Clinical trial NCT05857462: The Impact of Integrated Preoperative Fascia Iliaca Compartment Block in Elderly Hip Fracture
Official title: A Randomized Controlled Trial to Evaluate the Impact of Integrated Preoperative Fascia Iliaca Compartment Block (FICB) for Fast-track Surgery in Elderly Hip Fracture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Fractures
Pain, Acute
Hip Fracture Surgery
Delirium in Old Age
Pain Intensity
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Thailand
First posted: 2023-05-12
Enrollment: 420
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: In-hospital Delirium
timeFrame: In hospital admission, assess up to 30 days
Secondary outcomes:
measure: Preoperative pain score
timeFrame: 48 hours after hospital admission
measure: Post-operative pain score
timeFrame: Until postoperative 72 hours
measure: Preoperative morphine consumption
timeFrame: 48 hours after hospital admission
measure: Postoperative morphine consumption
timeFrame: Until postoperative 72 hours
measure: Major adverse cardiac events
timeFrame: In hospital admission, up to 30 days
measure: In-hospital morbidities
timeFrame: In hospital admission, up to 30 days
measure: Discharge hospital status
timeFrame: On hospital discharge day, up to 30 days
measure: Length of hospital stay
timeFrame: In hospital admission, up to 30 days
measure: In-hospital mortality rate
timeFrame: In hospital admission, up to 30 days
measure: 30 days mortality
timeFrame: In hospital admission, up to 30 days
measure: Predict 30-day mortality in hip fracture patient with multiple comorbidities
timeFrame: On admission day
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Suwimon Tangwiwat, MD
role: PRINCIPAL_INVESTIGATOR
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