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

Not Applicable

Recruiting

• Conditions: Pain, Acute; Delirium in Old Age; Pain Intensity; Hip Fracture Surgery; Hip Fractures
• Interventions: Procedure: Post-admission FICB

• Registration Number: NCT05857462
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study First Submitted: 2023-03-29
• Status Verified: 2023-05
• Study Start: 2023-05
• Study First Submitted QC: 2023-05-04
• Last Update Submitted: 2023-05-04
• Study First Posted: 2023-05-12
• Last Update Posted: 2023-05-12
• Primary Completion: 2025-10
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 420

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

3. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-admission FICB	Post-admission FICB	Post-admission FICB, drug 0.33% bupivacaine 30 ml + Pre-operative FICB 0.33% bupivacaine 30 ml. Peri-operative pain management protocol : paracetamol + opioid.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
30 days mortality	In hospital admission, up to 30 days	Incidence of death
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.
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)
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.
Postoperative morphine consumption	Until postoperative 72 hours	Milligram morphine equivalent
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
Discharge hospital status	On hospital discharge day, up to 30 days	Self-care ability to perform the activity of daily living (ADLs)
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
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
Length of hospital stay	In hospital admission, up to 30 days	Days of hospital stay

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok Noi, Bangkok, Thailand