[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658757":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":35,"studyPopulation":36,"armGroups":37,"interventions":43,"overallOfficials":48,"centralContacts":53,"locations":59,"responsibleParty":76,"collaborators":31,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":31,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":31,"studyType":92,"phases":31,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":101,"whyStopped":31,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Determination of the impact of peripheral nerve block (PNB) timing on the incidence of new-onset delirium in hip fracture patients.","Early administration of the PNB will be a PNB placed less than 6 hours after presenting to the hospital with a hip fracture. Intermediate administration of PNB would be within 6 to 12 hours, and late administration of PNB would be more than 12 hours after presentation to the hospital with a hip fracture. New-onset delirium is defined as a 4AT score ≥4 occurring after hospital admission or during the hospital stay in a patient who had a 4AT score \\\u003C4 at baseline, or a new increase in 4AT score consistent with delirium in a patient without delirium at admission. This will be measured by analyzing the results of the cognitive and delirium testing questionnaires and determining if there is an association between the occurrence of delirium and timing of PNB administration.","3 months",[14,17,20,23,27],{"measure":15,"description":16,"timeFrame":12},"Association between the timing of PNB administration (early versus intermediate versus late) and the severity of delirium in patients with hip fracture.","This will be measured by analyzing the results of the cognitive and delirium testing questionnaires and determining if there is an association between the occurrence of delirium and timing of PNB administration.",{"measure":18,"description":19,"timeFrame":12},"Determine impact of PNB administration timing on opioid consumption","This will be measured by comparing opioid consumption between participants who received early vs. intermediate vs. late PNBs.",{"measure":21,"description":22,"timeFrame":12},"Duration of hospital stay","This will be measured by recording how long the participant remained in hospital following surgery.",{"measure":24,"description":25,"timeFrame":26},"Occurrence of mortality at 30 days","This will be measured by recording (yes\u002Fno) if the participant died within 30 days of surgery.","30 days",{"measure":28,"description":29,"timeFrame":30},"Determination of recruitment feasibility","To assess recruitment feasibility and provide preliminary effect size estimates to inform the design and sample size calculation of a future adequately powered study. Recruitment feasibility will be measured by assessing the number of participants recruited over a defined period of time. Future sample sizes estimates will be measured by determining the significance of data analyzed within the pilot cohort","2 years",null,{"allocation":31,"interventionModel":31,"interventionModelDescription":31,"primaryPurpose":31,"observationalModel":33,"timePerspective":34,"maskingInfo":31},"COHORT","PROSPECTIVE","Delirium is a common complication among older adults hospitalized with hip fracture and is associated with adverse clinical outcomes. Acute pain is a potentially modifiable contributor to delirium, while opioid analgesics, although commonly used for hip fracture pain, may themselves contribute to adverse effects such as sedation and worsening cognitive dysfunction. Peripheral nerve blocks (PNBs), including fascia iliaca and femoral nerve blocks, provide effective regional analgesia and may reduce opioid requirements. However, the relationship between the timing of PNB administration after hospital presentation and the subsequent development and severity of delirium remains unclear.\n\nThis is a prospective, longitudinal, dual-centre pilot study designed to evaluate the association between the timing of PNB administration and delirium outcomes in adults aged 65 years or older admitted with a hip fracture requiring surgical repair and planned use of a PNB. The study will be conducted at the University Hospital and Victoria Hospital campuses of London Health Sciences Centre in London, Ontario, Canada.\n\nThe study is observational. Participation will not determine or alter the timing or type of PNB, surgical management, analgesic therapy, or other aspects of clinical care. Participants will receive standard hospital care, including multimodal analgesia, PNBs, surgery, and medical management as clinically indicated. PNBs may be performed in the Emergency Department or Block Room as part of routine clinical care. Delirium and cognitive assessments that are routinely obtained during hospitalization will be used for study purposes, together with additional study data collected from participants, caregivers, and the electronic medical record.\n\nApproximately 60 patient participants will be recruited during the planned 2-month pilot recruitment period using consecutive convenience sampling. Approximately 60 caregiver participants will also be recruited to provide information regarding the patient's baseline and follow-up cognitive and functional status. The pilot sample size is based on feasibility rather than a formal statistical power calculation. The study is intended to provide preliminary estimates of recruitment feasibility, delirium incidence, and the magnitude and direction of associations between PNB timing and delirium outcomes to inform the design and sample-size calculation of a future adequately powered prospective study.\n\nThe primary exposure of interest is the elapsed time between hospital presentation with hip fracture and administration of the PNB. PNB timing will be evaluated using three prespecified categories:\n\nEarly PNB: less than 6 hours after hospital presentation; Intermediate PNB: 6 to 12 hours after hospital presentation; and Late PNB: more than 12 hours after hospital presentation.\n\nActual elapsed time from hospital presentation to PNB administration will also be evaluated as a continuous exposure to explore whether increasing delay to PNB is associated with delirium outcomes.\n\nThe primary outcome is the development of new-onset delirium during hospitalization. Delirium will be assessed using the 4 A's Test (4AT), a brief screening instrument evaluating alertness, orientation, attention, and acute change or fluctuation in mental status. A 4AT score of 4 or greater is considered consistent with possible delirium. New-onset delirium is defined as a 4AT score of 4 or greater occurring after admission in a participant with a baseline 4AT score below 4, or a new increase in 4AT score consistent with delirium in a patient who did not have delirium at admission. Participants with delirium at admission will not be included in the primary analysis of new-onset delirium.\n\nThe study will also evaluate the severity and overall burden of delirium during hospitalization. Serial 4AT scores will be obtained as part of routine clinical care and followed until discharge. Measures of delirium burden may include the maximum 4AT score, mean daily 4AT score, number and proportion of assessed hospital days with a 4AT score of 4 or greater, time from admission to the first delirium-positive assessment, time from PNB administration to the first delirium-positive assessment, and duration of delirium.\n\nBaseline cognitive status will also be characterized using the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), which obtains caregiver or informant information regarding changes in cognitive function over time. Baseline functional status will be assessed using the Older Americans Resources and Services Activities of Daily Living (OARS ADL) instrument. The Family Confusion Assessment Method (Fam-CAM), a caregiver-administered delirium screening tool, will be used to obtain caregiver-reported information regarding delirium.\n\nIn addition to delirium outcomes, data collected will include patient age, biological sex, relevant medical comorbidities, fracture type, type of surgical procedure, time from hospital admission to surgery, type of PNB, and opioid exposure. PNB characteristics will include the type of block and, where applicable, whether the technique involved a single injection or continuous catheter.\n\nPerioperative opioid consumption will be examined as a secondary outcome. Opioid doses will be converted to standardized intravenous morphine-equivalent doses using a prespecified institutional conversion method. Opioid use may be summarized over clinically relevant periods, including admission to PNB administration, PNB administration to surgery, the intraoperative period, the postoperative period, and the total hospitalization where data are available. Opioid exposure will be compared among the early, intermediate, and late PNB groups.\n\nOther secondary outcomes include hospital length of stay and 30-day mortality. Length of stay will be measured from hospital admission to discharge. Thirty-day mortality will be determined following hospital admission and is expected to be analyzed primarily descriptively because of the pilot sample size.\n\nParticipants will also undergo follow-up at approximately 3 months after hospital discharge. Functional status will be reassessed using the OARS ADL instrument, allowing evaluation of change from baseline functional status. Caregiver-reported delirium or cognitive symptoms will be assessed using the Fam-CAM. These follow-up measures will be compared across PNB timing groups on an exploratory basis.\n\nThe primary analysis will estimate the association between PNB timing and new-onset delirium. Delirium incidence will be summarized within each PNB timing group. Where supported by the number of outcome events, multivariable logistic regression will be used to estimate the association between PNB timing and delirium while accounting for clinically relevant potential confounders. Potential confounding variables may include age, biological sex, baseline cognitive status, baseline functional status, relevant comorbidity burden, opioid exposure, fracture type, time to surgery, and PNB type. Because this is a pilot study with a limited sample size, the number of variables included in adjusted models will be restricted to reduce the risk of model overfitting.\n\nLongitudinal delirium severity will be evaluated using repeated 4AT measurements obtained during hospitalization. Where appropriate, mixed-effects modelling will be used to account for correlation among repeated assessments within the same participant and to examine differences in delirium trajectories among PNB timing groups. Exploratory analyses will also examine the relationship between actual time to PNB administration and measures of delirium severity and burden.\n\nBecause the timing of delirium onset may be clinically relevant, exploratory time-to-event analyses may be conducted using hospital admission as the starting point and the first occurrence of new-onset delirium as the event. Participants who do not develop delirium will be censored at hospital discharge. If the number of events and sample size permit, sensitivity analyses may account for PNB administration as a time-dependent exposure.\n\nAll statistical analyses are exploratory because this is a pilot study and no formal efficacy-based sample-size calculation has been performed. Interpretation will therefore emphasize the magnitude, direction, and precision of estimated associations, including confidence intervals, rather than statistical significance alone. Results will be used to assess study feasibility and to inform outcome selection, analytic methods, and sample-size requirements for a future adequately powered prospective study evaluating the relationship between the timing of PNB administration and delirium in older adults with hip fracture.\n\nThe study hypothesis is that earlier PNB administration, particularly within 6 hours of hospital presentation, will be associated with a lower incidence and severity of delirium compared with later PNB administration.","Patient Participants: Patients admitted for hip fractures requiring surgery with the use of a PNB.\n\nCaregiver Participants: Caregivers of patients admitted for hip fractures requiring surgery with the use of a PNB.",[38],{"label":39,"type":31,"description":40,"interventionNames":41},"Peripheral Nerve Block","Peripheral nerve block administered for hip fracture pain control",[42],"Procedure: Peripheral Nerve Block for Hip Fracture",[44],{"type":45,"name":46,"description":46,"armGroupLabels":47,"otherNames":31},"PROCEDURE","Peripheral Nerve Block for Hip Fracture",[39],[49],{"name":50,"affiliation":51,"role":52},"Abhijit Biswas, MD","London Health Sciences Centre and Western University","PRINCIPAL_INVESTIGATOR",[54],{"name":50,"role":55,"phone":56,"phoneExt":57,"email":58},"CONTACT","5196858500","Ext. 55956","abhijit.biswas@lhsc.on.ca",[60],{"facility":61,"status":31,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"London Health Sciences Centre","London","Ontario","N6A 5A5","Canada","CA",{"type":68,"coordinates":69},"Point",[70,71],-81.23304,42.98339,{"lat":71,"lon":70},[74],{"name":50,"role":55,"phone":56,"phoneExt":75,"email":58},"55956",{"type":52,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Abhijit Biswas","Anesthesiologist, Associate Professor","100658757","effects-of-pnb-timing-on-postoperative-delirium-for-hip-fracture-100658757",false,"NCT07856108","Effects of PNB Timing on Postoperative Delirium for Hip Fracture","Assessing the Effects of Nerve Block Timing on Delirium Severity in Elderly Patients With Hip Fractures: A Prospective Longitudinal Pilot Study","Inclusion Criteria:\n\nPatient Participant Inclusion Criteria\n\n1. Patients admitted to for hip fractures requiring surgery with the use of a PNB.\n2. Age ≥65 years.\n3. Able to give consent to participate in this project.\n4. Able to converse in English.\n\nCaregiver Inclusion Criteria\n\n1. Able to complete questionnaires assessing the functional physical and mental status of the patient participant.\n2. Able to converse in English\n\nExclusion Criteria:\n\nPatient Participant Exclusion Criteria\n\n1. Patient refusal to participate in this project.\n2. Patient with a 4 4AT score on admission\n3. Unable to give consent.\n4. Preexisting cognitive impairment preventing delirium assessment, including (but not limited to) advanced dementia.\n\nCaregiver Exclusion Criteria\n\n1\\. None","ALL","65 Years","100 Years",{"count":90,"type":91},120,"ESTIMATED","OBSERVATIONAL","Hip fracture is a common cause of hospitalization in older adults and is associated with substantial pain and a high risk of delirium. Peripheral nerve blocks (PNBs) can provide effective, opioid-sparing analgesia, but the relationship between the timing of PNB administration after hospital presentation and subsequent delirium is not well established.\n\nThis prospective, longitudinal, dual-centre pilot study will evaluate the association between the timing of PNB administration and the development and severity of delirium in adults aged 65 years or older admitted with a hip fracture requiring surgical repair and a planned PNB. Approximately 60 patient participants will be enrolled at University Hospital and Victoria Hospital, London Health Sciences Centre. Caregiver participants will also be recruited to provide information on baseline and follow-up cognitive and functional status.\n\nParticipants will receive standard clinical care; the study will not determine or alter the timing or type of PNB, surgery, analgesia, or other treatment. PNB timing will be classified as early (\\\u003C6 hours after hospital presentation), intermediate (6 to 12 hours), or late (\\>12 hours). The primary outcome is new-onset delirium during hospitalization, assessed using the 4 A's Test (4AT). Delirium severity will also be evaluated using serial 4AT scores collected during the hospital stay. The investigators hypothesize that earlier PNB administration will be associated with a lower incidence and severity of delirium.\n\nSecondary and exploratory outcomes include perioperative opioid consumption, hospital length of stay, 30-day mortality, delirium burden, and functional and caregiver-reported delirium outcomes at 3 months. The study will also assess recruitment feasibility and generate preliminary estimates of delirium incidence and effect size to inform the design and sample-size calculation of a future adequately powered prospective study.",[95],"Delirium - Postoperative",[97,98,99,100],"Anesthesia","Delirium","Peripheral nerve block","Hip fracture","NOT_YET_RECRUITING","2026-09-27",{"date":104,"type":105},"2026-10-02","ACTUAL",{"date":107,"type":91},"2026-11-01",{"date":109,"type":91},"2028-01-01",{"name":5,"class":6},1]