The Impact of Integrated Preoperative Fascia Iliaca Compartment Block in Elderly Hip Fracture

Study Overview
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Brief Summary
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This prospective randomized controlled study is aimed to determine the advantages of post-admission fascia iliaca compartment block (FICB) in geriatric hip fracture surgery combination with multimodal analgesia compared with no post-admission FICB. The primary outcome is incidence of delirium during hospital admission. Secondary outcomes are incidence of delirium at hospital discharge, pre- and post-operative pain intensity, peri-operative complications, opioid-related side effects, post-operative complications and length of hospital stay, and morbidities and mortality (in-hospital and 30 days).

Detailed Description
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Population: elderly patients age ≥ 65 years old, diagnosed with an isolated acute hip fracture within 7 days and plan to receive fast-track hip fracture. Statistic analysis plan surgery within 48 hours after hospital admission. Study population: elderly isolated hip fracture patients who are admitted in those 8 hospitals centers in Thailand and have moderate pain or higher than moderate pain during movement since hospital admission. Sample size : 210 patients per group (drop out 10%) total 420 patients Statistical analysis: SPSS will be used for study analysis. The category variables will be present as number and percentage, and chi-square or fisher exact test will be used to compare between the groups.The continuous variables will be tested the distribution, data presentation will be mean and standard deviation (SD) for normal distribution while median and interquartile rang (IQR) for non-normal distribution. Student t test or Wilcoxson rank some test will be used as appropriate to test for different between the group. And p value less than 0.05 will be considered statically significance.

Official Title
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A Randomized Controlled Trial to Evaluate the Impact of Integrated Preoperative Fascia Iliaca Compartment Block (FICB) for Fast-track Surgery in Elderly Hip Fracture

Conditions
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Hip Fractures, Pain, Acute, Hip Fracture Surgery, Delirium in Old Age, Pain Intensity

Intervention / Treatment
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* Procedure: Post-admission FICB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are aged ≥65 , <85 years old and diagnose hip fracture in 8 hospitals Planed for fast-track hip surgery Isolated acute hip fracture Pain on admission during movement ≥ 4 (moderate pain) Exclusion Criteria: refusal to participate the study ASA physical status >III 2. duration of fracture more than 7 days before admission 3. hip fracture after/at previous instrumentation 4. hip fracture causing by a traffic accident or high energy force 5. suspected pathologic fracture 6. unable to communication 7. abnormal consciousness or severe cognitive dysfunction that could not communication such as mental retardation, severe Alzheimer's disease and schizophenia 8. allergy to local anesthetic drug

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post-admission FICB<br>Post-admission FICB, drug 0.33% bupivacaine 30 ml + Pre-operative FICB 0.33% bupivacaine 30 ml. Peri-operative pain management protocol : paracetamol + opioid. | Procedure: Post-admission FICB<br>* Post-admission supra-inguinal FICB in hip fracture patient with 0.33% bupivacaine 30 ml<br>|
| No Intervention: Only preoperative FICB<br>No post-admission FICB + Pre-operative FICB 0.33% bupivacaine 30 ml. Peri-operative pain management protocol : paracetamol + opioid. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital Delirium | Incidence of delirium using Nursing Delirium Screening Scale (NU-DESC) Thai version plus backward counting 30-1. Total Scale 11 ( > or = 2 means delirium). The patient will be assessed once a day in the morning period. | In hospital admission, assess up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative pain score | Numeric rating scale (0-10; 0=no pain, 10 worst pain imaginable) will be used. The patient will be assessed every 6 hours duration until receiving surgery within 48 hours. | 48 hours after hospital admission | 
| Post-operative pain score | Numeric rating scale (0-10; 0=no pain, 10 worst pain imaginable) will be used. The patient will be assessed every 6 hours duration postoperatively until 72 hours | Until postoperative 72 hours | 
| Preoperative morphine consumption | Milligram morphine equivalent | 48 hours after hospital admission | 
| Postoperative morphine consumption | Milligram morphine equivalent | Until postoperative 72 hours | 
| Major adverse cardiac events | Incidence of major adverse cardiac events (fatal arrythmia, cardiac arrest, myocardial infarction, stroke, pulmonary emboli) | In hospital admission, up to 30 days | 
| In-hospital morbidities | Incidence of in-hospital morbidities include deep vein thrombosis sepsis, pneumonia, respiratory failure, urinary tract infection, acute kidney injury | In hospital admission, up to 30 days | 
| Discharge hospital status | Self-care ability to perform the activity of daily living (ADLs) | On hospital discharge day, up to 30 days | 
| Length of hospital stay | Days of hospital stay | In hospital admission, up to 30 days | 
| In-hospital mortality rate | Incidence related to all causes of death implant related (implant removal, implant exchange, implant failure,) infection related, bleeding related, non-union fracture, re-fracture | In hospital admission, up to 30 days | 
| 30 days mortality | Incidence of death | In hospital admission, up to 30 days | 
| Predict 30-day mortality in hip fracture patient with multiple comorbidities | Charlson Comorbidity Index (CCI) with 19 item-version (adjusted weights for each condition). Higher score of Charlson Comorbidity Index (CCI) is related to higher mortality. CCI score 1-2 = mild, 3-5 scores = moderate, > or = 5 scores = severe. | On admission day |