Delirium in Old Age, Hip Fractures, Hip Fracture Surgery, Pain, Acute, Pain Intensity
Conditions
Brief summary
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
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.
Interventions
PROCEDUREPost-admission FICB
Post-admission supra-inguinal FICB in hip fracture patient with 0.33% bupivacaine 30 ml
Sponsors
Ministry of Health, Thailand
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who are aged ≥65 , \<85 years old and diagnose hip fracture in 8 hospitals 2. Planed for fast-track hip surgery 3. Isolated acute hip fracture 4. Pain on admission during movement ≥ 4 (moderate pain)
Exclusion criteria
1. refusal to participate the study 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital Delirium | In hospital admission, assess up to 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain score | Until postoperative 72 hours | 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 |
| Preoperative morphine consumption | 48 hours after hospital admission | Milligram morphine equivalent |
| Postoperative morphine consumption | Until postoperative 72 hours | Milligram morphine equivalent |
| Major adverse cardiac events | In hospital admission, up to 30 days | Incidence of major adverse cardiac events (fatal arrythmia, cardiac arrest, myocardial infarction, stroke, pulmonary emboli) |
| In-hospital morbidities | In hospital admission, up to 30 days | Incidence of in-hospital morbidities include deep vein thrombosis sepsis, pneumonia, respiratory failure, urinary tract infection, acute kidney injury |
| Preoperative pain score | 48 hours after hospital admission | 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. |
| Length of hospital stay | In hospital admission, up to 30 days | Days of hospital stay |
| In-hospital mortality rate | In hospital admission, up to 30 days | Incidence related to all causes of death implant related (implant removal, implant exchange, implant failure,) infection related, bleeding related, non-union fracture, re-fracture |
| 30 days mortality | In hospital admission, up to 30 days | Incidence of death |
| Predict 30-day mortality in hip fracture patient with multiple comorbidities | On admission day | 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. |
| Discharge hospital status | On hospital discharge day, up to 30 days | Self-care ability to perform the activity of daily living (ADLs) |
Countries
Thailand
Contacts
Primary ContactSuwimon Tangwiwat, MD
Outcome results
None listed