NCT05857462

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Post-admission FICB	Post-admission supra-inguinal FICB in hip fracture patient with 0.33% bupivacaine 30 ml

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-10-01
• Completion: 2026-03-01
• First posted: 2023-05-12
• Last updated: 2023-05-12

Locations

1 site across 1 country: Thailand