NCT07856108

Brief Summary

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. This 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. Participants 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 (\<6 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. Secondary 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started Nov 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

1.2 years

First QC Date

September 27, 2026

Last Update Submit

September 27, 2026

Conditions

Keywords

AnesthesiaDeliriumPeripheral nerve blockHip fracture

Outcome Measures

Primary Outcomes (1)

  • 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 \<4 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

Secondary Outcomes (5)

  • Association between the timing of PNB administration (early versus intermediate versus late) and the severity of delirium in patients with hip fracture.

    3 months

  • Determine impact of PNB administration timing on opioid consumption

    3 months

  • Duration of hospital stay

    3 months

  • Occurrence of mortality at 30 days

    30 days

  • Determination of recruitment feasibility

    2 years

Study Arms (1)

Peripheral Nerve Block

Peripheral nerve block administered for hip fracture pain control

Procedure: Peripheral Nerve Block for Hip Fracture

Interventions

Peripheral Nerve Block for Hip Fracture

Peripheral Nerve Block

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient Participants: Patients admitted for hip fractures requiring surgery with the use of a PNB. Caregiver Participants: Caregivers of patients admitted for hip fractures requiring surgery with the use of a PNB.

You may qualify if:

  • Patients admitted to for hip fractures requiring surgery with the use of a PNB.
  • Age ≥65 years.
  • Able to give consent to participate in this project.
  • Able to converse in English.
  • Able to complete questionnaires assessing the functional physical and mental status of the patient participant.
  • Able to converse in English

You may not qualify if:

  • Patient refusal to participate in this project.
  • Patient with a 4 4AT score on admission
  • Unable to give consent.
  • Preexisting cognitive impairment preventing delirium assessment, including (but not limited to) advanced dementia.
  • \. None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Related Publications (11)

  • McGinn R, Talarico R, Hamiltoon GM, Ramlogan R, Wijeysundra DN, McCartney CJL, McIsaac DI. Hospital-, anaesthetist-, and patient-level variation in peripheral nerve block utilisation for hip fracture surgery: a population-based cross-sectional study. Br J Anaesth. 2022 Jan;128(1):198-206. doi: 10.1016/j.bja.2021.10.011. Epub 2021 Nov 16.

    PMID: 34794768BACKGROUND
  • Mouzopoulos G, Vasiliadis G, Lasanianos N, Nikolaras G, Morakis E, Kaminaris M. Fascia iliaca block prophylaxis for hip fracture patients at risk for delirium: a randomized placebo-controlled study. J Orthop Traumatol. 2009 Sep;10(3):127-33. doi: 10.1007/s10195-009-0062-6. Epub 2009 Aug 19.

    PMID: 19690943BACKGROUND
  • Guay J, Parker MJ, Griffiths R, Kopp S. Peripheral nerve blocks for hip fractures. Cochrane Database Syst Rev. 2017 May 11;5(5):CD001159. doi: 10.1002/14651858.CD001159.pub2.

    PMID: 28494088BACKGROUND
  • Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.

    PMID: 23992774BACKGROUND
  • American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. American Geriatrics Society abstracted clinical practice guideline for postoperative delirium in older adults. J Am Geriatr Soc. 2015 Jan;63(1):142-50. doi: 10.1111/jgs.13281. Epub 2014 Dec 12.

    PMID: 25495432BACKGROUND
  • Brown CH 4th, LaFlam A, Max L, Wyrobek J, Neufeld KJ, Kebaish KM, Cohen DB, Walston JD, Hogue CW, Riley LH. Delirium After Spine Surgery in Older Adults: Incidence, Risk Factors, and Outcomes. J Am Geriatr Soc. 2016 Oct;64(10):2101-2108. doi: 10.1111/jgs.14434. Epub 2016 Oct 3.

    PMID: 27696373BACKGROUND
  • Xue P, Wu Z, Wang K, Tu C, Wang X. Incidence and risk factors of postoperative delirium in elderly patients undergoing transurethral resection of prostate: a prospective cohort study. Neuropsychiatr Dis Treat. 2016 Jan 12;12:137-42. doi: 10.2147/NDT.S97249. eCollection 2016.

    PMID: 26834475BACKGROUND
  • Jin Z, Hu J, Ma D. Postoperative delirium: perioperative assessment, risk reduction, and management. Br J Anaesth. 2020 Oct;125(4):492-504. doi: 10.1016/j.bja.2020.06.063. Epub 2020 Aug 11.

    PMID: 32798069BACKGROUND
  • Kosar CM, Tabloski PA, Travison TG, Jones RN, Schmitt EM, Puelle MR, Inloes JB, Saczynski JS, Marcantonio ER, Meagher D, Reid MC, Inouye SK. EFFECT OF PREOPERATIVE PAIN AND DEPRESSIVE SYMPTOMS ON THE DEVELOPMENT OF POSTOPERATIVE DELIRIUM. Lancet Psychiatry. 2014 Nov;1(6):431-436. doi: 10.1016/S2215-0366(14)00006-6.

    PMID: 25642413BACKGROUND
  • Ding X, Gao X, Chen Q, Jiang X, Li Y, Xu J, Qin G, Lu S, Huang D. Preoperative Acute Pain Is Associated with Postoperative Delirium. Pain Med. 2021 Feb 4;22(1):15-21. doi: 10.1093/pm/pnaa314.

    PMID: 33040141BACKGROUND
  • Watne LO, Idland AV, Fekkes D, Raeder J, Frihagen F, Ranhoff AH, Chaudhry FA, Engedal K, Wyller TB, Hassel B. Increased CSF levels of aromatic amino acids in hip fracture patients with delirium suggests higher monoaminergic activity. BMC Geriatr. 2016 Aug 2;16:149. doi: 10.1186/s12877-016-0324-0.

    PMID: 27484129BACKGROUND

MeSH Terms

Conditions

Emergence DeliriumDeliriumHip Fractures

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental DisordersFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Abhijit Biswas, MD

    London Health Sciences Centre and Western University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abhijit Biswas, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist, Associate Professor

Study Record Dates

First Submitted

September 27, 2026

First Posted

October 2, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

No plan as not applicable.

Locations