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

May 4, 2023 updated by: Mahidol University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital, Mahidol University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Post-admission FICB
Post-admission supra-inguinal FICB in hip fracture patient with 0.33% bupivacaine 30 ml
No Intervention: Only preoperative FICB
No post-admission FICB + Pre-operative FICB 0.33% bupivacaine 30 ml. Peri-operative pain management protocol : paracetamol + opioid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital Delirium
Time Frame: 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.
In hospital admission, assess up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative pain score
Time Frame: 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.
48 hours after hospital admission
Post-operative pain score
Time Frame: 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
Until postoperative 72 hours
Preoperative morphine consumption
Time Frame: 48 hours after hospital admission
Milligram morphine equivalent
48 hours after hospital admission
Postoperative morphine consumption
Time Frame: Until postoperative 72 hours
Milligram morphine equivalent
Until postoperative 72 hours
Major adverse cardiac events
Time Frame: In hospital admission, up to 30 days
Incidence of major adverse cardiac events (fatal arrythmia, cardiac arrest, myocardial infarction, stroke, pulmonary emboli)
In hospital admission, up to 30 days
In-hospital morbidities
Time Frame: 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
In hospital admission, up to 30 days
Discharge hospital status
Time Frame: On hospital discharge day, up to 30 days
Self-care ability to perform the activity of daily living (ADLs)
On hospital discharge day, up to 30 days
Length of hospital stay
Time Frame: In hospital admission, up to 30 days
Days of hospital stay
In hospital admission, up to 30 days
In-hospital mortality rate
Time Frame: 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
In hospital admission, up to 30 days
30 days mortality
Time Frame: In hospital admission, up to 30 days
Incidence of death
In hospital admission, up to 30 days
Predict 30-day mortality in hip fracture patient with multiple comorbidities
Time Frame: 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.
On admission day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

Ministry of Health, Thailand

Investigators

  • Principal Investigator: Suwimon Tangwiwat, MD, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

October 1, 2025

Study Completion (Anticipated)

March 1, 2026

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC015/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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