Effects of PNB Timing on Postoperative Delirium for Hip Fracture

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65-100
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Peripheral Nerve Block for Hip Fracture

    Procedure/Surgery

    Peripheral Nerve Block for Hip Fracture

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Peripheral Nerve Block1 intervention

Trial outcomes

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.

Time frame
3 months

Secondary outcomes

1

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.

Time frame
3 months
2

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.

Time frame
3 months
3

Duration of hospital stay

This will be measured by recording how long the participant remained in hospital following surgery.

Time frame
3 months
4

Occurrence of mortality at 30 days

This will be measured by recording (yes/no) if the participant died within 30 days of surgery.

Time frame
30 days

Other outcomes

Sponsors and contacts

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