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

Sponsor
Mahidol University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05857462
Collaborator
Ministry of Health, Thailand (Other)
420
Enrollment
1
Location
2
Arms
34
Anticipated Duration (Months)
12.4
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Post-admission FICB
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
420 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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

  3. Preoperative morphine consumption [48 hours after hospital admission]

    Milligram morphine equivalent

  4. Postoperative morphine consumption [Until postoperative 72 hours]

    Milligram morphine equivalent

  5. 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)

  6. 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

  7. Discharge hospital status [On hospital discharge day, up to 30 days]

    Self-care ability to perform the activity of daily living (ADLs)

  8. Length of hospital stay [In hospital admission, up to 30 days]

    Days of hospital stay

  9. 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

  10. 30 days mortality [In hospital admission, up to 30 days]

    Incidence of death

  11. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine Siriraj Hospital, Mahidol University Bangkok Noi Bangkok Thailand 10700

Sponsors and Collaborators

  • Mahidol University
  • Ministry of Health, Thailand

Investigators

  • Principal Investigator: Suwimon Tangwiwat, MD, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Mahidol University
ClinicalTrials.gov Identifier:
NCT05857462
Other Study ID Numbers:
  • CREC015/2023
First Posted:
May 12, 2023
Last Update Posted:
May 12, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Acute Pain
Pain
Fractures, Bone
Hip Fractures

Study Results

No Results Posted as of May 12, 2023