Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture

Study Overview
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Brief Summary
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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

Detailed Description
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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. Perioperative 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. 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

Official Title
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Correlation Between Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture

Conditions
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Delirium, Delirium in Old Age, Hip Fractures, Dementia, Pain, Analgesia, Mental Status Change

Intervention / Treatment
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* Other: fascia iliaca compartment block with ropivacaine
* Other: fascia iliaca compartment block with placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: geriatric patients American Society of Anesthesiologists (ASA) I-III hip fracture patients Exclusion Criteria: dementia communication or language barriers patients with nutritional problems bedridden patients

Ages Eligible for Study
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Minimum Age: 75 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fascia iliaca compartment block with ropivacaine<br>in this arm, the fascia iliaca compartment block will be performed with 40 mL ropivacaine 0.25% | Other: fascia iliaca compartment block with ropivacaine<br>* 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%)<br>* Other names: medication in regional anesthetic technique;|
| Placebo Comparator: fascia iliaca compartment block with placebo<br>in this arm, the fascia iliaca compartment block will be performed with 40 mL normal saline | Other: fascia iliaca compartment block with placebo<br>* 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)<br>* Other names: medication in regional anesthetic technique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score 30 minutes after fascia iliaca block | 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 | 30 minutes after performance of fascia iliaca block | 
| pain score 12 hours after fascia iliaca block | 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 | 12 hours after performance of fascia iliaca block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score 1-8 days after fascia iliaca block | 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 | 1-8 days after fascia iliaca block |