallia Vitoula, MD', 'role': 'CONTACT', 'email': 'kvitoula@yahoo.com'}], 'overallOfficials': [{'name': 'Kassiani Theodoraki, PhD, DESA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aretaieion University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aretaieion University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'KAT General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Dr Kassiani Theodoraki', 'investigatorAffiliation': 'Aretaieion University Hospital'}}}}