Impact of Fascia Iliaca Block on Pain and Delirium in Elderly Hip Fracture Patients
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 study is testing if a special pain relief technique can help older patients with hip fractures feel less pain and reduce the chances of confusion after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Locations | 1 site (Bangkok Noi, Bangkok) |
| Trial ID | NCT05857462 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a fascia iliaca compartment block (FICB) combined with multimodal analgesia in elderly patients undergoing hip fracture surgery. It aims to compare outcomes between those receiving the FICB and those who do not, focusing on the incidence of delirium during hospital admission and other secondary outcomes such as pain intensity and postoperative complications. The study will enroll 420 patients aged 65 to 85 years with isolated acute hip fractures, and statistical analysis will be conducted using SPSS to evaluate the results. The trial is set in eight hospitals across Thailand.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 65 to 85 years with isolated acute hip fractures and moderate to severe pain upon admission.
Not a fit: Patients with severe cognitive dysfunction, those who refuse participation, or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of delirium and improve pain management in elderly patients undergoing hip fracture surgery.
How similar studies have performed: Previous studies have shown promising results with similar analgesic approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bangkok Noi, Bangkok
- Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok Noi, Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Suwimon Tangwiwat, MD — Mahidol University
- Study coordinator: Suwimon Tangwiwat, MD
- Email: stangwiwat@yahoo.com
- Phone: 66816456167
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.