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

Mahidol University420 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

420

Eligibility

Sex: ALLMin age: 65 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: In hospital admission, assess up to 30 days

Secondary Outcomes

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.

Time frame: 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

Time frame: Until postoperative 72 hours

Preoperative morphine consumption

Milligram morphine equivalent

Time frame: 48 hours after hospital admission

Postoperative morphine consumption

Milligram morphine equivalent

Time frame: Until postoperative 72 hours

Major adverse cardiac events

Incidence of major adverse cardiac events (fatal arrythmia, cardiac arrest, myocardial infarction, stroke, pulmonary emboli)